Archive for June, 2016

(FNJN) StockNewsNow.com Publishes New SNNLive Video Interview

LOS ANGELES, June 14, 2016  — StockNewsNow.com, The Official MicroCap News Source™, today published an SNNLive Video Interview with Phil Hartstein, President and CEO of Finjan Holdings, Inc. (NASDAQ: FNJN), a cybersecurity company, according to the company’s website (see here: www.Finjan.com). The video interview was recorded on Thursday, June 9th, 2016, at the LD Micro Invitational in Bel Air, CA.

Click the following link to watch the SNNLive Video Interview on StockNewsNow.com:

Update with Finjan Holdings, Inc. – Comments on Recent News, Growth Drivers for Cybersecurity and Catalysts Moving Forward

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About Finjan Holdings, Inc.

Established nearly 20 years ago, Finjan is a globally recognized leader in cybersecurity. Finjan’s inventions are embedded within a strong portfolio of patents focusing on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan continues to grow through investments in innovation, strategic acquisitions, and partnerships promoting economic advancement and job creation. For more information, please visit www.finjan.com.

About StockNewsNow.com

StockNewsNow.com is a microcap financial news portal that features news and insights from the microcap and emerging growth financial community. StockNewsNow.com is a multimedia destination hub for information about microcap and emerging growth public and private companies, market events, news, bulletins, stock quotes, expert commentary and company profiles that feature SNN-produced video like SNNLive CEO video interviews, as well as their latest news and headlines. Users can engage directly and share the information provided through social media.

Follow the companies YOU want to know more about; read and watch content from YOUR favorite microcap, emerging growth financial experts; register to attend financial conferences of YOUR choosing; find microcap and emerging growth financial professionals that YOU may be looking for – all here on StockNewsNow.com.

Tuesday, June 14th, 2016 Uncategorized Comments Off on (FNJN) StockNewsNow.com Publishes New SNNLive Video Interview

(PARR) to Acquire Wyoming Refining and Related Logistics Assets

Will Establish Downstream Presence in the Rocky Mountains

HOUSTON, June 14, 2016  —

Acquisition Highlights

  • Expected to be immediately accretive to earnings per share
  • 18,000 barrels per day refinery with Nelson Complexity Index of 11.01 generating an attractive clean product yield of approximately 95%
  • Strategic logistics asset base with 140 mile crude gathering system, 40 miles of refined product pipelines, and 650 MBbls of tankage
  • Refinery was expanded from 14,000 to 18,000 barrels per day at the end of 2015
  • Annualized commercial and cost synergies estimated over $5 million
  • Approximately $50 million of Adjusted EBITDA anticipated in first full year of operations based on forward crack spreads2

Par Pacific Holdings, Inc. (NYSE MKT: PARR) (“Par Pacific”) announced today that it has entered into a definitive agreement to acquire Hermes Consolidated, LLC (dba Wyoming Refining Company) for approximately $271.4 million, including the assumption of $58 million of indebtedness.  No additional consideration will be paid for the working capital associated with the operations.  Wyoming Refining owns and operates the 18,000 barrels per day (bpd) Newcastle, Wyoming refinery and related logistics assets.  The transaction is expected to close in mid-July 2016, subject to customary closing conditions and regulatory approvals.

“This acquisition fits perfectly with our previously disclosed acquisition strategy by utilizing our tax attributes and capital sources to build on our refining and logistics capabilities,” said William Pate, Par Pacific’s President and Chief Executive Officer. “The refinery enjoys attractive crude oil sourcing given its proximity to robust Powder River Basin production, pipeline connectivity to a niche refined products market, and a gasoline-oriented yield in a market with significant summer gasoline needs. The logistics infrastructure provides strategic access to crude and refined products markets, which we expect will generate stable cash flows and contribute to our Logistics segment profitability.”

The Wyoming Refining facility is highly-efficient, with a Nelson Complexity Index of 11.0,1 and is strategically configured to meet the transportation fuel needs of the primary marketing regions in Wyoming and South Dakota.  Wyoming Refining increased its processing capacity to 18,000 barrels per day (bpd) in November 2015 with the addition of new prefrac and crude units. Over the past four years, Wyoming Refining has invested approximately $85 million in new assets and upgrades.  The refinery business is expected to generate approximately $40 million of annual Adjusted EBITDA, based on current forward crack spreads and the logistics operations are expected to consistently generate approximately $10 million of annual Adjusted EBITDA.2

In addition to the refining assets, the transaction includes the 140-mile Thunder Creek crude oil gathering system in northeast Wyoming that sources crude oil from the Powder River Basin.  The Thunder Creek gathering system is also connected to the Butte pipeline, which allows Wyoming Refining to directly access Bakken crude from North Dakota.  The transaction also includes a 40-mile clean products pipeline system that serves the Rapid City markets through the Magellan Products pipeline, two truck racks, a proprietary jet fuel terminal in Rapid City and a jet fuel pipeline that connects Wyoming Refining’s proprietary aviation fuel terminal to Ellsworth Air Force Base.

The Thunder Creek gathering system is located within 20 miles of major drilling and development areas in the Powder River Basin, where production has increased more than 200% since 2011. With proximity to this growing resource base, discounted crude oil relative to WTI is a key benefit to Wyoming Refining.

One of Wyoming Refining’s primary downstream markets is the Rapid City, South Dakota metropolitan area with a population of approximately 135,000.  With several national parks and monuments in the area, this region is a major summer tourist destination that attracts millions of visitors annually.

Evercore acted as financial advisor to Black Elk Refining, LLC, the owner of Wyoming Refining.

Funding Details
Par Pacific expects to raise the necessary transactional financing with a mixture of debt, equity and cash on hand.  The equity component of the financing is expected to consist of a $50 million rights offering of common stock to all of its existing shareholders.  Affiliates of Sam Zell and Highbridge Capital have agreed to provide $52.5 million of mandatorily convertible bridge financing at a $15.00 per share conversion price to fund any shortfall of the anticipated proceeds from the rights offering.  An additional component of the financing is expected to consist of a private placement of $100 million of convertible notes pursuant to Rule 144A. Highbridge Capital and Whitebox Advisors LLC have committed to fully backstop the anticipated convertible notes offering at a premium of approximately 27% to yesterday’s closing price, or $18.00 per share, and a 5% interest rate.  Par Pacific plans to assume $58 million of existing indebtedness at Wyoming Refining and incur $65 million of additional indebtedness at the Wyoming Refining parent company. The remaining capital required will be financed with existing liquidity.

This news release does not constitute an offer of any securities for sale.  Any convertible notes to be offered in the private placement referenced above will not be and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Conference Call
A conference call to discuss this acquisition is scheduled for Tuesday, June 14, 2016 at 9:00 a.m. Central Time (10:00 a.m. Eastern Time). To access the call, please dial 1-877-404-9648 inside the U.S. or 1-412-902-0030 outside the U.S. and ask for the Par Pacific call. The webcast may be accessed online through the company’s website at http://www.parpacific.com on the Investor Relations page. Please log on at least 10 minutes early to register. A telephone replay will be available through June 21, 2016 and may be accessible by calling 1-877-660-6853 inside the U.S. or 1-201-612-7415 outside the U.S. and using the conference ID 13639348#. Also, an archive of the webcast will be available shortly after the call on the company’s website at www.parpacific.com and will be accessible for approximately 90 days.

About Par Pacific Holdings, Inc.
Par Pacific Holdings, Inc., based in Houston, Texas, is a growth-oriented company that manages and maintains interests in energy and infrastructure businesses. Our business is organized into three primary segments of refining, retail and logistics located in Hawaii.  Par Pacific also owns an equity investment in Laramie Energy, LLC, a joint venture entity focused on producing natural gas in Garfield, Mesa and Rio Blanco Counties, Colorado. In addition, Par Pacific transports, markets and distributes crude oil from the Western United States and Canada to refining hubs in the Midwest, Gulf Coast, East Coast and to Hawaii. More information is available at www.parpacific.com.

Non-GAAP Financial Measures
Adjusted EBITDA cannot be reconciled to Projected Net Income, the closest GAAP measure, without unreasonable efforts. This reconciliation would require estimating amounts that will ultimately be determined in the purchase price allocation, which has not yet been completed, such as depreciation and amortization expense and interest expense and other financing costs, net.  A purchase price allocation requires allocating the purchase price to the acquired assets and liabilities, including fixed assets, intangibles, and debt based on their estimated fair value as of the acquisition date.  Furthermore, the terms of the financing have not yet been finalized; therefore, interest expense cannot be projected.  Our estimate of Adjusted EBITDA is based upon the following key assumptions: (i) closing of the acquisition in the third quarter of 2016; (ii) the operation of the refinery at an average total throughput of approximately 15,500 bpd during the twelve months ending December 31, 2017, with no significant downtime during the period; (iii) capital expenditures of $5 million for the twelve months ending December 31, 2017; (iv) a realized average crude oil price discount of $3.15 per barrel to the benchmark price during the period; and (v) $7 million of general and administrative expenses net of anticipated synergies, based on Par Pacific’s internal estimates, of $4 million during the period.

Forward-Looking Statements
This press release includes certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to qualify for the “safe harbor” from liability established by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including, without limitation, statements with respect to the timing and completion of the Wyoming Refining acquisition, the anticipated synergies and other benefits of the Wyoming Refining acquisition, the anticipated financial and operating results of Wyoming Refining and the effect on Par Pacific’s cash flows, profitability and earnings per share, the pro forma Nelson complexity index for the Newcastle refinery, and Par Pacific’s plans for financing the proposed acquisition, the conditions to the closing of the Wyoming Refining acquisition and the possibility that the Wyoming Refining acquisition will not close, are forward-looking statements. Additionally, forward looking statements are subject to certain risks, trends, and uncertainties. Par Pacific cannot provide assurances that the assumptions upon which these forward-looking statements are based will prove to have been correct.  Should one of these risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those expressed or implied in any forward-looking statements, and investors are cautioned not to place undue reliance on these forward-looking statements, which are current only as of this date.  Par Pacific does not intend to update or revise any forward-looking statements made herein or any other forward looking statements as a result of new information, future events or otherwise. Par Pacific further expressly disclaims any written or oral statements made by a third party regarding the subject matter of this news release.

Contact:
Christine Thorp
Director, Investor Relations & Public Affairs
(832) 916-3396
cthorp@parpacific.com

1 This amount is pro forma for units in process.
2 See “Non-GAAP Financial Measures.”

Tuesday, June 14th, 2016 Uncategorized Comments Off on (PARR) to Acquire Wyoming Refining and Related Logistics Assets

(MDGS) Global Commercial Launch of Next-Gen MUSE™ System

Physicians can benefit from the latest technological advancements in microvisual, ultrasonic and endostapling to perform transoral fundoplication more effectively with the latest generation of the MUSE system

OMER, Israel, June 14, 2016 — Medigus Ltd. (NASDAQ:MDGS) (TASE:MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, today announced the global launch of the newest technological generation of the Medigus Ultrasonic Surgical Endostapler, or MUSE™ system. The MUSE system is a leading minimally-invasive option for the long-term treatment of GERD (gastroesophageal reflux disease), one of the most common chronic conditions in the world. Now in its seventh generation, system updates offer physicians enhanced usability through an improved ultrasound algorithm, a redesigned distal tip and enhanced software.

“Our newest generation of MUSE offers gastroenterologists enhanced capability through cutting-edge advancements in microvisual, ultrasonic and endostapling technology, allowing them to perform transoral fundoplication with a more advanced system and improved usability,” said Chris Rowland, CEO of Medigus.

System features that have been updated include:

  • A redesigned distal tip to allow for easier insertion
  • An improved console which now supports carbon dioxide insulation, allowing for quicker absorption
  • An enhanced ultrasound algorithm, which enables a more streamlined procedure
  • A refined GUI (Graphic User Interface), which enables more effective transmission of information from the device to the console

“I am pleased to introduce the technologically enhanced MUSE in my practice, as I believe the system offers unique benefits over existing therapies in GERD management,” said Dr. Shinil Shah, DO, General Surgeon at Memorial Hermann. “In my experience, transoral fundoplication with MUSE is a safe alternative to invasive surgery and may be the preferred method by patients who are looking for a long-term solution for their troublesome reflux symptoms.”

Since its introduction, several transoral fundoplication procedures have been performed with the Gen 7 MUSE system by leading healthcare institutions, including Indiana University Health, Memorial Hermann and Borland-Groover Clinic.

Learn more about the MUSE system at www.medigus.com.

About The MUSE™ System
The MUSE™ system is a leading technology in Transoral Fundoplication (TF) procedures. The system allows a single physician or surgeon to perform anterior partial fundoplication with standard surgical staples in a less invasive way, compared to other surgical procedures. The intuitive endosurgical platform consists of a single use flexible surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder. The endostapler includes a handle with controls, an 80 cm flexible shaft, a 5 cm rigid section holding a cartridge with 5 standard 4.8 mm titanium surgical staples, a ratchet controlled one-way articulating section, and a distal tip. The MUSE system is FDA cleared and CE marked, and has also has obtained the necessary licenses to market the product in Canada and Israel. For more information, visit www.RefluxHelp.com.

About Medigus
Medigus is a medical device company specializing in developing minimally invasive endosurgical tools and highly innovative imaging solutions. They are the pioneer developer of the MUSE™ system, an FDA cleared and CE marked endoscopic device to perform Transoral Fundoplication (TF) for the treatment of GERD (gastroesophageal reflux disease), one of the most common chronic conditions in the world. In 2016, the CMS established the Category I CPT® Code of 43210 for TF procedures, such as the ones performed with MUSE, which establishes reimbursement values for physicians and hospitals. MUSE is gaining adoption in key markets around the world – it is available in world-leading healthcare institutions in the U.S., Europe and Israel. Medigus is also in the process of obtaining regulatory clearance in China. Medigus is traded on the Nasdaq Capital Market and the TASE (Tel-Aviv Stock Exchange). To learn more about the company’s advanced technology, please visit www.medigus.com or www.RefluxHelp.com.

This press release may contain statements that are “Forward-Looking Statements,” which are based upon the current estimates, assumptions and expectations of the company’s management and its knowledge of the relevant market. The company has tried, where possible, to identify such information and statements by using words such as “anticipate,” “believe,” “envision,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.  By their nature, Forward-Looking Statements involve uncertainties which may cause future results of the company’s activity to differ significantly from the content and implications of such statements. Among the factors which may cause the actual results to differ from the Forward-Looking Statements are changes in the target market and the introduction of competitive products, our ability to secure favorable reimbursement rates, regulatory, legislative and policy changes, and clinical results. Other risk factors affecting the company are discussed in detail in the Company’s filings with the Securities and Exchange Commission. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind.

MEDIA CONTACT:
Chantal Beaudry/ Carrie Yamond
Lazar Partners Ltd.
212-867-1762
cbeaudry@lazarpartners.com
cyamond@lazarpartners.com

INVESTOR RELATIONS (U.S.):
David Carey
Lazar Partners Ltd.
212-867-1768
dcarey@lazarpartners.com

INVESTOR RELATIONS (Israel):
Iris Lubitch/ Noam Yellin
SmarTeam
972-3-6954333
Iris@Smartteam.co.il
Noam@Smartteam.co.il
Tuesday, June 14th, 2016 Uncategorized Comments Off on (MDGS) Global Commercial Launch of Next-Gen MUSE™ System

(CLIR) to Present at the East Coast IDEAS Conference in Boston

SEATTLE, June 14, 2016  — ClearSign Combustion Corporation (NASDAQ: CLIR), an emerging provider of industrial combustion technologies that help to reduce emissions and improve efficiency, announced today that Steve Pirnat, Chairman and Chief Executive Officer, will present at the 2016 East Coast IDEAS Conference on Tuesday, June 28 at the Boston Park Plaza hotel in Boston, Massachusetts.

ClearSign Combustion’s presentation is scheduled to begin at 1:10 PM EDT.  The presentation will be webcast live and may be accessed at the conference website, www.IDEASConferences.com, or in the “Investors” section of the ClearSign website, www.clearsign.com.  If you are interested in scheduling a one-on-one meeting, please contact Matthew Selinger at 817-310-8776.

About ClearSign Combustion Corporation

ClearSign Combustion Corporation designs and is developing products and technologies that strive to improve key performance characteristics of combustion systems, including emissions and operational performance, energy efficiency and overall cost-effectiveness. Our patent-pending Duplex™ and Electrodynamic Combustion Control™ platform technologies enhance the performance of combustion systems in a broad range of markets, including the chemical, petrochemical, refinery, power and commercial boiler industries. For more information, please visit www.clearsign.com.

About IDEAS Investor Conferences

The mission of the IDEAS Conferences is to provide independent regional venues for quality companies to present their investment merits to an influential audience of investment professionals.  Unlike traditional bank-sponsored events, IDEAS Investor Conferences are “Sponsored BY the Buyside FOR the Buyside” and for the benefit of regional investment communities.  Conference sponsors collectively have more than $200 Billion in assets under management and include: Barrow Hanley Mewhinney & Strauss, Aristotle Capital Boston, Granahan Investment Management, Marble Harbor Investment Counsel, Gabelli Asset Management, GRT Capital Partners, LLC, Keeley Asset Management, Hodges Capital Management, Luther King Capital Management, Allianz Global Investors: NFJ Investment Group, Perritt Capital Management, Fidelity Investments, Ironwood Investment Management, Great Lakes Advisors, Ariel Investments, Invicta Capital Management, LLC, William Harris Investors, Greenbrier Partners Capital Management, LLC, First Wilshire Securities Management, Inc., Constitution Research & Management , Inc., BMO Global Asset Management, and North Star Investment Management.

The IDEAS Investor Conferences are held annually in Boston, Chicago and Dallas and are produced by Three Part Advisors, LLC.  Additional information about the events can be located at www.IDEASConferences.com.

If interested in attending or learning more about the IDEAS Conferences, please contact Matthew Selinger, (817) 310-8776, mselinger@threepa.com.

Cautionary note on forward-looking statements
This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. Forward-looking statements may be identified by words such as “expect”, “anticipate”, “believe”, “intend”, “hope”, “could”, “plans” and other comparable or similar terminology as well as the negative of such terminology. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our Annual Report on Form 10-K and other periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.

Tuesday, June 14th, 2016 Uncategorized Comments Off on (CLIR) to Present at the East Coast IDEAS Conference in Boston

(EGT) Plans To Implement A Stock Option Exchange Program

HONG KONG, June 13, 2016  — Entertainment Gaming Asia Inc. (NASDAQ: EGT) announced today that its Board of Directors has approved a voluntary stock option exchange program for its employees, directors and certain others (the “Participants”). The stock option exchange program would be effected pursuant to a proposed new 2016 stock incentive plan, which amends the Company’s existing 2008 stock incentive plan to bring it more in alignment with the Hong Kong Stock Exchange listing rules, to which the Company’s equity incentive plans are subject as a result of the Company becoming a majority-owned subsidiary of Melco International Development Limited. The new 2016 stock incentive plan is subject to the approval of the Company’s shareholders and the Company expects that the exchange program will be approved, without a meeting of stockholders, by written consent of the majority shareholder. The Company expects to effect the options exchange in the third quarter of 2016, following the effectiveness of the new 2016 stock incentive plan.

Under the terms of the program, the Participants would have the opportunity to cancel their existing underwater outstanding stock options (i.e., options with exercise prices that are higher than the current market trading price of the Company’s common stock) in exchange for a replacement option grant for an equal number of shares. The replacement options would have an exercise price of $1.94, which is based on the higher of: (i) 100% of the fair market value of the Company’s common stock on the Board approval date and (ii) 100% of the average fair market value of one share of the Company’s common stock for the five business days immediately preceding the Board approval date.

The replacement options would have a ten-year term from the option exchange date and would be subject to a new vesting schedule. The replacement options would vest over three years, vesting 50% on the first anniversary and 25% on each of the second and third anniversaries of the option exchange date, subject to the Participants remaining continuously in service with the Company.

As of May 31, 2016, options to purchase 766,851 shares of common stock are outstanding under the Company’s 2008 and other stock incentive plans. Options to purchase 484,781 of these shares, or approximately 3% of total shares outstanding, are expected to be eligible for this exchange program. The number of the Company’s shares subject to outstanding options would not change as a result of this option exchange.

The Company believes the option exchange program will provide valuable incentive to retain certain individuals that are important to its future success. Further, it serves to motivate the Participants to contribute to the attainment of the Company’s business and financial objectives and, ultimately, the creation of value for all of the shareholders.

The detailed terms and conditions of the amended stock incentive plan and stock option exchange program will be contained in an Information Statement to be mailed to the Company’s shareholders and to be filed with the Securities and Exchange Commission in June 2016.

The exchange program is being structured to comply with FASB Interpretation No. 44 “Accounting for Certain Transactions Involving Stock Compensation”. As a result of the option exchange, the Company expects to incur additional non-cash compensation expense attributable to the incremental fair value of the replacement options granted to the Participants, measured as of the date such awards are granted. The incremental compensation expense associated with the replacement options would be recognized over the expected life of the replacement options.

About Entertainment Gaming Asia Inc.
Entertainment Gaming Asia Inc. (NASDAQ: EGT), an indirect, majority-owned subsidiary of Melco International Development Limited, is a gaming company in Pan-Asia engaged in the leasing of electronic gaming machines to the gaming industry in Cambodia and the Philippines and the development and operation of gaming venues in Asia under its “Dreamworld” brand.  The Company is also developing a free to play online social casino gaming platform for certain Asian markets.

Forward Looking Statements
This press release contains forward-looking statements concerning Entertainment Gaming Asia within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those forward-looking statements include statements regarding the benefits of implementing the stock option exchange program. Such statements are subject to certain risks and uncertainties, and actual circumstances, events or results may differ materially from those projected in such forward-looking statements. Factors that could cause or contribute to differences include, but are not limited to, the risk that the Company may not achieve the expected benefits from the option exchange program and those other risks set forth in the companies’ respective annual reports on Form 10-K for the year ended December 31, 2015 filed with the SEC and subsequently filed reports. The companies caution readers not to place undue reliance on any forward-looking statements and they  do not undertake, and specifically disclaim any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur.

Monday, June 13th, 2016 Uncategorized Comments Off on (EGT) Plans To Implement A Stock Option Exchange Program

(NBY) Appoints Mark M. Sieczkarek President and Chief Executive Officer

NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company focusing on commercializing prescription Avenova® lid and lash hygiene for the domestic eye care market, announces the appointment of Mark M. Sieczkarek as President and Chief Executive Officer, effectively immediately. Sieczkarek has been a NovaBay Director since January 2014, was named Chairman in April 2015 and has served as interim President and CEO since November 2015. He has been instrumental in the development and implementation of the go-to-market strategy for Avenova.

“I’m delighted to take on the executive responsibilities on a permanent basis and am fully committed to the successful commercialization of Avenova,” said Sieczkarek. “I’m proud of our team’s many fast-paced activities to advance the marketing strategy and appreciate the support from our Board in pursuing our goals. With our new strategy now in place, expense management in hand, a strengthened balance sheet and long-term committed investors, we are on track to achieve our target of positive cash flow from operations by the end of 2016 and accelerated revenue growth beyond.”

Mr. Sieczkarek previously was CEO of Solta Medical, Inc. (acquired by Valeant Pharmaceuticals) and of Conceptus, Inc. (acquired by Bayer HealthCare), where he led the launch of the medical device Essure®. Prior to that, he was Senior Vice President and President of The Americas and Europe for the leading ophthalmic company Bausch & Lomb (acquired by Valeant Pharmaceuticals), where he was responsible for overseeing multinational commercial launches of several leading products.

About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics

NovaBay Pharmaceuticals is a biopharmaceutical company focusing on the commercialization of prescription Avenova® lid and lash hygiene for the eye care market. Avenova is formulated with Neutrox™, which is cleared by the U.S. Food and Drug Administration (FDA) as a 510(k) medical device. Neutrox is NovaBay’s pure hypochlorous acid. Laboratory tests show that pure hypochlorous acid has potent antimicrobial activity in solution yet is non-toxic to mammalian cells and it also neutralizes bacterial toxins. Data from a multicenter clinical study show that Avenova reduced bacterial load, the underlying cause of blepharitis, on ocular skin surface by more than 90%. Avenova is marketed to optometrists and ophthalmologists throughout the U.S. by NovaBay’s direct medical salesforce. It is accessible from more than 90% of retail pharmacies in the U.S. through agreements with McKesson Corporation, Cardinal Health and AmeriSource Bergen.

Forward-Looking Statements

This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding our ability to become cash flow positive by the end of 2016, future sales of our products, the ability to raise additional capital through warrant exercises, and the Company’s expected future financial results. Forward-looking statements can be identified with words like (and variations of): “estimate,” “believe,” and “expect.” These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in manufacturing, distributing, and selling the Company’s products, unexpected adverse side effects or inadequate therapeutic efficacy of our product, the uncertainty of patent protection for the Company’s intellectual property, and the Company’s ability to obtain additional financing as necessary. Other risks relating to NovaBay’s business, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.

Stay informed on NovaBay’s progress:

Download our Mobile InvestorApp from the Apple Store or Google Play
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Visit NovaBay’s Website

 

NovaBay Contacts
For NovaBay Avenova purchasing information, please contact:
Email us
Call us: 1-800-890-0329
www.Avenova.com
or
From the Company
Thomas J. Paulson, 510-899-8809
Chief Financial Officer
Contact Tom
or
Investor Contact
LHA
Jody Cain, 310-691-7100
Jcain@lhai.com

Monday, June 13th, 2016 Uncategorized Comments Off on (NBY) Appoints Mark M. Sieczkarek President and Chief Executive Officer

(SRTSU) Appoints Dr. Darrell Rigel to its Board of Directors

–Past President of both the American Academy of Dermatology and American Society for Dermatologic Surgery –Recipient of American Academy of Dermatology’s Gold Medal in Recognition of a Lifetime of Achievement

BOCA RATON, Fla., June 13, 2016  — Sensus Healthcare, Inc. (NASDAQ: SRTSU), a medical device company specializing in the treatment of non-melanoma skin cancers and other skin conditions, such as keloids, with superficial radiation therapy, today announced the appointment of Darrell S. Rigel, MD, MS, to its Board of Directors.  Dr. Rigel is a Clinical Professor of Dermatology at New York University Medical Center and serves as Medical Director of the Schweiger Dermatology Group. He has also served as President of the American Academy of Dermatology and as a Director of the American Board of Dermatology.  In addition, he is a past President of both the American Society for Dermatologic Surgery and American Dermatological Association.

Dr. Rigel stated, “I am honored to join the Board of Directors of Sensus Healthcare. Having dedicated my professional life to dermatology, I have seen the impact that skin disorders have on my patients on a daily basis. With its innovative technology and non-invasive approach to treating skin cancer and keloids, Sensus Healthcare has taken a leadership position in treating skin cancer in a cost-effective manner and addressing the medical needs of large, underserved populations. I am confident that Sensus Healthcare will have an increasingly significant impact on patient care and I look forward to helping the Company expand access to their technologies for physicians and patients.”

Joe Sardano, Chief Executive Officer for Sensus Healthcare, added, “I am gratified Dr. Rigel has chosen to apply his experience and passion to the advancement of Sensus. Dr. Rigel joining the board speaks volumes about our value in the dermatology and skin cancer markets and shows how we are truly making a difference in the lives of our patients. In Dr. Rigel, we have secured the ideal board member: a highly recognized leader in the field of dermatology who brings to bear tremendous public and private company experience. I am confident he will be an enormous asset to Sensus for years to come.”

Dr. Rigel is a well-respected leader in dermatology and has chaired numerous national and international conferences and symposiums, delivering more than 900 presentations. He has authored many articles and abstracts in professional journals and is the lead editor of Cancer of the Skin, the primary textbook in the field.  Dr. Rigel has testified before Congress and the FDA on dermatology-related issues and frequently serves as an expert on national television and in magazines and newspapers that include CNN, ABC, FOX, NBC, CBS, The New York Times and Wall Street Journal.

Currently, Dr. Rigel is a member of the Board of Directors for Foamix Pharmaceuticals and Chief Medial Advisor to the Board of Directors of Strata Skin Sciences. He has also served as a board member for Lumenis and Triax Pharmaceuticals.

Dr. Rigel graduated from MIT with a BS in Management Information Science, has an MS (MBA) from the Sloan School of Management at MIT and received his MD from George Washington University. He attended Cornell University Medical Center for an internship in Internal Medicine and completed his training at New York University where he was Resident, Chief Resident, NIH Training Fellow and Dermatology Surgery Fellow.

Dr. Rigel has been widely recognized for his achievements in the field of dermatology:

  • American Academy of Dermatology’s Gold Medal – the highest award in the specialty in recognition of a lifetime of achievement
  • George B. Morgan Award from MIT recognizing exceptional achievement by an alumnus
  • Humanitarian Award of the Melanoma Research Foundation
  • American Cancer Society’s National Honor Citation for Skin Cancer Programs
  • Presidential Citations from the Academy and American Society for Dermatologic Surgery for public education programs in skin cancer

About Sensus
Sensus Healthcare, Inc. is a medical device company that is committed to enabling non-invasive and cost-effective treatment of non-melanoma skin cancers and keloids. Sensus uses a proprietary low energy x-ray radiation technology known as superficial radiation therapy (SRT), which is a result of over a decade of dedicated research and development activities. Sensus has successfully incorporated the SRT therapy into its portfolio of treatment devices, the SRT-100™ and SRT-100 Vision™. To date, the SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in thousands of patients. For more information, visit http://www.sensushealthcare.com.

Investor Relations:
Jeffrey Goldberger / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1249 / 212-896-1267
Email: jgoldberger@kcsa.com / asoss@kcsa.com

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(COYN) Expresses Condolences for Orlando Shooting Victims

Praise for First Responders Who Serve a “Noble Purpose”

DALLAS, June 13, 2016  — The chief executive officer of COPsync, Inc. (NASDAQ: COYN), Mr. Ronald A. Woessner expressed condolences for the Orlando shooting victims and praised first responders: “COPsync offers condolences to the family members and the community of Orlando who were impacted by the terrorist acts in the early hours of Sunday morning.  We also want to recognize the sacrifice and bravery of those who were the first responders to this heinous act and to those who protect and serve our communities every day.  Law enforcement officers serve a noble purpose because they fulfill our most basic human need to feel safe – in our schools, churches, places of entertainment and our communities.  These brave men and women deserve our honor and our respect.” Mr. Woessner continued, “Our Company condemns these crimes of hate and cowardice.  We are working every day to provide safety solutions to law enforcement officers and our fellow citizens.  Our goal is to ensure public and personal safety is both a policy and a funding priority for state and federal policymakers.”

A mass shooting during the early morning hours Sunday, June 12 at the Orlando nightclub Pulse, left 50 people dead and more than 50 injured; the FBI is investigating the shooting as an act of terrorism.

About COPsync, Inc.

COPsync, Inc. (NASDAQ: COYN) COPsync operates the COPsync911™ threat-alert service for schools, airports, government buildings, hospitals and other potentially at-risk facilities and the COPsync Network™, the nation’s only system connecting law enforcement officers and agencies nationwide and providing access to a national database of non-adjudicated law enforcement information and real-time communication capability to connected agencies, even those thousands of miles apart.

Contact:

For COPsync:
Ronald A. Woessner
Chief Executive Officer
972-865-6192
invest@copsync.com

Media:
Fred Sommer
Senior Consultant
Investor Relations
Ascendant Partners, LLC.
732-410-9810
fred@ascendantpartnersllc.com

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(EBIO) IND App for EBI-031 in Ocular Diseases

Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of EBI-031, a humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling, which may be effective for the treatment of ocular diseases such as diabetic macular edema and uveitis.

“We are pleased to have this IND under review by the FDA,” said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. “We look forward to providing additional details on the development of EBI-031 as a potential treatment for diseases of the eye, such as diabetic macular edema and uveitis, as they become available.”

About EBI-031

Eleven Biotherapeutics’ most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed and engineered for intravitreal delivery using Eleven’s AMP-Rx platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R).

About Eleven Biotherapeutics

Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven’s therapeutic approach is based on the role of cytokines in diseases of the eye, the Company’s understanding of the structural biology of cytokines and the Company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects. For more information please refer to the Company’s website www.elevenbio.com.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, advancement or maturation of its product candidates and product pipeline, clinical development of the Company’s product candidates, including expectations regarding timing of regulatory submissions and initiation of clinical trials, regulatory requirements for initiation of clinical trials and registration of product candidates, the review of its strategic alternatives and the outcome of such review, the completion and results of potential strategic transactions, the sufficiency of its cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or preclinical studies will be indicative of the results of future trials, the adequacy of any clinical models, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals and other factors discussed in the “Risk Factors” section of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2016 as filed with the Securities and Exchange Commission and other reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

 

Eleven Biotherapeutics
Leah Monteiro, 617-714-0619
Leah.Monteiro@elevenbio.com

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(VBIV) VBI Vaccines to Host Hepatitis B Key Opinion Leader Meeting

CAMBRIDGE, MASSACHUSETTS–(June 10, 2016) – VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) (“VBI”) will host a hepatitis B (“HBV”) Key Opinion Leader meeting on Monday, June 13 at 12:00 PM ET. The event is being held at the Lotte New York Palace in New York City.

The event will feature keynote presentations by Dr. Daniel Shouval, M.D. and Dr. Florian Schödel, M.D., who will discuss new approaches to vaccination against hepatitis B as well as the unmet medical need. In addition, members of the VBI management team will provide an overview of Sci-B-Vac™, a third-generation HBV vaccine that mimics all three viral surface antigens of the hepatitis B virus. Sci-B-Vac is approved in Israel and in 14 other countries and has demonstrated a favorable safety and efficacy profile in over 300,000 patients.

At the time of the event, a live webcast will be available at: http://lifesci.rampard.com/20160613/reg.jsp

Dr. Shouval is a Professor of Medicine and the former Dean of the Faculty of Medicine at the Hebrew University and Hadassah Medical School in Jerusalem, where he established Israel’s first liver unit in 1983. He is a visiting Professor at Albert Einstein College of Medicine and has held similar positions at Harvard Medical School, Massachusetts General Hospital, and the University of Paris. Dr. Shouval currently serves as a standing adviser to the European Viral Hepatitis Prevention Board and the World Health Organization (“WHO”), and has previously served as both President and Chairman of the Educational Committee of the European Association for the Study of the Liver (“EASL”).

Dr. Schödel has more than 20 years of pharmaceutical, biotech industry, and academic experience leading teams in the development of vaccines and biologics. A physician and microbiologist by training, Dr. Schödel holds adjunct faculty appointments at the University of Munich and at the Biodesign Center of ASU. Dr. Schödel’s research has focused on novel recombinant vaccines against diseases including hepatitis B, malaria, and typhoid. He has led the clinical teams responsible for several successful vaccine filings in the U.S., the European Union, and globally, including several pediatric combination vaccines.

The event is intended for institutional investors and sell-side analysts only. If you would like to attend, please contact Mac MacDonald at (212) 915-2567 or via e-mail at mac@lifesciadvisors.com.

Event Details

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac™, a hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14 other countries. VBI’s eVLP Platform technology allows for the development of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (“CMV”) and glioblastoma multiforme (“GBM”). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

Cautionary Statement on Forward-looking Information

Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements.

Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company’s products, including the receipt of necessary regulatory approvals; general economic conditions; competitive conditions; and changes in applicable laws, rules and regulations.

VBI cautions the reader that forward-looking statements and information involve known and unknown risks, uncertainties and other factors that may cause actual results and developments to differ materially from those expressed or implied by such forward-looking statements or information contained in this news release and VBI has made assumptions and estimates based on or related to many of these factors.

Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company’s current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

VBI Contact
Perri Maduri
Communications Executive
Phone: (617) 830-3031 x124
Email: ir@vbivaccines.com

VBI Investor Contact
Nell Beattie
Director, Corporate Development and Investor Relations
Phone: (617) 830-3031 x128
Email: nbeattie@vbivaccines.com

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(SRTSU), KCSA Strategic Communications Clutch in Successful IPO

Rings the NASDAQ Bell Along Side Sensus Management

NEW YORK, June 10, 2016 — KCSA Strategic Communications, a leading provider of integrated communications solutions announced its participation in the opening bell ringing ceremony at the Nasdaq MarketSite for its client, Sensus Healthcare, Inc. (NASDAQ: SRTSU), a medical device company specializing in the treatment of non-melanoma skin cancers and other skin conditions, such as keloids. With important employees, partners and families on hand, Sensus Healthcare Chief Executive Officer, Joseph Sardano, officially opened the trading day on Nasdaq. This ceremony comes on the heels of the successful Initial Public Offering (IPO) of Sensus Healthcare on Thursday, June 2, 2016.

“The excitement we have when we are able to successfully advise one of our clients through the listing process on a major U.S. exchange such as Nasdaq is extremely gratifying,” commented Jeffrey Goldberger, Managing Partner, KCSA Strategic Communications. “For Sensus Healthcare, its IPO is the culmination of years of hard work and success. Having worked closely with management over the past few months to prepare for this moment is what we live for as investor relations consultants. We congratulate Joe Sardano and his team and look forward to working closely with the team to execute an investor relations program based on best practices.”

“Today’s listing on Nasdaq is a significant milestone for Sensus Healthcare. With decades of experience in the medical device industry, we launched Sensus with a simple goal – to provide medical professionals and their patients access to non-invasive options to treat non-melanoma skin cancer and keloids,” noted Joseph Sardano, Chief Executive Officer of Sensus Healthcare. “I am extremely proud of the entire Sensus team and wish to express my sincere gratitude for their tireless and continued support.”

About KCSA Strategic Communications

KCSA is a fully integrated communications agency specializing in public relations, investor relations and marketing with expertise in healthcare, technology and financial / professional services. Since 1969, the firm has demonstrated strategic thinking and program execution that drives results for its clients in the ever-changing communications and digital landscape. The firm’s clients are its best references. For more information, please visit www.kcsa.com.

About Sensus

Sensus Healthcare, Inc. is a medical device company that is committed to enabling non-invasive and cost-effective treatment of non-melanoma skin cancers and keloids. Sensus uses a proprietary low energy x-ray radiation technology known as superficial radiation therapy (SRT), which is a result of over a decade of dedicated research and development activities. Sensus has successfully incorporated the SRT therapy into its portfolio of treatment devices, the SRT-100™ and SRT-100 Vision™. To date, the SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in thousands of patients. For more information, visit http://www.sensushealthcare.com.

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(GALE) Receives Two Orphan Drug Designations

SAN RAMON, Calif., June 10, 2016  — Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has granted two orphan-drug designations for Galena’s two cancer immunotherapy peptides derived from Folate Binding Protein (FBP) for the treatment (including prevention of recurrence) of ovarian cancer: one for GALE-301 (E39), and one for GALE-301 (E39) and GALE-302 (E39’). In clinical trials, GALE-301, and GALE-301/GALE-302 are combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the treatment of ovarian cancer in the adjuvant setting.

“Ovarian cancer is a very aggressive disease with almost fifty percent of women recurring within five years after their initial treatment1,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer.  “This designation supports our efforts to advance our FBP-targeted immunotherapy program consisting of GALE-301 and GALE-302 to prevent cancer recurrence in this underserved patient population.”

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.2 Orphan designation qualifies the sponsor of the drug for various development incentives including marketing exclusivity in the U.S. for seven years after product approval3, tax credits, and exemption from the prescription drug user fee.

Sources: 1U.S. Ovarian Cancer http://seer.cancer.gov/statfacts/html/ovary.html; 2FDA Website – Developing Products for Rare Diseases & Conditions; 3FDA Frequently Asked Questions on Patents and Exclusivity

About GALE-301 and GALE-302

GALE-301 and GALE-302 are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with GM-CSF for the treatment (including prevention of recurrence) of ovarian cancer in the adjuvant setting.  GALE-301 is the E39 peptide, while GALE-302 is an attenuated version of this peptide, known as E39’.  FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers, and is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Two trials are ongoing with FBP peptides in gynecological cancers: the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial is ongoing in ovarian and endometrial adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696); the GALE-301 plus GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian cancers (ClinicalTrials.gov Identifier: NCT02019524).

About Ovarian Cancer

New cases of ovarian cancer occur at an annual rate of 12.1 per 100,000 women in the U.S., with an estimated 21,290 cases for 2015. Although ovarian cancer represents about 1.3% of all cancers, it represents about 2.4% of all cancer deaths, or an estimated 14,180 deaths in 2015.  Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2010 – 2012 data).  The prevalence of ovarian cancer in the U.S. is about 192,000 women, and the five-year survivorship for women with ovarian cancer is 45.6%.

Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While many patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse.  Depending upon their level of residual disease, the risk for recurrence after completion of primary therapy ranges from 60% to 85%.  Unfortunately for these women, once the disease recurs, treatment options are limited and the disease remains incurable.

Source: National Cancer Institute Surveillance, Epidemiology, and End Results Program

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301.  NeuVax is currently in a pivotal, Phase 3 breast cancer clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with GALE-302.   For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such statements include, but are not limited to, statements about the progress of the development of Galena’s product candidates, including GALE-301 and GALE-302, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2015 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

NeuVax is a trademark of Galena Biopharma, Inc.

Contact:

Remy Bernarda 
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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(CYTX) Leads to Improved Function and Reduced Scar Tissue

Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication in The Journal of Urology of a preclinical study applying Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori Cell Therapy in a large animal model of urethral injury.

The results show that delivery of the cell therapy product immediately after injury resulted in a >50% decrease in fibrotic scar tissue from 17% of total urethral surface area in the control to 7% in the treated group (p=0.05) 30 days following treatment. The study further reported that delaying delivery of the cell therapy product until 30 days after injury—a time at which urethral fibrosis was well-established—led to >10-fold decrease in injured surface area (from 13% of the urethra in the control group to 1% in the treated group; p<0.05) at 60 days after injury (30 days after treatment). ADRC-treatment was also associated with a statistically significant increase in the maximum pressure generated by the urethra, an important component of urinary sphincter function.

This study was led by Drs. Giles Karsenty and Romain Boissier of Aix-Marseille University in Marseille, France supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, Assistance Publique-Hôpitaux de Marseille.

“These now published findings support the use of either immediate or delayed application of Cytori Cell Therapy to help reduce injury and scarring,” said Dr. Marc Hedrick, President and CEO of Cytori. “This important safety and proof of concept preclinical study will be useful in forthcoming regulatory submissions in the US, Europe and Japan.”

Data from this preclinical study supported the company’s recently enrolled the STAR clinical trial, an FDA-approved, 88 patient, multi-center, randomized controlled Phase III trial of Cytori Cell Therapy for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma as well as the investigator-initiated, ADRESU urinary incontinence trial currently enrolling in Japan. A reduction in cutaneous fibrosis as measured by the modified Rodnan Skin Score (mRSS) of the hand was also noted in the previous published SCLERADEC I clinical trial.

Links:

Boissier et al (2016) “Histologic and urodynamic effects of autologous stromal vascular fraction extracted from fat tissue with minimal ex vivo manipulation on a porcine model of intrinsic sphincter deficiency.” J Urol pii: S0022-5347(16)30555-9. doi: 10.1016/j.juro.2016.04.099. [Epub ahead of print]

The ADRESU Trial

The STAR Trial

The SCLERADEC I Trial

The SCLERADEC II Trial

About Cytori

Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information visit www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including statements regarding clinical trial results and related benefits of Cytori Cell Therapy, and possible benefits of preclinical study data to Cytori (including its pipeline and prospects) are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties, which include inherent uncertainties in conduct of preclinical and clinical trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Cell Therapy) are described under the heading “Risk Factors” in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

 

CYTORI THERAPEUTICS CONTACT
Tiago Girao, +1.858.458.0900
ir@cytori.com

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(GBT) New Clinical Data Supports Safety and Efficacy of GBT440

90-Day Data Show Sustained Treatment Response and Support Company’s Plan to Initiate Pivotal Trial This Year Results Presented at European Hematology Association’s (EHA) 21st Congress Company to Host Webcast Today at 1:30 p.m. CEST/7:30 a.m. ET to Discuss Data

SOUTH SAN FRANCISCO, Calif., June 10, 2016  — Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, today announced new results from its ongoing Phase 1/2 GBT440-001 study in sickle cell disease (SCD) that further support the company’s plans to develop GBT440 as a potential disease-modifying therapy for SCD. The data being presented today at the European Hematology Association’s (EHA) 21st Congress in Copenhagen include a poster presentation of 90-day data from a cohort of patients in the Phase 1/2 study who were taking 700 mg/day of GBT440 and 28-day results from three dosing cohorts of GBT440 (abstract #P371). Data on the pharmacokinetics (PK) and pharmacodynamics (PD) of GBT440 are being highlighted in a separate poster presentation (abstract #P370).

“These new GBT440 clinical data continue to support the hypothesis that GBT440 inhibits sickle hemoglobin (HbS) polymer formation, allowing it to potentially stop red blood cell hemolysis, improve blood flow and transform the treatment of the disease,” said Dr. Paul Telfer, consultant in hematology and pediatric hematology at Barts Health NHS Trust and a senior lecturer in hematology at Queen Mary, University of London. “Based on the data we have seen to date, GBT440 has the potential to be a once-daily treatment that could improve the devastating clinical course of sickle cell disease.”

“All SCD patients dosed with GBT440 have shown a positive hematologic response. Additionally, a rapid and durable reduction in hemolytic anemia and sickling has been shown over 90 days. We continue to see a linear, dose proportional relationship between pharmacokinetics and pharmacodynamics, and the data continue to support the inhibition of polymerization of sickle hemoglobin through increased oxygen affinity as the mechanism of action of GBT440,” said Ted W. Love, M.D., chief executive officer of GBT. “Overall, the data collected to date in study GBT440-001 indicate that we have a drug candidate that we can move into a pivotal trial later this year. We look forward to discussing the design of that trial with the U.S. Food and Drug Administration.”

About the Ongoing Phase 1/2 Trial            

GBT440-001 is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study evaluating the safety, tolerability, PK and PD of GBT440 in both healthy subjects and patients with SCD. The study is being conducted in three parts: Part A (single dose administration), Part B (multiple dose administration, daily for 15 days in healthy subjects and 28 days in SCD patients) and Part C (multiple dose administration, daily for 90 days in SCD patients). As of June 2, 2016, eight SCD patients completed Part A of the study, 38 SCD patients completed Part B of the study, and 8 patients have either completed Part C of the study or are still being followed (700 mg cohort); the higher dose cohort in Part C (900 mg) is currently enrolling. Of the 46 SCD patients in Parts B and C, 16 patients have completed 700 mg/day dosing for 28 days and follow-up (12 on GBT440, 4 on placebo), 14 patients have completed 500 mg/day dosing for 28 days and follow-up (10 on GBT440, 4 on placebo), 8 patients have completed 1,000 mg/day dosing for 28 days and follow-up (6 on GBT440, 2 on placebo) and 8 patients have completed 700 mg/day dosing for 90 days (6 on GBT440, 2 on placebo).

90-Day Results in GBT440-001 700 mg/day

The new 90-day results with GBT440 700 mg/day (n=6) showed:

  • A durable reduction in hemolysis from baseline to day 90, as evidenced by a rapid and sustained reduction in bilirubin starting as early as day 4 and continuing through day 90 (median decrease of greater than 35% compared with an increase of approximately 20% with placebo).
  • A median 1.1g/dL increase in hemoglobin concentration was observed with GBT440 treatment compared with 0.2 g/dL decrease with placebo.
  • A median decrease of approximately 20% in reticulocyte count compared with an approximately 20% increase with placebo, suggesting that the observed increase in hemoglobin is due to a decrease in hemolysis (red blood cell destruction).
  • After initial variability of hemoglobin and reticulocytes during the first 3-6 weeks (likely due to bone marrow adjusting to dramatic reduction in hemolysis), hemoglobin and reticulocyte counts show steady improvement through day 60 to 90.
  • A sustained reduction in irreversibly sickled cells, with a median decrease of approximately 70% within 90 days compared to an increase of approximately 15% with placebo.
  • GBT440 was well tolerated over 90 days of dosing. The most common adverse event was headache, seen in both the placebo and GBT440 arms. There have been no drug-related serious adverse events.

28-Day Results in GBT440-001 from Three Dosing Cohorts

The complete 28-day results from three dosing cohorts of GBT440 (500 mg [n=10]), 700 mg [n=12] and 1,000 mg administered as 500 mg BID [n=5]) showed:

  • The therapeutic target between 10-30% Hb modification was achieved at GBT440 doses ≥500 mg.
  • A consistent beneficial effect was seen in at least one key parameter: hemolysis, reticulocytosis or sickle cell counts.

GBT440 Pharmacokinetic (PK) and Pharmacodynamic (PD) Data

GBT440 demonstrates linear, dose-proportional pharmacokinetics with a half-life of 2.8 and 1.6 days in healthy subjects and SCD patients, respectively. While SCD subjects are right-shifted at baseline, a dose proportional left shift in the P50 to the normal range (26-29 mm Hg) in the oxygen equilibrium curve was observed. Collectively, these data confirm the mechanism of action and pharmacodynamic effect of GBT440 and support once daily dosing.

GBT440-001 Overall Safety Summary

Across the GBT440 clinical development program, GBT440 has now been dosed in 177 adults, including 99 subjects in multiple dosing cohorts up to 90 days. It has been shown to be well tolerated with no drug-related serious adverse events. There has been no evidence of tissue hypoxia in healthy subjects up to approximately 40% Hb modification or in SCD subjects up to approximately 30% Hb modification.

About GBT440

GBT440 is being developed as an oral, once-daily therapy for patients with sickle cell disease. GBT440 works by increasing hemoglobin’s affinity for oxygen. Since oxygenated sickle hemoglobin does not polymerize, GBT believes GBT440 blocks polymerization and the resultant sickling of red blood cells (RBCs). With the potential to restore normal hemoglobin function and improve oxygen delivery, GBT440 may be capable of modifying the progression of SCD. The U.S. Food and Drug Administration (FDA) has granted GBT440 both Fast Track and Orphan Drug designation for the treatment of patients with SCD in recognition of the critical need for new treatments.

Investor Event Webcast Details

Today, Friday, June 10, at 1:30 p.m. CEST/7:30 a.m. ET, members of GBT’s management team and distinguished experts Dr. H. Franklin Bunn of Harvard Medical School and Brigham and Women’s Hospital, Dr. Paul Telfer of Barts Health NHS Trust and Queen Mary, University of London, and Dr. Wally R. Smith of Virginia Commonwealth University, will review the GBT440 data. The investor event will be webcast live and available for replay from GBT’s website at www.globalbloodtx.com in the Investors & Media section.

About Global Blood Therapeutics

Global Blood Therapeutics, Inc. (GBT) is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its lead product candidate, GBT440, as an oral, once-daily therapy for sickle cell disease (SCD) and is currently evaluating GBT440 in both healthy subjects and SCD patients in a randomized, placebo-controlled, double-blind Phase 1/2 clinical trial. In addition to GBT440 for the treatment of SCD, GBT is engaged in research and development activities targeted toward hypoxemic pulmonary disorders, including idiopathic pulmonary fibrosis (IPF) and hereditary angioedema (HAE). To learn more, please visit: www.globalbloodtx.com.

Forward-Looking Statements

Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. We intend these forward-looking statements, including statements regarding the therapeutic potential and safety profile of GBT440,  our ability to advance GBT440 into a pivotal trial in SCD, our plans to discuss the design of that trial with the U.S. Food and Drug Administration and the timing of these events, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved, and furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, the risks that our clinical and preclinical development activities may be delayed or terminated for a variety of reasons, that regulatory authorities may disagree with our clinical development plans or require additional studies or data to support further clinical investigation of our product candidate, and that drug-related adverse events may be observed in later stages of clinical development, along with those set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Friday, June 10th, 2016 Uncategorized Comments Off on (GBT) New Clinical Data Supports Safety and Efficacy of GBT440

(GBSN) Attends ASM Microbe 2016

Three Featured Posters Validate the Company’s Newly-Cleared Staph ID/R Blood Culture Panel and Shiga Toxin Direct Molecular Assays

Great Basin Scientific, Inc. (NASDAQ:GBSN), a molecular diagnostics company, announced today it is bringing its innovative solution to ASM Microbe 2016 in Boston, Mass., June 17-20 to help small to medium-sized hospitals learn more about the company’s cost-effective, sample-to-result platform to reduce costs, increase efficiency and provide better patient outcomes. ASM Microbe 2016—integrating the American Society for Microbiology’s two premier events, the General Meeting and ICAAC—showcases the best microbial sciences in the world and provides a one-of-a-kind forum to explore the complete spectrum of microbiology, from basic science to translation and application. Great Basin will be exhibiting in booth 219, where ASM attendees can receive one-on-one demonstrations of the platform and schedule meetings with Product and Sales team leaders.

“We are pleased to be able to present the benefits of our diagnostic platform and unique customer-centric business model to a larger audience, and are excited to meet new users at ASM this year,” said Sandra Nielsen, senior vice president of sales and marketing, human resources of Great Basin Scientific. “Our exceptional customer growth and the ongoing positive feedback from our users are indicative of the overwhelming need in the market for an innovative solution like ours. Great Basin can uniquely offer low cost, ease-of-use and versatility in a molecular diagnostic system that so many U.S. hospitals and clinics desperately need.”

In addition to the exhibition, the Scientific Program has selected posters featuring outcomes by third party researchers using the Great Basin platform. Two posters will be presented with clinical study findings on Great Basin’s Staph ID/R Blood Culture Panel the Company’s first U.S. Food & Drug Administration (FDA)-cleared multiplex panel:

  • Poster# MONDAY-086: Multi-Center Evaluation of the Portrait Staph ID/R Blood Culture Panel, G. Denys, S. Young, J. Daly, M. Couturier, B. Buchan, N. Ledeboer, shows the evaluation of the performance of the Staph ID/R Panel compared to standard reference methods. Researchers found the performance characteristics of the Panel compared favorably to reference methods, and the that the multiplex amplification assay provides valuable information beyond the initial Gram stain in less than two hours of testing. The findings concluded that the Panel’s accurate and rapid organism identification and resistance mechanism could have a positive impact on patient management.
  • Poster# MONDAY-083: Evaluation of the Portrait Staph ID/R Blood Culture Panel in Pediatric and Adult Patient Populations, A. Hopper, M. V. Powers-Fletcher, S. Holt, A. Phillips, R. Grand-Pre, M. Dickie, A. Blaschke, M. R. Couturier, J. A. Daly, shows that the panel performs with high sensitivity and specificity for the identification of Staphylococcus species and detection of mecA, compared to standard culture and molecular study methods. The poster states that implementation of this methodology in clinical laboratories could allow for accurate and more rapid identification of blood stream infections caused by methicillin-resistant staphylococci, and thus improve patient care.

Outcomes of a multi-center clinical evaluation on Great Basin’s Shiga Toxin Direct Test —the only FDA-cleared standalone molecular test enabling the fast, precise detection of STEC—will also be presented:

  • Poster# MONDAY-197: Evaluation of the Great Basin Shiga Toxin Direct Molecular Assay for the Detection of Shiga-like Toxin Producing Escherichia coli (STEC) in Diarrheal Stool Specimens, M. L. Faron, N. A. Ledeboer, J. Connolly, P. A. Granato, J. Dien Bard, J. A. Daly, S. Young, B. W. Buchan, shows the assay is 100 percent sensitive for detection of STEC, including serotype O:157, compared to culture and enzyme-linked immunosorbent assay (EIA) test. The study found ST Direct identified an additional eight specimens, including two serotype O:157, that were missed by culture. Compared to ST Direct, EIA is only 33 percent sensitive for detection of STEC. Culture is insensitive for the detection of O:157.

“The results of the studies being shared with the attendees at ASM Microbe 2016 validate Great Basin’s hard work to meet the needs of our customers by creating tests that are not only easy to do and provide fast, actionable results for life threatening diseases, but also perform with excellent sensitivity and specificity in the clinical setting,” said Robert D. Jenison, chief technology officer, Great Basin Scientific. “We continue to strive to provide diagnostic solutions that provide faster results to aid in directing appropriate treatments, contributing to improved patient care and outcomes. Additionally, all of our current and future assays work with our benchtop analyzer, making our solution efficient and cost-effective for the small and mid-sized hospital customers we serve.”

Posters will be available after ASM Microbe 2016 on the Great Basin website at www.gbscience.com, or on ASM’s website, http://www.asmmicrobe.org/images/AbstractsPull_6-1.pdf.

About ASM

The American Society for Microbiology (ASM) is the largest single life science society, composed of over 47,000 scientists and health professionals. ASM’s mission is to promote and advance the microbial sciences.

ASM advances the microbial sciences through conferences, publications, certifications and educational opportunities. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences. For more information about ASM, please visit http://www.asm.org/.

About Great Basin Scientific

Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the company’s website at www.gbscience.com.

Forward-Looking Statements

This press release includes forward-looking statements regarding the Company’s continuing business efforts related to its products, including but not limited to, presentation at the ASM, the potential market for the Company’s products, the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases and related statements. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history of losses; (ii) our ability to develop and commercialize new products and the timing of commercialization; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. These forward-looking statements speak only as of the date hereof and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.

 

Media:
ICR
Kate Ottavio Kent, 203.682.8276
Kate.Ottavio-Kent@icrinc.com
or
Investor Relations:
Corprominence
Scott Gordon, 516.222.2560
gbinfo@corprominence.com
or
ICR
David Clair, 646.277.1266
david.clair@icrinc.com

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(IRMD) Provides Regulatory Update

Provides regulatory update on the status of its MRI compatible IV infusion pump

WINTER SPRINGS, Fla., June 09, 2016 — IRADIMED CORPORATION (NASDAQ:IRMD)

CURRENT NEWS
IRADIMED CORPORATION has received the FDA’s written response to our appeal of their determination that our 510(k) application for the MRidium 3860+ MRI compatible IV infusion pump was not substantially equivalent to its predicate device. The FDA has now reinstated the subject 510(k) and we have been granted another 180 days to make certain specified changes to several messages displayed by the infusion pump. Specifically, changes to messages the infusion pump displays to clarify whether the Dose Error Reduction System (DERS) is active or inactive and to better describe the over and under range indications. Further, the FDA’s response also stated that no additional human factors usability testing is required.

ACTION PLAN
The Company intends to revise the messages identified by the FDA, consistent with the agency’s explicit recommendations, and submit the required additional information within the 180 day period as prescribed in the FDA’s response.

“We are very pleased with this outcome and now have a clear path to fully resolving this matter. In the coming weeks, we will begin taking the necessary steps of revising the specific messages identified by the agency and revalidate the pump’s software. We anticipate completing this process well before the end of the 180 day period. We are also very pleased with FDA’s conclusion that no additional human factors usability testing is required,” said Roger Susi, President and Chief Executive Officer.

BACKGROUND
In September 2014 we were required by the FDA to stop selling our MRI compatible infusion pump systems and submit a new 510(k) application because of the addition of the DERS feature. In response we halted domestic shipments of our infusion pumps and the DERS feature. In November 2014 we filed the requested 510(k) and in December 2014, with the FDA’s consent, we resumed shipping the infusion pump product without the DERS feature. In January 2015, again with the FDA’s consent, we resumed shipping the infusion pump with the DERS feature. In March 2016, we received a letter stating that our infusion pump was not substantially equivalent to its predicate device. Their finding was based upon a lack of human factors data supportive of certain aspects of exiting the DERS feature. The FDA stated that we may resubmit a new 510(k) application with data showing our infusion pump is substantially equivalent to similar devices in the market. In April 2016, we appealed the FDA’s determination to a higher level within the agency and on May 2, 2016, met with the agency to discuss the appeal. While the FDA’s response to our appeal did not withdraw their consent to our continued marketing of the infusion pump with the DERS system, we cannot guarantee that the FDA will not change its position on allowing the continued marketing of our MRI compatible infusion pump systems with DERS.

About IRADIMED CORPORATION

IRADIMED CORPORATION is the only known provider of non-magnetic intravenous (IV) infusion pump systems that are specifically designed to be safe for use during magnetic resonance imaging (MRI) procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components which can create radio frequency (RF) interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system. Our patented MRidium MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor, uniquely-designed non-ferrous parts and other special features in order to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. Our pump solution provides a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan, which is important to critically-ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated in order to remain immobile during an MRI scan.

MRidium is a trademark of IRADIMED CORPORATION.

For more information please visit www.iradimed.com.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Act of 1995, particularly statements regarding our expectations, beliefs, plans, intentions, future operations, financial condition and prospects, and business strategies. These statements relate to future events or our future financial performance or condition and involve unknown risks, uncertainties and other factors that could cause our actual results, level of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. The risks and uncertainties referred to above include, but are not limited to, risks associated with the Company’s ability to receive clearance of its 510(k) submission, additional actions by or requests from the FDA (including a request to cease domestic distribution of products) and unanticipated costs or delays associated with resolution of these matters; our reliance on a single product; unexpected costs, expenses and diversion of management attention resulting from the FDA warning letter; potential disruptions in our limited supply chain for our products; a reduction in international distribution as we focus on fulfilling orders from our U.S. backlog; actions of the FDA or other regulatory bodies that could delay, limit or suspend product development, manufacturing or sales; the effect of recalls, patient adverse events or deaths on our business; difficulties or delays in the development, production, manufacturing and marketing of new or existing products and services; changes in laws and regulations or in the interpretation or application of laws or regulations.

Further information on these and other factors that could affect the Company’s financial results is included in filings we make with the Securities and Exchange Commission from time to time. All forward-looking statements are based on information available to us on the date hereof, and we assume no obligation to update forward-looking statements.

Media Contact:
Chris Scott
Chief Financial Officer
IRADIMED CORPORATION
(407) 677-8022 
InvestorRelations@iradimed.com
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(STAF) Pre-Announces Fiscal Year 2016 Revenue of $165 Million

Revenue for the Fiscal Fourth Quarter Expected to Be $44 Million, a 38% Increase Over the Same Period Last Year of $32 Million

NEW YORK, NY–(June 09, 2016) – Staffing 360 Solutions, Inc. (NASDAQ: STAF), a public company executing a global buy-and-build strategy through the acquisition of staffing organizations in the US and the UK, today announced that it expects the Company’s reported revenue for fiscal year 2016 to be $165 million, an increase of 28% compared to fiscal year 2015 revenue of $129 million.

For the fourth quarter ended May 31, 2016, the Company expects revenue to be $44 million, an increase of 38% compared to the same period last year of $32 million.

The Company expects to announce its financial results for the fiscal year ended May 31, 2016 via press release and Form 10-K before the SEC filing deadline, along with an earnings conference call.

“We continue to achieve record quarterly revenue, bringing our annual run-rate in excess of the $175 million level,” stated Brendan Flood, Executive Chairman of Staffing 360 Solutions. “Compared to $129 million last year, this is a major testament to our consolidation strategy. Our most recent fiscal year includes the acquisitions of Lighthouse Placement Services and The JM Group, two great additions to the Staffing 360 story. As we continue to grow and complete acquisitions, we remain highly focused on boosting our top line and realizing cost synergies.”

Matt Briand, President and CEO of Staffing 360 Solutions, further remarked, “Achieving this level of revenue is a remarkable achievement for our management team and our employees alike. We look forward to sharing more details shortly when we announce our full results. This will be the largest single quarterly revenue figure in the company’s history.”

Staffing 360 Solutions believes that a consolidation strategy is ideally suited for the highly fragmented temporary staffing industry. The management team has been engaged in the development of a comprehensive program to create a robust pipeline of prospective acquisitions, with a longer term objective of driving annual revenues to $300 million.

For more information about Staffing 360 Solutions and complete investor materials such as investor presentations, white papers and webcasts of past earnings calls, please visit:

www.staffing360solutions.com/res.html

About Staffing 360 Solutions, Inc.

Staffing 360 Solutions, Inc. (NASDAQ: STAF) is a public company in the staffing sector engaged in the execution of a global buy-and-build strategy through the acquisition of domestic and international staffing organizations in the US and the UK. The Company believes the staffing industry offers opportunities for accretive acquisitions that will drive its annual revenues to $300 million. As part of its targeted consolidation model, the Company is pursuing acquisition targets in the finance and accounting, administrative, engineering and IT staffing space. For more information, please visit: www.staffing360solutions.com.

Follow Staffing 360 Solutions on Facebook, LinkedIn and Twitter.

Forward-Looking Statements

Certain matters discussed within this press release are forward-looking statements including, but not limited to the timing and ability to enter into any additional acquisitions, as well as the size of future revenue. Although Staffing 360 Solutions, Inc. believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Specifically, in order for the Company to achieve annualized revenues of $300 million, the Company will need to successfully raise sufficient capital, to consummate additional target acquisitions, successfully integrate any newly acquired companies, organically grow its business, successfully defend current and any potential future litigation, as well as various additional contingencies, many of which are unknown at this time and generally out of the Company’s control. The Company can give no assurance that it will be able to achieve these objectives. Staffing 360 Solutions does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. Factors that could cause actual results to differ materially from expectations include general industry considerations, regulatory changes, changes in local or national economic conditions and other risks detailed from time to time in Staffing 360 Solutions’ reports filed with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K.

 

Investor Relations Firm:
PCG Advisory Group
Stephanie Prince
Managing Director
646.762.4518
Email contact


Corporate Investor Contact:

Staffing 360 Solutions, Inc.
Darren Minton
Executive Vice President
212.634.6413
Email contact


Financial Contact:

Staffing 360 Solutions, Inc.
David Faiman
Chief Financial Officer
212.634.6410
Email contact

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(SPHS) Reports Successful Results from Completed Phase 2a Study of Topsalysin

Topsalysin successfully ablated tumor cells in patients with clinically significant localized disease Investor webcast scheduled for today at 2:00 p.m. Pacific Time

SAN DIEGO and VANCOUVER, British Columbia, June 9, 2016 – Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, today announced the biopsy results from all 18 patients enrolled in the Phase 2a proof of concept study of topsalysin in localized prostate cancer. The one-time administration of topsalysin was well tolerated with no serious adverse events and no new safety signals being reported. Topsalysin demonstrated an ability to ablate tumor cells in 50 percent of patients (9/18 patients) six months after treatment in a patient population with pre-identified, clinically significant prostate cancer. The results support advancing topsalysin into a Phase 2 study to confirm dose and optimize delivery.

“These promising early results open up the possibility of treating early prostate cancer by the simple administration of an injection into the prostate – something that could be done in an office setting,” according to Dr. Mark Emberton, Investigator, Dean, Faculty of Medical Sciences, University College London and Honorary Consultant Urologist at University College London Hospital NHS Foundation Trust.

All 18 patients enrolled completed the study. Biopsy data at six months following treatment showed that:

  • Two men experienced complete ablation of their targeted tumor with no evidence of any tumor remaining at 6 months;
  • Seven men experienced a partial response, defined as either a reduction in the maximum cancer core length or a reduction in Gleason pattern;
  • Nine patients had no response to treatment.

“It was impressive to observe complete tumor ablations in this proof of concept study. We have demonstrated that topsalysin can safely ablate prostate tumor cells, so these responses increase our confidence that topsalysin could obviate or prolong the time to the need for radical therapy in this patient population,” stated Dr. Hashim Ahmed, Principal Investigator for the study, Division of Surgery and Interventional Sciences, University College London. “With the experience from this study, we believe we can further improve responses by optimizing dosing topsalysin based on the size of the tumor and not the prostate and optimizing the delivery of topsalysin, which we will confirm in a larger Phase 2 study.”

Allison Hulme, Ph.D., chief operating officer and head of research and development at Sophiris, added: “The breakthrough for us is the ability to inject topsalysin, an enzymatically-activated ablative agent, directly into the identified tumor using imaging technology. Topsalysin has been engineered to be activated only by enzymatically-active PSA, which is only found in the prostate tissue. We believe that with the favorable side effect profile observed to date, topsalysin has the potential to become a focal targeted therapy for the ablation of localized prostate cancer while avoiding many of the complications and side effects associated with radical treatments that are aimed at the entire prostate.”

The Phase 2a proof of concept study was a single-center, open-label study at University College London, which is well known for the focal treatment of prostate cancer in the UK. In this study, previously obtained multiparametric magnetic resonance images (mpMRIs) of each patient’s prostate tumor lesions are mapped to real-time three-dimensional transrectal ultrasound using an elastic image-fusion software. These images are used to guide the injection of topsalysin to treat a single, histologically-proven, clinically significant prostate cancer lesion. The primary objective of the study was to evaluate the safety and tolerability, and the key efficacy variable was the change in the treated lesion on targeted biopsy after 6 months. The study was designed to assess whether topsalysin has the potential to provide patients with clinically significant, localized, low to intermediate risk prostate cancer a tissue-sparing cancer treatment that carries little in the way of side effects. A total of 18 patients were enrolled and treated in this study. Detailed results from this study will be presented at a future medical conference.

Webcast scheduled for today at 2:00 p.m. Pacific Time

The Sophiris management team will host a conference call and webcast today, June 9, at 2:00 p.m. Pacific Time to review the topsalysin prostate cancer data. Dr. Hashim Ahmed, University College London and Principal Investigator of the prostate cancer study will also participate in the call.

A live audio webcast will be accessible on the “Investor Relations” page of the Sophiris corporate website at www.SophirisBio.com. A replay will be available at the same location.

About Localized Prostate Cancer

Prostate cancer is the second most common form of cancer in men in the US with an estimated 220,800 new cases in 2015. Approximately 80 percent of patients in the US are diagnosed with localized disease. Research has shown that patients with early, localized disease have a low likelihood of the cancer spreading beyond the confines of the prostate; however, many men with clinically significant localized disease choose to undergo radical treatment. Radical therapies include surgery to remove the entire prostate and/or radiation. Potential toxicities from radical treatments can be significant and permanent and include erectile dysfunction, urinary incontinence, and rectal toxicity.

Topsalysin for the Targeted Treatment of Localized Prostate Cancer

Topsalysin (PRX302) has the potential to provide a focal targeted therapy for the ablation of localized prostate cancer while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in mapping previously obtained mpMRI images with real-time three-dimensional ultrasound images enables physicians to more accurately locate tumors within the prostate when taking biopsies. This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate.

Topsalysin, an inactivated pore-forming protein, was engineered to be activated only by enzymatically-active PSA, which is present only in prostate tissue. The targeted focal treatment of prostate cancer is in line with current treatments for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ as possible.

About Sophiris

Sophiris Bio Inc. is a biopharmaceutical company developing topsalysin, a clinical-stage, targeted therapy for the treatment of urological diseases. Topsalysin has successfully completed a Phase 3 clinical study for the treatment of the symptoms of benign prostatic hyperplasia (BPH), and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Topsalysin has also successfully completed a Phase 2a study for the treatment of clinically significant, localized low to intermediate risk prostate cancer prior to radical therapy. For more information, please visit www.sophiris.com.

Certain statements included in this press release may be considered forward-looking, including expectations about the potential use of topsalysin for the ablation or focal treatment of prostate cancer tumors, expectations that the Company will able to use data from the proof of concept study to develop more effective delivery and dosing protocols for future clinical trials and implications that the Company will be able to continue to advance the development of topsalysin.  Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Some of the risks and uncertainties that could cause actual results, performance or achievements to differ include without limitation, risk associated with clinical trial development, including the risks that clinical data from a subset of patients may not be predicative of clinical data observed in subsequent patients or in subsequent clinical trials of the same drug candidate and other risks associated with the process of developing, manufacturing commercial scale drug products, obtaining regulatory approval of and commercializing treatments that are safe and effective, and risks relating to obtaining sufficient capital to enable the Company to continue to operate as a going concern and continue to advance clinical development of topsalysin.  All forward-looking statements are based on Sophiris’ current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, clinical trial results, market acceptance, ability to raise capital and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Thursday, June 9th, 2016 Uncategorized Comments Off on (SPHS) Reports Successful Results from Completed Phase 2a Study of Topsalysin

(JAGX) Announces $15 Million Common Stock Purchase Agreement

Jaguar Animal Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, announced today that it has entered into a $15 million common stock purchase agreement (the “Agreement”) and a registration rights agreement with Aspire Capital Fund, LLC (“Aspire”), a Chicago-based institutional investor. Immediately upon the execution of the Agreement, Aspire purchased 222,222 shares of Jaguar common stock for $500,000.

After a registration statement related to the transaction has been filed and declared effective by the U.S. Securities and Exchange Commission, Jaguar will have the right to sell up to the remaining $14.5 million of its common stock to Aspire under the Agreement over a 30-month period, at prices based on prevailing market prices at the time of each sale, and Aspire has the obligation to purchase common stock from Jaguar in amounts and timing determined by Jaguar in its sole discretion. The Agreement does not contain any financial covenants, restrictions on future financings, rights of first refusal, limits to the use of any of the proceeds, participation rights or penalties. Jaguar can terminate the Agreement at any time without any penalty.

“This Agreement provides Jaguar with added balance sheet strength and flexibility to support our ongoing clinical activities and the expected commercialization of our drug product candidates, and we welcome Aspire as a stockholder,” commented Lisa Conte, Jaguar’s president and CEO. “Additionally, we expect that this Agreement may serve as an important asset as Jaguar continues discussions regarding potential business development and M&A activity.”

Jaguar and Napo Pharmaceuticals, Inc. (“Napo”) have been engaged in exploratory discussions since February 2016 regarding a potential merger and/or other ways to cooperate with their respective business endeavors. San Francisco-based Napo owns 26.3% of the outstanding shares of Jaguar Animal Health, Inc. Napo took over ownership of the new drug application (“NDA”) and commercial rights for human applications of crofelemer last month from Valeant Pharmaceuticals International Inc., which acquired those rights from Salix Pharmaceuticals, Inc. in April 2016.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

For additional information about the common stock purchase agreement and registration rights agreement with Aspire, refer to the current report on Form 8-K filed on June 9, 2016 with the Securities and Exchange Commission.

About Jaguar Animal Health, Inc.

Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Canalevia is Jaguar’s lead prescription drug product candidate, intended for the treatment of various forms of diarrhea in dogs. SB-300 is Jaguar’s prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia and SB-300 contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm Calf and Neonorm Foal are the Company’s lead non-prescription products. Neonorm is a standardized botanical extract derived from the Croton lechleri tree. Canalevia and Neonorm are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm in six additional target species, formulations of SB-300 in horses, and Canalevia for cats and dogs.

For more information, please visit www.jaguaranimalhealth.com.

About Aspire Capital Fund, LLC

Aspire Capital is an institutional investor based in Chicago, Illinois, with a focus on making direct investments in publicly traded companies in a broad range of industries and investment structure. The company offers innovative investments designed for companies whose prospects are bright, but who need additional capital to fuel growth.

Important Safety Information:

Crofelemer is currently FDA approved only for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Rule out infectious etiologies of diarrhea before starting crofelemer, in order to avoid the risk of potential worsening of disease due to delay of appropriate therapy. The most common adverse reactions (incidence > 3%) seen with crofelemer in the registrational trial for US approval were upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s ability to sell shares to Aspire under the terms of the agreement with them, whether the registration statement related to the financing with Aspire will become and remain effective with the SEC, the expected commercialization of the Company’s drug product candidates, Jaguar’s expectation that the Agreement with Aspire may serve as an important asset as the Company continues discussions regarding potential business development and M&A activity, Jaguar’s intention to develop formulations of SB-300 in horses and species-specific formulations of Neonorm in additional target species, and the Company’s plan to develop formulations of Canalevia for cats and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Jaguar-JAGX

 

KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com

Thursday, June 9th, 2016 Uncategorized Comments Off on (JAGX) Announces $15 Million Common Stock Purchase Agreement

(OPCO) Now Licensing Polymer Bonded Pet Bowl Patent

FAIRPORT HARBOR, OH–(June 09, 2016) – OurPet’s Company (OTCQX: OPCO) announced the general licensing of U.S. Patent US 8,973,529 B1 to qualified companies. The technology relates to the application of a polymer material to the bottom of pet stainless steel bowls to minimize sliding and noise while pets are feeding. Patent US 8,973,529 B1 was issued March 10, 2015.

This licensing decision does not affect the remainder of the OurPet’s patent portfolio, including patent US 8,286,589 B1 that was issued October 16, 2012 that covers the application of a polymer to the bottom and slightly up the side of the stainless steel bowl. OurPet’s offers a wide selection of quality polymer bonded stainless steel bowls under its Durapet® brand as well as under private label.

Commented Dr. Steven Tsengas, OurPet’s CEO, “The polymer bonding on stainless steel technology has proven very popular and has attracted many domestic and foreign competitors who have not always appreciated US patent regulations, thus necessitating legal action.” To date OurPet’s has successfully defended both patents against domestic and foreign companies, has licensed six companies and is negotiating with two more. Litigation has proven time-consuming, expensive and sometimes disruptive, especially when litigation against an infringing company has suddenly halted supplies to their retailer. It is hoped that the licensing of U.S. Patent US 8,973,529 will expand the usage of the technology and enhance OurPet’s’ overall profitability.

OurPet’s has rapidly grown through the development and marketing of innovative products for improving the health, safety, comfort and enjoyment of pets. Its intellectual technology is covered by over 170 patents issued or pending and accounts for approximately 75 percent of revenues. OurPet’s specializes in three main areas — toys and accessories for healthy mental and physical stimulation, waste and odor management and healthy, comfortable feeding systems. Since its founding 21 years ago, OurPet’s has set industry trends such as elevated feeding (Big Dog Feeder®), interactive/electronic sound cat toys (Play-N-Squeak®), quality rubber bonded stainless steel bowls (Durapet® bowls), cork/catnip agglomerate cat toys (Corknip®) and more recently Intelligent Pet Care™ (Bluetooth/Wi-Fi technology for improving human/pet connectivity).

For more information regarding OurPet’s Company or licensing under patent US 8,973,529 B1 please contact:
Dr. Steven Tsengas
CEO
OurPet’s Company
stsengas@ourpets.com
Phone: (440) 354-6500
www.ourpets.com

Thursday, June 9th, 2016 Uncategorized Comments Off on (OPCO) Now Licensing Polymer Bonded Pet Bowl Patent

(IVTY) to Present at the William Blair 36th Annual Growth Stock Conference

SAN FRANCISCO, June 08, 2016 — Invuity, Inc. (NASDAQ:IVTY), a leading surgical photonics company, today announced that company management is scheduled to present at the William Blair 36th Annual Growth Stock Conference on Thursday, June 16, 2016, at 8:40 a.m. Central Time in Chicago.

A live, listen-only webcast of the presentation may be accessed by visiting the Events & Presentations section of the Company’s website at www.invuity.com under Investors & Media.  A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the Company’s website for 30 days following the presentation.

About Invuity®
Invuity, Inc. is a medical technology company focused on developing and marketing advanced photonics devices to improve the ability of surgeons to illuminate and visualize the surgical cavity during open minimally invasive and minimal access surgery. The company’s patented Intelligent Photonics™ technology enables enhanced surgical precision, efficiency and safety by providing superior visualization. Clinical applications include breast and thyroid oncology, plastic reconstructive, spine, orthopedic, cardiothoracic and general surgery among others. Invuity is headquartered in San Francisco, CA. For more information, visit www.invuity.com.

 

CONTACT:

Company Contact:
Jim Mackaness
Chief Financial Officer
Invuity, Inc.
415-655-2129

Investors:
Mark Klausner
Westwicke Partners
443-213-0501
irdept@invuity.com
Wednesday, June 8th, 2016 Uncategorized Comments Off on (IVTY) to Present at the William Blair 36th Annual Growth Stock Conference

(APTO) and CrystalGenomics Exclusive Inhibitor Agreement

TORONTO and SEOUL, South Korea, June 08, 2016  — Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) and CrystalGenomics, Inc. (KOSDAQ:083790) today announced an exclusive global option and license agreement focused on the development of CG026806 (CG’806), a first-in-class, highly potent, non-covalent small molecule inhibitor of the Bruton’s tyrosine kinase (BTK), FMS-like tyrosine kinase 3 (FLT3) and the Aurora kinases (AURK). Further to enacting the agreement, Aptose expects to undertake Investigational New Drug (IND) enabling studies immediately, and, if it exercises its option under the agreement, to initiate a Phase 1 clinical trial by mid 2017.

The potential option exercise would occur prior to submission of an IND application in the U.S.  Upon exercise of the option, Aptose will own global rights to develop and commercialize the program outside of Korea and China – the Licensed Territory.  Total deal value is up to $303 million USD, inclusive of development, regulatory and commercial-based milestones. CrystalGenomics will also receive a single-digit royalty on sales in the Licensed Territory.

CG‘806 has the potential to serve as a transformational agent for multiple forms of cancer, particularly those resistant to current BTK inhibitors or those that possess the FLT3-ITD alteration.  BTK plays a critical role in B-cell hematologic malignancies, such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), and certain autoimmune diseases.  FLT3, including the Internal Tandem Duplication (ITD), a mutation of the FLT3 gene, occurs in approximately 30-35% of patients with acute myeloid leukemia (AML).  Aurora kinases participate in the epigenetic phosphorylation of histones and are key drivers in a series of hematologic malignancies and solid tumors.

“CG’806 offers a unique capacity through a non-covalent, reversible mechanism to inhibit wild type and mutant forms of the validated BTK, FLT3 and AURK targets, but with the discretion to offer a robust safety profile,” commented Avanish Vellanki, Senior Vice President and Chief Business Officer of Aptose. “Indeed, we are impressed by the ability of once-daily oral dosing of CG’806 to demonstrate tumor eradication in the absence of toxicity in murine xenograft models of human hematologic malignancies,” added William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose.

“We are excited to work with the Aptose team, which is uniquely qualified to accelerate development of our  BTK/FLT3/AURK inhibitors, including our lead compound CG’806,” said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics.  “With a demonstrated commitment to high scientific and development standards, Aptose and its clinical advisors recognize the potential of this class of anticancer compounds and will make clinical development a priority.”

“The in vivo potency of CG’806 shows unprecedented potential,” said Michael Andreeff, M.D., Ph.D., Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center (MDACC), and a member of the Aptose Scientific Advisory Board. “The combination of this candidate’s potency with a stellar in vivo safety profile gives us enthusiasm for CG’806 as a therapeutic option for patients with AML, CLL and other malignancies.”

About CrystalGenomics

CrystalGenomics, Inc. is a commercial stage biopharmaceutical company focused in the structure-based drug discovery and development of novel therapeutics in unmet medical need areas of inflammation, oncology, and infectious disease. In addition to several drug programs in the R&D pipeline, the Company has one drug on the market for osteoarthritis and, has recently added commercial manufacturing capabilities through acquisitions. CrystalGenomics, Inc. is listed on KOSDAQ (083790).

About Aptose

Aptose Biosciences is a clinical-stage biotechnology company committed to discovering and developing personalized therapies addressing unmet medical needs in oncology. Aptose is advancing new therapeutics focused on novel cellular targets on the leading edge of cancer research coupled with companion diagnostics to identify the optimal patient population for our products. The company’s small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. For further information, please visit www.aptose.com. Aptose Biosciences Inc. is listed on NASDAQ under the symbol APTO and on the TSX under the symbol APS.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws. Such statements include, but are not limited to, statements relating to the exclusive global option and license agreement between Aptose and CrystalGenomics and the potential exercise of the option under the agreement by Aptose, the potential clinical development of CG’806 and its therapeutic effects, that the Aptose team is uniquely qualified to accelerate the development of CG’806 as well as statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “should”, “would”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; uncertainty in the length of the clinical hold and the conditions the FDA may impose to lift it; potential loss of API; inability of new manufacturers to produce acceptable batches of cGMP clinical supplies in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.

Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.

For further information, please contact:

Aptose Biosciences Inc.
Avanish Vellanki
Senior Vice President, Chief Business Officer
650-718-5021
avellanki@aptose.com 

CrystalGenomics, Inc.
Steven Kim
Director, Business Development
+82-31-628-2720
skim@cgxinc.com 

BCC Partners
Karen L. Bergman or Susan Pietropaolo
650-575-1509 or 845-638-6290 
kbergman@bccpartners.com or spietropaolo@bccpartners.com
Wednesday, June 8th, 2016 Uncategorized Comments Off on (APTO) and CrystalGenomics Exclusive Inhibitor Agreement

(BDSI) to Present at the William Blair Annual Growth Stock Conference

RALEIGH, N.C., June 8, 2016  — BioDelivery Sciences International, Inc. (NASDAQ: BDSI) will present at the William Blair Annual Growth Stock Conference.  The presentation, which will be webcast, is scheduled for Wednesday, June 15, 2016, at 11:40 AM Eastern Time at the Four Seasons Hotel in Chicago.

BDSI will discuss recently announced strategic initiatives supporting BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) and the launch of BELBUCA™ (buprenorphine) buccal film (CIII) by BDSI’s commercial partner, Endo Pharmaceuticals.  Also covered will be an update on the development of Clonidine Topical Gel for painful diabetic neuropathy and the buprenorphine 30 day injection for opioid dependence and chronic pain.

The presentation will be webcast live and can be accessed at www.bdsi.com.  For those who are not available to listen to the live broadcast, replay of the webcast will be available on the BDSI website.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine.  BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.

BDSI’s development strategy focuses on utilization of the FDA’s 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.

BDSI’s particular area of focus is the development and commercialization of products in the areas of pain management and addiction. These are areas where BDSI believes its drug delivery technologies and products can best be applied to address critical unmet medical needs.  BDSI’s marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain, painful diabetic neuropathy and opioid dependence.  BDSI’s headquarters is located in Raleigh, North Carolina.

For more information, please visit or follow us:
Internet:          www.bdsi.com
Facebook:      Facebook.com/BioDeliverySI
Twitter:           @BioDeliverySI

BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is marketed in the U.S. by BioDelivery Sciences.  BELBUCA™ (buprenorphine) buccal film (CIII) is commercialized in the U.S. by Endo Pharmaceuticals pursuant to the worldwide licensing and development agreement between BDSI and Endo.  ONSOLIS® (fentanyl buccal soluble film) (CII) is commercialized in the U.S. by Collegium Pharmaceutical pursuant to the U.S. licensing and development agreement between BDSI and Collegium. For full prescribing information and important safety information on BDSI products, including BOXED WARNINGS for ONSOLIS, please visit www.bdsi.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at (800) 469-0261.  For full prescribing and safety information on BELBUCA, please visit www.belbuca.com.

Cautionary Note on Forward-Looking Statements

This press release, the presentation described herein, and any statements of employees, representatives and partners of BioDelivery Sciences International, Inc. (the “Company”) related thereto (including, without limitation, at the presentation described herein) contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve significant risks and uncertainties.  Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions.  These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission.  Actual results (including, without limitation, the results of commercialization efforts for the Company’s approved products and the clinical trials for, and regulatory review of, the Company’s products in development) may differ significantly from those set forth in the forward-looking statements.  These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control).  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

BDSI®, BEMA®, ONSOLIS® and BUNAVAIL® are registered trademarks of BioDelivery Sciences International, Inc.  The BioDelivery Sciences and BUNAVAIL logos are trademarks owned by BioDelivery Sciences International, Inc.  BELBUCA™ is a trademark owned by Endo Pharmaceuticals.  All other trademarks and tradenames are owned by their respective owners.

© 2016 BioDelivery Sciences International, Inc.  All rights reserved.

Wednesday, June 8th, 2016 Uncategorized Comments Off on (BDSI) to Present at the William Blair Annual Growth Stock Conference

(ACUR) LIMITX™ Confirms Oral Abuse Deterrence Capabilities

Topline Results From Study AP-LTX-400 Cohort 2

PALATINE, IL–(June 08, 2016) – Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that topline results from cohort 2 of clinical study AP-LTX-400 (Study 400) confirmed that LTX-04P tablets, a hydromorphone hydrochloride immediate-release tablet using the Company’s new LIMITX oral abuse deterrent technology, successfully retarded the release of the active opioid ingredient when four, six and eight intact tablets were ingested. The Company previously announced similar abuse deterrent findings from cohort 1 of Study 400 for a 3 tablet dose of LTX-04P but that additional formulation development will be required for LTX-04P to deliver a sufficient amount of the active ingredient to patients when one or two tablets are administered. The Company expects to resume clinical testing of a new formulation of LTX-04 in the fourth quarter of 2016 following completion of ongoing reformulation work and a discussion with the U.S. Food and Drug Administration (FDA) regarding the results of Study 400.

The patented LIMITX technology works by neutralizing stomach acid as increasing numbers of tablets are swallowed and relying on stomach acid to play a role in the release of the active ingredient from micro-particles contained in the tablets.

Cohort 2 of Study 400 studied 4, 6 and 8 tablet dosage subgroups of LTX-04P against the marketed comparator product, DILAUDID. Cohort 1 studied 1, 2 and 3 tablet dosage subgroups. Study 400 measured the rate and extent of absorption of the active drug ingredient into the blood stream with the maximum drug concentration, or Cmax, typically associated with an increase in drug abuse. Subjects in Study 400 had an average 22% reduction in relative Cmax when 3 or more tablets were ingested as shown in the table below.

Study 400 – Mean Ratio of Cmax (ng/mL) by Dosing Group
Compared to the 1 Tablet Group for the Same Formulation
Dosing in mg DILAUDID LTX-04P Change
2 Tablet Group 2x 1.9x 2.2x 15%
3 Tablet Group 3x 4.8x 3.8x -22%
4 Tablet Group 4x 6.4x 4.8x -25%
6 Tablet Group 6x 6.2x 5.2x -15%
8 Tablet Group 8x 8.4x 6.8x -18%
Average 3-8 -22%

All Subjects in cohort 2 had extent of drug absorption (measured by AUC) for LTX-04P comparable to DILAUDID when the same number of tablets were ingested. Likewise, the time to maximum plasma concentration, or Tmax, was comparable at all doses. All doses in Study 400 were generally well tolerated with no serious adverse event reported.

Dr. Al Brzeczko, Acura’s Vice President of Technical Affairs commented, “We are excited the dosing levels studied in cohort 2 of Study 400 confirmed the LIMITX technology concept of reducing Cmax as higher, more abused doses are ingested. Study 400 provided us with a wealth of data that we will mine to adjust our formulation to achieve better performance for the one and two tablet doses. We will also look to see if we can improve upon the abuse deterrent performance as well.”

“To see this level of abuse deterrence with our first test formulation is wonderful for this new technology,” noted Bob Jones, President and CEO of Acura. “We look forward to completing our analysis of Study 400, finishing our reformulation and getting back in the clinic as soon as possible.”

The Company continues to advance its reformulation work on the LIMITX technology micro-particles to improve the drug delivery with one and two tablets and hopes to have a dialogue with the FDA regarding these results and the next clinical phase under its Fast Track development designation for LTX-04.

About Study AP-LTX-400

StudyAP-LTX-400 (Study 400) is a two cohort, open label, crossover design pharmacokinetic study in healthy adult subjects. Cohort 1 enrolled 30 subjects who were randomized into three subgroups of 10 taking either 1, 2 or 3 tablets. Each subgroup subject orally swallowed the planned number of tablets in a randomized manner taking single doses of two different test formulations of LTX-04 (designated as LTX-04P and LTX-04S) and the marketed drug DILAUDID as a comparator. All tablets contained 2mg of hydromorphone hydrochloride. The 1, 2 and 3 tablets subgroups in Cohort 1 completed 8, 10 and 8 subjects, respectively.

Cohort 2 enrolled 30 subjects who were randomized into three subgroups of 10 taking either 4, 6 or 8 tablets. Each subgroup subject orally swallowed the planned number of tablets in a randomized manner taking single doses of LTX-04P and the marketed drug DILAUDID as a comparator. The 4, 6 and 8 tablets subgroups in Cohort 2 completed 8, 9 and 8 subjects, respectively.

All tablets contained 2mg of hydromorphone hydrochloride. All subjects received doses of naltrexone and there was a one week washout between doses. Blood samples were taken at pre-designated time-points after dosing and were subsequently analyzed for the concentration of hydromorphone contained in the sample. All subjects in Cohort 1 had continuous pH (a measure of acid concentration) monitoring of their stomach acid. The objective of Cohort 1 was to determine if adequate active drug entered the blood stream when one or two LIMITX tablets were swallowed and to begin assessing the ability of the LIMITX technology to start retarding the release of active ingredients when three tablets are ingested. The objective of Cohort 2 was to further explore the extent the release of the hydromorphone active ingredient from LTX-04P tablets is retarded as the dose level increases to abusive levels. A safety assessment of LIMITX Hydromorphone will be made from both study cohorts.

LTX-04 is being developed in part with a grant from the National Institute on Drug Abuse (NIDA). NIDA is not responsible for the results of any of the research. The LTX-04 development program is also designated as Fast Track by the FDA for its potential to address an unmet medical need.

To further discuss these results Acura’s management will host a live conference call and webcast at 8:30 am ET on Thursday, June 9, 2016. The presentation will be webcast live and may be accessed by visiting the Company’s website, Acurapharm.com and selecting the “News and Events” option under the “Investors” tab. For those wishing to listen only you may dial 1-888-576-4398 with passcode 1705487. A replay of the webcast will be available for 60 days on the Acura website.

About Acura Pharmaceuticals

Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.

OXAYDO® (oxycodone HCl immediate-release tablets) which incorporates the AVERSION Technology, is FDA approved and marketed in the U.S. by our partner Egalet Corporation.

Acura markets NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Forward-looking statements may include, but are not limited to:

  • our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITX and Impede® technologies;
  • the expected results of clinical studies relating to LTX-04P, the date by which such study results will be available and whether LTX-04P will ultimately receive FDA approval;
  • whether LIMITX will retard the release of opioid active ingredients as dose levels increase;
  • whether we will be able to reformulate LTX-04P to provide an efficacious level of drug when one or two tablets are taken;
  • whether we will be able to reformulate LTX-04P to improve its abuse deterrent performance;
  • whether the extent to which products formulated with the LIMITX technology deter abuse will be determined sufficient by the FDA to support approval or labelling describing abuse deterrent features;
  • whether our LIMITX technology can be expanded into extended-release formulations;
  • our and our licensee’s ability to successfully launch and commercialize our products and technologies, including Oxaydo® Tablets and our Nexafed® products;
  • our and our licensee’s ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;
  • the market acceptance of, timing of commercial launch and competitive environment for any of our products;
  • expectations regarding potential market share for our products;
  • our ability to develop and enter into additional license agreements for our product candidates using our technologies;
  • the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;
  • the ability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation;
  • the ability to fulfill the FDA requirements for approving our product candidates for commercial manufacturing and distribution in the United States, including, without limitation, the adequacy of the results of the laboratory and clinical studies completed to date, the results of laboratory and clinical studies we may complete in the future to support FDA approval of our product candidates and the sufficiency of our development process to meet over-the-counter (“OTC”) Monograph standards, as applicable;
  • the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support FDA approval of our product candidates;
  • changes in regulatory requirements;
  • adverse safety findings relating to our commercialized products or product candidates in development;
  • whether the FDA will agree with our analysis of our clinical and laboratory studies;
  • whether further studies of our product candidates will be required to support FDA approval;
  • whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications and whether we will be able to promote the features of our abuse discouraging technologies; and
  • whether Oxaydo or our Aversion and LIMITX product candidates will ultimately deter abuse in commercial settings and whether our Nexafed products and Impede technology product candidates will disrupt the processing of pseudoephedrine into methamphetamine.

In some cases, you can identify forward-looking statements by terms such as “may,” “will”, “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “indicates”, “projects,” predicts,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in our filings with the Securities and Exchange Commission.

DILAUDID is a trademark of Purdue Pharma L.P.

Contact:
for Acura Investor Relations
Email contact

847-705-7709

Renmark Financial Communications Inc.
Robert Thaemlitz
Email contact

(416) 644-2020 or (514) 939-3989
www.renmarkfinancial.com

Wednesday, June 8th, 2016 Uncategorized Comments Off on (ACUR) LIMITX™ Confirms Oral Abuse Deterrence Capabilities

(FNJN) Announces License and Settlement Agreement With Proofpoint

EAST PALO ALTO, CA–(Jun 8, 2016) – Finjan Holdings, Inc. (NASDAQ: FNJN), a cybersecurity company, and its subsidiary Finjan, Inc. (“Finjan”), today announced that Finjan and Proofpoint have reached a mutually agreed patent license, settlement and release agreement (“the Agreement”). Specifically, Case No. 3:15-cv-5808-HSG, entitled Finjan, Inc. v. Proofpoint, Inc. and Armorize Technologies, Inc. (collectively “Proofpoint”), pending before the Honorable Haywood S. Gilliam, Jr. in the U.S. District Court for the Northern District of California, was dismissed with prejudice on June 7, 2016.

As part of the settlement, Proofpoint will obtain a license to the Finjan patent portfolio and pay an aggregate of $10.9 million in cash as follows: (A) $4.3 million within three (3) business days of execution of the definitive agreement, which Finjan received on June 6, 2016, (B) $3.3 million on or before January 4, 2017, and (C) $3.3 million on or before January 3, 2018. The terms of the Agreement are confidential.

ABOUT FINJAN
Established nearly 20 years ago, Finjan is a globally recognized leader in cybersecurity. Finjan’s inventions are embedded within a strong portfolio of patents focusing on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan continues to grow through investments in innovation, strategic acquisitions, and partnerships promoting economic advancement and job creation. For more information, please visit www.finjan.com.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, the matters set forth herein that are forward-looking statements involve certain risks and uncertainties that could cause actual results to differ. Potential risks and uncertainties include, but are not limited to, Finjan’s expectations and beliefs regarding Finjan’s licensing program, the outcome of pending or future enforcement actions, the granting of Inter Partes Review (IPR) of our patents or an unfavorable determination pursuant to an IPR or other challenges at the USPTO of our patents, the enforceability of our patents, the cost of litigation, the unpredictability of our cash flows, our ability to expand our technology and patent portfolio, the continued use of our technologies in the market, our stock price, changes in the trading market for our securities, regulatory developments, general economic and market conditions, the market acceptance and successful business, technical and economic implementation of Finjan Holdings’ intended operational plan; and the other risk factors set forth from time to time in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2015, and the Company’s periodic filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from Finjan Holdings, Inc. All forward-looking statements herein reflect our opinions only as of the date of this release. These statements are not guarantees of future performance and actual results could differ materially from our current expectations. Finjan Holdings undertakes no obligation, and expressly disclaims any obligation, to update forward-looking statements herein in light of new information or future events.

Investor Contact:
Vanessa Winter
Finjan Holdings, Inc.
Alan Sheinwald or Valter Pinto
Capital Markets Group LLC
(650) 282-3245
investors@finjan.com

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(BLIN) Sets Eyes on Mid-Market Expansion with iAPPS Pro

New product offering more than triples market opportunity

BURLINGTON, Mass., June 08, 2016  — Bridgeline Digital Inc. (NASDAQ:BLIN) announced today the launch of their new iAPPS Pro product line, a Web Experience Management System catering to the mid-market and nimble enterprise companies. The SaaS-based solution offers fully integrated marketing automation, web content management and eCommerce capabilities for companies and retailers.

Built on the 2015 CODiE award winning iAPPS platform, iAPPS Pro combines the enterprise capabilities inherent in the technology with a set of highly flexible modules and common functionality – enabling midmarket and enterprise companies to use this robust functionality while benefiting from the inherent efficiency gained from repeatable functionality blocks.

“iAPPS is an established player in the web content management space – it powers thousands of websites,” Ari Kahn, CEO at Bridgeline Digital said. “Over the past year we made a substantial investment in repeatable building blocks – a set of flexible modules that we see in nearly every website out there. With this investment, companies can take advantage of our technology and years of experience to build out websites and webstores on a world-class platform.”

This strategic addition is unique in a space where companies have a choice between large enterprise giants with big up-front investments or small open-source technologies lacking functionality like marketing automation, personalization and user segmentation.

The launch is a clear indicator of Bridgeline’s focus in this underserved market. “For years we have done a great job of serving customers needing fully customized solutions. Over the past year we saw a distinct need for web experience management tools where efficiency was paramount,” Kahn said. “With iAPPS Pro, we can serve these more nimble companies and smaller companies who still need to build rich digital experiences – more than tripling our addressable market.”

About Bridgeline Digital

Bridgeline Digital helps customers maximize the performance of their full digital experience – from websites and intranets to online stores and campaigns. Bridgeline’s iAPPS platform deeply integrates Web Content Management, eCommerce, eMarketing, Social Media management, and Web Analytics to help marketers deliver digital experiences that attract, engage and convert their customers across all channels. Headquartered in Burlington, Mass., Bridgeline has thousands of quality customers that range from small- and medium-sized organizations to Fortune 1000 companies. To learn more, please visit www.bridgeline.com or call (800) 603-9936.

 

Becki Dilworth
Bridgeline Digital, Inc.
Senior Vice President of Marketing
303.785.3858
bdilworth@bridgeline.com
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(INVT) Announces Settlement With Sonus Networks, Inc.

Settlement Includes a Patent License Agreement Providing Revenue for Inventergy

CAMPBELL, CA–(Jun 7, 2016) – Inventergy Global, Inc. (NASDAQ: INVT) (“Inventergy” or the “Company”), an intellectual property company, today announced that it has entered into a settlement agreement with Sonus Networks, Inc. (“Sonus”), resolving the patent infringement litigation between the parties in the Northern District of California involving six U.S. patents from Inventergy’s IMS and VoIP technology portfolio. On mutually agreeable terms, Sonus agreed to make a one-time payment to Inventergy in exchange for a license to all Inventergy IMS and VoIP patents. The parties agreed to dismiss with prejudice each of their lawsuits and counterclaims against the other.

Inventergy’s CEO Joe Beyers said, “We are pleased to have successfully concluded this settlement and patent license agreement with Sonus. This settlement further reinforces the strength of our IMS and VoIP portfolios which continue to generate significant value for the Company. The royalty rate for the patent license agreement is consistent with the rate we have established in other license agreements for these patent assets.”

Mr. Beyers continued, “In addition to our patent licensing efforts, we continue to negotiate larger transactions involving the sales of portions of our patent assets. We remain focused on enhancing stockholder value through a range of monetization efforts.”

The patent license agreement provides Sonus with a license to two of Inventergy’s portfolios purchased from Nokia and Huawei. These portfolios include 56 patent families comprised of over 250 patents and patent applications, including standards-essential patents pertaining to IMS and VoIP technology.

About Inventergy Global, Inc.
Inventergy Global, Inc. is a Silicon Valley-based intellectual property company dedicated to identifying, acquiring and licensing the patented technologies of market-significant technology leaders. Led by IP industry pioneer and veteran Joe Beyers, the Company leverages decades of corporate experience, market and technology expertise, and industry connections to assist Fortune 500 companies in leveraging the value of their innovations to achieve greater returns. For more information about Inventergy, visit www.inventergy.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements, estimates, forecasts and projections with respect to future performance and events, which constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent and belief or current expectations of the Company and its affiliates and subsidiaries and their respective management teams. Forward-looking statements are not statements of historical fact and often contain words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “will,” “should,” “seek” and similar expressions. Investors and prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including the risk factors set forth from time to time in our filings with the Securities and Exchange Commission. These risks could cause actual results to differ materially from those expressed or implied in the forward-looking statements. We make forward-looking statements based on currently available information, and we assume no obligation to, and expressly disclaim any obligation to, update or revise publicly any forward-looking statements made in this release, whether as a result of new information, future events or otherwise, except as required by law.

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(WLDN) Awarded New $40.6 Million Contract

Willdan Group, Inc. (“Willdan”) (NASDAQ: WLDN) today announced that it has been awarded a new two-and-a-half-year $40.6 million contract to implement Consolidated Edison’s (Con Edison’s) Multifamily Energy Efficiency (Multifamily) program across the utility’s New York City and Westchester County service area. This new program, which is expected to ramp up throughout the third quarter of 2016, expands upon Willdan’s existing Small Business Direct Install (SBDI) program with Con Edison and increases the overall diversification of the Company’s relationship with the energy company.

“We thank Con Edison for entrusting Willdan with another of their important energy efficiency programs,” said Tom Brisbin, Willdan’s CEO. “We have consistently met energy efficiency targets in our programs for Con Edison and we were very proud to have recently been named the winner of the Con Edison 2016 Supplier Diversity & Sustainability Excellence Award. As we begin work on the new Multifamily program, we intend to utilize an extensive trade ally network, which has proven to be a highly effective strategy in our other energy efficiency programs.”

The Multifamily program is one of the energy efficiency programs Con Edison offers to help customers save energy, lower their bills, and protect the environment. The Multifamily program focuses on reducing energy usage in residential facilities with multiple units on the property. Services for the new contract include outreach and direct sales to potential Multifamily participants, on-site energy efficiency surveys, direct implementation of energy savings measures, and trade ally management. To reduce the payback period for energy efficiency investments, Con Edison provides incentives to help its customers identify and install energy efficiency measures.

Willdan now has more than 200 employees and six offices located in the New York area, and has further broadened its clean energy offerings through the recent acquisition of Genesys Engineering, P.C.

About Willdan

Willdan provides professional consulting and technical services to utilities, public agencies and private industry throughout the United States. The Company’s service offerings span a broad set of complementary disciplines that include energy efficiency and sustainability, engineering and planning, financial and economic consulting, and national preparedness. Willdan provides integrated technical solutions to extend the reach and resources of its clients, and provides all services through its subsidiaries specialized in each segment. For additional information, visit Willdan’s website at www.willdan.com.

Forward Looking Statements

Statements in this press release that are not purely historical, including statements regarding Willdan’s intentions, hopes, beliefs, expectations, representations, projections, estimates, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that Willdan will not be able to expand its services or meet the needs of customers in markets in which it operates. It is important to note that Willdan’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, a slowdown in the local and regional economies of the states where Willdan conducts business and the loss of or inability to hire additional qualified professionals. Willdan’s business could be affected by a number of other factors, including the risk factors listed from time to time in Willdan’s SEC reports including, but not limited to, the Annual Report on Form 10-K filed for the year ended January 1, 2016. Willdan cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Willdan disclaims any obligation to, and does not undertake to, update or revise any forward looking statements in this press release.

 

Willdan Group, Inc.
Stacy McLaughlin
Chief Financial Officer
714-940-6300
smclaughlin@willdan.com
or
Investor/Media Contact
Financial Profiles, Inc.
Tony Rossi, 310-622-8221
trossi@finprofiles.com

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(CAPN) Exclusive Distribution Agreement for CoSense®

-Agreement represents continued expansion of CoSense outside the US-

REDWOOD CITY, Calif., June 07, 2016 — Capnia, Inc. (NASDAQ:CAPN), a diversified healthcare company that develops and commercializes innovative diagnostics, devices and therapeutics addressing unmet medical needs, today announced that it has entered into an exclusive three-year distribution agreement with M/s.Healthware Private Limited (Healthware) for the sale of its CoSense End-Tidal Carbon Monoxide (ETCO) Monitor and Precision Sampling Sets in India.

Under the terms of the agreement, Healthware will be responsible for all sales and related activities supporting the distribution of CoSense in India. Additionally, Healthware will, at its own expense, secure and maintain all registrations and approvals necessary to facilitate sales of CoSense in India. Sales of CoSense to Healthware will commence immediately.

“A key component of our global commercialization strategy is to partner with strong national and regional distributors with proven capabilities who we believe can be integral to the global expansion of CoSense into high-growth territories,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia. “This distribution agreement with Healthware provides us with a significant footprint in India, where over 25 million babies are born each year, and early detection of hemolysis using our portable, point-of-care CoSense ETCO monitor can have a positive impact on health outcomes.”

“At Healthware, we strive to bring to our hospital and physician customers best-in-class medical devices that represent the latest in technology and innovation,” said K. Ray Narayan, Managing Director of Healthware. “Hemolytic disease is a significant problem in India and its detection in newborns would help ensure timely diagnosis and appropriate treatment.  We are eager to introduce CoSense to our portfolio of products that improve the lives of patients and families nationwide.”

Healthware is a leading importer and distributor of medical technology and related equipment to hospitals and health care practitioners in India.

About Capnia

Capnia is a leading provider and developer of innovative healthcare products to be used for the screening, detection and treatment of medical conditions.  The Company’s flagship products are based on its proprietary technologies, which utilize precision metering of gas flow.  Capnia currently markets Serenz® Allergy Relief in the European Union (E.U.).  The CoSense® End-Tidal Carbon Monoxide (ETCO) Monitor measures ETCO, which can be used to detect hemolysis and the Infant Solutions product line, including innovative pulmonary resuscitation devices for neonates and infants, are marketed globally.  The Company is also clinically evaluating its nasal, non-inhaled CO2 technology to treat trigeminally-mediated pain conditions such as cluster headache and trigeminal neuralgia.  For more information, please visit www.capnia.com.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to generate sales under this distribution agreement.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-Q filed with the Securities and Exchange Commission on May 12, 2016, including under the caption titled “Risk Factors.” Capnia expressly disclaims any intent or obligation to update these forward looking statements, except as required by law.

Investor Relations Contact:
Michelle Carroll/Susie Kim
Argot Partners
(212) 600-1902
michelle@argotpartners.com
susan@argotpartners.com
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(AEHR) Receives $4.5 Million Order for New FOX-XP™

FREMONT, Calif., June 07, 2016  — Aehr Test Systems (NASDAQ:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced that it has received the first order for its new FOX-XP production test cell. The order totals over $4.5 million and includes a FOX-XP Multi-Wafer Test and Burn-in System, a FOX-XP WaferPakTM Aligner, and an initial set of FOX-XP WaferPak Contactors. $1.4 million of the order is shippable and payable immediately, and the remaining shipments and revenue from this sale are expected to continue through early calendar 2017.

Gayn Erickson, President and CEO of Aehr Test Systems, commented, “We are very excited about this new customer for our FOX-XP multi-wafer burn-in and test system and to receive the first order for a full production test cell of this new product. The customer is one of the world’s largest semiconductor manufacturers and has selected the FOX-XP solution for a high-volume production application where extended burn-in is required to meet their stringent quality standards. The customer’s end product will be used for high-speed communications in enterprise and server applications. It is much more cost-effective to do the burn-in required for this critical application at the wafer level on our new FOX-XP platform instead of in package form.

“The key features of our new FOX-XP test cell that contributed to the cost-effectiveness of the solution include the ability to provide up to 2,048 independent device power supplies per wafer which allows the system to test all the devices on the wafer in parallel, our proprietary WaferPak full wafer contactor which allows us to meet the very high pin count and small pad size and pad pitch requirements of the devices, and our high performance thermal chucks that enable us to manage the temperature of the high power density of the devices on the wafer. The footprint of our 18 wafer test cell is similar to the footprint of typical Semiconductor Test Equipment that can only test one wafer at a time.

“We have worked very closely with this customer to meet their wafer’s special test requirements by using our proprietary WaferPak full-wafer contactor and enhancing the FOX-XP system capabilities to meet their needs. We believe that the FOX-XP test cell is a perfect fit for this new and exciting application. The customer is forecasting device capacity growth that will drive the need for additional production burn-in capacity for multiple years into the future.

“With this new customer, we now have two very high quality lead customers for our new FOX-XP system. We could not be more pleased and believe that both of these customers represent a significant opportunity for Aehr Test with our FOX Wafer Level Test and Burn-in products in not only the initial applications but also with other application areas at both of these customers. We look forward to expanding our initial customer list as we address the many other opportunities where our multi-wafer test and burn-in systems can deliver significant cost and quality of test advantages to our customers.”

Aehr Test’s FOX-XP system is the company’s next-generation multi-wafer test solution that is capable of functional test and burn-in/cycling of flash memories, microcontrollers, sensors, optical devices, laser diodes, VCSELs, LEDs and other leading-edge ICs in wafer form before they are assembled into multi-die packages or other applications where known good die are critical. These end applications can span enterprise solid state drives, automotive devices, highly valuable mobile applications, communications and mission critical integrated circuits and sensors.

The FOX-XP system utilizes Aehr Test’s FOX WaferPak contactor, which provides a cost effective solution for making full wafer electrical die contact in a multi-wafer environment. Aehr Test’s WaferPak contactors contain up to tens of thousands of probes to contact all die simultaneously on wafers and substrates up to 300mm. FOX-XP systems may be configured to test more than 50 wafers in parallel using multiple FOX-XP systems in a single test cell which occupies a very efficient manufacturing space footprint. Aehr Test estimates the test equipment and consumables for the emerging multi-wafer level test and burn-in market will add $200 million to $300 million to its served available market.

About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, capacity needs and opportunities for Aehr Test products in package and wafer level test. Aehr Test has developed and introduced several innovative products, including the ABTSTM and FOX families of test and burn-in systems and the DiePak® carrier. The ABTS system is used in production and qualification testing of packaged parts for both lower-power and higher-power logic as well as all common types of memory devices. The FOX system is a full wafer contact test and burn-in system used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers and systems-on-a-chip. The DiePak carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of bare die. For more information, please visit the Company’s website at www.aehr.com.

Safe Harbor Statement
This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test as of the date hereof and actual results could differ materially from those stated or implied due to risks and uncertainties. Forward-looking statements include statements regarding Aehr Test’s expectations, beliefs, intentions or strategies regarding the FOX products, including statements regarding future market opportunities and conditions, expected product shipment dates and customer orders or commitments. These risks and uncertainties include, without limitation, acceptance by customers of the FOX and WaferPak contactor technologies, acceptance by customers of the FOX-XP system, WaferPak Aligner and WaferPak contactors shipped upon receipt of a purchase order and the ability of new products to meet customer needs or perform as described, as well as general market conditions, customer demand and acceptance of Aehr Test’s products and Aehr Test’s ability to execute on its business strategy. See Aehr Test’s recent 10-K, 10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing Aehr Test’s business. Aehr Test disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

 

Aehr Test Systems		
Carl Buck			
Vice President of Marketing
(510) 623-9400 x381		

Investor Relations Contact:
Todd Kehrli or Jim Byers
MKR Group, Inc.
(323) 468-2300
aehr@mkr-group.com
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