$VSTM Positive Top-line Data, Pivotal Phase 3 DUO™ Study in Leukemia Lymphoma

Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today reported positive top-line results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first in class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Regarding the DUO study’s primary endpoint of progression free survival (PFS) as determined by Independent Review Committee (IRC), oral duvelisib monotherapy showed superiority over ofatumumab, an approved standard of care treatment for patients with CLL/SLL, achieving a statistically significant improvement in median PFS of 13.3 months, compared to 9.9 months for ofatumumab with a hazard ratio (HR) of 0.52 (p<0.0001), representing a 48% reduction in the risk of progression or death. Median PFS in the subset of patients with 17p deletion randomized to duvelisib was also significantly higher (12.7 months compared to 9.0 months for ofatumumab; HR of 0.41, p=0.0011).

“Although the treatment of CLL/SLL has advanced in recent years, there remains a substantial unmet need with many patients progressing or relapsing following the available therapies,” commented Ian Flinn, MD, PhD, Director of the Blood Cancer Research Program at Sarah Cannon Research Institute and the Lead Investigator on the DUO study. “These positive results from the randomized DUO study demonstrate that duvelisib prolongs progression-free survival (PFS) with a manageable safety profile in patients with relapsed or refractory CLL/SLL, including in high risk patients with the 17p deletion. For our patients with CLL/SLL, and for the physicians who treat them, a convenient, oral monotherapy that is taken at home would be a valuable addition to the treatment landscape.”

Verastem plans to share these clinical data with the U.S. Food and Drug Administration (FDA) with the goal of filing a New Drug Application (NDA) with the FDA during the first half of 2018. The duvelisib NDA submission will be supported by favorable results from both the DUO study in CLL/SLL and the DYNAMO™ study in indolent non-Hodgkin’s lymphoma (iNHL), which also achieved its primary endpoint with an ORR of 46% (p<0.0001).

In the Phase 3 DUO study, 319 patients were randomized 1:1 to receive either duvelisib 25mg twice daily until disease progression or unacceptable toxicity or ofatumumab, an approved standard of care treatment for use in CLL/SLL, per its label with an initial infusion of 300 mg followed by 7 weekly infusions and 4 monthly infusions of 2,000 mg. In addition to the primary endpoint of PFS in the ITT population a stratification factor to evaluate the outcome in the patients with 17p deletion CLL/SLL, a known poor prognostic subgroup, was conducted. PFS and other efficacy endpoints were analyzed using response determinations per the IRC using modified iwCLL/IWG criteria.

Duvelisib monotherapy had a manageable safety profile, with results from this study consistent with the well-characterized safety profile of duvelisib monotherapy in patients with advanced hematologic malignancies. Verastem intends to submit detailed results from the Phase 3 DUO study for publication in a peer-reviewed medical journal and for presentation at an upcoming scientific meeting.

“We are extremely grateful to the patients, caregivers, and investigators who participated in the DUO study and we are pleased to be that much closer to delivering on our mission to develop drugs that improve the lives of patients with cancer,” said Robert Forrester, President and Chief Executive Officer of Verastem. “Duvelisib was an important strategic acquisition for Verastem. Both of our late-stage trials with duvelisib monotherapy (DUO and DYNAMO) have now achieved their primary endpoints, highlighting the significant potential of duvelisib in the treatment of advanced hematologic malignancies. We anticipate sharing these results with the FDA in preparation for a potential NDA filing during the first half of 2018 and look forward to exploring subsequent development opportunities for duvelisib in additional cancers.”

Conference Call Information

The Verastem management team will host a conference call today, Wednesday, September 6, 2017, at 8:00 AM (ET). The call can be accessed by dialing 1-877-341-5660 (toll-free) or 1-315-625-3226 (international) five minutes prior to the start of the call and providing the passcode 81095627.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Duvelisib

Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.^1,2,3 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO™, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory CLL/SLL,⁴ and DYNAMO™, a single-arm, Phase 2 monotherapy study in patients with refractory iNHL.⁵ Both DUO and DYNAMO achieved their primary endpoints upon topline analysis of efficacy data. Duvelisib is also being evaluated for the treatment of other hematologic malignancies, including T-cell lymphoma, through investigator-sponsored studies.⁶ Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Verastem, Inc.

Verastem, Inc. (NASDAQ:VSTM) is a biopharmaceutical company focused on discovering and developing drugs to improve outcomes for patients with cancer. Verastem is currently developing duvelisib, a dual inhibitor of PI3K-delta and PI3K-gamma, which has successfully met the primary endpoints in both a Phase 2 study in double-refractory iNHL and a Phase 3 clinical trial in patients with relapsed/refractory CLL/SLL. In addition, Verastem is developing the FAK inhibitor, defactinib, which is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types, including pancreatic, ovarian, non-small cell lung cancer, and mesothelioma. Verastem’s product candidates seek to treat cancer by modulating the local tumor microenvironment, enhancing anti-tumor immunity and reducing cancer stem cells. For more information, please visit www.verastem.com.

Verastem, Inc. forward-looking statements notice:

This press release includes forward-looking statements about Verastem’s strategy, future plans and prospects, including statements regarding the development and activity of Verastem’s investigational product candidates, including duvelisib and defactinib, and Verastem’s PI3K and FAK programs generally, the structure of our planned and pending clinical trials and the timeline and indications for clinical development. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the full data from the DUO study will not be consistent with the top-line results of the study; that the preclinical testing of Verastem’s product candidates and preliminary or interim data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials; that even if data from clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and effective; that the degree of market acceptance of product candidates, if approved, may be lower than expected; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; that our product candidates will cause unexpected safety events or result in an unmanageable safety profile as compared to their level of efficacy; that duvelisib will be ineffective at treating patients with lymphoid malignancies; that Verastem will be unable to successfully initiate or complete the clinical development of its product candidates; that the development of Verastem’s product candidates will take longer or cost more than planned; that Verastem may not have sufficient cash to fund its contemplated operations; that Verastem or Infinity Pharmaceuticals, Inc. will fail to fully perform under the duvelisib license agreement; that Verastem will not pursue or submit regulatory filings for its product candidates; and that Verastem’s product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients. Other risks and uncertainties include those identified under the heading “Risk Factors” in Verastem’s Annual Report on Form 10-K for the year ended December 31, 2016 and in any subsequent filings with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Verastem’s views as of the date of this release, and Verastem does not undertake and specifically disclaims any obligation to update any forward-looking statements.

References

¹ Winkler et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 2013; 20:1-11.
² Reif et al. Cutting Edge: Differential roles for phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
³ Schmid et al. Receptor tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.
⁴ www.clinicaltrials.gov, NCT02004522
⁵ www.clinicaltrials.gov, NCT01882803
⁶ www.clinicaltrials.gov, NCT02783625, NCT02783625, NCT02158091

Verastem, Inc.
Brian Sullivan, 781-292-4214
Director, Corporate Development
bsullivan@verastem.com

$MKGI Prepares for Nasdaq Application, Convertible Debt Elimination & Divesting Non-Core

$SKLN Enters Innovative Technology Partnership with Intalere for STREAMWAY® System

Provides access to more than 90,000 members, including 3,733 hospitals

MINNEAPOLIS, Sept. 05, 2017 — Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces that the Company has entered into an innovative technology partnership with Intalere for the STREAMWAY System. Intalere is a professional supply chain company offering a comprehensive suite of services to empower healthcare providers to better manage their entire spend and ultimately deliver superior care.

This contract includes STREAMWAY in Intalere’s Innovation and New Technology category, indicating STREAMWAY demonstrates unique capabilities compared to existing products on contract or available in the market. Preferred pricing for more than 90,000 Intalere members extends to 3,733 acute care hospitals, 3,715 ambulatory surgery centers and 175 hospital-based physicians.

“This partnership with Intalere is very exciting and is further validation of the STREAMWAY technology,” said Dr. Carl Schwartz, chief executive officer of Skyline Medical.  “Intalere is an organization that is committed to discovering appropriate innovative and new technology companies that are interested in partnering with healthcare group purchasing organizations to remain competitive in delivering optimal cost, quality and clinical outcomes for its members. STREAMWAY continues to be recognized for its unique advantages over other products in the market, now for the benefit of Intalere members. As we work towards expanding our presence and increasing sales around the country, this partnership will continue to introduce new avenues to reach member organizations as potential customers for STREAMWAY.”

About Intalere

Intalere’s mission focuses on improving the operational health of America’s healthcare providers by designing tailored, smart solutions that deliver optimal cost, quality and clinical outcomes. We strive to be the essential partner for operational excellence in healthcare through customized solutions that address customers’ individual needs. We assist our customers in managing their entire spend, providing innovative technologies, products and services, and leveraging the best practices of a provider-led model. As Intalere draws on the power of our owner Intermountain Healthcare’s nationally-recognized supply chain expertise and leadership in technology, process improvement and evidence-based clinical and business best practices, we are uniquely positioned to be the innovation leader in the healthcare industry. Visit www.intalere.com to learn more.

About the STREAMWAY System

Skyline’s revolutionary, FDA-cleared STREAMWAY System is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids.  As of June 30, 2017, Skyline Medical customers have installed 101 STREAMWAY Systems in 52 facilities across 20 states, and in Canada.

The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. Furthermore, the STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S.  For a demonstration please visit www.skylinemedical.com or call 855-785-8855.

About Skyline Medical

Skyline Medical produces a fully automated, patented, FDA-cleared waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods that require hand carrying and emptying filled fluid canisters present an exposure risk and potential liability. Skyline Medical’s STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers; 2) improve compliance with OSHA and other regulatory agency safety guidelines; 3) improve efficiency in the operating room, and radiology and endoscopy departments, thereby leading to greater profitability; and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills each year in the U.S.  For additional information, please visit www.skylinemedical.com.

Forward-looking Statements

Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include risks related to our proposed merger with CytoBioscience, Inc., including the fact that we may not complete the merger; we do not have complete information about CytoBioscience, including audited financial statements; the combined company will not be able to continue operating without additional financing; possible failure to realize anticipated benefits of the merger; costs associated with the merger may be higher than expected; the merger may result in disruption of the Company’s and CytoBioscience’s existing businesses, distraction of management and diversion of resources; delay in completion of the merger may significantly reduce the expected benefits; and the market price of the Company’s common stock may decline as a result of the merger. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov.  This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company’s financial position. See the Company’s most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.

Contacts:

Skyline Medical
Carl Schwartz, Chief Executive Officer
(651) 389-4800
cschwartz@skylinemedical.com

Investors
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

$RNN to Present Updated Clinical and Preclinical Data at 2017 #ESMO

ROCKVILLE, Md., Sept. 05, 2017 — Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, today announced that it will present updated preliminary data from the Phase IIa study of RX-3117 in advanced and metastatic bladder cancer and also the final data on the Supinoxin™ Phase I clinical study at the 2017 European Society for Medical Oncology (ESMO) Congress, which is being held September 8-12, 2017 in Madrid, Spain. Rexahn will also present the data from preclinical studies evaluating RX-3117 in combination with other anticancer agents including Abraxane® and immuno-oncology agents.

Title: RX-3117, An Oral Hypomethylating Agent to Treat Advanced Solid Tumors (ST): Interim results from an Ongoing Phase 2a Study in Advanced Urothelial Cancer
Abstract #: 873P
Session Date/Time: Sunday, September 10, 2017 1:15– 2:15 pm CET, Hall 8
Authors: Drs M.C. Maia, S.K. Pal, S.T. Tagawa, V. Chung, J. Picus, S. Gupta and Rexahn Pharmaceuticals

Title: Phase 1 study of RX-5902, a novel Orally Bioavailable Inhibitor of Phosphorylated P68, which prevents β-catenin Translocation in Advanced Solid Tumors
Abstract #: 258P
Session Date/Time: Monday, September 11, 2017 1:15– 2:15 pm CET, Hall 8
Authors: Drs.J. Diamond, G. Eckhardt, W. Larry Gluck, Martin Gutierrez and Rexahn Pharmaceuticals

Title: A Novel Small Molecule Nucleoside Analog, RX-3117, Shows Potent Therapeutic Activity in Combination with Nab-paclitaxel and Checkpoint Inhibitors in Xenograft Models
Abstract #: 413P
Session Date/Time: Monday, September 11, 2017 1:15– 2:15 pm CET, Hall 8
Authors: Drs. J Frank, D.J. Kim, E Benaim, Rexahn Pharmaceuticals

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals Inc. (NYSE MKT:RNN) is a clinical stage biopharmaceutical company dedicated to developing novel, best-in-class therapeutics for the treatment of cancer. The Company’s mission is to improve the lives of cancer patients by developing next generation cancer therapies that are designed to maximize efficacy while minimizing the toxicity and side effects traditionally associated with cancer treatment. Rexahn’s product candidates work by targeting and neutralizing specific proteins believed to be involved in the complex biological cascade that leads to cancer cell growth. The Company has a broad oncology pipeline that includes three anti-cancer compounds currently in Phase II clinical development: Supinoxin^™, RX-3117, and Archexin^®, and a novel nanopolymer-based drug delivery platform technology that may increase the bio-availability of FDA-approved chemotherapies. For more information about the Company and its oncology programs, please visit www.rexahn.com.

Safe Harbor
To the extent any statements made in this press release deal with information that is not historical, these are forward looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn’s plans, objectives, expectations and intentions with respect to cash flow requirements, future operations and products, enrollments in clinical trials, the path of clinical trials and development activities, and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn’s actual results to be materially different than those expressed in or implied by Rexahn’s forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer; drug candidates being in early stages of clinical development; the timing of completion of clinical trials; the ability to initially develop drug candidates for orphan indications to reduce the time-to-market and take advantage of certain incentives provided by the U.S. Food and Drug Administration; and the ability to transition from our initial focus on developing drug candidates for orphan indications to candidates for more highly prevalent indications. More detailed information on these and additional factors that could affect Rexahn’s actual results are described in Rexahn’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
LifeSci Advisors, LLC
Michael Rice 
mrice@lifesciadvisors.com 
(646) 597-6979 	

LifeSci Advisors, LLC
Ashley Robinson
arr@lifesciadvisors.com 
(646) 597-6979

$AKCA Expands Leadership Team in Preparation for First Commercial Launch

Expansion of Akcea Leadership Further Strengthens Financial, Clinical and Commercial Foundation

CAMBRIDGE, Mass., Sept. 05, 2017 — Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc. focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, announced today the appointment of four experienced pharmaceutical and biotech industry leaders to key leadership roles including:

• Michael MacLean, chief financial officer
• Mustafa Noor, M.D., FACP, chief development officer
• Samuel Yonren, MB BS, MRCPI, vice president and head of pharmacovigilance and drug safety
• Kyle Jenne, U.S. commercial head

“We are excited to welcome Mike, Mustafa, Sam and Kyle to the Akcea team at such a paramount time for the company. Each of these individuals brings a strategic and critical set of skills to the organization as we prepare for the global commercial launch of volanesorsen and continue to advance our pipeline,” said Paula Soteropoulos, president and chief executive officer of Akcea Therapeutics. “As a newly public company approaching the commercialization of our first product, we believe this expansion of our leadership team strengthens our position to achieve success in the near and long term.”

Michael MacLean, Chief Financial Officer
“I am thrilled to be joining Akcea at this pivotal moment for the company as they prepare to commercialize volanesorsen globally,” said Michael MacLean, chief financial officer of Akcea Therapeutics. “I look forward to working closely with the high-caliber leadership team to provide financial insight to advance the Company’s key business strategies and drive shareholder value.”

As chief financial officer, Mr. MacLean will be responsible for the strategic leadership of Akcea’s financial imperatives. He comes to Akcea with more than a decade of leadership experience in the life sciences industry across a range of commercial, research and development (R&D), and manufacturing environments globally, including North America and Europe. Mr. MacLean will bring to Akcea a deep financial understanding as the Company develops its global operating models to advance its corporate objectives. He has also built finance teams, scaled up infrastructure and processes for companies in high growth mode, as well as progress fundraising for programs and other initiatives. Most recently, he worked at PureTech Health as inaugural chief financial officer immediately following PureTech’s initial public offering. Previously, Mr. MacLean served as senior vice president of finance and chief accounting officer of Biogen Inc. where he led the Company’s worldwide finance organization, as well as evaluated financial implications of commercial, R&D and other expansion strategies.

Mustafa Noor, M.D., FACP, Chief Development Officer
“Having the ability to work at a company with a late-stage pipeline of four novel drugs is a remarkable opportunity,” said Dr. Mustafa Noor, chief development officer of Akcea Therapeutics. “There still remains severe unmet need for therapies tackling largely unaddressed drivers of cardiometabolic disease. I am excited to play a role in Akcea’s dedication to advance its promising drugs targeting these poorly addressed lipid risk factors, which include APOCIII, Lp(a) and ANGPTL3, to patients who need these medicines most.”

As chief development officer, Dr. Noor will be responsible for the integrated activities of Clinical Development and Development Operations at Akcea. In this role, Dr. Noor will report to Louis O’Dea, chief medical officer and head of regulatory affairs. Dr. Noor brings to Akcea over 20 years of experience in cardiovascular and metabolic clinical research and development in the industry. He joined the industry at Bristol-Myers Squibb and over the next 17 years has advanced his career through GSK and Pfizer Inc., principally in cardiovascular and metabolic medicine. Dr. Noor also worked at Ipsen Group where he was therapeutic area head for endocrinology global clinical development. Most recently, he was chief medical officer at Rugen Therapeutics. Dr. Noor holds a medical degree (M.D.) from the Pritzker School of Medicine, University of Chicago. He completed his residency in Internal Medicine at the Scripps Clinic, La Jolla, CA and his Fellowship in Endocrinology and Metabolism at the University of California, San Francisco, CA. Dr. Noor is a Fellow of the American College of Physicians.

Samuel Yonren, MB BS, MRCPI, Vice President and Head of Pharmacovigilance and Drug Safety
As vice president and head of pharmacovigilance and drug safety, Dr. Yonren will serve as the global safety leader responsible for all medical aspects of safety assessment and safety risk management strategy across Akcea‘s pipeline. In this role, Dr. Yonren will report to Louis O’Dea, chief medical officer and head of regulatory affairs. Dr. Yonren brings to Akcea expertise in data systems that support effective pharmacovigilance and a depth of leadership experience in cardiometabolic clinical development and  postmarketing safety. After a number of years of training and practice in internal medicine and infectious diseases at academic centers including New York University, Dr. Yonren came to industry as a clinical research physician at Pfizer Inc. in the U.K. and soon afterwards moved into drug safety at GSK. He came to the U.S. as senior director of safety at Millennium Pharmaceuticals Inc. and gathered further years of experience in safety and pharmacovigilance at Medimmune, Ovation Pharmaceuticals, Inc., Alcon/Novartis Pharma AG and most recently Aegerion Pharmaceuticals, where, as head of drug safety, he supervised safety programs for lomitapide and metreleptin. Dr. Yonren holds a medical degree (MB BS) from the University of Lagos and a Membership in the Royal Colleges of Physicians of Ireland (MRCPI) in Internal Medicine.

Kyle Jenne, U.S. Commercial Head
As U.S. commercial head, Mr. Jenne will be responsible for building and leading Akcea’s customer-facing organization in the U.S., including all teams that will directly engage with U.S. health care providers (HCPs), patients and payers to support improved diagnosis and treatment of patients with familial chylomicronemia syndrome (FCS). In his role, Mr. Jenne will report to Molly Harper, vice president, global commercial development. Mr. Jenne brings to Akcea more than 18 years of commercial leadership experience in the industry, including the build-out and leadership of organizations in therapeutic areas including cardiovascular and lipid-driven diseases, rare diseases, and oncology. He previously held sales and marketing leadership roles at Acorda Therapeutics and Pfizer Inc, where he worked with commercial teams on the design, development, and implementation of patient support programs and payer strategy in the U.S. for rare disease products. Most recently, he served as national sales director for neurology in autoimmune and rare diseases at Mallinckrodt Pharmaceuticals.

ABOUT AKCEA THERAPEUTICS
Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, Inc., is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders. Akcea is advancing a mature pipeline of four novel drugs with the potential to treat multiple diseases, including volanesorsen, AKCEA-APO(a)-L_Rx, AKCEA-ANGPTL3-L_Rx and AKCEA-APOCIII-L_Rx. All four drugs were discovered and are being co-developed by Ionis, a leader in antisense therapeutics, based on Ionis’ proprietary antisense technology. The most advanced drug in its pipeline, volanesorsen, is under regulatory review in the U.S. and EU for the treatment of familial chylomicronemia syndrome, or FCS, and is currently in Phase 3 clinical development for the treatment of familial partial lipodystrophy, or FPL. Akcea is building the infrastructure to commercialize its drugs globally with a focus on lipid specialists as the primary call point. Akcea is located in Cambridge, Massachusetts. Additional information about Akcea is available at www.akceatx.com.

FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the business of Akcea Therapeutics, Inc. and the therapeutic and commercial potential of volanesorsen and other products in development. Any statement describing Akcea’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Akcea’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Akcea’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Akcea. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea’s programs are described in additional detail in its final prospectus for its initial public offering and its most recent quarterly report on Form 10-Q, which are on file with the SEC.

In this press release, unless the context requires otherwise, “Akcea,” “Company,” “we,” “our,” and “us” refers to Akcea Therapeutics.

Akcea Therapeutics™ is a trademark of Ionis Pharmaceuticals, Inc. Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc.

Media and Investor Contact:
D. Wade Walke, Ph.D.
Vice President, Corporate Communications and Investor Relations
760-603-2741

$EYEG to Present at the 19th Annual Rodman and Renshaw Global Investment Conference

WALTHAM, Mass., Sept. 05, 2017 — EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using our two proprietary platform technologies for treating diseases and disorders of the eye, today announced that it will be featured as a presenting company at the 19th Annual Rodman & Renshaw Global Investment Conference, being held on September 10-12, 2017 at The Lotte New York Palace Hotel in New York, NY.

Details for the presentation are as follows:

Date: Tuesday, September 12, 2017
Time: 10:00 – 10:25 AM EDT
Room: Holmes II

Investors attending the conference who would like to schedule a one-on-one meeting with EyeGate’s management may do so by contacting their Rodman & Renshaw representative, or Lee Roth or Janhavi Mohite at The Ruth Group at lroth@theruthgroup.com / jmohite@theruthgroup.com.

About EyeGate:
EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using its two proprietary platform technologies for treating diseases and disorders of the eye. EyeGate’s most advanced platform is based on a cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (“HA”), which is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries.

EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com.

Forward-looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s EGP-437 combination product and those of Jade Therapeutics, Inc., a wholly owned subsidiary of EyeGate, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, plus other risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Contact:
Lee Roth / Janhavi Mohite
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com

$WATT Announces GaN-based High-Power, Near Field WattUp Charging Solution

New WattUp Near Field transmitter offers additional power to charge larger electronic devices including smartphones, tablets and smart speakers

$PULM Receives Award from Cystic Fibrosis Foundation

The Award Supports Advancement of PUR1900 to Phase 1/1B Clinical Trial in 2018

LEXINGTON, Mass., Sept. 5, 2017 — Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that it has received an award from Cystic Fibrosis Foundation Therapeutics (CFFT), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, to support the development of its lead inhaled anti-fungal product candidate PUR1900 for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with cystic fibrosis and asthma.

“This award will help fund the non-clinical safety studies needed for the Phase 1/1B clinical trial that we plan to begin in 2018,” explained Pulmatrix CEO Dr. Robert Clarke. “It underscores the potential for PUR1900 to treat this serious condition, which is currently a major unmet medical need.”

ABPA is caused by the spore-forming mold Aspergillus fumigatus. People breathe in Aspergillus spores all the time. Usually, the spores get stuck in the moist linings of the airways and are expelled in mucus, or are tackled and neutralized by the immune system. But in cystic fibrosis patients or others with compromised lung function or immune systems, the mold can lead to serious infections—and allergic reactions that manifest as ABPA.

Fighting these lung infections and the allergic reactions has been difficult. Oral anti-fungal drugs exist, but getting enough drug through the bloodstream to the lungs requires high doses that cause severe side effects—and still have low efficacy.

Pulmatrix has addressed this problem by combining an anti-fungal drug, itraconazole, with the company’s innovative and proprietary iSPERSE^TM dry powder. The powder is designed to “fly” easily into the lungs when inhaled, delivering the high amounts of the drug directly to the lungs where it is needed.

The inhaled drug delivery approach is expected to reduce the risk of serious side effects and drug-drug interactions, while increasing the levels of the drug in the lung compared to oral dosing. In fact, preclinical trials with PUR1900 show that it achieves much higher concentrations of the drug in the lung, and much lower levels in the blood, compared to giving the drug orally.

The new award from CFFT will help fund on-going non-clinical safety studies of PUR1900. The company plans to follow those studies with a Phase 1/1B clinical study in healthy volunteers and asthmatic patients to compare PUR1900 with oral itraconazole dosing in early 2018.

PUR1900 has already received an Orphan Drug designation and a Qualified Infectious Disease Product (QIDP) designation from the FDA for the treatment of fungal infections in patients with cystic fibrosis. These two designations together provide up to 12 years of market exclusivity for PUR1900 if approved for cystic fibrosis patients.

For more information on cystic fibrosis, go to www.cff.org.

About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF) and severe asthma, and PUR1800, a narrow spectrum kinase inhibitor for patients with COPD. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for COPD.  Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

FORWARD-LOOKING STATEMENTS
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2017, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

$INSM Announces Proposed Public Offering of Common Stock

BRIDGEWATER, N.J., Sept. 05, 2017 — Insmed Incorporated (Nasdaq:INSM) announced today that it has commenced an underwritten public offering of $250 million of shares of its common stock. All of the shares of common stock in the offering would be sold by Insmed.  In addition, Insmed intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering at the public offering price, less the underwriting discount.  The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Insmed intends to use the net proceeds from this offering to fund ongoing and future clinical development of amikacin liposome inhalation suspension (ALIS) for patients with treatment refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) and its efforts to obtain potential regulatory approvals and, if approved, commercialize ALIS in its approved indication; invest in increased third-party manufacturing capacity for and commercial inventory production of ALIS in anticipation of possible commercial launch, initially in the United States and subsequently in Japan and other countries; fund further clinical development of INS1007, a novel oral reversible inhibitor of dipeptidyl peptidase 1; and fund working capital, potential debt repayment, capital expenditures, general research and development, and for other general corporate purposes, which may include the acquisition or in-license of additional compounds, product candidates, technology or businesses.

Goldman Sachs & Co. LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Evercore Group L.L.C. is acting as a passive bookrunner. Stifel, Nicolaus & Company, Incorporated is acting as co-lead.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above has been filed with the Securities and Exchange Commission (SEC) and became automatically effective upon filing.  A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus related to this offering may be obtained, when available, from (1) Goldman Sachs & Co. LLC at Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, by facsimile at 212-902-9316 or by email at prospectus-ny@ny.email.gs.com, or (2) Leerink Partners LLC at Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 extension 6132 or by email at syndicate@leerink.com.

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

About Insmed

Insmed Incorporated is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The Company’s lead product candidate is ALIS for adult patients with treatment refractory NTM lung disease caused by MAC, which is a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. The Company is not aware of any approved inhaled therapies specifically indicated for refractory NTM lung disease caused by MAC in North America, Japan or Europe.  Insmed’s earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of dipeptidyl peptidase 1 with therapeutic potential in non-cystic fibrosis bronchiectasis, and INS1009, an inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension.

Forward-looking statements

This press release contains forward looking statements. “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others: risks that the full six-month data from the CONVERT study or subsequent data from the remainder of the study’s treatment and off-treatment phases will not be consistent with the top-line six-month results of the study; uncertainties in the research and development of the Company’s existing product candidates, including due to delays in data readouts, such as the full data from the CONVERT study, patient enrollment and retention or failure of the Company’s preclinical studies or clinical trials to satisfy pre-established endpoints, including secondary endpoints in the CONVERT study and endpoints in the CONVERT extension study; failure to obtain, or delays in obtaining, regulatory approval from the U.S. Food and Drug Administration, Japan’s Ministry of Health, Labour and Welfare, the European Medicines Agency, and other regulatory authorities for the Company’s product candidates or their delivery devices, such as the eFlow Nebulizer System, including due to insufficient clinical data, selection of endpoints that are not satisfactory to regulators, complexity in the review process for combination products or inadequate or delayed data from a human factors study required for U.S. regulatory approval; failure to maintain regulatory approval for the Company’s product candidates, if received, due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from confirmatory clinical studies; safety and efficacy concerns related to the Company’s product candidates; lack of experience in conducting and managing preclinical development activities and clinical trials necessary for regulatory approval, including the regulatory filing and review process; failure to comply with extensive post-approval regulatory requirements or imposition of significant post-approval restrictions on the Company’s product candidates by regulators; uncertainties in the rate and degree of market acceptance of product candidates, if approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of the Company’s product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s product candidates or limitations by regulators on the proposed treatment population for the Company’s product candidates; failure of third parties on which the Company is dependent to conduct the Company’s clinical trials, to manufacture sufficient quantities of the Company’s product candidates for clinical or commercial needs, including the Company’s raw materials suppliers, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business; inaccurate estimates regarding the Company’s future capital requirements, including those necessary to fund the Company’s ongoing clinical development, regulatory and commercialization efforts as well as milestone payments or royalties owed to third parties; failure to develop, or to license for development, additional product candidates, including a failure to attract experienced third-party collaborators; uncertainties in the timing, scope and rate of reimbursement for the Company’s product candidates; changes in laws and regulations applicable to the Company’s business and failure to comply with such laws and regulations; inability to repay the Company’s existing indebtedness or to obtain additional capital when needed; failure to obtain, protect and enforce the Company’s patents and other intellectual property and costs associated with litigation or other proceedings related to such matters; restrictions imposed on the Company by license agreements that are critical for the Company’s product development, including the Company’s license agreements with PARI Pharma GmbH and AstraZeneca AB, and failure to comply with the Company’s obligations under such agreements; competitive developments affecting the Company’s product candidates and potential exclusivity related thereto; the cost and potential reputational damage resulting from litigation to which the Company is a party, including, without limitation, the class action lawsuit pending against the Company; loss of key personnel; lack of experience operating internationally; and risks that the net proceeds from the offering are not spent as currently intended or in ways that enhance the value of your investment in the Company’s common stock.

For additional information about the risks and uncertainties that may affect the Company’s business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Investor Contact:
Blaine Davis
Vice President, Head of Investor Relations
Insmed Incorporated
(908) 947-2841
blaine.davis@insmed.com

$CIIX WallStreet Research™ Issues Updated Corporate Profile on ChineseInvestors.com

NEW YORK, September 5, 2017

WallStreet Research™ (WSR), a top-ranked independent research firm with a history spanning over three decades, today announced that the firm has updated Corporate Profile coverage on ChineseInvestors.com Inc. (OTCQB: CIIX).  WallStreet Research™ is ranked Number One on the Google, Yahoo, and Bing search engines in both small and microcap research with a global following.  An updated analyst Corporate Profile Report, together with additional information about WallStreet Research™, is available at the http://www.WallStreetResearch.org website. The WSR Corporate Profile highlights the Company’s recent accomplishments and growth plans for 2017 and beyond.

Founded in 1999, ChineseInvestors.com, Inc. (“CIIX” or “the Company”) headquartered in San Gabriel, California, with offices in New York and Shanghai China, is a premier financial information website for Chinese speaking investors. http://www.Chinesefn.com, provides web-based, timely market information about United States publicly traded stocks and foreign currencies with free quotes, charts, market news, and links to investment research. The Company recently announced it is planning to launch the first Chinese Daily Video News Broadcast from the NYSE floor covering cryptocurrencies and Bitcoin currency.  CEO, Mr. Warren Wang, an expert in the cryptocurrency market, will be able to add his commentary to the daily broadcasts on the Company’s website at http://www.ChineseFN.com .   The Company earlier announced it is launching cryptocurrency education and trading subscription services on its ChineseFN.com website platform to subscribers.

The Company currently tracks United States stock market quotes and provides access to sample investment portfolios for educational purposes, as well as real-time trading demonstrations. Through its relationship with Phoenix Television, the Company produces and broadcasts a weekly television show covering the financial markets entitled “Wall Street Weekly.” In addition, CIIX offers a wide range of investor relations services to publicly-traded companies in the United States and China. CIIX went public in 2011 and has profited from earning and holding shares in publically traded companies through its consulting and advisory services over the past few years.

In recognition of the unprecedented opportunities in the non-industrial hemp industry, CIIX has expanded its business to capitalize on the growing demand for non-industrial hemp based products including healing oils, food products, and other health and beauty products.  CIIX has opened its retail store “Chinese Wellness Center” in the predominantly Chinese community of San Gabriel, California.  In addition, CIIX announced its release of its first CBD oil product line, “OptHemp™”, a premium, private label oil, made from full-spectrum, Colorado grown, GMO-Free, non-industrial hemp, manufactured using a CO2 Extraction process. As part of its expansion, the Company also has established a wholly owned foreign enterprise, “XiBiDi Biotechnology Co. Ltd,” also known as CBD Biotechnology Co. Ltd., which operates its site ChineseCBDoil.com. In May 2017, CBD Biotechnology appointed Summer (XiangYang) Yun as CEO.  Yun’s initial focus will be the launch o “CBD Magic Hemp Series” cosmetics line, which is expected to launch this quarter with 3-5 CBD-based core skin care products.  Yun is a marketing and branding executive with over 25 years of experience. CBD Biotechnology Co., Ltd. plans to use multiple sales channels to implement its sales plan.

The Company filed its most recent 10K report for the year ended May 31, 2017, and reported total revenues of $1.67 million, up from $.95 million in the previous year, a growth rate of 76%.  The growth in revenues consisted of strong revenue growth from subscription sales and from increased investor relations and consulting activities.  The operating loss was $4.9 million vs. $2.9 million, and EPS was ($.86) vs. ($.26) from the prior fiscal year.  The Company had incurred additional costs related to its growth strategy of adding several new lines of business including the ChineseHempOil.com activities, CBD Biotechnology, and others.

The Company in its 10K filing announced it has authorized up to 10 million shares in Series D Convertible Preferred Stock to accredited investors at $1 per share, each share converting into two shares of common, with a 6% annual dividend for two years.  It has thus far completed approximately $2 million of the offering.

Mr. Alan Stone, Managing Director of WallStreet Research™ commented, “CIIX is gearing up for another year of strong growth with its new expanded business activities and improved financial position.”

About WallStreet Research™

WallStreet Research™ (“WSR”) is a prominent research boutique led by Mr. Alan Stone, Managing Director of Alan Stone & Company, LLC (ASC). The firm specializes in the microcap and small cap investment arena, looking for emerging growth companies with strong management, unique or proprietary technology, significant market potential, financial strength, and outstanding long-term earnings growth possibilities. The firm has offices in Los Angeles, CA, Palm Beach, FL, and New York City, NY, and is well known for discovering undervalued companies and bringing them to the attention of the investment community. ASC/WSR also arranges road shows for its publicly traded clients, before the investment community in New York City, California and Florida.

Information on WallStreet Research™ can be found at http://www.WallStreetResearch.org.

About ChineseInvestors.com, Inc. (CIIX)

ChineseInvestors.com, Inc., (CIIX), headquartered in Los Angeles, with offices in New York and Shanghai China, is a company that engages in providing a wide range of products, services, and information for the global Chinese population. Founded in 1999, CIIX endeavors to be an innovative company providing (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) support services to various partners; (c) consultative services to smaller private companies considering becoming a public company; (d) advertising and public relation related support services; and (e) other services they may identify having the potential to create value or partnership opportunity with their existing services.  http://www.Chinesefn.com.

The Company offers various products beyond its website information, the Company also offers a wide range of investor relations and is now beginning to change focus of solely being a premier Internet information provider by expanding into retail and online sales of CBD products via http://www.ChineseCBDoil.com and http://www.ChineseHempOil.com .

CIIX maintains its commitment to continue to grow its membership subscriptions and investor relations business thus adding to the potential for continued growth in the near future.

Information on CIIX can be found at http://www.ChineseInvestors.com.

Disclaimer

The information presented herein is not to be construed as an offer to sell, nor a solicitation of an offer to purchase, any securities. This corporate profile is not a research report, but a compilation of information available to the public, which has been furnished by the featured company or gathered from other sources, in each case without independent verification, and no representations are made as to the accuracy or validity thereof. The information may include certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Commission Act of 1934, which may be affected by unforeseen circumstances or certain risks. Any investment in securities contains inherent risks and should only be done after consulting an investment professional. The featured company paid a fee of $3500 in cash to Alan Stone & Company LLC for preparation and distribution of this profile, including other potential fees associated with various consulting and investor relations’ services. For complete disclaimer information, readers are hereby referred to the Disclaimer Page at the http://www.WallStreetResearch.org website.

Contact / Source:

WallStreet Research™

Alan Stone, +1-310-444-3940
astone@alanstone.com

Barbara Blake, +1-415-419-4239
bjblake1229@att.net

http://www.WallStreetResearch.org
http://www.SouthFloridaInvestmentForum.com
http://www.SouthernCaliforniaInvestmentForum.com
http://www.SmallCapConference.org

ChineseInvestors.com Inc.
227 W. Valley Blvd. Suite 208 A
San Gabriel, CA 91776

Alan Klitenic, Investor Relations
+1(214)636-2548
Email: warrenwang@chinesefn.com
Headquarters: +1(888)789-1670

http://www.Chineseinvestors.com
http://www.Chinesefn.com
http://www.ChineseCBDoil.com
http://www.ChineseHempOil.com

$ACOR Adopts Shareholder Rights Plan

ARDSLEY, N.Y.

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that its Board of Directors has adopted a Shareholder Rights Plan, effective September 1, 2017, and declared a dividend distribution of one preferred share purchase right on each outstanding share of the Company’s Common Stock. The Rights Plan will expire on August 31, 2018.

The Acorda Board and management team are committed to taking actions that are in the best interest of all of our shareholders. The Board is undertaking this action in accordance with its fiduciary duties to act in the best interests of shareholders, as well as its responsibilities to all of its stakeholders, including the many patients with debilitating neurological disorders who are served by the Company’s innovations, commitment and expertise.

The Rights Plan is intended to promote the fair and equal treatment of all Acorda shareholders and ensure that no person or group can gain control of Acorda through open market accumulation or other tactics potentially disadvantaging the interest of all shareholders. The Rights Plan will also position the Acorda Board of Directors to fulfill its fiduciary duties on behalf of all shareholders by ensuring that the Board has sufficient time to make informed judgments about any attempts to take over the Company. The Rights Plan applies equally to all current and future shareholders and is not intended to deter offers that are fair and otherwise in the best interest of the Company’s shareholders.

The Rights Plan, which was adopted by the Board following evaluation and consultation with the Company’s advisors, is similar to plans adopted by numerous publicly traded companies. The Board adopted the Rights Plan in response to the recent accumulations of significant portions of Acorda’s outstanding Common Stock.

Under the Rights Plan, the Rights will become exercisable if a person or group becomes the beneficial owner of 15% or more of the Company’s outstanding Common Stock. In the event that the Rights become exercisable due to the triggering ownership threshold being crossed, each Right will entitle its holder to purchase, at the Right’s exercise price, a number of shares of Common Stock or equivalent securities having a market value at that time of twice the Right’s exercise price. Rights held by the triggering entity will become void and will not be exercisable to purchase shares at the reduced purchase price. The Board of Directors will, in general, be entitled to redeem the Rights at $0.001 per Right at any time before the triggering ownership threshold is crossed.

The Rights Plan may be amended, redeemed or terminated by the Acorda Board of Directors at any time prior to being triggered or its expiration. The Rights Plan exempts any person or group currently owning 15% or more of the Company’s outstanding Common Stock. However, the Rights will be exercisable if a person or group that already owns 15% or more of the Company’s Outstanding Common Stock acquires any additional shares after the time of announcement of the Rights Plan.

Additional details regarding the Rights Plan are in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease and multiple sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA^® (dalfampridine) Extended Release Tablets, 10 mg.

Forward-Looking Statement
This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to realize the benefits anticipated from the Biotie and Civitas transactions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the ability to successfully integrate Biotie’s operations into our operations; we may need to raise additional funds to finance our operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the recently announced court decision in our litigation against filers of Abbreviated New Drug Applications to market generic versions of Ampyra in the U.S.; the risk of unfavorable results from future studies of Inbrija (CVT-301, levodopa inhalation powder), tozadenant or from our other research and development programs, or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market Inbrija, tozadenant, or any other products under development; third party payers (including governmental agencies) may not reimburse for the use of Ampyra, Inbrija or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the occurrence of adverse safety events with our products; failure to maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; competition; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

$ZEAL Increases Its Share Capital As A Consequence Of Exercise of Employee Warrants

Company announcement – No. 43 / 2017

Zealand increases its share capital as a consequence of exercise of employee warrants

Copenhagen, September 1, 2017 – Zealand has increased its share capital by a nominal amount of DKK 1,500 divided into 1,500 new shares with a nominal value of DKK 1 each. The increase is a consequence of the exercise of warrants granted under one of Zealand’s employee warrant programs. Employee warrant programs are part of Zealand’s incentive scheme, and each warrant gives the owner the right to subscribe for one new Zealand share at a pre specified price, the exercise price, in specific predefined time periods before expiration. For a more detailed description of Zealand’s warrant programs, see the company’s Articles of Association, which are available on the website: www.zealandpharma.com.

The exercise price was DKK 87.45 per share and the total proceeds to Zealand from the capital increase amount to DKK 131,175.

The new shares give rights to dividend and other rights from the time of the warrant holder’s exercise notice. Each new share carries one vote at Zealand’s general meetings. Zealand has only one class of shares.

The new shares will be listed on Nasdaq Copenhagen after registration of the capital increase with the Danish Business Authority. Following registration of the new shares, the share capital of Zealand will be nominal DKK 30,720,152 divided into 30,720,152 shares with a nominal value of DKK 1 each.

The amendment to Zealand’s Articles of Association entailed by the share capital increase has today been registered with the Danish Business Authority.

For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer
Tel.: +45 51 67 61 28, e-mail: bmj@zealandpharma.com

Mats Blom, Executive Vice President and Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com

About Zealand Pharma A/S
Zealand (Nasdaq Copenhagen and New York: ZEAL) is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines.
Zealand is based in Copenhagen (Glostrup), Denmark.

$MDWD Successfully Completes Second Cohort of EscharEx® Phase 2 Study

Company intends to initiate EscharEx U.S. pivotal program in first half of 2018

YAVNE, Israel, Sept. 01, 2017 — MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, reports positive top-line results from the second cohort of the Company’s Phase 2 clinical trial evaluating EscharEx^® for debridement of dead or damaged tissue in diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

The second cohort was a prospective, randomized, controlled, assessor-blinded Phase 2 trial to evaluate EscharEx safety over extended periods of application (24-72 hours) in up to eight applications to provide supportive data for a future Biologics License Application (BLA) filing. The second cohort included 38 patients with DFUs or VLUs that were randomized to either EscharEx or the hydrogel vehicle at a ratio of 2:1, respectively. The top-line results include data following the completion of the debridement period by all patients. The primary objective of the second cohort of the study was to assess safety.

The overall patient demographics and wound baseline characteristics were comparable across both arms. No related systemic adverse events were reported and adverse events related to local application were mild to moderate, reversible and resolved during the trial. Vital signs, pain scores, infection rates, laboratory parameters and blood loss were comparable between the two arms of the trial. Overall, no material safety concerns were identified.

“Effective debridement is a critical first step to facilitate wound management and is complementary to existing wound healing products, which require a clean wound bed. In the treatment of chronic wounds, it is important to adjust the treatment strategy to the patients’ needs and wound conditions, and therefore establishing safety over extended period of application is important,” stated Prof. Lior Rosenberg, M.D., Chief Medical Technology Officer of MediWound, former Chief of Plastic Surgery at Soroka University Medical Center (Beer Sheva, Israel).

“We believe EscharEx has the potential to become an important product in the wound care market, and a valuable asset for MediWound.  We intend to initiate the EscharEx U.S. Phase 3 pivotal program in the first half of 2018,” stated Gal Cohen, President and Chief Executive Officer of MediWound.

About MediWound Ltd.

MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds, connective tissue disorders and other indications. MediWound’s first innovative biopharmaceutical product, NexoBrid^®, received marketing authorization from the European Medicines Agency as well as the Israeli and Argentinian Ministries of Health, for the removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns and was launched in Europe, Israel, and Argentina. NexoBrid^® represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier, relative to the existing standard of care, without harming viable tissues.

MediWound’s second innovative product candidate, EscharEx^®, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds and is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx^® contains the same proteolytic enzyme technology as NexoBrid^®, and benefits from existing development data on NexoBrid^®. In January 2017, MediWound reported final results from the first cohort of its second phase 2 study evaluating EscharEx for the debridement of chronic and other hard-to-heal wounds in which EscharEx met its primary endpoint demonstrating higher incidence of complete debridement with statistical significance.  For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to the regulatory authorizations and launch dates. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2016 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Contacts:				
Sharon Malka				
Chief Financial and Operations Officer
MediWound				
ir@mediwound.co.il                                 

Bob Yedid
Managing Director
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com

$BLUE to Present at Investor Conferences in September

CAMBRIDGE, Mass.

bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, today announced that members of the management team will present at the following upcoming investor conferences:

• Wells Fargo Healthcare Conference, Thursday, September 7, 1:40 p.m. ET at Westin Boston Waterfront, Boston, Massachusetts
• Morgan Stanley 15th Annual Global Healthcare Conference, Wednesday, September 13, 9:55 a.m. ET at the Grand Hyatt, New York City
• LEERINK Partners Roundtable Series: Rare Disease & Immuno-Oncology, Thursday, September 28, 9:30 am ET at the Lotte New York Palace, New York City

To access the live webcast of bluebird bio’s presentation, please visit the “Calendar of Events” page within the Investors and Media section of the bluebird bio website at http://investor.bluebirdbio.com. Replays of the webcast will be available on the bluebird bio website for 90 days following the conference.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s product candidates and research programs. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks that the preliminary results from our clinical trials will not continue or be repeated in our ongoing clinical trials, the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates, the risk of a delay in the enrollment of patients in our clinical studies, risks that the current or planned clinical trials of the LentiGlobin drug product will be insufficient to support regulatory submissions or marketing approval in the United States and European Union, the risk that our collaborations, including the collaboration with Celgene, will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our annual report on Form 10-K and our most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

$RDFN Demand Index Dipped from June to July as Inventory Shortage Deepened

SEATTLE

(NASDAQ: RDFN) — The Redfin Housing Demand Index fell 5.0 percent from its all-time high of 130 in June to 124 in July, according to Redfin (www.redfin.com), the next-generation real estate brokerage. Still, the Demand Index was up 29.7 percent year over year. The Demand Index is adjusted for Redfin’s market share growth.

The Demand Index is based on thousands of Redfin customers requesting home tours and writing offers. A level of 100 represents the historical average for the three-year period from January 2013 to December 2015. The underlying methodology to the Redfin Housing Demand Index was revised in August 2017 to improve the way it accounts for the company’s market share.

Across the 15 metros covered by the Demand Index, there were 13.9 percent fewer homes for sale in July than there were a year prior, and there was a 5.9 percent decline in new listings. July marked the 26th consecutive month of year-over-year inventory declines.

“Buyer demand has been stronger so far in 2017 than last year, but the combination of low inventory and rising home prices is taking its toll heading into the fall,” said Redfin chief economist Nela Richardson. “Sellers are still in control of the market, but their advantage is narrowing as buyers are becoming less willing or able to chase escalating prices.”

The seasonally adjusted number of buyers requesting home tours fell 3.3 percent from June to July, while the number of those who wrote offers dropped 11.0 percent. Compared to last year, 35.3 percent more buyers requested tours in July and 21.0 percent more wrote offers.

To read the full report, including metro-level demand data and charts, please visit: https://www.redfin.com/blog/2017/09/redfin-housing-demand-index-dipped-in-july-as-inventory-shortage-deepened.html

About Redfin

Redfin (www.redfin.com) is the next-generation real estate brokerage, combining its own full-service agents with modern technology to redefine real estate in the consumer’s favor. Founded by software engineers, Redfin has the country’s #1 brokerage website and offers a host of online tools to consumers, including the Redfin Estimate, the automated home-value estimate with the industry’s lowest published error rate for listed homes. Homebuyers and sellers enjoy a full-service, technology-powered experience from Redfin real estate agents, while saving thousands in commissions. Redfin serves more than 80 major metro areas across the U.S. The company has closed more than $50 billion in home sales.

For more information or to contact a local Redfin real estate agent, visit www.redfin.com. To learn about housing market trends and download data, visit the Redfin Data Center. To be added to Redfin’s press release distribution list, subscribe here. To view Redfin’s press center, click here.

Redfin Journalist Services
Jon Whitely, 206-588-6863
press@redfin.com

$CONN Status of Business post Hurricane Harvey, $200,000 Donation Matching Program

THE WOODLANDS, Texas

Conn’s, Inc. (NASDAQ:CONN), a specialty retailer of furniture and mattresses, home appliances, consumer electronics and home office products, and provider of consumer credit, today reported on the status of the Company after Hurricane Harvey made landfall on August 25, 2017.

As a result of the Hurricane and unprecedented levels of rain and flooding, Conn’s closed 23 stores, its distribution and service centers in Beaumont and Houston, as well as its Beaumont corporate office. The Company’s corporate offices in The Woodlands and San Antonio remained open, and supported store, credit and collections, and customer service operations outside the path of the storm.

All but two stores are now open for business and able to serve their local communities. The Company also reopened its Beaumont corporate office, and distribution and service centers. Conn’s has currently lost approximately 100 store-days between August 25, 2017 and September 1, 2017. Despite the severe impact of Hurricane Harvey, this number of days compares favorably with both the impact of Hurricane Rita, which reported 134 lost store-days and Hurricane Ike, at 144 lost store-days.

“I want to thank our employees for their exceptional dedication and desire to start serving our customers in their time of need,” commented Norm Miller, the Company’s Chairman and CEO. “Our advanced planning, resilient infrastructure and the determination of our staff has enabled the business to minimize the impact of this terrible event.”

Conn’s also announced that it is pledging up to $200,000 through a donation matching program. Conn’s will match dollar-for-dollar every donation from customers, employees and partners up to $200,000, and will direct the funds raised to locally based organizations and charities that need them the most, as well as to employees who have lost so much. On the ground, Conn’s is supporting a number of activities within the local community through its Conn’s Cares Program, which will initially see the launch of a Toy and Book Drive to support children affected by the Hurricane.

“As a Texas based business with a meaningful presence in Houston and Beaumont, we have seen firsthand how Hurricane Harvey has affected our customers, employees and communities,” said Mr. Miller. “We stand by to provide support to those in need from the tragic effects of this historic natural disaster.”

The Company will provide more detailed information and analysis about the impact of Hurricane Harvey when it reports second quarter fiscal year 2018 results on Thursday September 7^th, 2017.

$NVCN Decision from Appeals Court Upholds Lower Court Decisions But Denies Injunction

VANCOUVER, Sept. 1, 2017 – Neovasc Inc. (“Neovasc” or the “Company“) (NASDAQ, TSX: NVCN) reported today, in a non-precedential opinion, a panel of the United States Court of Appeals for the Federal Circuit affirmed the judgment of the United States District Court for the District of Massachusetts in the case of CardiAQ Valve Tech., Inc. v. Neovasc Inc.  The panel also affirmed the district court’s decision not to enjoin Neovasc’s Tiara™ program.

In summary, if the judgement is not altered through additional appellate proceedings, Neovasc must pay the full judgement of approximately US$112 million, of which approximately US$70 million is already held in an escrow account.  There are no other monetary damages arising from this award; and Neovasc remains the joint inventor of the ‘964 patent, one of the patents in the Tiara™ patent family, along with two employees of CardiAQ Valve Technologies, Inc., both parties having freedom to use the patent without an obligation to pay royalties to the other.

Neovasc is presently considering whether to pursue further appellate review of the panel’s decisions on the other issues presented by the judgment and will continue to evaluate all other options.

About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.  Its products include the Neovasc Reducer™, for the treatment of refractory angina which is not currently available in the United States and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the United States, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit: www.neovasc.com.

This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws regarding the Company’s plans and expectations concerning its litigation with CardiAQ. Words and phrases such as “intends”,  “expects”, “considering”, “continue”, and “will”, and similar words or expressions, are intended to identify these forward-looking statements.  Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances.  Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, risks relating to the Company’s litigation with CardiAQ, including the Company’s ability to successfully appeal the validity of the awards as well as the ruling on inventorship, which create material uncertainty and which cast substantial doubt on the Company’s ability to continue as a going concern; the substantial doubt about the Company’s ability to continue as a going concern; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to claims by third parties alleging infringement of their intellectual property rights; the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build the Company’s in-house sales capabilities or secure third-party marketing or distribution partners; the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks associated with the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks associated with post-market regulation of the Company’s products; health and safety risks associated with the Company’s products and the Company’s industry; risks associated with the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risk of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks associated with future changes in financial accounting standards and new accounting pronouncements; the Company’s dependence upon key personnel to achieve the Company’s business objectives; the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks associated with consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; anti-takeover provisions in the Company’s constating documents which could discourage a third party from making a takeover bid beneficial to the Company’s shareholders; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to the influence of significant shareholders of the Company over the Company’s business operations and share price.  These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Company’s Management’s Discussion and Analysis of Financial Condition and Results of Operations (copies of which filings may be obtained at www.sedar.com or www.sec.gov, each of which are included in the Company’s Annual Report on Form 40-F).  These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements.  The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.