(KOOL) Publication of a Case Report on AMIRST in AMI
Data highlights promising results obtained from the AMIRST pilot study.
RANCHO CORDOVA, Calif., May 19, 2016 — Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced publication of data from a pilot study utilizing the company’s innovative technology for treatment of Acute Myocardial Infarction. The report was published in the “International Journal of the Cardiovascular Academy”, currently online*.
Results from the single-patient study titled, “Autologous bone marrow concentrate enriched in progenitor cells – an adjuvant in the treatment of acute myocardial infarction” were obtained using Cesca’s integrated point-of-care technology, Acute Myocardial Infarction Rapid Stem cell Therapy (AMIRST).
The patient was able to return to normal life two weeks after the AMIRST procedure, and the main findings of the study showed a significant improvement in the Left Ventricular Ejection Fraction (LVEF) from 35% at patient’s initial assessment to 60.3% at 24 months post-AMIRST intervention. LVEF is a key indicator of cardiac function, and reduced LVEF levels are considered risk factors for cardiovascular morbidity and mortality. In the publication, the authors note that, “This degree of improvement is considered atypical for a patient having suffered an ST elevated myocardial infarction (STEMI) with an ejection fraction below 40% post reperfusion (stenting).” No major adverse events were observed during the procedure and throughout the 24 month follow-up period. Additionally, data from the study demonstrated that Cesca’s AMIRST integrated technology provided all the components necessary for collection, processing and intracoronary delivery of concentrated stem cells from a patient’s own bone marrow directly into the target artery of the heart. The Company’s patented cell processing technology and proprietary protocol was developed to optimize the quality and quantity of the cells being administered to patients.
Dr. Venkatesh Ponemone, the Study Director and Executive Director of TotipotentRX, a subsidiary of Cesca Therapeutics Inc., commented, “The current standard of care treatment for cardiac regenerative medicine can benefit from improved technology. Cesca’s point-of-care technology overcomes some of the present challenges while also offering a clinical alternative for AMI patients and their physicians. The results from this case encourage our efforts to continue the AMIRST Phase II trial.”
“Cardiovascular morbidity and mortality are a significant economic burden on society, and it is encouraging to see Cesca’s innovative approach with the AMIRST protocol,” added Dr. Vinay Sanghi, MD, Principal Investigator and Associate Director, Interventional Cardiology, Fortis Hospital, Shalimarbagh, India.
*The full report is available online here: http://www.sciencedirect.com/science/article/pii/S2405818116300095
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. These include:
- The SurgWerks™ System (in development) – a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure Kits for use in regenerative stem cell therapy at the point-of-care for vascular and orthopedic diseases.
- The CellWerks™ System (in development) – a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
- The AutoXpress® System (AXP®) – a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
- The MarrowXpress™ System (MXP™) – a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
- The BioArchive® System – an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
- Manual bag sets for use in the processing and cryogenic storage of cord blood.
Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change. Forward-looking statements can often be identified by words such as “may,” “could,” “potential,” “continue,” and similar expressions and include, but are not limited to, statements regarding research and product commercialization. These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption “Risk Factors” in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.
Company Contact: Cesca Therapeutics Inc. ir@cescatherapeutics.com Investor Contact: The Ruth Group Lee Roth / Tram Bui 646-536-7012 / 7035 lroth@theruthgroup.com / tbui@theruthgroup.com
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