Press release Communiqué de presse
Press release Communiqué de presse
April 18, 2012 18 April, 2012
Sernova Receives Ethics Board Approval To Initiate First Clinical Study Of Cell Pouch™
-Company Completes Manufacture and Release
Pouch(TM) Clinical Product-
Source: Sernova Corp
LONDON, ONTARIO--(Marketwire -- April 19, 2012) -- Sernova Corp. ("Sernova" or the "Company") (TSX VENTURE: SVA - News) today announced it has received the University of Alberta hospital ethics board approval to initiate the first clinical study of the Cell Pouch(TM) pending Health Canada clearance. The company has also completed the manufacture and release of the Cell Pouch(TM) clinical product from its contract manufacturer, Moog Medical Devices Group of Buffalo, New York.
"Completion of the manufacture and release of the Cell Pouch(TM) for clinical evaluation demonstrates that the Cell Pouch(TM) can be manufactured to tight specifications and under strict regulatory guidelines," said Dr. Philip Toleikis, President and CEO of Sernova. "The final step to initiate the clinical study is Health Canada clearance of our submission, which is currently under review."
The process development and the manufacturing of the Cell Pouch(TM) at Moog Medical Devices Group of Buffalo, New York, is conducted in accordance with Moog's Quality System, which is compliant to ISO 13485:2003, MDD 93/42/EEC, US FDA Quality System Regulations (QSR) 21 CFR 820, and Canadian Medical Device Regulation (CMDR). The sterilization of the Cell Pouch(TM) has been performed in accordance to ANSI/AAMI/ISO 11135-1: 2007 -- Sterilization of Health Care Products -- Ethylene Oxide -- Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices, and associated technical information reports. As a scalable product, the process developed will enable Moog to manufacture the Cell Pouch(TM) to the size and number required for any future clinical applications.
The upcoming clinical trial of the Cell Pouch (TM) is a Phase I/II safety and efficacy study of up to 20 patients with diabetes undergoing allograft pancreatic islet transplantation. The study is to be conducted at the University of Alberta under the direction of Dr. James Shapiro as principal investigator.
Sernova also announced that it has granted incentive stock options (the "Options") to purchase up to 2,365,000 common shares of the Company to directors, officers, employees and consultants of the Company, of which 1,975,000 options were granted to directors and officers of the Company. The Options are subject to the terms of the Company's stock option plan and are exercisable for a period of five years at $0.18 per share.
Furthermore, Mr. Hans Mader will not be standing for reelection to the Sernova board. "I can speak for all the Directors in thanking Hans for his expert advice and gracious presence on the Board", said Dr. George Adams, Chairman.
Sernova Corp. is a clinical stage health-sciences company focused on commercializing medical technologies. Sernova is currently developing a platform technology for a number of serious disease indications, starting with a novel treatment for insulin-dependent diabetes, using the novel Cell Pouch System(TM) and its patented Sertolin(TM) cell technology.
For further information contact: Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939 firstname.lastname@example.org www.sernova.com
Tony Russo, Ph.D. Russo Partners, LLC Tel: (212) 845-4251 email@example.com
Forward Looking Information This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in such forward- looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements.
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