Press Room

    Back

    Press Release - April 19, 2012

    Sernova Receives Ethics Board Approval To Initiate First Clinical Study Of Cell Pouch™


    -Company Completes Manufacture and Release of Cell 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.

    About Sernova

    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 info@sernova.com www.sernova.com

    Tony Russo, Ph.D. Russo Partners, LLC Tel: (212) 845-4251 tony.russo@russopartnersllc.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.

    Forward-looking statements are based on the beliefs, estimates and opinions of Sernova's management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

    Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Back



    Press Releases from:

    2017 2016 2015 2014 2013 2012 2011

    2010 2009 2008 2007 2006 2005 2004

    2003 2002 2001 2000 1999

    Featured News

    2014, January 22

    Sernova’s Disruptive Regenerative Medicine Technologies Set to Improve the Treatment of Chronic Diseases While Reducing Healthcare Costs

    Link

    2012, July 11

    Sernova Corp. developing a tiered approach to the treatment of diabetes

    Publisher: Canadian Investor Magazine
    Author: Rochelle Emnance

    PDF

    2012, July 30

    Feds back local diabetes discovery

    Publisher: London Free Press
    Author: Norman De Bono

    2012, July 30

    Federal program pumps $3 million into new, London business

    Publisher: The London Free Press

    Author: Norman De Bono

    2010 July 10

    Canada's economic action plan supports business innovators

    Publisher: Federal Economic Development Agency for Southern Ontario

    Link

    2007, February 20

    "Transplanted cells may protect against diabetes without forced drug use: An interview with Dr. David White"

    Publisher: StockInterview.com
    Author: Julie Ickes and James Finch

    2006, October 04

    "Sertoli Cells: Mother nature's anti-rejection drug"

    Publisher: StockInterview.com
    Author: James Finch

    2006, August 24

    "Mass marketing diabetes reversal; novel xeno-transplants may offer new hope for type 1 diabetics"

    Publisher: StockInterview.com
    Author: James Finch

    Presentation and Video

    September 11, 2017

    Sernova Fact Sheet

    September 11, 2017

    Sernova's 2017 Corporate Presentation

    PDF Presentation

    Subscribe to Sernova News

Subscribe to our News Dispatch Service

* indicates required




Latest Video and Presentation


Sernova Fact Sheet - / September 11, 2017 Open


Sernova's 2017 Corporate Presentation - PDF Presentation / September 11, 2017 Open

All Presentations →