CorNova Announces Award of ISO 13485 Certification
Published: Jan 05, 2006
WILMINGTON / WAKEFIELD, Mass., Jan. 5 /PRNewswire-FirstCall/ -- CardioTech International, Inc. and Implant Sciences Corporation jointly announce that CorNova GmbH of Munich, Germany has achieved ISO 13485 certification. CorNova, GmbH is a wholly-owned subsidiary of CorNova, Inc. headquartered in Billerica, MA. CardioTech and Implant Sciences, which each own approximately 18% of CorNova, Inc. on a fully-diluted basis, are working with CorNova to commercialize both the metallic as well as the drug-eluting stent for the interventional cardiology market.
CorNova plans to launch its first advanced cobalt-chromium coronary stent system in the second quarter of this calendar year. By obtaining ISO 13485 certification, CorNova will be able to sell its products throughout Europe and many other world-wide markets, excluding the United States and Japan. CorNova is in the process of establishing an additional wholly-owned subsidiary based in Argentina to facilitate distribution in Latin America.
CardioTech and CorNova are progressing with their development of a next- generation polymer system and generic drug for CorNova's drug-eluting stent program. CorNova is working with CardioTech to develop a specialized polymer coating containing an anti-restenosis drug. This proprietary polymer coating is being designed to supply the optimal drug-eluting kinetics while providing the physical properties and integrity required for today's difficult interventions, including bifurcations and long-lesion stenting.
S. Eric Ryan, M.D, Chairman and CEO of CorNova, said, "We are very pleased and would like to congratulate our European subsidiary, CorNova, GmbH, for achieving ISO 13485 certification. We look forward to launching our first coronary stent system in Europe and Latin America. We are also excited about our continuous progress with our advanced drug-eluting stent system and are eager to continue this development with our partners, CardioTech International and Implant Sciences."
CardioTech International, Inc. is a medical device company that develops, manufactures and sells advanced products to surgically treat cardiovascular disease. CardioTech is currently developing new products that address annual worldwide markets exceeding $1 billion. CardioPass is CardioTech's proprietary, synthetic coronary artery bypass graft and CardioTech has partnered to develop a drug-eluting stent with CorNova. CardioTech's corporate headquarters are located in Wilmington, Massachusetts, with operations in California and Minnesota. CardioTech generates revenues from sales of advanced medical devices and disposables used during cardiopulmonary bypass procedures, as well as from contracted product design and development services. More information can be found about CardioTech at its website: http://www.cardiotech-inc.com.
CardioTech believes that this press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties. Such statements are based on management's current expectations and are subject to facts that could cause results to differ materially from the forward-looking statements. For further information you are encouraged to review CardioTech's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the period ended March 31, 2005, and Quarterly Reports on Form 10-Q for the periods ended June 30, 2005 and September 30, 2005. The Company assumes no obligation to update the information contained in this press release
For more information, please contact: CardioTech International, Inc. Michael Szycher Ph.D. CEO and Chairman 978-657-0075 Eric G. Walters Vice President and CFO 978-657-0075 Catalyst Financial Resources, LLC Tom O'Brien 716-830-6611CardioTech International Inc.
CONTACT: Michael Szycher, Ph.D., CEO and Chairman, +1-, or Eric G.Walters, Vice President and CFO, +1-978-657-0075, both of CardioTechInternational Inc.; or Tom O'Brien of Catalyst Financial Resources, LLC,+1-716-830-6611
Web site: http://www.cardiotech-inc.com//