CTE - for those of us who like to pick up stocks that have retraced - closed yesterday about 40% off its high. 4.20.
From BRIEFING.COM
8:37AM CardioTech wins FDA clearance (CTE) 4.20: Co announces that its wholly owned subsidiary, Gish Biomedical, has received FDA clearance to sell the Vision Blood Cardioplegia System with GBS blood compatible coating in conjunction with Gish's line of heart bypass products. The co says the potential market for coated heart-lung bypass products is expected to reach $200 mln annually. The entire market for heart-lung products is estimated at $500 mln annually.
COMPANY PR
CardioTech Gains FDA Clearance For Heparin-Coated Cardioplegia System
PR Newswire - April 13, 2004 08:30
WILMINGTON, Mass., Apr 13, 2004 /PRNewswire-FirstCall via COMTEX/ -- CardioTech International, Inc. (Amex: CTE) today announced that its wholly owned subsidiary, Gish Biomedical Inc. ("Gish") has received FDA clearance to sell the Vision(TM) Blood Cardioplegia (VBC) System with GBS(TM) blood compatible coating in conjunction with Gish's line of heart bypass products. The potential market for coated heart-lung bypass products is expected to reach $200 million annually. The entire market for heart-lung products is estimated at $500 million annually.
The GBS (Gish Biocompatible Surface) coating is a proprietary heparin based coating developed at Gish. The GBS Coating is a heparin based, covalently bonded, biocompatible coating. It is composed of heparin and hyaluronic acid, or hyaluronan. Hyaluronan is a biopolymer that occurs naturally in the human body. Because it is found in extracellular matrices and lacks immunogenicity, hyaluronan is a perfect candidate for blood-contacting applications.
Douglas E. Whittaker, President of Gish stated; "The release of the VBC with GBS coating completes Gish's line of coated Vision products for heart- lung bypass surgery. Gish has previously received FDA clearance for Gish's other Vision products including oxygenators, reservoirs, filters and tubing. (see Press Release of June 18, 2003). We sell our heart-lung bypass products to over 300 hospitals worldwide. This product provides us with another opportunity to increase our market share of heparin based products."
Heparin-based coatings have been reported to decrease the risk of Systemic Inflammatory Response Syndrome (SIRS), by reducing complement activation and platelet adhesion. These coatings provide stable antithrombotic activity and reduce thrombus formation. Heparin-based coatings have been shown to decrease leucocyte activation and reduce blood loss and hemolysis. Both Heparin and Hyaluronan have demonstrated benefit for short-term cellular biocompatibility. Activation of granulocytes and fibroblasts have been shown to be markedly reduced on surfaces modified with heparin or hyaluronan.
The Vision Blood Cardioplegia (VBC) System's proven heat exchange design offers greater than 90% heat exchange efficiency at 250 mL/min and has a maximum rated flow rate of 600 mL/min. The VBC offers a uniquely designed, integrated bubble trap; complete visibility to the blood path as well as one handed installation into the VBC Quick Lock Holder. The VBC is available in a variety of tubing configurations to meet individual patient needs.
About CardioTech:
CardioTech International, Inc. produces and markets innovative medical devices. CardioTech is comprised of established products, augmented with product development activities, with operations in Wilmington, Massachusetts, Plymouth, Minnesota and Rancho Santa Margarita, California. Revenue sources include patented biomaterials, OEM products for Fortune 100 companies, and devices for heart-lung bypass. CardioTech's wound dressings address a $600 million annual market. CardioTech is also developing a synthetic coronary artery bypass graft that addresses a potential market of $1.5 billion annually. Additionally, CardioTech has partnered with Implant Sciences and CorNova to accelerate the development of a drug-eluting stent that addresses a $1 billion market.
CardioTech believes that this Release contains forward-looking statements that are subject to risks and uncertainties. Such statements are based on management's current expectations and are subject to factors that could differ materially from the forward-looking statements. Please refer to CardioTech's SEC filings.
For more information, please contact:
Dave Gentry
Investor Relations Specialist
Aurelius Consulting Group
407-644-4256
Dave@aurcg.com
www.runonideas.com
SOURCE CardioTech International, Inc.
Dave Gentry, Investor Relations Specialist of Aurelius
Consulting Group, +1-407-644-4256, Dave@aurcg.com
cardiotech-inc.com
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