Healthcare Industry News: surgical sealant
News Release - April 19, 2006
ThermoGenesis Expands CryoSeal(R) Fibrin Sealant System and Thrombin Processing Device(TM) (TPD) Distribution in Europe to United Kingdom and HungaryProducts Compete in $120 Million Market
RANCHO CORDOVA, Calif., April 19 (HSMN NewsFeed) -- ThermoGenesis Corp. today announced that the Company signed exclusive agreements with distributors in the United Kingdom and Hungary for its CE-Marked CryoSeal FS System, which produces fibrin surgical sealant from a patient's own blood in about an hour, and the TPD which produces activated thrombin in less than 30 minutes. These new distribution agreements allow ThermoGenesis to advance its strategy of penetrating the European fibrin sealant market and the platelet gel market. Both markets have been limited due to the past reliance on the high cost of conventional fibrin sealants and Factor V antibody risks associated with the use of bovine thrombin for platelet gels.
BVM Medical Limited, a U.K.-based device distributor focusing on interventional congenital cardiology, interventional radiology, cardiothoracic and vascular surgery, will distribute the CryoSeal FS System and TPD in England, Scotland, Wales and Ireland, while Neurotrade Bt, a unit of Switzerland-based Medivent Medizintechnik, will distribute these products throughout Hungary. Neurotrade markets products for the surgical, dental and plastic surgery markets.
According to Rudy Huylebroeck, Director of Global Sales and Marketing Hospital/Wound Care Division, "Signing distribution agreements with BVM and Neurotrade will allow ThermoGenesis to further expand its CryoSeal and TPD business in Europe. With excellent relationships with surgeons and hospitals, these distributors are already promoting our products successfully and receiving favorable reactions from potential customers who have discovered CryoSeal Fibrin Sealant is a cost-effective alternative to conventional fibrin sealants, sourced from pooled human blood and bovine lung tissue."
Kevin Simpson, President commented, "CryoSeal is now marketed in 11 European countries and we anticipate playing a significant role in expanding the $120 million fibrin sealant market as more distribution agreements are signed in other European countries. These conventional sealants can pose a risk of viral transmission, allergic reaction or immune mediated coagulopathy associated with their clinical use."
Physicians both in Japan and Europe have reported finding the CryoSeal FS System well suited for large bleeding surgical applications such as cardiac, ear nose & throat (ENT), orthopedic, neurological, and gastrointestinal surgeries due to the large volume of fibrin sealant the system is able to harvest from a single unit of patient blood plasma. In the United States ThermoGenesis completed a 150-patient pivotal clinical trial in non-trauma, non-transplant liver surgeries.
About ThermoGenesis Corp.
ThermoGenesis Corp. is a leader in developing and manufacturing automated blood processing systems and disposables that enable the manufacture, preservation and delivery of cell and tissue therapy products.
-- The BioArchive® System, an automated cryogenic device, is used by cord blood stem cell banks in 26 countries for cryopreserving and archiving cord blood stem cell units for transplant.
-- The AutoXpress® System, is a newly developed semi-automated device and companion sterile closed blood processing disposable, to harvest stem cells from cord blood.
-- The CryoSeal FS System, an automated device and companion sterile blood processing disposable, is used to prepare hemostatic and adhesive surgical sealants from the patient's blood in about an hour. Enrollment in a 150 patient U.S. pivotal clinical trial has been completed and a PMA is being reviewed by the FDA.
-- The Thrombin Processing Device(TM), is a sterile plasma processing disposable that prepares activated thrombin from a small of aliquot of patient blood, or blood plasma in less than 30 minutes. The TPD market launch is underway in Europe.
This press release, including statements regarding financial information for future periods, contain forward-looking statements, and such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors, including timing of FDA approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal year 2006, and introduction of competitive products and other factors beyond our control, could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2006. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward looking statements.
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