Healthcare Industry News: surgical sealant
News Release - June 14, 2006
ThermoGenesis Expands European Distribution of CryoSeal(R) Fibrin Sealant (FS) System and Thrombin Processing Device(TM) (TPD) to Czech Republic, Slovakia and GreeceRANCHO CORDOVA, Calif., June 14 (HSMN NewsFeed) -- ThermoGenesis Corp. (Nasdaq: KOOL ) today announced that the Company signed exclusive agreements with distributors in the Czech Republic, Slovakia and Greece for its CE-Marked CryoSeal FS System, which produces fibrin surgical sealant from a patient's own blood in about an hour. The two distributors also signed agreements to be the non-exclusive distributors of the TPD, which produces activated thrombin in less than 30 minutes for platelet gel preparation.
These new distribution agreements allow ThermoGenesis to advance its strategy of penetrating the European fibrin sealant market and the autologous platelet gel market which has previously been limited due to the high costs of conventional fibrin sealants and the clotting risks associated with Factor V antibody reaction when using bovine thrombin for platelet gels.
Prague-based Vivacom s.r.o. will distribute the CryoSeal FS System and the TPD throughout the Czech Republic and Slovakia. Vivacom, which is also known as Vamex, distributes medical products to blood transfusion departments, hematologists, hemo-oncologists and anesthesiologists in the Czech and Slovak republics.
Amed Therapeutics Ltd., based in Athens, will distribute these products throughout Greece. Amed currently targets the surgical market, including neurosurgeons, orthopedic surgeons, cardiovascular and thoracic surgeons.
"With the addition of Vivacom and Amed Therapeutics, ThermoGenesis' CryoSeal FS and the TPD are now marketed in 15 European countries," said Rudy Huylebroeck, Director of Global Sales and Marketing Hospital/Wound Care Division, ThermoGenesis. "Both of these companies possess the experience and relationships with surgeons and hospitals in their respective countries to successfully penetrate the marketplace."
"We are executing our plan to gain market share in the existing global fibrin sealant market of $470 million and the global thrombin market of $200 million per year by partnering with key distributors who will market the CryoSeal System to both new and existing fibrin sealant users," said Kevin Simpson, Chief Operating Officer of ThermoGenesis. "The European market is currently dominated by conventional sealants sourced from pooled human blood and bovine lung tissue that pose a potential risk of viral transmission, allergic reaction or immune mediated coagulopathy associated with their clinical use."
Surgeons in Europe and those who participated in the Japan PMA Clinical Trial 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. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These products include:
-- The BioArchive System, an automated cryogenic device, is used by cord blood stem cell banks in more than 25 countries for cryopreserving and archiving cord blood stem cell units for transplant. GE Healthcare is the non-exclusive global distribution partner for the BioArchive System.
-- The AutoXpress System, is a newly developed semi-automated device and companion sterile closed blood processing disposable, to harvest stem cells from cord blood. GE Healthcare is the exclusive global distribution partner for the AXP AutoXpress System.
-- The CryoSealŽ FS System, an automated device and companion sterile blood processing disposable, is used to prepare fibrin sealants from plasma 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 CryoSeal FS System has received the CE-Mark. From a marketing perspective, the CE Mark is the European equivalent to an FDA approval, in that it allows sales of the product throughout the European community.
-- The Thrombin Processing Device(TM) (TPD(TM)) is a sterile blood processing disposable that prepares activated thrombin from a small aliquot of plasma in less than 30 minutes. The CE-Marked TPD is currently being marketed in Europe by Biomet, Inc., subsidiary Biomet Biologicals, Medtronic, Inc. and independent distributors.
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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