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THERMOGENESIS CORP. -- KOOL -- Completes FDA Submission Requesting Approval to Initiate Human Clinical Trials of the CryoSeal Fibrin Sealant -- ``FS'' -- System U.S. Fibrin Sealant Market is Expected to Rise to $400 Million by Year 2006
RANCHO CORDOVA, Calif., Aug 8, 2001 (BW HealthWire) -- THERMOGENESIS CORP. (Nasdaq: KOOL chart, msgs) announced it completed pre-clinical trials, and has submitted an Investigational Device Exemption ("IDE") to the U.S. Food and Drug Administration ("FDA") requesting approval to initiate human clinical trials with its CryoSeal(R) FS System. Based upon independent market reports, the Company believes the U.S. fibrin sealant market to be approximately $100 million annually and is expected to grow to $400 million over the next five years. The CryoSeal FS System was recently approved for sale in Europe, where the annual sales of commercial fibrin sealants is believed to be approximately $100 million per annum.
FDA approval of the IDE will enable THERMOGENESIS CORP. to initiate human clinical trials with the CryoSeal FS System in September 2001, or shortly thereafter. The human trials are expected to take a minimum of 10 months to complete at an estimated expense of $2.5 million. In May of this year, the Company announced that it had raised $7.1 million to cover the costs of the U.S. human clinical trials and ongoing operating costs.
Dr. James Godsey, president and COO of THERMOGENESIS CORP. commented, "The IDE submission for the CryoSeal FS System's human clinical trials for liver resectioning is a critical milestone in the Company's history, as it signals the transformation of THERMOGENESIS CORP. into a late stage biopharmaceutical company." The results of pre-clinical trials demonstrated the ability of CryoSeal Fibrin Sealant to control bleeding of a resectioned pig liver in less than four minutes. This rapid control of bleeding leads to minimal use of transfusion blood products which are currently in short supply in the U.S. due to a significant shortage in the availability of blood donors.
The CryoSeal FS System prepares both components (cryoprecipitate and thrombin) of CryoSeal Fibrin Sealant from a single unit of human plasma in about an hour. Once prepared, the CryoSeal Fibrin Sealant may be frozen or used immediately. The use of single units of human plasma, rather than pools of plasma, such as those used to manufacture commercially available fibrin sealants, which combine 10,000 or more units of plasma, also minimizes the risk of infectious disease transmission if one of the donors has a viral or prion infection. Dr. Godsey went on to state, "We believe that the production of fibrin sealant from a single unit of blood offers both an attractive alternative to commercially available fibrin sealants, and the first methodology to prepare a truly autologous fibrin sealant, that will grow in demand as acceptable blood donors continue to dwindle in number."
In contrast to commercially available fibrin sealants, the CryoSeal technology enables the CryoSeal FS System to prepare CryoSeal Fibrin Sealant free of animal proteins such as bovine aprotinin or bovine thrombin. Animal proteins are a potential source of viral and prion contamination to blood products, the latter of which are resistant to all forms of viral inactivation technology available to fractionators at this time. With the threat of nvCJD continuing to mount in Europe and the ever increasing possibility of nvCJD and/or Mad Cow disease making their way to the U.S. as a result of unrestricted global air travel, the Company feels that CryoSeal Fibrin Sealant is a product which meets the needs of the biological sealant marketplace of today and tomorrow.
The Company has also developed a proprietary FS Applicator System to precisely apply CryoSeal Fibrin Sealant to the wound site during surgery. The FS Applicator System consists of a gun-like handle which delivers 200 micro-liter metered doses of CryoSeal Fibrin Sealant to the bleeding surface. Interchangeable spray tip and drop tip disposables, that provide essentially instantaneously clotting, were designed for applying CryoSeal fibrin sealant to large surface areas with oozing bleeding such as liver resection. The CryoSeal FS System was designed to accommodate both autologous (patient's own) plasma and allogeneic (donor) plasma.
The design of the CryoSeal FS System is based upon two of the Company's recent technological breakthroughs enabling real time processing of blood products, including: (a) automated cryoprecipitation technology which prepares fibrinogen-rich cryoprecipitate from plasma in as little as 51 minutes, as compared to two to three days for standard blood center methodology; and (b) thrombin activation technology which prepares activated human thrombin from a small aliquot of the same human plasma.
Regulatory Status
In March of 2001, the CryoSeal FS System received CE Mark approval from the European Union Competent Authorities to initiate commercialization of the CryoSeal FS System in Europe. The CryoSeal System is patent-protected, and will require a pre-market approval by the U.S. FDA before marketing in the U.S. The Company obtained U.S. FDA clearance of its 510(k) pre-market notification for automated preparation of Cryoprecipitated Anti-Hemophilic Factor (AHF) in February 1999. Until U.S. FDA approval, the CryoSeal FS System, including FS applicator kits, will be marketed, as permitted under U.S. Export Laws, applicable foreign regulations, in geographies including Latin America, South America, Asian Pacific Rim, Australia and ROW. In May 2001, the CryoSeal FS System received a license to market in Canada.
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