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ThermoGenesis Corp. to Supply Autologous Thrombin Kits to Biomet,
Inc.
Agreement Addresses the Need for Autologous Clotting Factors and Reduces the
Risk of Exposure to Bovine Thrombin
RANCHO CORDOVA, Calif., April 5 /PRNewswire-FirstCall/ -- ThermoGenesis Corp.
(NASDAQ:KOOL) announced today that the Company and Biomet, Inc (NASDAQ:BMET)
reached agreement for the Company to supply Biomet's subsidiary, Cell Factor
Technologies, Inc. (CFT) with disposable kits that produce stable, activated
thrombin from the patients own blood in less than 30 minutes. Approximately
$180 million of thrombin annually is consumed worldwide as a blood clotting
enzyme that surgeons use for topical hemostasis, the treatment of
pseudoaneurysms, and to form "platelet gels" for the treatment of damaged
tissue.
Kevin Simpson, President & COO of ThermoGenesis noted, "We are very excited
about our new partnership with Biomet's CFT subsidiary to address the many
potential thrombin applications in their orthopedic, neurosurgery,
maxilliofacial, and dental reconstructive markets. This novel disposable
device, based on our technology and patents, allows surgeons to treat patients
with autologous thrombin (thrombin manufactured from their own blood), instead
of bovine thrombin that has been reported to cause adverse reactions in
patients as reported in 28 peer reviewed journal articles. In Europe and Japan,
these health risks and additional concerns about "mad cow disease" have nearly
ended the clinical use of bovine thrombin.
Joel Higgins, Vice President of Technical Affairs for CFT, commented, "Our
agreement with ThermoGenesis will provide a key product for our customers to
create the highest quality and safest biological solutions for enhanced
recovery. This new thrombin device will enable our Gravitational Platelet
Separation System (GPS) to provide a completely "autologous" platelet gel that
our customers are currently demanding. We look forward to working with
ThermoGenesis to bring this device to market."
Regulatory Status
An autologous thrombin disposable device manufactured by ThermoGenesis has
received CE Mark approval from the European Union Competent Authorities and is
being sold in Europe by the Biomet subsidiary, Interpore International, Inc.
This newly configured thrombin disposable device will be marketed under the
Biomet trademarked name, Clotalyst(TM) Thrombin Device, and is expected to be
submitted for CE Mark this year. The regulatory pathway in the United States is
unclear and may require a Pre-Market Approval Application for the platelet gel
product of which the autologous thrombin is a component.
About Biomet Inc.
Biomet, Inc and its subsidiaries design, manufacture and market products used
primarily by musculoskeletal medical specialists in both surgical and
non-surgical therapy. The company's product portfolio encompasses
reconstructive products, including orthopedic joint replacement devices, bone
cements and accessories, and dental reconstructive implants; fixation products,
including electrical bone growth stimulators, internal and external orthopedic
fixation devices, craniomaxillofacial implants and bone substitute materials;
spinal products, including spinal stimulation devices, spinal hardware and
orthobiologics; and other products, such as arthroscopy products and softgoods
and bracing products. Headquartered in Warsaw, Indiana, Biomet and its
subsidiaries currently distribute products in more than 100 countries.
About ThermoGenesis Corp.
After extensive research, ThermoGenesis Corp.'s newly introduced technology
platforms lead the world in their ability to produce biological products from
single units of blood. Umbilical cord blood banks are utilizing the Company's
BioArchive(R) System as a critical enabling technology for cryogenic archiving
of stem cells for transplant, while its CryoSeal FS System is used to prepare
hemostatic and adhesive surgical sealants from patient blood in about an hour.
ThermoGenesis Corp. has been a leading supplier of state-of-the-art Ultra-Rapid
Blood Plasma Freezers and Thawers to hospitals and blood banks since 1992.
The statements contained in this release which are not historical facts are
forward-looking statements that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed in the
forward-looking statements, including, but not limited to, certain delays
beyond the company's control with respect to market acceptance of new
technologies and products, delays in testing and evaluation of products, and
other risks detailed from time to time in the Company's filings with the
Securities and Exchange Commission.
DATASOURCE: ThermoGenesis Corp.
CONTACT: Kevin Simpson of ThermoGenesis Corp., +1-916-858-5100
Web site: http://www.thermogenesis.com/