ThermoGenesis Corp. to Supply Autologous Thrombin Kits to Biomet, Inc.
April 05 2005 - 9:30AM
PR Newswire (US)
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/
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