ThermoGenesis Corp. Signs Agreement With Biomet Biologics, Inc. to Produce Intra-Operative Autologous Fibrin Sealant
04 August 2006 - 12:00AM
PR Newswire (US)
Global Fibrin Sealant Market Estimated at $450 Million RANCHO
CORDOVA, Calif., Aug. 3 /PRNewswire-FirstCall/ -- ThermoGenesis
Corp. (NASDAQ:KOOL) announced today that the Company entered into a
development, license and supply agreement with Biomet Biologics,
Inc., a wholly owned subsidiary of Biomet, Inc. (NASDAQ:BMET).
Biomet Biologics plans to combine ThermoGenesis' protein harvesting
technology with its currently offered and future autologous
therapies to manufacture autologous fibrin sealant in a
peri-operative setting. The product will feature a fibrinogen
harvesting disposable in combination with Biomet Biologics'
Clotalyst(TM) System that can produce fibrin sealant from a
patient's own blood in less than 30 minutes. Fibrin sealant is an
adhesive gel used by surgeons to stop bleeding and bond tissue. "We
are pleased that Biomet Biologics chose to expand our alliance to
enable the development of this unique surgical product. This new
agreement will allow Biomet to compete in the $450 million fibrin
sealant market," said Kevin Simpson, President & COO of
ThermoGenesis. "This new agreement will strengthen Biomet
Biologics' efforts to provide autologous surgical products that
enhance outcomes and reduce patient risk as compared to animal
derived and pooled human blood products," said Joel Higgins, Vice
President of Technical Affairs for Biomet Biologics. Under the
development phase of this agreement, Biomet Biologics will pay
ThermoGenesis up to $1 million in milestone payments to develop the
fibrinogen disposable and additional revenues upon the commencement
of sales. Biomet Biologics will be responsible for regulatory
submissions and any studies that may be necessary to gain approval
with local regulatory authorities. In a previous agreement,
ThermoGenesis developed and now supplies Biomet Biologics with the
Clotalyst(TM) System that prepares autologous thrombin from a small
volume of the patient's blood in approximately 30 minutes. 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. ThermoGenesis Corp. (
http://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(R) 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(TM)
(AXP(TM)), 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 CryoSeal(R) 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 Biologics, 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
harbour 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. Contact: Fern Lazar of
Lazar Partners +1-212-867-1762 DATASOURCE: ThermoGenesis Corp.
CONTACT: Fern Lazar of Lazar Partners, +1-212-867-1762, for
ThermoGenesis Corp. Web site: http://www.thermogenesis.com/
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