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. ( thermogenesis/ ) 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.
ThermoGenesis Corp.
thermogenesis/