ThermoGenesis Expands CryoSeal(R) Fibrin Sealant System and Thrombin Processing Device(TM) (TPD) Distribution in Europe to Unit
19 Aprile 2006 - 4:00PM
PR Newswire (US)
Products Compete in $120 Million Market RANCHO CORDOVA, Calif.,
April 19 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. today
announced that the Company signed exclusive agreements with
distributors in the United Kingdom and Hungary for its CE-Marked
CryoSeal FS System, which produces fibrin surgical sealant from a
patient's own blood in about an hour, and the TPD which produces
activated thrombin in less than 30 minutes. These new distribution
agreements allow ThermoGenesis to advance its strategy of
penetrating the European fibrin sealant market and the platelet gel
market. Both markets have been limited due to the past reliance on
the high cost of conventional fibrin sealants and Factor V antibody
risks associated with the use of bovine thrombin for platelet gels.
BVM Medical Limited, a U.K.-based device distributor focusing on
interventional congenital cardiology, interventional radiology,
cardiothoracic and vascular surgery, will distribute the CryoSeal
FS System and TPD in England, Scotland, Wales and Ireland, while
Neurotrade Bt, a unit of Switzerland-based Medivent Medizintechnik,
will distribute these products throughout Hungary. Neurotrade
markets products for the surgical, dental and plastic surgery
markets. According to Rudy Huylebroeck, Director of Global Sales
and Marketing Hospital/Wound Care Division, "Signing distribution
agreements with BVM and Neurotrade will allow ThermoGenesis to
further expand its CryoSeal and TPD business in Europe. With
excellent relationships with surgeons and hospitals, these
distributors are already promoting our products successfully and
receiving favorable reactions from potential customers who have
discovered CryoSeal Fibrin Sealant is a cost-effective alternative
to conventional fibrin sealants, sourced from pooled human blood
and bovine lung tissue." Kevin Simpson, President commented,
"CryoSeal is now marketed in 11 European countries and we
anticipate playing a significant role in expanding the $120 million
fibrin sealant market as more distribution agreements are signed in
other European countries. These conventional sealants can pose a
risk of viral transmission, allergic reaction or immune mediated
coagulopathy associated with their clinical use." Physicians both
in Japan and Europe have reported finding the CryoSeal FS System
well suited for large bleeding surgical applications such as
cardiac, ear nose & throat (ENT), orthopedic, neurological, and
gastrointestinal surgeries due to the large volume of fibrin
sealant the system is able to harvest from a single unit of patient
blood plasma. In the United States ThermoGenesis completed a
150-patient pivotal clinical trial in non-trauma, non-transplant
liver surgeries. About ThermoGenesis Corp. ThermoGenesis Corp. is a
leader in developing and manufacturing automated blood processing
systems and disposables that enable the manufacture, preservation
and delivery of cell and tissue therapy products. -- The
BioArchive(R) System, an automated cryogenic device, is used by
cord blood stem cell banks in 26 countries for cryopreserving and
archiving cord blood stem cell units for transplant. -- The
AutoXpress(R) System, is a newly developed semi-automated device
and companion sterile closed blood processing disposable, to
harvest stem cells from cord blood. -- The CryoSeal FS System, an
automated device and companion sterile blood processing disposable,
is used to prepare hemostatic and adhesive surgical sealants from
the patient's blood 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 Thrombin Processing Device(TM), is a
sterile plasma processing disposable that prepares activated
thrombin from a small of aliquot of patient blood, or blood plasma
in less than 30 minutes. The TPD market launch is underway in
Europe. This press release, including statements regarding
financial information for future periods, contain forward-looking
statements, and such statements are made pursuant to the safe
harbor 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. DATASOURCE:
ThermoGenesis Corp. CONTACT: Fern Lazar of ThermoGenesis Corp.,
+1-212-867-1762 Web site: http://www.thermogenesis.com/
Copyright