ThermoGenesis Provides Update on Res-Q Clinical Evaluations at Leading Stem Cell Therapy Conference
INITIAL DATA SHOW POSITIVE OUTCOMES IN TREATING CRITICAL LIMB
ISCHEMIA AND LONG BONE FRACTURES
RANCHO CORDOVA, Calif., Feb. 1, 2012 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, today provided updates on two clinical evaluations involving its Res-Q® 60 BMC (Res-Q) system, a point-of-care platform designed for the preparation of cell concentrates from bone marrow.
Speaking at the Seventh International Conference on Cell Therapy for Cardiovascular Disease, Vijay Kumar, Ph.D., the Company's principal scientist and Manager of Research, said the initial data are encouraging for patients being treated in clinical evaluations for Critical Limb Ischemia (CLI) and long bone fractures with concentrates prepared by the Res-Q.
The studies covered in Kumar's presentation included:
•A clinical evaluation in India co-sponsored by
ThermoGenesis and Totipotent SC, the Company's distributor for the
Res-Q in India. Ten of 15 planned patients with advanced CLI have
been enrolled to date with the primary endpoints of safety and rate
of limb salvage at one year. Kumar reported a statistically
significant improvement in ankle brachial index, six-minute walk
test, and rest pain though further data remain to be collected. The
lead investigator for this study is Dr. Suhail Bukhari of Fortis
Escorts Heart Institute and Research Center in New Delhi.
•A clinical evaluation that has enrolled sixteen of 20 planned
patients with a non-union or delayed union fracture of a long bone
who have undergone composite grafting with autologous bone marrow
cell concentrate to evaluate the procedure's safety and effect on
fracture healing. To date, there have been no intra-operative
complications, and one non-device related adverse event. Of the
nine patients who are at three-to-six months post-treatment, four
have fractures that have united and four have experienced partial
unions of the bone fracture. The lead investigator of this study
which was sponsored by SpineSmith, LLC is Dr. Mark Lee of
University of California, Davis, Medical Center.
"These outcomes demonstrate encouraging preliminary results with
stem cell concentrates collected with our Res-Q System. CLI is a
severe form of peripheral artery disease, with as many as 200,000
patients in the U.S. undergoing a limb amputation annually.
Currently, there are more than 30 studies underway exploring stem
cell therapy as an alternative treatment regimen for CLI patients.
In addition, we are hopeful that stem cells will provide a new
avenue for promoting the healing of serious bone fractures," said
Matthew Plavan, Chief Executive Officer.
About ThermoGenesis Corp.
ThermoGenesis Corp. (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 include:
•The BioArchive® System, an automated cryogenic device,
used by cord blood stem cell banks in more than 30 countries for
cryopreserving and archiving cord blood stem cell units for
transplant.
•AXP® AutoXpress® Platform (AXP), a proprietary family
of automated devices that includes the AXP and the MXP®
MarrowXpress® and companion sterile blood processing
disposables for harvesting stem cells in closed systems. The AXP
device is used for the processing of cord blood. The MXP is used
for the preparation of cell concentrates, including stem cells,
from bone marrow aspirates in the laboratory setting.
•The Res-Q® 60 BMC/PRP (Res-Q), a point-of-care system
designed for the preparation of cell concentrates, including stem
cells, from bone marrow aspirates and whole blood for platelet rich
plasma (PRP).
•The CryoSeal® FS System, an automated device and
companion sterile blood processing disposable, used to prepare
fibrin sealants from plasma in about an hour. The CryoSeal FS
System is approved in the U.S. for liver resection surgeries. The
CryoSeal FS System has received the CE-Mark which allows sales of
the product throughout the European community.
This press release contains forward-looking statements. 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
and foreign regulatory 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 2012, 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 2012. 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.
Web site: http://www.thermogenesis.com
Contact: Investor Relations
+1-916-858-5107, or
ir@thermogenesis.com
SOURCE ThermoGenesis Corp.
Posted: February 2012