Tepha Announces First Human Usage of Medical Devices Derived from New Class of Resorbable Polymers
17 Abril 2008 - 8:00AM
PR Newswire (US)
Tepha Corporate Partners, Aesculap and Tornier, Conduct Clinical
Evaluations of TephaFLEX(R) Suture Products LEXINGTON, Mass., April
17 /PRNewswire/ -- Tepha, Inc., a developer of medical devices
derived from a new class of polymers, announced today that two of
its corporate partners, Aesculap and Tornier, are conducting
initial clinical evaluations of the Company's new TephaFLEX(R)
suture products. These clinical evaluations, conducted in both the
United States and Europe, represent the first human usage of
medical devices derived from Tepha's new class of resorbable
polymers called polyhydroxyalkanoates ("PHA's"). The Tepha PHA
polymer family is a product of the Company's patented recombinant
DNA technology which allows the engineering of resorbable medical
devices with mechanical and biologic properties that are matched to
specific tissue repair and replacement applications. TephaFLEX(R)
monofilament suture is up to 30% stronger, more flexible, and has
longer strength retention than currently marketed resorbable
sutures. Dr. Simon Williams, President and CEO of Tepha, commented,
"The first human usage of a medical device based on our proprietary
polymer technology is an important milestone in Tepha's history. We
are grateful for the support of such capable and committed partners
as Aesculap and Tornier, and we look forward to these
collaborations progressing to the successful commercialization of
TephaFLEX(R) suture products." Aesculap AG, a Tepha corporate
partner since 2004, currently is conducting a European trial
evaluating suture products based on TephaFLEX(R) fiber in 150
patients undergoing abdominal wall repair procedures. The results
of this trial will be submitted to European regulatory authorities
to support Aesculap's application for CE Mark approval. Based in
Germany, Aesculap is a division of B. Braun Melsungen AG, focused
on products for core processes in operative medicine. Aesculap's
product range includes sutures, implants for orthopedic and spinal
surgery, surgical instruments, endoscopes, surgical motor systems,
container and storage systems, and vascular therapy products.
Tornier, a Tepha corporate partner since 2007, recently supported
the clinical evaluation of the TephaFLEX(R) Absorbable Suture by
several leading orthopedic surgeons in the United States. The
TephaFLEX(R) Absorbable Suture, FDA 510(k) cleared in February
2007, was utilized in a range of orthopedic soft tissue repair
procedures. Tornier, based in Edina, Minnesota, is a leader in the
extremity orthopedics market and is collaborating with Tepha on
several products for orthopedic soft tissue repair. About Tepha,
Inc. Tepha, Inc, is a developer of medical devices derived from a
new class of resorbable polymers that have been engineered
utilizing recombinant DNA technology. The unique biologic and
mechanical properties of the Tepha PHA polymers has been recognized
by an expanding list of corporate partners that now includes
Aesculap AG, ENTrigue Surgical, HemCon Medical Technologies,
LifeCell Corporation (NASDAQ:LIFC), NMT Medical (NASDAQ:NMTI), and
Tornier, Inc. Tepha received its first FDA 510(k) clearance for its
TephaFLEX(R) Absorbable Suture in February, 2007 and the Company
and its partners have now received five 510(k)'s covering a range
of medical devices including sutures, meshes, and films. For
further information about Tepha, please contact Dr. Ajay Ahuja,
M.D., Director of Business Development, Tepha, Inc., 99 Hayden Ave,
Lexington, MA 02421, tel: 781-357-1700. Email: . Or visit:
http://www.tepha.com/ DATASOURCE: Tepha, Inc. CONTACT: Dr. Ajay
Ahuja, M.D., Director of Business Development, Tepha, Inc.,
+1-781-357-1700, Web site: http://www.tepha.com/
Copyright
Lifecell Corp (MM) (NASDAQ:LIFC)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Lifecell Corp (MM) (NASDAQ:LIFC)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024