April 17, 2008. Tepha Announces First Human Usage of Medical Devices Derived from New Class of Resorbable Polymers
LEXINGTON, MA., /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® 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® 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® suture products.”
Aesculap AG, a Tepha corporate partner since 2004, currently is conducting a European trial evaluating suture products based on TephaFLEX® 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® Absorbable Suture by several leading orthopedic surgeons in the United States. The TephaFLEX® 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 – News), NMT Medical (Nasdaq: NMTI – News), and Tornier, Inc. Tepha received its first FDA 510(k) clearance for its TephaFLEX® 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: email@example.com Or visit: https://www.tepha.com.
Tepha – a new generation of absorbable medical devices.