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Innovative suture undergoes clinical evaluations

Tepha : 18 April, 2008  (New Product)
Tepha has announced that two of its corporate partners, Aesculap and Tornier, are conducting initial clinical evaluations of the company's new TephaFLEX suture products.
The clinical evaluations, conducted in both the USA and Europe, represent the first human usage of medical devices derived from Tepha's new class of resorbable polymers called polyhydroxyalkanoates (PHAs).

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 percent stronger, more flexible, and has longer strength retention than currently marketed resorbable sutures.

Dr Simon Williams, president and chief executive officer 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 commercialisation of TephaFLEX suture products.'

Aesculap, a Tepha corporate partner since 2004, currently is conducting a European trial evaluating suture products based on TephaFLEX fibre 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, focused on products for core processes in operative medicine. Aesculap's product range includes sutures, implants for orthopaedic 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 orthopaedic surgeons in the USA. The TephaFLEX Absorbable Suture, FDA 510(k) cleared in February 2007, was utilised in a range of orthopaedic soft tissue repair procedures.

Tornier, based in Edina, Minnesota, is a leader in the extremity orthopaedics market and is collaborating with Tepha on several products for orthopaedic soft tissue repair.

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