May 1, 2009. TEPHA PARTNER LAUNCHES NOVEL MONOFILAMENT ABSORBABLE SUTURE UTILIZING TEPHA’s PROPRIETARY BIOMATERIAL
LEXINGTON, MASSACHUSETTS – May 1, 2009 – Tepha, Inc., a developer of medical devices announced today that its corporate partner, Aesculap AG, has received a CE Mark and is launching its MonoMax monofilament absorbable suture for general surgical indications in Europe. The product is made with TephaFLEX® fiber, one of Tepha’s new class of novel resorbable polyhydroxyalkanoate (PHA) polymers. 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. MonoMax monofilament suture has longer strength retention than currently marketed resorbable sutures, and is more flexible. The product joins a strong portfolio of suture products from B. Braun Aesculap, currently at number two in share of the European suture market.
Miguel Pablo, Vice President Marketing & Sales and Regulatory Affairs Closure Technologies for the Aesculap Division stated, “B. Braun Aesculap is excited to be introducing this new technology into the European market for wound closure. We have been working with Tepha for several years to develop the MonoMax product line and believe Tepha’s unique biomaterial will provide benefits to our customers and to their patients”.
A clinical trial, the Multi-Center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax for Abdominal Wall Closure or (ISSAAC) was recently concluded with positive results. The trial enrolled approximately 150 patients who were followed for twelve months after surgery. In the trial, the MonoMax suture was used for a continuous all-layer (except skin) suture to close abdominal wall after midline incisions. The primary objective of the trial was to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in previously reported clinical trials.
Dr. Simon Williams, President and CEO of Tepha, commented, “We are pleased to witness the launch of the MonoMax product and look forward to continued collaboration with our partner Aesculap on additional products based on our TephaFLEX technology”.
About Aesculap AG
Aesculap, a Tepha corporate partner since 2004, introduced the MonoMax product to customers at a symposium held in conjunction with the German Surgical Congress in Munich and will be commercializing the product in Europe commencing with Germany immediately following the congress. Based in Germany and Spain, 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.
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, NMT Medical (NASDAQ: NMTI), 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 six 510(k)’s covering a range of medical devices including sutures, meshes, and films.
For further information about Tepha, please contact John Hartnett., COO and EVP, at Tepha, Inc., 99 Hayden Ave, Lexington, MA 02421, tel: 781-357-1700. Email: email@example.com. Or visit: https://www.tepha.com.
For further information about B. Braun Aesculap, please contact Miguel Pablo, Vice President Marketing & Sales and Regulatory Affairs, Closure Technologies at B. Braun Surgical S.A., Carretera de Terrassa, 121, 08191 Rubí, Barcelona, Spain, tel: +34 93 586 6231. Email: firstname.lastname@example.org. Or visit: www.bbraun.com.