Tepha, Inc. Receives FDA Clearance For First Medical Device Derived From New Class Of Biopolymers
Cambridge, MA - Tepha, Inc., a privately held medical device company, recently announced that the FDA has cleared its TephaFLEX Absorbable Suture product for marketing in the U.S. The TephaFLEX Absorbable Suture is the first medical device derived from a new class of biopolymers that is the product of patented recombinant DNA technology developed by Tepha and licensed from the Massachusetts Institute of Technology (MIT). The TephaFLEX material has biological and mechanical properties that are uniquely suited for implantable medical devices. Tepha and its corporate partners are pursuing a wide array of medical device applications for the TephaFLEX technology.
Dr. Simon Williams, President and CEO of Tepha, stated, "We are delighted that the FDA has cleared the TephaFLEX Absorbable Suture, and determined that devices of this type will be regulated as class II (510k) devices. The Company's novel biopolymer technology can now be further applied to the development of a range of medical devices to meet unmet clinical needs."
TephaFLEX polymer is a member of a new class of biopolymers with mechanical and biological properties that are uniquely applicable to implantable medical devices when compared to conventional synthetic and biologically derived polymers. Compared to synthetic polymers such as polylactic acid (PLA) and polyglycolic acid (PGA), TephaFLEX material is tougher and more flexible with an absorption rate and degradation profile that are compatible with human tissue repair and replacement applications. However, unlike other biopolymers such as collagen and hyaluronate, TephaFLEX polymer is a thermoplastic and can be fabricated into virtually any shape or form -- including fibers, films, tubes, foams, textiles, microspheres, and molded constructs -- using a wide range of conventional melt and solvent processing techniques.
The TephaFLEX Absorbable Suture is engineered to be one of the strongest absorbable fibers known, offering up to 50% greater tensile strength than currently marketed monofilament absorbable sutures. In addition to high strength, the TephaFLEX Absorbable Suture also offers surgeons improved flexibility, good knot security, and prolonged strength retention when implanted.
The new class of biopolymers to which the TephaFLEX polymer belongs is a product of Tepha's patented recombinant DNA technology. This technology allows the Company to engineer materials with a range of biological and mechanical properties for specific tissue repair and replacement applications. After the repair process, the biopolymers degrade in the body to natural metabolites in a biocompatible, cell-friendly manner.
Professor Anthony Sinskey of the MIT Department of Biology, and a co- inventor of the recombinant DNA technology, commented: "This breakthrough technology will allow Tepha and its partners to progress beyond the constraints of traditional medical device materials to offer new solutions for the unmet needs of physicians and their patients."
Several leading medical device companies have recognized the unique properties profile of TephaFLEX material for human tissue repair and replacement applications. Tepha's current corporate partners are pursuing a wide array of products including sutures, surgical meshes for orthopedic and hernia repair, anti-adhesion films, hemostats, intra-cardiac devices, absorbable stents, ligament and tendon repair and replacement devices, embolization agents, and drug delivery systems. Tepha's current partners include Aesculap AG, HemCon Medical Technologies, LifeCell Corporation,NMT Medical, and Tornier, Inc.
The development of the TephaFLEX Absorbable Suture was supported by grants from the National Institutes of Health (NIH), and the U.S. Department of Commerce's National Institute of Standards and Technology Advanced Technology Program (NIST ATP).
Tepha was formed as a sister company to Metabolix, Inc. (Nasdaq: MBLX). Both companies are engaged in commercializing new polymers derived from recombinant DNA technology licensed from the Massachusetts Institute of Technology. Tepha is focused specifically on in vivo medical applications of the technology. Metabolix, which recently had its initial public offering (IPO), is focused on using the technology in the development of environmentally sustainable alternatives to petrochemical-based plastics, fuels, and chemicals.
Tepha's institutional investors include The Vertical Group, a New Jersey based venture capital firm specializing in medical devices and biotechnology; Integra Ventures, a life science venture capital firm located in Seattle, WA; The Novartis Venture Fund, based in Basel, Switzerland, the venture capital arm of Novartis -- one of the world's largest life science companies; and Westfield Life Sciences Fund, a Boston-based fund specializing in health care companies since 2000.
SOURCE: Tepha, Inc.