Tepha, Inc. Receives FDA Clearance for First Medical Device Derived from New Class of Biopolymers

    CAMBRIDGE, Mass., April 9 /PRNewswire/ -- Tepha, Inc., a privately held
 medical device company, today announced that the FDA has cleared its
 TephaFLEX(R) 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
 (Nasdaq:   LIFC), NMT Medical (Nasdaq:   NMTI), 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.
     Additional Information
     For information on Tepha and its technology, please contact: Dr. Ajay
 Ahuja, M.D., Director of Business Development, Tepha, Inc., 840 Memorial
 Drive, Cambridge, MA 02139, tel: 617-995-5404, fax: 617-995-5401. Email:
 contact@tepha.com. Or visit http://www.tepha.com.
     About Tepha, Inc.
     Tepha is a medical device firm engaged in the development of a new
 range of absorbable devices for therapeutic applications. The Company is
 applying a patented core technology, comprising over 40 issued U.S.
 patents, which allows it to produce absorbable polymers suitable for use in
 a wide range of implantable products in the areas of surgical repair,
 regenerative medicine, and drug delivery.
     The Company's proprietary technology uses genetic engineering to
 produce a new class of biomaterials that can be converted into a wide range
 of products that restore, maintain, or improve tissue function. Potential
 products range from relatively simple medical devices to more complex
 products that include cardiovascular stents, intra-cardiac closure devices,
 ligament and tendon repair devices - as well as drug delivery systems.
     Tepha - a new generation of absorbable medical devices.
 
     For further information, please visit our website:
     http://www.tepha.com
 
 

SOURCE Tepha, Inc.

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

 

PR Newswire Membership

Fill out a PR Newswire membership form or contact us at (888) 776-0942.

Learn about PR Newswire services

Request more information about PR Newswire products and services or call us at (888) 776-0942.