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
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.
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:
firstname.lastname@example.org. 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:
SOURCE Tepha, Inc.