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

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

April 09, 2007

    CAMBRIDGE, Mass., April 9 /Xinhua-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: [phone], fax: [phone].  Email:
[e-mail]. 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 


    For more information, please contact:

     Dr. Ajay Ahuja, M.D.
     Director of Business Development
     Tepha, Inc.
     Tel:   [phone]
     Fax:   [phone]
     Email: [e-mail]