Spine Wave Receives Approval in Europe to Begin Clinical Testing
of NuCore(TM) Injectable Disc Nucleus in Surgery for Herniated Discs
SAN DIEGO, July 26 /PRNewswire-FirstCall/ -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI) today announced that its licensee, Spine Wave,
Inc., has notified PPTI of its intent to initiate commercial manufacture of
NuCore(TM) Injectable Disc Nucleus (IDN), an injectable protein polymer
formulation for repair of spinal discs damaged as a result of injury or aging.
Spine Wave recently received approval to begin human clinical testing of
NuCore(TM) IDN in Europe. As a result of the notice, PPTI and Spine Wave will
begin negotiations on the terms and conditions for PPTI's provision of
commercial manufacturing services.
NuCore(TM) IDN, based on PPTI's patented tissue adhesive technology, is
injected as a liquid that quickly cures to a solid hydrogel, with properties
similar to the natural disc nucleus material. It has the potential to
ultimately be used in a minimally invasive outpatient procedure to intervene
early in the disc degeneration process and provide relief from chronic low
back pain. Avoiding spinal fusion as a last resort treatment for disc
degeneration disease would be of tremendous benefit to patients, since it
destroys the natural function and mobility of the spine.
Back pain is the leading cause for healthcare expenditures in the United
States. According to spine industry reports, back pain results in more than
$50 billion in direct and indirect medical expense. Despite the invasive
surgery associated with many spinal procedures, particularly spinal fusion,
the worldwide spinal device market represents more than $3 billion in
revenues, growing at a rate of over 25% annually.
Spine Wave is a private, venture-funded company formed in 2001 to develop
and commercialize PPTI's technology for spinal and orthopedic applications.
Spine Wave contracts with PPTI for certain product development services
associated with the technology it has exclusively licensed from PPTI. The
license agreement between PPTI and Spine Wave provides for PPTI's right of
first offer to manufacture protein polymers contained in licensed Spine Wave
products. PPTI also will receive royalties on the sales of products derived
from the licensed rights.
About PPTI and Protein Polymers:
Protein polymers are synthetic proteins created "from scratch" through
chemical DNA (gene) synthesis and produced in quantity by bacteria through
large-scale fermentation. As a result, protein polymers are capable of
uniquely combining specified biological, chemical, and physical properties of
natural proteins which make up the body's own tissues, while containing no
human or animal components that could potentially transmit or cause disease.
They can also be processed into a wide variety of different materials (such as
films, fibers, adhesives, and gels), while retaining these properties. PPTI
pioneered the development of this technology and now holds 25 U.S. patents on
the design, composition of matter, and production of protein polymers, with
corresponding international applications in major markets.
Protein Polymer Technologies, Inc. (PPTI), is a San Diego-based company
focused on developing products to improve medical and surgical outcomes. From
its inception in 1988, PPTI has been a pioneer in protein polymer design and
synthesis, developing an extensive portfolio of proprietary biomaterials. In
addition to the spinal disc repair product being developed with Spine Wave,
PPTI is conducting pilot clinical studies of both a urethral bulking agent for
the treatment of stress urinary incontinence and a dermal contouring agent for
cosmetic surgery and dermatology. Other targeted products include tissue
adhesives and sealants for general surgical use, scaffolds for wound healing
and tissue engineering, and depots for local drug delivery.
This press release contains forward-looking statements that are based on
management's views and expectations. Actual results could differ materially
from those expressed here; further, the Company is not obligated to comment
specifically on those differences. Risks associated with the Company's
activities include scientific and product development uncertainties,
competitive products and approaches, continuing collaborative partnership
interest and funding, regulatory testing and approvals, and manufacturing
scale-up. The reader is encouraged to refer to the Company's 2003 Annual
Report on Form 10-KSB, its 2004 quarterly filings on form 10-QSB and other
recent filings with the Securities and Exchange Commission, copies of which
are available from the Company, to further ascertain the risks associated with
the above statements.
SOURCE Protein Polymer Technologies, Inc.
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CONTACT: J. Thomas Parmeter, Chairman of Protein Polymer Technologies, Inc., +1-858-558-6064
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