PROTEIN POLYMER AND SPINE WAVE TO BEGIN NEGOTIATIONS
ON TERMS FOR COMMERCIAL MANUFACTURING OF SPINAL DISC
REPAIR PRODUCT
Spine Wave receives approval in Europe to begin
clinical testing
of NuCore™ Injectable Disc Nucleus in surgery for herniated
discs
SAN DIEGO,
July 26, 2004 -- Protein Polymer Technologies, Inc. (OTC
BB: PPTI) today announced that its licensee, Spine Wave,
Inc., has notified PPTI of its intent to initiate commercial
manufacture of NuCore™ 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™ 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™ 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.
Contacts:
J. Thomas Parmeter, Ph.D.
Chairman
jtp@ppti.com
Protein Polymer Technologies
(858) 558-6064 |
|
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.
Safe Harbor
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 10QSB
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.