FOR
IMMEDIATE RELEASE
CONTACTS:
Protein Polymer Technologies, Inc.
J. Thomas Parmeter
President
(858) 558-6064
|
Spine Wave, Inc.
Mark LoGuidice
President
(203) 259-2232
|
PROTEIN POLYMER AND SPINE WAVE EXTEND R&D TIES
FOR DEVELOPMENT OF SPINAL DISC REPAIR PRODUCT
SAN DIEGO, December 12, 2003 -- Protein Polymer Technologies,
Inc. (OTC BB: PPTI) and Spine Wave, Inc. today announced
the extension of the contractual research and development
relationship between the two companies. PPTI estimates
it will receive from Spine Wave approximately $1.2 million
in R&D payments under the revised agreement.
Under the amended Supply and Services Agreement, PPTI,
on behalf of Spine Wave, is continuing product characterization
studies, and preparations for the supply of product to
be used in human clinical trials following required regulatory
approvals. During the subsequent periods leading to regulatory
marketing approvals, PPTI’s contractual responsibilities
include the supply of clinical product and preparation
for commercial manufacturing operations. Spine Wave is
responsible for clinical testing, regulatory approvals,
and commercialization.
Spine Wave is a private company formed in 2001 by PPTI
and Windamere Venture Partners to develop and commercialize
an injectable protein-based formulation for the repair
of spinal discs damaged either by injury or aging. Based
on PPTI’s proprietary tissue adhesive technology,
the initial product under development has the potential
to be utilized in a number of spinal and other orthopedic
procedures including discectomy and the treatment of chronic
low back pain. In addition to receiving R&D Payments,
PPTI holds an equity position in Spine Wave, has rights
to commercial manufacturing, and will receive a royalty
on product sales.
Back pain is the leading cause for healthcare expenditures
in the United States. According to a 2000 Viscogliosi Bros.,
LLC, Spine Industry report, back pain results in more than
$50 billion in direct and indirect medical expense. Despite
the invasive surgery associated with many spinal procedures,
such as spinal fusion, the worldwide spinal market represents
more than $2 billion in revenues, growing at a rate of
over 25% annually. It is the fastest growing major segment
of the orthopedic industry.
In many instances, spinal fusion is a procedure of last
resort, since it destroys the natural function and mobility
of the spine by replacing the shock absorbing intervertebral
disc with metal and/or bone. Currently, there are no approved
products to replace or restore the function of the invertebral
disc that has degenerated, nor to intervene in the degenerative
process. Using PPTI’s patented technology, Spine
Wave and PPTI are developing a product (the Injectable
Disc Nucleus) designed to restore natural disc function
by replacing or augmenting the natural disc nucleus that
has degenerated or that has been surgically removed in
a discectomy procedure. The product has the potential to
be used independently in minimally invasive outpatient
procedures as well as in combination with traditional open
procedures.
Spine Wave recently completed its Series B financing providing
assurance that sufficient resources will be available to
maintain a focused development effort for the injectable
spinal disc repair product and other products under development.
Spine Wave, which holds a license to PPTI’s technology
for spinal and orthopedic applications and contracts with
PPTI for product development and manufacturing services,
raised $22.25 million in Series B funding with Morgenthaler
Ventures, New Enterprise Associates, Canaan Partners, Thoma
Cressey Equity Partners, Collinson Howe & Lennox, California
Technology Ventures, New Venture Partners, NeuroVentures
Capital and Spring Ridge Ventures.
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
2002 Annual Report on Form 10-KSB, its 2003 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.