SAN DIEGO, April 3 /PRNewswire-FirstCall/ -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI) and Spine Wave, Inc. today announced the
expansion of the contractual research and development relationship between the
two companies. Spine Wave is a private company formed last year 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 procedures including discectomy and the treatment of chronic low back
pain.
Under the amended Supply and Services Agreement, PPTI on behalf of Spine
Wave is proceeding with preclinical safety and performance studies of the
device to support Spine Wave's filing of an Investigational Device Exemption
with the FDA to obtain approval to initiate human clinical testing. PPTI
estimates it will receive from Spine Wave approximately $1.5 million in R&D
payments over the next year, exclusive of the preclinical study costs. During
the subsequent period leading to regulatory marketing approvals, PPTI's
contractual responsibilities include the supply of product to be used in
clinical testing and preparation for commercial manufacturing operations.
Spine Wave is responsible for clinical testing, regulatory approvals, and
commercialization.
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.
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 21 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 2001 Annual
Report and 10-KSB, and 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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Company News On-Call:
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CONTACT:
John E. Flowers, Vice President of Protein
Polymer Technologies, Inc., +1-858-558-6064; or Mark LoGuidice,
President of Spine Wave, Inc., +1-203-259-2232
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