Protein Polymer Receives Additional Spinal Wave Equity and Incentives for
Development of Spinal Disk Repair Product
Spinal Wave Also acquires VERTx, Inc. and Completes Equity
Finacing
SAN DIEGO, April 4 -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI) and Spinal Wave, Inc. today announced the
execution of agreements providing PPTI with additional equity incentives
in the form of Spinal Wave common stock and warrants for the continued development
of a unique Spinal disc repair product based on PPTI's patented technology.
Spinal 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.
In a related transaction, Spinal Wave announced that it
has raised approximately $15 million through the sale of Series A Preferred
Stock. In addition to Windamere Venture Partners, investors in the Series
A Preferred financing included Canaan Partners and New Enterprise Associates.
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. Within the overall Spinal market, it is estimated
that the potential market for treatment of Spinal disc conditions will surpass
$1 billion by 2007
The concept of disc repair by replacing or augmenting
the internal disc nucleus, as opposed to Spinal fusion or implantation of
an artificial disc, has been investigated since the 1950's. To date, however,
no product has been able to meet the extreme mechanical requirements while
offering the potential to be used in a minimally invasive outpatient procedure.
The ideal product is one that:
- mimics the physical properties of the natural nucleus;
- is mechanically able to withstand the extreme loads placed on the disc,
while also resisting expulsion from the disc;
- is biocompatible; and
- can be delivered by minimally invasive techniques, avoiding disruption
of the tissues surrounding the Spinal and damage to the disc wall.
Initial "proof of concept" studies recently completed
by PPTI and Spinal Wave have provided evidence to support the capability
of PPTI's technology to meet these stringent requirements. As a result,
preclinical studies have been initiated to support the filing of an Investigational
Device Exemption with the FDA to obtain approval for initiating human clinical
studies.
When formed in 2001, Spinal Wave acquired a license to
PPTI's technology for use in Spinal and other defined orthopedic applications.
PPTI received founding stock in Spinal Wave, continuing payments for R&D
supplies and services, and will receive royalties on the sale of products
derived from the licensed rights. PPTI also retained potentially valuable
manufacturing rights.
Spinal Wave also recently completed the acquisition of
VERTx, Inc. Formed in 2001, VERTx is an orthopedic company developing products
to improve the repair of vertebral fractures due to injury and aging. This
acquisition significantly broadens Spinal Wave's technology base and gives
it a platform in two of the fastest growing segments of the Spinal industry
Ð disc repair and vertebral compression fracture treatment.
Spinal Wave's Chief Executive Officer is Mark LoGuidice,
formerly the President of Sofamor Danek U.S. (now a subsidiary of Medtronic,
Inc.), a leading developer of orthopedic products for the Spinal. Mr. LoGuidice
continues to assemble in Spinal Wave a team of seasoned orthopedic veterans.
Protein Polymer Technologies, Inc. (PPTI), is a San DiegoÐbased
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,
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. In addition to the Spinal disc repair product being developed
with Spinal 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.
