SPINE WAVE NOTIFIES PROTEIN POLYMER
TECHNOLOGIES OF FDA APPROVAL TO CONDUCT U.S. CLINICAL
TRIALS
Patient
Enrollment for NuCore™ Injectable Nucleus
IDE Clinical Trial Begins
SAN DIEGO, February 21 -- Protein Polymer
Technologies, Inc. (OTC Bulletin Board: PPTI.OB), today
announced that it has been notified by Spine Wave, Inc., that approval for
an Investigational Device Exemption has been received from the U.S. Food
and Drug Administration (FDA). This allows Spine Wave to conduct a pilot
human clinical trial to investigate the safety and effectiveness of the company’s
NuCore™ Injectable Nucleus.
NuCore™ Injectable Nucleus, based on PPTI’s
patented tissue adhesive technology, is an injectable
protein polymer formulation for repair of spinal discs
damaged as a result of injury or aging. Injected in a
liquid form, the NuCore material rapidly cures to a gel
that has physical properties which mimic those of the
natural nucleus. The companies are engaged in a program
to develop and commercialize PPTI’s technology
for certain spinal and orthopedic applications. PPTI
manufactures the NuCore material for Spine Wave’s
clinical trials.
“
The FDA’s approval to conduct clinical trials of
NuCore™ Injectable Nucleus in the U.S. is a true
affirmation of our core technology,” said William
N. Plamondon III, Chief Executive Officer of PPTI. “There
is an unmet medical need for improved treatment options
of low back pain. We believe this new technology provides
surgeons a minimally invasive option for treating patients
who suffer from back pain caused by damaged or degenerated
discs.”
NuCore™ Injectable Nucleus offers the potential
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
fusion destroys the natural function and mobility of
the spine.
Back pain is the leading cause for healthcare expenditures
in the United States. According to the American Academy
of Orthopaedic Surgeons, treatment for back pain costs
an estimated $100 billion a year in medical costs, lost
working days and workers compensation. More than 31 million
Americans wrestle with bouts of low back pain at any
given time. One third of all Americans over the age of
18 had a back problem in the past five years severe enough
for them to seek medical treatment.
Spine Wave has enrolled patients in microdiscectomy studies
of NuCore Injectable Nucleus in four countries: Switzerland,
Australia, Germany and the United States, and expects
to expand enrollment of this and other studies in the
first half of 2006.
Contacts
Investor Contact:
Erin Davis
Director of Communications and Investor Relations
Protein Polymer Technologies, Inc.
(858) 558-6064 x 120
edavis@ppti.com |
Media Contact:
Bryan deCastro, (631) 495-9177
Carole Boucard, (954) 370-2524
Creative Public Relations
|
About
Protein Polymer Technologies
Protein Polymer Technologies, Inc. is a biotechnology company that discovers
and develops innovative therapeutic devices to improve medical and surgical
outcomes. The Company focuses on developing technology and products to be used
for soft tissue augmentation, tissue adhesives and sealants, wound healing
support and drug delivery devices. Protein Polymer Technologies’ proprietary
protein-based biomaterials are uniquely tailored to optimize clinical performance
and contain no human or animal components that could potentially transmit or
cause disease. The Company is headquartered in San Diego, California. For additional
information about the Company, please visit www.ppti.com.
To date, PPTI has been issued twenty-six U.S. patents on its core technology
with corresponding issued and pending patents in key international markets.
About Spine Wave
Spine Wave is a medical device company focused on the
development and marketing of clinical solutions for three
of the largest and fastest growing spinal market segments:
nuclear replacement and augmentation, vertebral compression
fracture repair and spinal fusion.
The company’s product portfolio includes the NuCore™ Injectable
Nucleus, the StaXx™ FX Fracture Repair System,
the StaXx™ XD Expandable Device, and several products
in development.
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 raising adequate capital to continue operations,
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 2004
Annual Report Form 10-KSB, and 10KSB/A 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.
