PROTEIN POLYMER TECHNOLOGIES RECEIVES
FDA 510(k) CLEARANCE FOR
NEW EMBOLIZATION CONVENIENCE KITS
SAN DIEGO, February 6, 2006 -- Protein Polymer
Technologies, Inc. (OTC Bulletin Board: PPTI.OB), a biotechnology
device company that is a pioneer in protein design and synthesis, today announced
that it has received 510(k) clearance from the U.S. Food and Drug Administration
(FDA) to market its new convenience kits which are packaged with Surgica
Corporation's proprietary foam embolization products. These three new convenience
kits have been designed to offer improved ease of use and overall procedure
efficiency for physicians in the field of Interventional Radiology.
With the new, more user-friendly convenience kits, PVA
Plus™ and MicroStat™ spherical foam embolization
particles are pre-packaged dry in a sterile syringe,
ready for rapid hydration and administration. Based on
Surgica’s patented manufacturing process, these
particles, which are porous throughout, rapidly equilibrate
in contrast media. The new dry particle kits offer physicians
the means to prepare their embolization injections in
a quick, simple and clean manner.
The newly developed MaxiStat™ particles, which
offer the advantages of a spherical PVA foam embolization
particle as an alternative to small coils for up to medium-sized
vessels, are packaged individually, dry in a vial, hydrating
almost instantaneously in contrast media. Larger than
other spherical PVA particles, MaxiStat™ particles
are compressible and resilient, enabling delivery of
a 4 mm particle through a 0.38” guidewire compatible
catheter.
“
The 510(k) clearance of the new convenience kits within
six weeks of executing the license with Surgica represents
a significant milestone for PPTI,” said William
N. Plamondon III, Chief Executive Officer of PPTI. “Capitalizing
on our internal development and regulatory capabilities,
these new products offer distinct advantages to the physician
over other products in the marketplace.”
PPTI completed a worldwide License Agreement with Surgica
for its products and technology in December 2005, acquiring
the exclusive rights to develop and commercialize Surgica’s
three FDA-cleared PVA based embolization products – PVA
Plus™, MicroStat™ and MaxiStat™ and
one additional product under development, Blocker™.
Embolization, a minimally invasive procedure performed
by interventional radiologists, is used to treat a variety
of medical conditions including neurovascular conditions,
uterine fibroids and inoperable liver cancer. PPTI estimates
a conservative annual market potential for embolization
could exceed $400 million in the U.S. and $800 million
worldwide.
To schedule media interviews or request
product images, please contact Bryan deCastro or Carole
Boucard.
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.
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.
