PROTEIN POLYMER TECHNOLOGIES SUBMITS 510(k) APPLICATION
FOR EXPANDED INDICATIONS OF ITS EMBOLIZATION PRODUCTS
SAN DIEGO, CA -- May 10, 2006 -- Protein Polymer Technologies, Inc. (OTC Bulletin
Board: PPTI.OB), a biotechnology device company that is a pioneer in protein
design
and synthesis, announced that it has filed a 510(k) application with the
U.S. Food and Drug Administration (FDA) for clearance to expand the labeled
indications of Surgica’s embolization products to include treatment
of hypervascular tumors including uterine fibroids, liver and renal tumors.
Surgica’s proprietary foam embolization products are currently cleared
for use in the endovascular management of neurovascular arteriovenous malformations
and neoplastic lesions when presurgical devascularization is desirable. Surgica
has three FDA-cleared polyvinyl alcohol (PVA) based embolization products – PVA
Plus™, MicroStat™ and MaxiStat™ and one additional product
under development, Blocker™.
“
The submission of this application is an important milestone in the regulatory
process for advancing the commercialization of Surgica’s proprietary
embolization products,” commented William N. Plamondon III, Chief Executive
Officer of PPTI. “This submission further demonstrates our commitment
to the use of embolization products to treat a variety of conditions. The
expanded indications will allow us to significantly increase our market potential.”
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 embolization products.
An estimated 70 percent of the approximately 275,000 hysterectomies performed
to treat uterine fibroids in 2005 would have benefited from this procedure.
PPTI estimates a conservative annual market potential for uterine fibroid
embolization could exceed $200 million in the U.S. and $300 - $500 million
worldwide.
Embolic agents are also used in the treatment of inoperable liver cancer,
a condition affecting approximately 75,000 people in the United States in
2005, with an annual market potential of $200 million in the U.S. and $400
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.