Press Release Source: Protein Polymer Technologies, Inc.
Protein Polymer Technologies Receives FDA 510(k) Clearance of New Indication for Embolization Convenience Kits Wednesday October 25, 7:00 am ET
SAN DIEGO, CA--(MARKET WIRE)--Oct 25, 2006 -- Protein Polymer Technologies, Inc. (OTC BB:PPTI.OB - News), 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 PVA foam embolization convenience kits for peripheral vascular indications including treatment of liver and renal tumors. The products were previously cleared only for use within the neurovascular system.
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 PVA Plus™, MicroStat™ and MaxiStat™ embolization products. A major use of embolic agents is for 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.
"Gaining regulatory clearance to market the Surgica products for additional indications is a key part of our growth strategy for this business," said William N. Plamondon III, Chief Executive Officer of PPTI. "This is a significant milestone for PPTI, while we continue our work towards clearance for the other major use of embolization particles, the treatment of symptomatic uterine fibroids."
Approximately 70 percent of the estimated 275,000 hysterectomies performed to treat uterine fibroids in 2005 would have benefited from the embolization treatment 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.
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 http://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.
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 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.
Investor/Media Contact: Erin Davis Director of Communications and Investor Relations Protein Polymer Technologies, Inc. (858) 558-6064 x 120 Email Contact
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