Healthcare Industry News: uterine fibroids
News Release - February 6, 2006
Protein Polymer Technologies Receives FDA 510(k) Clearance for New Embolization Convenience KitsSAN DIEGO, CA--(Healthcare Sales & Marketing Network)--Feb 6, 2006 -- Protein Polymer Technologies, Inc. (OTC BB: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(TM) and MicroStat(TM) 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(TM) 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(TM) 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(TM), MicroStat(TM) and MaxiStat(TM) and one additional product under development, Blocker(TM).
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.
About Protein Polymer Technologies, Inc.
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.
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.
Source: Protein Polymer Technologies
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