Healthcare Industry News:  TYRX 

Devices Biopharmaceuticals

 News Release - January 17, 2006

TyRx Announces FDA 510(k) Filing for New Antibiotic Eluting Surgical Mesh

Surgical Mesh is designed to improve patient comfort and reduce bacterial colonization

MONMOUTH JUNCTION, N.J., Jan. 17 (HSMN NewsFeed) -- TYRX Pharma, Inc. announced today that it has recently filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for its novel antimicrobial surgical mesh product. TYRX expects to launch this new surgical mesh in Q1-06. This is the second in a series of combination medical products that TYRX expects to market next year. In December 2005, FDA granted 510(k) clearance for TYRX's new bioresorbable polymer coated surgical mesh product. Like its predecessor, the TYRX antimicrobial mesh is designed to facilitate insertion and improve patient comfort long-term.

The TYRX bioresorbable polymer antibiotic eluting surgical mesh is indicated for the repair of hernias and other abdominal fascial or muscular deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The bioresorbable polymer antibiotic eluting surgical mesh is designed to provide protection for 5-7 days post implantation from colonization of the surgical mesh by the most common sources of surgical infection.

"We are extremely excited to have reached this value-creating milestone with our new surgical mesh," said Bill Edelman, CEO of TYRX Pharma. "We feel that the features of this product will help to alleviate some of the problems associated with mesh implantation for the treatment and repair of hernia. The unique properties associated with this product give the surgical mesh good handling characteristics that facilitate precise placement during the surgical repair and leaves less implant material following the resorption of the bioresorbable polymer coating. We believe that less implant material will help to facilitate patient comfort during the post-operative period and beyond. The additional feature of antibiotic elution will help to prevent common sources of post-surgical infection."

TYRX anticipates its bioresorbable polymer antibiotic eluting surgical mesh will help reduce the incidence of post-operative infections, resulting in better medical care and lower healthcare costs.

According to Infection Control Today (8/2003), the average cost of each infection related to invasive medical devices varies from $34,000 to $56,000; these infections incur an annual financial burden up to $2.3 billion to the American healthcare system. The New England Journal of Medicine (N Engl J Med 2004;350:1422-9) states about half of the 2 million cases of nosocomial infection that occur each year in the United States are associated with indwelling devices. Infections associated with surgical implants are generally more difficult to manage because they require a longer period of antibiotic therapy and repeated surgical procedures.

This notice follows TYRX's January 9, 2006 announcement that its Anesthetic Coated Surgical Mesh has received a designation of "Combination Product with Device Primary Mode of Action (PMOA)" from the Office of Combination Products at the FDA. Since 2002, Boston Scientific Corporation and TYRX have been co-developing novel drug eluting coatings for cardiovascular stents under a licensing agreement. TYRX is focused on developing a family of proprietary bioresorbable drug-eluting polymers for use in combination medical devices and specialty pharmaceuticals.

About TYRX Pharma, Inc.

TYRX was organized in 1998 to commercialize a novel combinatorial chemistry-based biomaterials technology licensed exclusively from Rutgers, The State University of New Jersey, using substances such as tyrosine to build medical-grade biodegradable polymers. Using proprietary polymerization processes, TYRX efficiently creates customized polymers to meet precise product specifications. TYRX is deploying its capabilities across a broad range of combination products. The combination products sector (products incorporating both a drug & a device component) is expected to be the highest growth segment of the medical products industry and TYRX is positioned to be an innovative applications leader in the space. For more information, please visit http://www.TYRXpharma.com.


Source: TyRx Pharma

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