Healthcare Industry News:  minocycline 

Devices Surgery FDA

 News Release - July 24, 2006

TyRx Pharma, Inc., Announces FDA Clearance of PIVIT(TM) AB, a Novel Antimicrobial-Coated Surgical Mesh

PIVIT(TM) AB is Designed to Improve Patient Comfort and Reduce Bacterial Colonization of the Mesh During Implantation

MONMOUTH JUNCTION, N.J., July 24 (HSMN NewsFeed) -- TyRx Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for PIVIT(TM) AB, a new surgical mesh product coated with a proprietary bioresorbable polymer containing the antimicrobial agents rifampin and minocycline. TyRx expects to launch this new surgical mesh during the 3rd quarter of 2006. PIVIT(TM) AB is indicated for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The antimicrobial coating is designed to help provide protection from microbial colonization of the device during surgical implantation.

"We are extremely excited to have reached this value-creating milestone with PIVIT(TM) AB," said Bill Edelman, CEO of TyRx Pharma. "This is the second in a series of combination medical products that TyRx has will launch this year. In December 2005, FDA granted 510(k) clearance for PIVIT(TM), TyRx's 1st bioresorbable polymer coated surgical mesh product. The unique properties associated with PIVIT(TM) 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 addition of the antimicrobial agents in PIVIT(TM) AB will help provide protection from microbial colonization of the device during surgical implantation."

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 June 20th announcement that an independent panel of three judges on behalf of the 3rd International Hernia Congress (Boston) awarded TyRx Pharma, Inc., and Forrest T. Smith, PhD, Associate Professor of Clinical Toxicology and Pharmacology, Virginia Commonwealth University (Richmond), the 2006 Fruchaud Prize for Best Scientific Poster Presentation from among the 90 scientific posters accepted for the presentation, "Pharmacokinetic and Dermal Anesthetic Properties of an Anesthetic-Eluting Surgical Mesh."

In May of 2006, TyRx announced that Mason Diamond, D.D.S., Vice President, Clinical and Regulatory Affairs, was selected as the Industry Representative to the FDA Devices Advisory Committee Dental Products Panel of the Center for Devices and Radiological Health.

In January of 2006, TyRx announced that the company entered into an exclusive license with Baylor College of Medicine and The University of Texas M. D. Anderson Cancer Center for the utilization of three product patents and associated technologies developed by the two institutions for the development of innovative Cardiovascular and Surgical medical devices designed to address the problem of postsurgical nosocomial infection.

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.

TyRx recently launched http://www.pivitmesh.com a comprehensive website discussing the capabilities of this innovative combination device for the treatment of hernia and other soft tissue defects.


Source: TyRx Pharma

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