Healthcare Industry News:  M. D. Anderson Cancer Center 

Devices Cardiology FDA

 News Release - October 16, 2006

TyRx Pharma, Inc. Announces Submission of a Premarket Application for PIVIT(TM) CRM, an Innovative Mesh Pouch Designed to Hold and Reduce Bacterial Colonization of a Pacemaker or Implantable Defibrillator Pulse Generator (ICD) When Implanted in the Body

PIVIT(TM) CRM is Designed to Reduce Bacterial Colonization of the Mesh Pouch and Pulse Generator During Implantation

MONMOUTH JUNCTION, N.J., Oct. 16 (HSMN NewsFeed) -- TyRx Pharma, Inc. announced today that it has filed a Premarket Application for PIVIT(TM) CRM, an innovative mesh pouch coated with a proprietary bioresorbable polymer containing the antimicrobial agents rifampin and minocycline designed to enclose a pacemaker or ICD pulse generator when implanted in the body. PIVIT(TM) CRM acts to provide protection from microbial colonization of the pulse generator during surgical implantation. According to a recent study presented during the Heart Rhythm Society 2006 Scientific Sessions (Boston) the University of Pittsburgh Medical Center noted that the 2003 national incident of infection for pacemakers was estimated to be 5.82% and for ICDs 3.71%.

"We are extremely excited to have reached this value-creating milestone with the filing of a Premarket 510(k) Application for PIVIT(TM) CRM," said Bill Edelman, CEO of TyRx Pharma. "With over 500,000 annual implants of pulse generators, we believe PIVIT(TM) CRM will become a valuable tool in the effort to suppress microbial colonization of pulse generators during surgical implantation. This is the third in a series of combination medical products that TyRx will launch this year.

In July, 2006, FDA granted TyRx 510(k) clearance for PIVIT(TM) AB, TyRx's Antimicrobial Surgical Mesh coated with rifampin and minocycline. 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 the PIVIT(TM) surgical mesh products provide excellent handling characteristics that facilitate precise placement during surgical repair of soft tissue defects, leaving 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.


Source: TyRx Pharma

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