Healthcare Industry News:  TYRX 

Devices FDA

 News Release - January 9, 2006

TyRx Pharma's Anesthetic Coated Surgical Mesh Combination Product Assigned to 'Device' Center at FDA

TYRX plans to initiate clinical trials in the first half of 2006

MONMOUTH JUNCTION, N.J., Jan. 9 (HSMN NewsFeed) -- TYRX Pharma, Inc., announced today 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 U.S. Food and Drug Administration (FDA). This designation and assignment to the Center for Devices and Radiologic Health (CDRH) has historically indicated a faster regulatory and commercial timeline for a product as compared to when the FDA considers a combination product to be a "drug".

TYRX is scheduled to meet with FDA January 26th to discuss the development plan and clinical study design for the Anesthetic Coated Surgical Mesh. TYRX plans to initiate clinical trials in the first half of 2006 to assess the efficacy and safety of TYRX's Anesthetic Coated Surgical Mesh combination product in patients requiring surgical mesh implantation during hernia repair.

"We consider this decision by the Office of Combination Products as a positive step forward for our Anesthetic Coated Surgical Mesh program, and we look forward to a productive meeting with CDRH," said Mason Diamond, Vice President, Clinical & Regulatory Affairs at TYRX.

This release follows TYRX's January 3, 2006 announcement of 510(k) clearance by FDA for TYRX's new bioresorbable polymer coated surgical mesh product. The TYRX bioresorbable polymer 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 company expects to launch this new surgical mesh in Q1-06. This is the first in a series of combination medical products that TYRX expects to market next year.

In January 2005, TYRX received an equity investment from Boston Scientific Corporation. Since 2002, Boston Scientific 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. Terms of the agreement were not disclosed. The law firm of Brown Rudnick Berlack Israels LLP represented TYRX Pharma in the financing round.

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.

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Source: TyRx Pharma

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