MONMOUTH JUNCTION, N.J., May 15 /PRNewswire/ -- TyRx Pharma, Inc. today announced that Mason Diamond, D.D.S., Vice President, Clinical and Regulatory Affairs for TyRx Pharma, was selected as the Industry Representative to the FDA Devices Advisory Committee Dental Products Panel of the Center for Devices and Radiological Health.
Dr. Diamond will be participating in an upcoming joint meeting of the Dental Products Panel and the Peripheral & Central Nervous System Drugs Advisory Committee of the Center for Drug Evaluation and Research, where the issue of the potential toxicity from mercury in dental restorative materials will be explored.
"We are extremely excited to have one of our executive management team members selected to participate in this important cause, as this election exemplifies the thought leadership abilities within the TyRx management team in the combination product space," said TyRx Chief Executive Officer, Bill Edelman, "Mason's participation as Industry Representative further demonstrates TyRx's commitment to the emerging area of Combination Medical Products, which are well represented in the Dental field."
Dr. Diamond represented TyRx at the FDA 2006 Science Forum in Washington, D.C, where he presented a poster on "A Novel Method of Measuring Mass Loss from Bioresorbable Polymers Containing Optically-active Compounds" and delivered a presentation on "Reporting Adverse Experiences for Combination Products" at an international conference on Adverse Event Reporting.
This notice follows TyRx's January 30th announcement 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 post-surgical nosocomial infection.
In January of 2006, TyRx announced that the company filed a 510(k) application with the FDA for its new surgical mesh coated with their novel polyarylate bioresorbable polymer containing two antimicrobial agents. The TyRx antimicrobial-coated surgical mesh 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 surgical mesh is designed to provide protection from bacterial colonization of the surgical mesh during implantation. In December 2005, the FDA granted 510(k) clearance for TyRx's new bioresorbable polymer coated surgical mesh product.
In January of 2006, TyRx announced that its Anesthetic Coated Surgical Mesh received a designation of "Combination Product with Device Primary Mode of Action (PMOA)" from the Office of Combination Products at the 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".
In January 2005, TyRx received an equity investment from Boston Scientific Corporation, enabling the two companies to continue to co-develop novel drug eluting coatings for cardiovascular stents under a licensing agreement. TyRx anticipates it will raise an additional institutional round of financing at the end of this year.
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 www.tyrxpharma.com.
TyRx Pharma, Inc.CONTACT: Bill Edelman, CEO, TyRx Pharma, Inc., Office: +1-732-246-8676,Direct: +1-732-964-1101, Cell: +1-617-759-5451, william@tyrxpharma.com
Web site: http://www.tyrxpharma.com/
