AIGISRx DEB is designed to reduce the severity of capsular contracture following breast implantation via a reduction in bacterial colonization and
MONMOUTH JUNCTION, N.J., Oct. 24 /PRNewswire/ -- TyRx Pharma, Inc., a leader in the commercialization of implantable medical-pharmaceutical devices, announced today acceptance for presentation during the Plastic Surgery 2007 Society meeting, (October 26-31, 2007, Baltimore, MD) the paper entitled, "Prevention of Experimental Capsular Contracture in Breast Implants by an Antimicrobial-Impregnated Biodegradable Wrap". These study results demonstrate the potential of the TyRx AIGISRx DEB technology to address a significant unmet clinical need for women who have had breast augmentation.
William P. Adams, Jr., MD, Principal Investigator, Plastic Surgeon, Dallas, an international expert in breast augmentation, breast implants and capsular contracture, will present the paper during the "Hot Topics in Plastic Surgery" session, October 27 between 12-4PM. Dr. Adams was Chief of Plastic Surgery, Parkland Health and Hospital System, Dallas, and formerly Associate Professor, Department of Plastic Surgery, UT Southwestern Medical. Dr. Adams graduated B.A. Princeton University, Cum Laude, Biology and received his medical training at Vanderbilt School of Medicine. TyRx Pharma sponsored the study.
Regarding the results of the In-Vivo Efficacy Study of AIGISRx DEB, Dr. Adams remarked, "We have seen great success minimizing capsular contracture with standardized techniques and appropriate breast pocket irrigations. The study results demonstrate that this device provides superior antimicrobial protection compared to current irrigation methods with less inflammation and capsule formation. It appears that this device may greatly benefit all patients with breast implants."
Capsular Contracture, a deformation of the breast implant due to formation of fibrotic tissue following breast augmentation, affects up to 30%(1) of the approximately 290,000(2) elective breast implant procedures performed annually in the U.S. and has been the single biggest complication in aesthetic and reconstructive breast surgery since breast implants were invented 45 years ago.
"We are excited to be working with Dr, Adams in this effort," said Bill Edelman, CEO of TyRx Pharma, "The study results begin the validation of our AIGISRx DEB concept. Despite intensive therapeutic efforts spanning more than four decades, capsular contracture continues to be the most common, perplexing, and frustrating problem associated with mammary augmentation."
Although the exact etiology of capsular contracture is unknown, subclinical infection is widely believed to be the major contributor. Irrigation is a standard procedure in most clinical practices involving breast implants. "Dr. Adams is one of a handful of plastic surgeons actively studying the relationship between subclinical infection, inflammation, and capsular contracture. The data to be presented show that bacterial contamination can have a direct effect on capsular contracture," said Arikha Moses, Ph.D., CSO of TyRx Pharma.
This notice follows TyRx's August 9th announcement of Mark Citron joining TyRx as Vice President, Clinical and Regulatory Affairs.
About TyRx Pharma, Inc.
TyRx Pharma, Inc., an ISO 9001:2000 and ISO 13485:2003 certified medical device manufacturer, commercializes combination medical products utilizing novel biomaterials technology licensed exclusively from Rutgers, The State University of New Jersey. Additionally, TyRx has exclusively licensed from Baylor College of Medicine and The University of Texas M. D. Anderson Cancer Center product patents and associated technologies to address the problem of postsurgical nosocomial infection. 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.
(1) Inamed(R) Silicone-Filled Breast Implants, Directions For Use, L034-03 (C)2006 Allergan, Inc., Mentor Memorygel(TM) Silicone Gel-Filled Breast Implants, 102872-001 Rev. C Effective November 2006, Product Insert Data Sheet
(2) American Society of Plastic Surgeons, 2005 data
|SOURCE TyRx Pharma, Inc.|
Copyright©2007 PR Newswire.
All rights reserved