PLAINSBORO, N.J., Dec. 13, 2007 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the launch of Integra(TM) Flowable Wound Matrix. Integra has received 510(k) clearance from the United States Food and Drug Administration to market Integra(TM) Flowable Wound Matrix in the United States.
Integra(TM) Flowable Wound Matrix is an advanced wound care device. Its design is based on Integra's proven collagen technology and provides an alternative to filling deep soft tissue or tunneling wounds in diabetic foot and venous leg ulcers. When hydrated with saline, the matrix forms a gel that can be applied to difficult-to-access wound sites, and provides a scaffold for cellular invasion and capillary growth.
Dr. John Steinberg, Assistant Professor in the Department of Plastic Surgery at the Georgetown University School of Medicine and a member of the hospital's Limb Salvage Team, specializes in advanced technology for wound healing and has been involved with Integra(TM) Flowable Wound Matrix over the course of its development.
"Integra(TM) Flowable Wound Matrix is a ground-breaking technology for the treatment of tunneled wounds in diabetic foot and lower extremity ulcers. The clinically proven Integra collagen-glycosaminoglycan matrix, which was originally developed for Integra(R) Dermal Regeneration Template, has been modified into a flowable form to close difficult, irregular wounds. This flowable form of the matrix maintains intimate contact with the wound margins and provides a scaffold for rapid in-growth of new cells, vascularization and tissue deposition. Integra has made good use of its proven regenerative technologies to provide a helpful new treatment option in the care and healing of complex wounds."
There are currently 18 million people with diabetes in the U.S. 15% of those sustain one or more diabetic foot ulcers during their lifetime, and this population is also 15 times more likely to suffer an amputation due to non-healing diabetic foot ulcers. However, approximately 85% of all amputations are preventable if proper intervention is provided. Approximately 500,000 adults seek treatment for venous leg ulcers (VLUs) annually in the United States -- a figure that likely underestimates the true prevalence of VLUs because many individuals fail to seek medical care for recurrent ulcers. Integra estimates that the market opportunity for the flowable product in wounds is $150 million.
"We are excited to utilize our extensive collagen technology to design, engineer and manufacture a new wound matrix, which specifically fills a clinical need in the treatment of wounds," said Tom Tarca, Integra's VP of Marketing for the Extremity Reconstruction Business.
Integra(TM) Flowable Wound Matrix will be sold by Integra's Extremity Reconstruction sales organization, which includes over 70 U.S. sales specialists focused on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing, and marketing of cost-effective surgical implants and medical instruments. The company's products are used to treat millions of patients every year, primarily in neurosurgery, extremity reconstruction, orthopedics and general surgery. Integra's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. www.Integra-LS.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning expectations for the future use of Integra(TM) Flowable Wound Matrix. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of physicians to use this product may affect the prospects for its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Risk Factors" included in section IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2006 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
IART-P