INTEGRA Dermal Regeneration Template Launched in Japan
PLAINSBORO, N.J., Apr 15, 2009 (GlobeNewswire via COMTEX News Network) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today its plan to launch INTEGRA(R) Dermal Regeneration Template in Japan with its long-time distributor, Century Medical, Inc.
"We have been working very closely with Century Medical in Japan to complete the rigorous clinical study and regulations required by the Japanese Regulatory authorities for the Seizo Hanbai Shonin approval (Marketing Authorization License). We are excited that INTEGRA(R) Dermal Regeneration Template received this approval from Japan's Ministry of Health, Labor and Welfare for the treatment of deep second- and third-degree burns (life-threatening burns). This product has been extensively evaluated in Japan and will provide surgeons with a novel treatment for life-threatening burns that can improve the quality of life for patients," said Judith O'Grady, Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs at Integra LifeSciences Corporation.
INTEGRA(R) Dermal Regeneration Template was the first regenerative product approved by the FDA for the treatment of life-threatening burn and scar revisions. Since gaining the initial FDA approval in 1996, the INTEGRA(R) Template has been used successfully on over 100,000 patients, and is sold worldwide in over 40 countries.
"We are extremely pleased that our innovative product has been approved in Japan and that Century Medical's experienced professionals will be handling its distribution," said Stuart Essig, Integra's President and CEO. "INTEGRA(R) Dermal Regeneration Template has enjoyed broad commercial acceptance around the world and we look forward to entering the Japanese market."
INTEGRA(R) Dermal Regeneration Template is an advanced bilayer skin replacement system, designed to provide immediate wound closure and permanent regeneration of the dermis. The inner layer is placed in direct contact with the excised wound and consists of a complex 3-dimensional porous matrix that acts as a scaffold for cell migration that allows for regeneration of the dermal layer of the patient's skin. The outer layer is a thin silicone film that protects the regenerative matrix and the wound from infection and controls both heat and moisture loss. Once the dermis has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft, providing the patient with their own flexible, living skin.
Century Medical's President and CEO, Mr. Akira Hoshino said, "Century Medical, Inc. is looking forward to working closely with Integra and applying our in-house sales and marketing expertise and capabilities to bring the benefits of INTEGRA(R) Dermal Regeneration Template to Japanese patients."
Century Medical, Inc. is one of the largest independent medical device distributors in Japan. With over 35 years experience in marketing medical devices in Japan, Century Medical has been a pioneering force, successfully introducing many new technologies to the Japanese healthcare community.
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 clinically relevant, innovative, and cost-effective surgical implants and medical instruments. Integra's products, used primarily in neurosurgery, orthopedics and general surgery, are used to treat millions of patients every year. The company's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. For more information visit 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 the future use of Integra products. 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 INTEGRA(R) Dermal Regeneration Template 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, 2008 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
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SOURCE: Integra LifeSciences Holdings Corp.
Integra LifeSciences Holdings Corporation Gianna Sabella, Director of Corporate Communications (609) 936-2389 gsabella@integra-LS.com
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