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Advanced BioHealing Will Offer Dermagraft, TransCyte

Advanced BioHealing, Inc (ABH), New York, NY, has acquired the assets and rights associated with the advanced wound care products Dermagraft and TransCyte from Smith & Nephew (Largo, FL). Both products are approved for sale in the United States and are also approved and marketed in a number of other countries. Financial terms of the transaction were not disclosed.


Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers. The cryopreserved human fibroblast-derived dermal substitute is supplied frozen in a clear bag containing 1 piece of approximately 2 x 3 inches for a single-use application. TransCyte is indicated for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds. The product is a human fibroblast-derived temporary skin substitute that is supplied in a cassette containing 2 aseptically processed sheets that are each approximately 5 x 7.5 inches.


Advanced BioHealing was founded in 2003 by David Eisenbud, MD, CWS, now President and Chief Operating Officer, to commercialize an innovative keratinocyte-based healing technology that is enabled by the company's proprietary cell culture and tissue preservation techniques. Dr Eisenbud believes that the acquisition of Dermagraft and TransCyte and their reintroduction into the regenerative medicine market will be a major benefit to patients.


"There is a large body of scientific and clinical information supporting the benefit of these products compared with less advanced wound therapies," he said. "I think awareness and appreciation of advanced wound management options-bioengineered skins, growth factors, and so forth-is increasing dramatically, and patient access to them is increasing as providers and insurers realize the huge added value that such approaches bring."


With this acquisition, ABH has a portfolio of 3 advanced products (adding to its keratinocyte-based wound therapy, for which an investigational device exemption has been submitted to the US Food and Drug Administration) that could cover all the major wound market segments. "We are truly positioned to be one of the leading companies in the regenerative medicine space," noted Dr Eisenbud. "Our investigational device, which may represent an improved next-generation biologic dressing, will require years of additional clinical testing and regulatory approval before it may reach commercialization. Meanwhile, Dermagraft and Transcyte are excellent products that we can offer now to benefit patients."


According to Dr Eisenbud, the earliest Dermagraft can be expected to be available for commercial sale would be May 2007. TransCyte will follow later.


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