Revised Organogenesis/Novartis Deal Ensures Sure-Footing For Vitrix Trials
This article was originally published in The Gray Sheet
Organogenesis plans to enter pivotal clinical trials for its Vitrix living dermal replacement for deep diabetic foot ulcers this spring after amending a 1996 exclusive marketing agreement with Novartis covering Apligraf, announced Feb. 26.
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Firm announces submission of a premarket approval application to FDA for its Dermagraft wound dressing to treat diabetic foot ulcers. Clinical trials for the Dermagraft, which will be marketed by Smith & Nephew, indicate that the product heals significantly more ulcers than control treatment, the firm says in an Aug. 25 release. Competitor Organogenesis received an approvable recommendation from FDA's General and Plastic Surgery Devices panel in May (1"The Gray Sheet" May 15, 2000, p. 8)
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