Organogenesis Inc. announced Friday that clinical trials on itsfull-thickness living skin equivalent Graftskin havedemonstrated positive preliminary results for three medicalapplications: for treating chronic wounds resulting from venousstasis, for replacing skin lost to dermatological surgery, and fortreating burn wounds.
In all three trials on 65 patients, Graftskin did not elicit animmune response, the product had an excellent safety profileand it enhanced wound healing or graft take.
"If these trends continue," said Thomas Tully, president andchief operating officer of the Canton, Mass. company(AMEX:ORG), "submission of a pre-market application (PMA) forFDA approval of Graftskin for at least one clinical applicationmay be possible before the end of 1993."
Organogenesis also announced that it has discontinued themanufacture and sale of Testskin, its living skin equivalent foruse in in vitro testing. "While Testskin has performed well in atechnical sense, the in vitro toxicology market has notdeveloped sufficiently to make the product commerciallyviable. Annual revenues from Testskin were approximated$500,000 in 1991 and 1992. Total worldwide sales for all invitro toxicology testing products amounted to less than $5million for 1992, with little growth expected in the near future.Our decision to exit the business will allow us to realize anestimated annual savings of $2 million," commented Tully.
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