BioSurface Technology Inc. has started a pivotal clinical trial ofits Allograft cultured human skin product for use in burnpatients.
Allografts are laboratory-grown human epidermal tissue grownfrom donor skin. The trial will test Allograft's ability toaccelerate healing of surgical wounds, called donor site wounds,resulting from procedures to obtain skin grafts.
The company estimates it will file pre-market approvalapplications for Allograft by 1994.
In March, the company completed a $5.5 million round offinancing from unidentified investors. "The financing wasalmost exclusively Japanese," said company President DavidCastaldi, and included a few individuals along with theinvesting companies.
The financing will provide working capital for BioSurface'sAutograft product, which is already on the market, and willfund Allograft's clinical testing.
Autograft uses a postage stamp-size piece of a patient's skin,which is then expanded in culture 10,000 times, enough tocover the body surface within four weeks. The companyreceives the skin sample from burn centers and returns thegraft material after culture in its facility.
The company's key technology is protected by patents thatwere licensed from Harvard University and the MassachusettsInstitute of Technology. Other patents have been filed by thecompany.
In March, BioSurface received a U.S. patent, No. 5,100,676, thatcovers techniques to preserve a cultured Autograft beyondeight hours. The company keeps Autograft tissue fresh andfunctional for 24 hours, which enables delivery throughout theU.S. and Europe, Castaldi said.
BioSurface also has exclusive rights, except in Italy, to a patentapplication for cryopreservation of skin tissue.
The wound healing market targeted by competitorsOrganogenesis Inc. (AMEX:ORG) and Advanced Tissue SciencesInc. (NASDAQ:ATISA) is about $15 billion worldwide, comparedwith the market for Allograft, estimated at $100 million. Salesthrough 1991 of Autograft in the U.S. and Europe totaled $15million.
With the most recent funding, the company has raised morethan $19 million since its founding in 1987. The company'smajor investors include Venrock Associates, AssetManagement, Kleiner Perkins Caufield & Byers, BerkeleyInternational Capital Corp., Greylock Management, Sutter HillVentures and HLM Management.
-- Roberta Friedman, Ph.D. Special to BioWorld
(c) 1997 American Health Consultants. All rights reserved.