Ortec International Inc. announced that it has received a U.S.patent on its Composite Cultured Skin (CCS) technology. Thecompany is set to begin clinical trials with 120 burn patients atCornell University following FDA approval of a pendingInvestigational Device Exemption.

Ortec's vice president of financing, Ron Lipstein, said Ortec'sskin-replacement product differs from other products indevelopment -- with the exception of Organogenesis Inc.'sGraftSkin -- in that it is bilayered, having both an externalepidermal and an internal dermal layer. It thus eliminates theneed to apply an epidermal layer by taking autografts of apatient's own skin.

Ortec said its composite cultured skin is grown from a third-party donor skin (infant foreskin), using both the epidermaland dermal cells introduced into a proprietary collagen sponge.The graft stimulates the patient's own body to regenerate areal, whole, mature skin that is not temporary or artificial, thecompany said.

Comparing CCS with other skin replacement products indevelopment, Lipstein said Advanced Tissue Sciences Inc.'sDermaGraft and LifeCell Corp.'s AlloDerm, which is freeze-driedcadaver dermis, both require epidermal autografts. He saidBioSurface Technology Inc.'s Epicel auto-epidermal culturedgraft has had a low success rate.

Ortec was founded in New York in 1991 by Mark Eisenberg, aphysician who developed the cultured skin product inAustralia, and other principals, including Lipstein. Since 1988,Eisenberg has tested the product on 20 people in Australia,including 15 children with Epidermolysis Bullosa (EB), a raregenetic disorder that Ortec said causes the skin to be extremelyfragile and to fall off with the slightest friction, resulting ininfection and usually early death. Eisenberg, whose son wasborn with EB, has also tested the skin replacement on four menhaving tattoos removed and a boy with third-degree burns.

"The success rate in these trials was over 90 percent, withsignificantly less scarring and skin contraction, and more rapidhealing than generally experienced with conventional modes oftreatment," Ortec said. The company plans to develop thetechnology for the treatment of skin ulcers and scar revisions.In addition to the U.S. trial, Ortec has begun a separate trial of20 patients at the Royal Alexandra Children's Hospital inSydney, Australia. Ortec has one lab at Cornell and one inAustralia.

Steven Katz, chairman and chief executive officer of Ortec,acquired exclusive worldwide rights outside of Australia to theCCS technology from Eisenberg. Eisenberg is the company'sexecutive vice president in charge of research anddevelopment.

-- Brenda Sandburg News Editor

(c) 1997 American Health Consultants. All rights reserved.