ProCyte Corp. said Thursday it filed a 510 (k) premarketnotification with the FDA to market Iamin gel wounddressing.

The submission seeks approval of the copper-basedproduct as a Class I medical device, which requires datashowing safety and substantial equivalency to alreadyapproved products. The Kirkland, Wash., company wastesting Iamin as a drug for the treatment of diabeticplantar ulcers, but results released last year showed itfailed to perform better than placebo in that indication.

Kissei Pharmaceuticals Co. Ltd., of Matsumoto, Japan,_ ProCyte's partner for Iamin in that country _ initiatedPhase I studies of the product there for wound-healingindications. The 510 (k) application does not precludeProCyte from seeking approval of Iamin as a drug downthe road. The company intends to further evaluatepossible scenarios for the tripeptide copper complex afterlooking at results from Kissei's trials, said Karen Hedine,ProCyte's vice president, business development andadministration.

The company, which reported having $40.3 million incash and equivalents on June 30, intends to seek nearer-term revenue opportunities through mergers, acquisitionsand/or technology licensing, Hedine said. It also hasproprietary products in the clinic.

ProCyte recently finished a Phase I study of Tricomin, apeptide copper compound, for hair-loss indications.Iamin-IB is in a Phase I/II trial for the treatment of mildto moderate ulcerative colitis. Another class of copper-based drug is being developed for antiviral indications,particularly HIV.

Hedine said ProCyte has a strategy to differentiate Iaminfrom other wound dressing, but said it was premature todisclose that before getting FDA approval.

ProCyte's stock (NASDAQ:PRCY) gained 31 cents onThursday's news, and closed unchanged Monday at$3.00. _ Jim Shrine

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