Ortec International plans to file a PMA supplement for its composite cultured skin (CCS) for venous skin ulcer treatment by mid-2002, according to company officials.

Data from a 25-center, 200-patient pivotal trial expected to be complete by the first quarter of 2002 will be used to support the filing, the firm said.

CCS consists of a bioengineered bovine collagen matrix seeded with specialized cells taken from infant foreskins. Dermal fibroblast and epidermal cells are applied to a layer of porous collagen matrix sponge after being screened for pathogens. A physician sutures the human tissue and regeneration product into place.

Ortec currently sells the product under a humanitarian device exemption for the management of chronic ulcers in patients with junctional and dystrophic forms of epidermolysis bullosa. The firm is pursuing several additional indications that would provide access to a broader patient population.

On July 17, FDA's General and Plastic Surgery Devices Panel is scheduled to review the company's March 7 PMA submission for treatment of donor sites of burn victims.

The PMA includes data from a 12-center, 82-patient study showing that wounds treated with CCS healed four to seven days faster than in the control arm, Ortec maintains.

Ortec also is planning to pursue FDA approval for treatment of diabetic foot ulcers. The firm recently completed a multi-center trial and expects to submit a PMA supplement to the agency by the end of 2002.

Receipt of the diabetic foot ulcer approval would put Ortec on a more level playing field with competitors Organogenesis and Advanced Tissue Sciences.

Organogenesis gained approval in May 1998 and June 2000 for use of its Apligraf product for venous leg ulcers and diabetic foot ulcers, respectively.

Apligraf differs from Ortec's CCS in that it is produced in three separate phases over a 20-day period.

Initially, the dermal layer is formed by the combination of cultured fibroblasts from neonatal foreskins with bovine collagen in a culture dish.

Six days later, keratinocytes are seeded over the first layer. After four days of growth, the product is finalized following a 10-day incubation period.

Ortec says CCS offers several advantages over Apligraf.

For example, the product's collagen sponge medium is more conducive to cryopreservation than solid gel because the sponge's porous nature allows for liquid crypopreservant to infiltrate the medium and preserve the cells until they are thawed for use.

La Jolla, California-based Advanced Tissue Sciences has a PMA pending for use of the firm's Dermagraft dermal replacement product for treatment of diabetic foot ulcers. In February 2001, the agency requested clarification of the August 2000 PMA.

Dermagraft's eight-month shelf life provides an advantage over competing products, ATS maintains. While Dermagraft is cryogenically preserved, tissue-engineered products that are shipped fresh have a shelf life of only four to five days, the firm notes.

Dermagraft is currently marketed in the UK and Canada. The company says it will likely seek FDA approval for venous and periodontal indications after the agency completes review of its pending diabetic foot ulcer PMA.

Organogenesis estimates the U.S. diabetic foot ulcer market at 600,000 patients annually, and the venous leg ulcer market at 1 mil. ATS says it plans to market Dermagraft to the 400,000 patients with "hard-to-heal" diabetic foot ulcers following FDA approval.

Regarding CCS, Ortec estimates the size of the market for all potential indications of the product to be in excess of $1 bil.

Incorporated in 1991, the New York City-based company developed CCS from technology based on research by Australian physician Mark Eisenberg, MD.

Ortec CCS Venous Leg Ulcer PMA Due 2002; Panel Will Review Burn Indication

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