WASHINGTON (Reuters Health) – Ortec International Inc. has received approval from the US Food and Drug Administration (FDA) to market the nation's first bilayered cellular matrix for the treatment of donor site wounds in burn victims, the New York City-based corporation announced on Tuesday.
Ortec said that it received FDA approval to market Orcel, a composite skin culture containing human cells and bovine-derived collagen. Prior to the FDA approval, Orcel was available under a Humanitarian Device Exemption for the treatment of dystrophic epidermolysis bullosa, a rare genetic hand disorder.
Ortec said that the FDA approval should now help expand the potential market for Orcel to over $100 million a year. The company added that it is pursuing additional indications such as the treatment of venous ulcers and diabetic ulcers, which taken together would expand Orcel's potential market to over $1 billion a year.
But Ortec said that its initial focus would be to find a marketing partner. The company said that it hopes to realize revenue from sales of Orcel by the first quarter of 2002.
An estimated 1.25 million people are treated for burns in the US each year.
In July, an FDA advisory committee unanimously endorsed the approval of Orcel for treatment of patients ages 12 years and older with a total burn surface area of over 20%. But the panel expressed concern about the design of the company's clinical trial, in which patients also received the testosterone analog oxandrolone. Studies have shown that oxandrolone may reduce the time to healing by as much as 2 days.
In clinical trials, the company said that the healing time for donor site wounds treated with Orcel was, on average, about one-third shorter than those treated by conventional means.
According to Orcel, adverse events included odor, pain, redness, itching, cellulitis, infection, rash and scarring.
Company officials could not immediately be reached to add further details.
In Tuesday morning trading, shares of the Mountain View, California-based concern were down 0.58 at 7.18 on the NASDAQ.