Telios Pharmaceuticals Inc. announced late Thursday that it hassubmitted a pre-market approval application (PMA) to FDA forits wound-healing treatment, Telio-Derm, for the treatment ofchronic dermal ulcers associated with diabetes.
Telios (NASDAQ:TLIO) of San Diego said the PMA filing is basedon statistically significant results of a multicenter, randomized,placebo-controlled prospective clinical trial in patients withdiabetic foot ulcers. The study showed a fourfold increase inthe number of ulcers completely healed in the Telio-Dermgroup compared to the control group, the company said, and astatistically significant improvement in the rate of healing forpatients treated with Telio-Derm.
The company estimated that 1 million diabetics in the U.S. willdevelop chronic dermal ulcers, usually on their feet, whichoften result in serious complications such as amputation andlife-threatening infections.
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