A wholly owned subsidiary of San Diego-based Cardium Therapeutics has filed for FDA approval to market a protein-based topical gel for treating diabetic foot ulcers.
The Tissue Repair Co., bought by Cardium for $1 million plus liabilities three years ago, is seeking approval to market Excellagen, a collagen-based gel designed for treating wounds on top of standard care. In an announcement Dec. 3, the company said it would be intended for “more complex, irregular and difficult to access wounds” such as those that may occur with pressure, venous and diabetic ulcers and surgical wounds.
The company’s FDA submission follows a midstage study that demonstrated some improvements for patients with nonhealing diabetic foot ulcers following one or two applications. In the study, Cardium said 48 percent of patients treated with a single dose of Excellagen had complete wound closure after 12 weeks, compared with 31 percent of patients treated with the standard of care.
Shares of Cardium, traded under the symbol CXM on the American Stock Exchange, jumped almost 7 percent at 62 cents in early trading Dec. 3.
— Heather Chambers