Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) and ExcellagenFX(TM)
Cardium Therapeutic has announced that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen(TM) product candidate based on positive data from the Company’s recently completed Phase 2b Matrix clinical study. ExcellagenXL(TM) and ExcellagenFX(TM) are advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds.
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