| The company plans to submit a 510(k) premarket notification with the U.S. Food and Drug Administration seeking marketing clearance of its ExcellagenXL(TM) product candidate. ExcellagenXL is an advanced wound care device composed of highly-refined, soluble bovine dermal collagen, which is modified to reduce immunogenicity and promote its usefulness in wound settings. ExcellagenXL is designed for use by physicians in patients with topical wounds, which include diabetic ulcers as well as pressure ulcers, venous ulcers, surgical and trauma wounds, second degree burns, and other types of wounds. The Company expects to submit its FDA 510(k) application for ExcellagenXL during fourth quarter 2009. The planned 510(k) filing is based in part on positive findings from the Company's Phase 2b Matrix clinical study, reported October 14, 2009, indicating that substantial improvements in wound healing responses were observed in patients with non-healing diabetic foot ulcers following one or two applications of ExcellagenXL. :theflyonthewall.com |
