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Cardium collagen topical gel wins FDA nod

Cardium Therapeutics has recieved the US Food and Drug Administration (FDA) approval for its new Excellagen advanced wound care product to treat diabetic foot ulcers and other dermal wounds.

Excellagen is a professional-use, sterile, syringe-based, fibrillar flowable bovine collagen topical gel (2.6%) which is immediately applied following surgical debridement procedures.

Excellagen is intended for use at one- to two-week intervals following surgical debridement and will initially be supplied in the form of a kit consisting of four sterile, pre-filled, ready to use single-use syringes.

Each syringe containing 0.5 cc of Excellagen and four sterile flexible applicators, is intended to treat wounds up to 5.0 cm2 in size.

Excellagen is also used to treat partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds and draining wounds.

The company said the advancement of Excellagen provides the opportunity to perform post-clearance studies which aims to treat non-healing diabetic foot and pressure ulcers, as well as other wounds.