Cardium Therapeutics has updated on the status of 510(K) application seeking clearance from the US Food and Drug Administration (FDA) to market its topical wound care management device - Excellagen.
The Excellagen kit consists of four single-use 1.0 cc syringes, each containing 0.5 cc of 2.6% Excellagen formulated collagen gel, and four sterile flexible applicators to facilitate topical administration to the wound site over a course of up to four treatments.
Cardium has initiated production of commercial supplies for its Excellagen product candidate at Devro and fill/finish providers.
The company intends to transfer the final steps for formulated collagen manufacturing to a US based operation while continuing to use key starting materials (collagen in solution) produced and supplied by Devro.
Cardium also expects to organize its own Device Master File with the FDA’s Center for Devices and Radiological Health (CDRH) covering the company’s process for manufacturing its finished 2.6% formulated fibrillar collagen gel.
Cardium chairman and CEO Christopher Reinhard said they look forward to work with the FDA to secure regulatory clearance and the commercial launch of Excellagen.
"We are continuing to work with potential new collaborative partners and to explore additional product opportunities for our Excellagen formulation," Reinhard said.
In addition to diabetic foot ulcers, dermal wounds for which Excellagen is intended include partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds and draining wounds.