Synedgen gets FDA clearance to market wound care product OTC

CLAREMONT, Calif.— Synedgen, a company leveraging its glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, has received 510(k) clearance from the U. S. Food and Drug Administration to market its Catasyn Advanced Technology Wound Hydrogel both under the direction of a healthcare professional and OTC.

“This FDA clearance for Catasyn provides patients with a new option to treat both minor burns and skin lacerations and physicians with an alternative to treat more severe dermal ulcers, post-operative incision sites and second degree burns,” said Shenda Baker, president and chief operating officer of Synedgen. “Catasyn has been developed using our Glycomics Technology Platform to provide a moist wound environment that supports healing. We look forward to making Catasyn commercially available as we continue to develop new products to improve care for oral, dermal and mucosal lesions and wounds.”

In its OTC indication, Catasyn can be used for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

When administered by a healthcare professional, Catasyn can be used for the dressing and management of partial to full thickness dermal ulcers including pressure sores, venous stasis ulcers, arterial ulcers and diabetic ulcers, surgical wounds including post-operative incisions and donor sites and superficial and partial thickness (second degree) burns.

Catasyn is the third marketed product in Synedgen’s wound care portfolio, which includes SynePure Wound Cleanser for the cleansing of dermal wounds as well as Synoplex for veterinary indications.