Synedgen Receives FDA 510(k) Clearance for Catasyn™ Advanced Technology Wound Hydrogel
May 23, 2018–Synedgen, a company leveraging its proprietary glycomics technology platform to develop glycopolymer-based therapeutics for infectious and inflammatory conditions, today announced that it has received 510(k) clearance from the U. S. Food and Drug Administration (FDA) to market its Catasyn™ Advanced Technology Wound Hydrogel both under the direction of a health care professional and over-the-counter (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, Ph.D., 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.”
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. 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.
“Catasyn development was supported by the U.S. Army with the goal of creating a product that can help speed wound healing and mitigate infection risk in soldiers,” said William Wiesmann, M.D., Chief Executive Officer of Synedgen. “While it was tailored to the needs of the military for indications such as postoperative wounds and traumatic, thermal, chemical and radiation wounds and burns, Catasyn is also applicable for the civilian population.”
Synedgen is developing its wound care portfolio based on the science of glycomics to provide superior wound cleansing and a barrier to infection. Synedgen aims to develop products that support a healthy environment for healing without the use of harsh and abrasive chemicals that can cause further pain and inflammation to damaged tissue. 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.
Synedgen is developing a new class of health care products based on glycomics, a revolutionary approach using glycopolymers to target mucosal and dermal interfaces. Synedgen uses its Glycomics Technology Platform (GTP) to discover and develop ultra-purified glycopolymers that enhance and mimic the innate immune system by targeting the cell surface glycocalyx and mucosal surfaces. Synedgen has successfully leveraged the GTP to develop marketed Prisyna oral care and Synedgen wound care products, as well as SNSP113, which has been licensed to Synspira and is currently in clinical development for the treatment of cystic fibrosis. Synedgen has established research and manufacturing facilities in Claremont, California.