– Investment funds commercialization efforts for FDA 510(k)-cleared products Catasyn and SynePure –
CLAREMONT, Calif.–(BUSINESS WIRE)–Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, today announced that it has received $2.6 million in private financing to fund the commercialization of Catasyn™ Advanced Technology Wound Hydrogel and SynePure™ Wound Cleanser, two U. S. Food and Drug Administration (FDA) 510(k)-cleared products that form part of Synedgen’s Wound Care portfolio.
The development of Catasyn and SynePure, which address complex wounds, has been supported respectively by U.S. Army (W81XWH-16-C-0023) and Defense Advanced Research Projects Agency (DARPA, N66001-14-C-4009) grants. Clinical trials are planned for both products in anticipation of increasing their technological readiness level (TRL) for broad DoD adoption.
“I’m delighted to announce that we have secured financing to launch our two Wound Care products, Catasyn and SynePure, two innovative treatments borne out of Synedgen’s glycochemistry technology platform. This focused investment will fund commercialization and final manufacturing processes, as well as future indication expansion efforts for these wound care products,” said Shenda Baker, Ph.D., CEO and President of Synedgen. “Synedgen has developed its Wound Care portfolio to provide superior wound cleansing and wound management without contributing to antimicrobial resistance. The company’s Wound Care products support a healthy environment for healing, without harsh chemicals that can further inflame and delay healing of already damaged tissue. I’m pleased that today’s investment will help put these much-needed treatments into the hands of patients.”
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.
SynePure is specifically designed to provide immediate and effective irrigation of wounds following injury and is designed to become part of the first aid kit carried by all U.S. soldiers. It is packaged for use in a squeezable bottle fitted with a nozzle to direct a focused stream of cleanser with sufficient force to help dislodge debris and contamination. SynePure’s advanced glycopolymer technology aggregates contaminants in the wound to help facilitate their removal. SynePure is also suitable for hospital and emergency care use, with clearance for both single- and multiple-use bottles.
About Synedgen
Synedgen is a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system. The company’s lead development candidate is SYGN305, for gastrointestinal mucositis, where a large unmet need exists to prevent intestinal radiation injury, the single most important dose-limiting factor in cancer radiotherapy. Synedgen’s glycochemistry platform has already generated five FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 program, to Synspira, for the potential treatment of pulmonary complications of cystic fibrosis. Synedgen has research and manufacturing facilities in Claremont, California. For more information please visit www.synedgen.com.
Contacts
Laurence Watts
Gilmartin Group, LLC.
619 916 7620
laurence@gilmartinir.com