Synedgen Receives FDA 510(k) Clearance for Synvazatm Mouth Sore and Wound Rinse

Synedgen, a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Synvaza Mouth Sore and Wound Rinse over-the-counter (OTC). Synvaza is the most recent addition to Synedgen's oral health care business unit, Prisyna, which already includes Moisyn and Moisyn Mist for dry mouth, as well as Synedent® and Synedent® FLX oral rinses.

"The Agency's clearance of Synvaza provides a new and effective treatment option that helps manage pain while promoting healing for patients who suffer from painful ulcers and mouth sores of the oral mucosa. Synvaza also provides an innovative solution for patients with many types of oral wounds, including traumatic ulcers and surgical injuries," said Shenda Baker, Ph.D., President and Chief Executive Officer of Synedgen. "With Prisyna's multiple offerings, Synedgen is uniquely positioned to improve oral health across multiple patient segments."

Prisyna's oral care portfolio contains cutting-edge ChitoTek® technology, which has been developed using Synedgen's proprietary glycochemistry platform. Synvaza is an oral wound rinse formulated with ChitoTek, mucoadhesive, hygroscopic biopolymers that form a protective barrier around oral wounds to prevent irritation and help manage pain. This formulation provides a moist wound environment, which is optimal for wound healing.

In a clinical study, Synvaza was shown to decrease pain associated with ulcerative oral lesions. Patients reported decreases in oral soreness related to drinking, swallowing, eating, talking, and sleeping. Pain relief was reported by patients including those with aphthous stomatitis, oral lichen planus, and chronic graft versus host disease. Studied lesions were associated with medications, cancer treatment, acid reflux, and other underlying conditions.

Synedgen's glycochemistry platform is also being used to develop therapeutics for pulmonary and gastrointestinal diseases, as well as for ocular and dermal injuries. Synedgen has developed its technology with support from the Defense Advanced Research Projects Agency (DARPA), Defense Health Agency (DHA), Medical Research and Materiel Command (MRMC), and six institutes of the National Institutes of Health. We formally thank the National Institute for Dental and Craniofacial Research (R44DE019740) for supporting Synvaza's development.

About Award

The project described was supported by Award Number R44DE019740 from the National Institute Of Dental & Craniofacial Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Dental & Craniofacial Research of the National Institutes of Health.

About Synedgen

Synedgen is a biotechnology company using glycochemistry to develop therapeutics that mimic and enhance 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 seven FDA 510(k)-cleared therapeutics, one OTC drug, one veterinary indexed drug, and an out-licensed Phase 2 drug program, to Synspira (Framingham, MA), 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.