Sofregen Medical

About Sofregen Medical

Sofregen Medical, Inc. operates as a medical device company focused on soft tissue engineering, leveraging a proprietary platform of products derived from silk protein, also known as fibroin. The company was founded in 2014, originating from technology developed at Tufts University and the University of Pittsburgh. It was established by Anh Hoang, who serves as the Chief Science Officer, and Howard Weisman. Dr. Hoang's background includes a Ph.D. in material science from Vanderbilt University and postdoctoral training in biomedical engineering at Harvard Medical School, providing a strong scientific foundation for the company's focus on silk-based biomaterials.

The company's core business involves developing and commercializing silk-based medical technologies to address soft tissue defects for both medical and aesthetic applications. Its revenue stream is based on the sale of its products to medical practitioners, including surgeons and aesthetic specialists. The market opportunity is significant, with the global market for soft-tissue aesthetics estimated to reach into the billions. Sofregen targets clinicians by providing natural biomaterials designed to enhance surgical outcomes and offer durable results for patients.

Sofregen's product portfolio is built upon the unique properties of purified silk protein, which provides a scaffold for the body's own tissue regeneration. A key milestone was the acquisition of the SERI® Surgical Scaffold from Allergan in late 2016. SERI®, which received FDA clearance in 2013, is a silk-based implantable scaffold for soft tissue support in reconstructive and aesthetic procedures. Another flagship product is Silk Voice®, an injectable implant made of silk and hyaluronic acid, which gained FDA 510(k) clearance in 2019. Silk Voice® is specifically indicated for vocal fold medialization and insufficiency, providing immediate bulking and a framework for long-term tissue replacement. The product is offered as a kit with prefilled syringes and a proprietary single-use catheter system for in-office procedures. In 2021, Sofregen entered into an exclusive development agreement with Galderma to create next-generation biostimulator fillers using its silk-based technology.