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Sofregen Receives 510(k) Clearance for Silk Voice® - The First and Only Natural Silk Protein Injectable Product for Tissue Bulking

Sofregen Medical, Inc. (Sofregen), an early stage commercial biotechnology company developing products for medical aesthetics and reconstructive surgery, announced today that Silk Voice has been cleared by the U.S. Food and Drug Administration (FDA) for augmenting vocal fold tissue for phonation improvement. This is the first and only FDA cleared product made from solubilized silk protein and is expected to significantly impact the treatment of this condition due to the unique material properties of silk protein scaffold and a proprietary single-use catheter delivery system.

“The clearance of Silk Voice for Vocal Fold Medialization is an important milestone for Sofregen. Working closely with leading laryngologists who currently treat these patients and Tufts University, where the technology was initially developed, Sofregen is the first company to translate nearly 20 years of regenerated silk protein research into a product for medical use”, states Howard J. Weisman, co-founder and Executive Chairman of Sofregen. Mr. Weisman continued, “We are excited to bring Silk Voice and its highly anticipated delivery system to market in the U.S. and look forward to expanding its applications into other markets soon.”

Vocal fold paralysis and glottic insufficiency affect many individuals who lose partial or complete use of their voice due to trauma, surgery, diseases or aging. A recent survey of U.S.-based physicians revealed that only 3% of patients who have this condition are actively treated, indicating a large unmet medical need. Physicians currently treat these patients with a range of options including corrective surgery. The use of injectable products for relief of vocal fold paralysis offer many patients a minimally invasive solution and Silk Voice, with its unique delivery system, will allow physicians to perform this procedure in their office setting.

Thomas Carroll, MD, a consultant to Sofregen, who is also Assistant Professor in Otolaryngology-Head and Neck Surgery at Harvard Medical School and is the Director of the Brigham and Women’s Hospital Voice Program remarked, “The research surrounding the development of silk proteins as the foundation of a novel vocal fold augmentation material has revealed excellent tissue integration and potential longevity with properties that afford similar characteristics to native vocal fold deep tissues. This research, combined with a novel catheter delivery system, provides an opportunity for laryngology specialists, as well as general otolaryngologists, to treat vocal fold insufficiency, increasing access to appropriate therapy in both the outpatient and inpatient setting and restoring function for more patients.”

Silk Voice will be available later this year as a kit including two prefilled syringes and a single-use flexible catheter.

Dr. Carroll has participated in research studies related to Silk Voice, co-developed the device, and shares a patent on the novel catheter delivery system relating to this product.

Important Safety Information

Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

Patients with the presence of foreign bodies, acute inflammation, infection, inadequately controlled malignancy, or rapidly advancing disease when these involve the laryngeal or upper respiratory tract. Patients with bilateral laryngeal paralysis and vocal disorders of psychogenic or emotional origin.

Silk Voice should be used only by trained otolaryngologists or experienced head and neck physicians. Airway obstruction following vocal fold injection can occur immediately or at any time up to seven (7) days following injection. Airway obstruction results from aggressive vocal fold injection, over-injection, or laryngeal edema from trauma and manipulation of the larynx. Silk Voice should not be injected into the airway. Confirm placement of needle tip visually before initiating Silk Voice injection. Silk Voice should not be injected into blood vessels. Injection into blood vessels may cause platelet aggregation, vascular occlusion, infarction, embolic phenomena or hemolysis. Use of Silk Voice during pregnancy has not been established.

About Sofregen Medical

Sofregen began its commercial operations following the acquisition of SERI Surgical Scaffold® from Allergan PLC (NYSE: AGN), the first and only surgical implant made from silk fiber. Sofregen is a pioneer in soft tissue engineering with an advanced platform based on silk protein, also known as fibroin, which has been shown to have unique properties for tissue support and regeneration. Silk Voice is carefully engineered to match the biomechanics of soft tissue for immediate bulking and long-term tissue replacement.

For more information on Sofregen, please visit its website at

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Last Updated: 22-Jan-2019