Sofregen Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Silk Voice, an injectable product made from solubilized silk protein for use in tissue bulking.


Image: Sofregen Medical secures FDA clearance for Silk Voice. Photo: Courtesy of Daino_16/

Sofregen Medical stated that the new product will be useful in augmenting vocal fold tissue for phonation improvement. The unique material properties of silk protein scaffold could have a significant impact the treatment of the condition.

Vocal fold paralysis and glottic insufficiency can affect people who lose partial or complete use of their voice due to trauma, surgery, diseases or aging, said Sofregen Medical.

According to a recent survey of the US-based physicians, only 3% of patients who have this condition are actively treated, indicating large unmet medical need. Presently, physicians treat such patients with several options including corrective surgery.

The biotechnology firm said that the use of injectable products for relief of vocal fold paralysis could offer patients a minimally invasive solution. The Silk Voice can support physicians in performing this procedure in their office setting.

Sofregen Medical co-founder and executive chairman Howard Weisman said: “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.

“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.”

The company stated that the Silk Voice will be available later this year as a kit, which will include two prefilled syringes and a single-use flexible catheter.

Sofregen Medical said that Silk Voice is indicated for vocal fold medialization and vocal fold insufficiency that could be improved by injecting soft tissue bulking agent.  Silk Voice injection increases the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation.