East Troy company gets FDA approval for voice disorder product

East Troy-based RegenScientific has received FDA clearance for its Renu Gel injectable implant used for vocal fold injection augmentation. The company today began shipments of the new product to physicians and hospitals in the United States.

Renu Gel is a resorbable buffered hydrogel intended for short-term vocal fold injection augmentation in patients with suspected vocal fold paresis, or as a trial vocal fold injection augmentation prior to selecting a long-term augmentation therapy.

“The addition of Renu Gel to our otolaryngology product line means that we now have a complete product offering compared to our competition,” said William Hubbard, president and chief executive officer. “Our company is very excited about providing products that are more cost-effective to otolaryngologists and their patients.”

The company already has FDA clearance for its Renu Voice injectable implant based on bio-ceramic particles of Calcium Hydroxyapatite (CaHA). The Renu CaHA particles are suspended in a buffered hydrogel, and the Renu Voice product can be injected through a 25-gauge, two-inch needle using percutaneous vocal fold injection augmentation techniques. Renu Voice is intended for long-term vocal fold injection augmentation in patients with vocal fold paralysis.

“Our products are equivalent to our competitors’ products, but are easier to use and more cost-effective, providing benefits to physicians, patients, hospital staff and administrators, and payers,” said chief business officer Charles Milo. “RegenScientific is committed to supply superior, safe, efficacious and cost-effective products that benefit patients and society.”

Renu is not yet FDA approved for aesthetic medicine indications, but the company plans to file an Investigational Device Exemption later this year. It will subsequently start a U.S. clinical study in aesthetic medicine to gain FDA approval.

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