RegenScientific announced that it has received FDA-clearance for its Renu® Gel injectable implant indicated for vocal fold injection augmentation and today the company commenced shipments of this new product to physicians and hospitals in the United States.
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 2-inch needle using percutaneous vocal fold injection augmentation techniques. A separate ENT needle specifically designed for otolaryngologists performing trans-oral vocal fold injection is available. Renu® Voice is intended for long-term vocal fold injection augmentation in patients with vocal fold paralysis.
Renu® Gel is a resorbable buffered hydrogel and it is 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 G. Hubbard, PhD, President and CEO. Dr. Hubbard has extensive academic and product development experience with calcium phosphate biomaterials, and he has over 25 years industry experience in research, development, and manufacturing of injectable biomaterials based on Calcium Hydroxyapatite. Dr. Hubbard is the original inventor of the class of injectable biomaterial products based on Calcium Hydroxyapatite. Dr. Hubbard continued, "Our company is very excited about providing products that are more cost-effective to otolaryngologists and their patients."
"We are pleased to announce the FDA-clearance of our Renu® Gel product and to commence shipments of the product to ENT physicians," said Mr. Robert G. Voigts, Chief Operating Officer, VP of Regulatory, and General Manager. Mr. Voigts has over 12 years experience in the development and manufacturing injectable biomaterials for ENT, aesthetic, and urology indications. Mr. Voigts continued, "We are ready to meet the demands of ENT doctors who are caring for an ever growing number of patients with voice and swallowing disorders."
Mr. Charles F. Milo, MBA, Chief Business Officer said, "Our products are equivalent to our competitor's products, but are easier to use and more cost-effective, providing benefits to physicians, patients, hospital staff and administrators, and payers." Mr. Milo has 30 years experience in product development and new product launch, sales and marketing, and business development in the life science industry, and he previously led the market introduction of a CaHA product for vocal fold injection augmentation that now has wide-spread global use. Mr. Milo continued, "RegenScientific is committed to supply superior, safe, efficacious, and cost-effective products that benefit patients and society."
Mr. Milo stated, "Renu® is not yet FDA approved for aesthetic medicine indications, but we plan to file an Investigational Device Exemption (IDE) later this year and subsequently we will start a US clinical study in aesthetic medicine to gain FDA approval."
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