Cytophil wholly-owned business unit RegenScientific has obtained approval from the US Food and Drug Administration (FDA) for its Renu Gel injectable implant for vocal fold injection augmentation.
Renu Gel is a resorbable buffered hydrogel, which 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.
RegenScientific president and CEO William Hubbard said: "The addition of Renu Gel to our otolaryngology product line means that we now have a complete product offering compared to our competition."
The company has started selling the new product to physicians and hospitals in the US.
Earlier, the company received FDA approval for its Renu Voice injectable implant that is based on bio-ceramic particles of Calcium Hydroxyapatite (CaHA).
The company also produces RegenOsteo (beta-TCP) that is indicated to fill bony voids or gaps in the extremities, posteriolateral spine and pelvis, which are caused by trauma or surgery, and RegenPerio (beta-TCP) that can be used as a bone grafting material to fill, augment, or reconstruct periodontal or oral-maxillofacial defects.