cCytophil launched Renú® Gel and Renú® Voice in the United States in 2015 after receiving FDA-clearance for Vocal Fold Insufficiency which is a condition often found in patients with voice and swallowing disorders. The company subsequently secured the CE-mark on its Renú® Voice, Renú® Dermal Filler and Transoral needle.
Cytophil, an ISO 13485 certified company, provides physicians and patients with high-quality, safe, efficacious and cost-effective tissue augmentation implants. The company has a CE-Mark for its Renú® Soft Tissue Volumizing Implant for Lipoatrophy, Vocal Fold Insufficiency and Soft Tissue Augmentation in Europe. Cytophil has FDA 510k clearances for its Renú® Gel and Renú® Voice otolaryngology products indicated for vocal fold injection augmentation. Renú® is not yet FDA approved as a dermal filler in the United States. Renú® is a registered trademark of Cytophil, Inc..
Soluvos Medical BV is a privately owned company specialising in innovative products for office-based treatments to improve quality of life. Ms. Rose Henrichs MBA and Mr Jeroen Doomernik started Soluvos Medical in 2015. They have many years of experience in the pharmaceutical and medical device industry. In addition, they have extensive business experience with ENT and laryngology products and a successful history of collaboration with laryngologists in Europe.
The company currently has the following range of laryngology products:
- Renú® Voice – a Calcium Hydroxylapatite (CaHA) injectable implant for long-term vocal fold augmentation;
- The full surgical ENT A.R.C. Laser line, oa with the innovative TruBlue Laser – a ‘blue’ laser operating at 445 nm, which is a wavelength highly absorbed by oxyhemoglobin and delivers precise coagulation leaving the surrounding tissue unaffected;
- Boston Medical Products;
- Montgomery® Thyroplasty Implant system;
- bess Medizintechnik;