RegenScientific and Soluvos Medical enter into distribution agreement for Renú® Voice in the UK, Benelux, Scandinavia.
www.regenscientific.com
Vocal Fold Injectable Implant
East Troy, Wisconsin, USA and Eindhoven, The Netherlands, September 27, 2016 -- RegenScientific and Soluvos Medical announced today that the companies have entered into an exclusive distribution agreement for Renú® Voice and Renú® Gel in the United Kingdom, Ireland, The Netherlands, Belgium, Luxembourg, Denmark, Sweden, Finland, Norway and Iceland. Soluvos Medical will also serve as the temporary distributor to physicians in other European countries where RegenScientific has regulatory clearance to market its products. RegenScientific secured the CE-mark on its Renú® Voice and Renú® Dermal Filler in December 2015, and on its Transoral needle in September 2016. The company is currently in the process of applying for the CE-mark on its Renú® Gel product.
RegenScientific 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. RegenScientific currently co-markets these products in the United States with Boston Medical Products, Inc.
“We launched Renú® Voice at the 2016 European Laryngological Society Congress in Genoa, Italy. We received great interest from laryngologists at the congress, and we are excited to team up with Soluvos Medical to expand the availability of our cost-effective vocal fold injection augmentation products to physicians in Europe,” said Mr. Charles Milo, MBA, Chief Business Officer at RegenScientific, and he added, “The Managing Directors of Soluvos Medical - Ms. Rose Henrichs, MBA, and Mr. Jeroen Doomernik - have extensive business experience with laryngology products and a successful history of collaboration with laryngologists in Europe.”
Ms. Rose Henrichs, MBA, Managing Director at Soluvos Medical said, “We are enthusiastic about our distribution agreement with RegenScientific,” and she continued, “Renú® Voice is pivotal in our product offering and we’re eager to add Renú® Gel when RegenScientific secures the CE-mark for that product.”
Mr. Jeroen Doomernik, Managing Director at Soluvos Medical said, “Soluvos Medical will exhibit at Cutting Edge Laryngology in London, UK, 5-7 October 2016, Endoscopy Course at the University of Nijmegen, The Netherlands, 24 November 2016, Winter Days of Laryngology in Crans Montana, Switzerland, 11-14 January 2017, and at the ELS workshop in Leipzig, Germany, 27-28 January 2017. We are looking forward to introduce physicians to the product portfolio of RegenScientific.”
About RegenScientific:
RegenScientific, a wholly-owned business unit of privately held Cytophil, Inc., an ISO 13485 certified company, is dedicated to providing physicians and patients with high-quality, safe, efficacious, and cost-effective tissue augmentation implants. The company has CE-Mark for its Renú® Soft Tissue Volumizing Implant for Lipoatrophy, Vocal Fold Insufficiency and Soft Tissue Augmentation in Europe. The company 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. REGENSCIENTIFIC™ and the REGENSCIENTIFIC logo are trademarks of Cytophil, Inc.
Contact RegenScientific:
Gregory Johnson, MBA
VP, Sales and Marketing
Tel: (262) 215-6779
Email: gjohnson@cytophil.com
About Soluvos Medical BV:
Soluvos Medical BV is a privately owned company specialized in innovative products for office-based treatments to improve quality of life. Ms. Rose Henrichs, MBA and Mr. Jeroen Doomernik started Soluvos Medical in 2016 after many years of experience in the pharmaceutical and medical device industry.
The company currently has the following range of laryngology products: Renú® Voice; a Calcium Hydroxylapatite (CaHA) injectable implant for long term vocal fold augmentation - ARC Nuvolas KTP laser; a ‘green’ laser operating at 532 nm which is a wavelength highly absorbed by oxyhemoglobin and delivers precise coagulation leaving the surrounding tissue unaffected - RezaBand® UES assist device; a non-medication, non-surgical medical device that reduces Laryngeal Pharyngeal Reflux (LPR) symptoms due to acid reflux into the throat and lungs.
Contact Soluvos Medical BV:
Rose Henrichs, MBA
Managing Director Tel: +31 (6) 12 50 98 56 Email: rose@soluvos.com
Jeroen Doomernik
Managing Director
Tel: +31 (6) 24 43 01 85
Email: jeroen@soluvos.com
Charles Milo
RegenScientific - Cytophil, Inc.
650-933-8019
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