EAST TROY, Wis., Dec. 16, 2015 /PRNewswire/ -- REGENSCIENTIFIC announced today that it has received the CE-mark (CE 630688) for the Renú® Soft Tissue (Volumizing) Implant for Lipoatrophy, Vocal Fold Insufficiency and Soft Tissue Augmentation. The CE-mark allows REGENSCIENTIFIC to sell the Renú® product for these indications in the 32 member states of the European Union as well as in seven cooperating countries of the European Economic Area, and in other countries that recognize or require the CE-mark.
The company will launch its Renú® filler for aesthetic medicine at the IMCAS World Congress in Paris, France, January 28-31, 2016. The company will launch its Renú® otolaryngology products in Europe at various congresses and events in 2016, including the Manchester Phonosurgery & Neurolaryngology Dissection Course in Manchester, UK, March 14-15, 2016 and the European Laryngological Society (ELS) Congress in Genoa, Italy, June 8-11, 2016.
The Renú® product is a cost-effective injectable implant based on bio-ceramic particles of Calcium Hydroxyapatite (CaHA) which provide a long-lasting augmentation effect. The CaHA particles are suspended in a buffered hydrogel that facilitates easy injections.
"The Company received ISO 13485 re-certification following a successful inspection of its Quality System and manufacturing facility by our Notified Body, British Scientific (BSI). We are pleased to announce the CE-mark for our Renú® products following BSI's review of the Renú® Design Dossier," said Mr. Bob Voigts, President and Chief Operating Officer. Mr. Voigts continued, "We are committed to bringing the highest quality products to the market for our customers and this regulatory milestone represents one of many steps we're taking towards fulfilling that goal."
"Our organization is patient focused in everything we do, and this includes making high-quality cost-effective products available to physicians who practice aesthetic medicine and otolaryngology, and to our ultimate customers: their patients," said Dr. William Hubbard, PhD, CEO. Dr. Hubbard has extensive academic experience and product development experience with calcium phosphate biomaterials, and he has over 25 years of experience in research, development, and manufacturing of injectable implant biomaterials based on Calcium Hydroxyapatite.
"It is with great excitement and pride that we now make Renú® available to physicians in Europe, and certain other markets outside of the United States, for these indications," said Mr. Charles Milo, MBA, Chief Business Officer. Mr. Milo continued, "Our Renú® otolaryngology products (Renú® Gel and Renú® Voice) are already FDA-cleared for vocal fold insufficiency. Renú® is not yet FDA approved as a filler for aesthetic medicine indications, but the Company has filed an Investigational Device Exemption (IDE), and we are currently identifying the Principal Investigator and investigational sites for the study. We plan to start a clinical study of Renú® for aesthetic medicine in 2016 to gain FDA approval for Renú® as a dermal filler."
REGENSCIENTIFIC, a wholly-owned business unit of 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. RegenOsteo™ (β-TCP), its orthopedic surgery product is indicated to fill bony voids or gaps in the extremities, posteriolateral spine and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. RegenPerio™ (β-TCP), its maxillofacial surgery product is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral-maxillofacial defects.
Renú® is a registered trademark of Cytophil, Inc. REGENSCIENTIFIC™ and the REGENSCIENTIFIC logo, RegenOsteo™ and RegenPerio™ are trademarks of Cytophil, Inc.
Charles F. Milo, MBA
Chief Business Officer
Tel: (262) 215-6779