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EGENSCIENTIFIC has announced 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. 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, and the European Laryngological Society (ELS) Congress in Genoa, Italy. The Renú® product is a cost-effective
injectable implant based on bio-ceramic particles
Allergan plc has acquired Anterios, Inc., a clinical stage biopharmaceutical company developing a next generation delivery system and botulinum toxin-based prescription products. Under the terms of the agreement, Allergan acquired Anterios for an upfront payment of $90 million and potential development and commercialization milestone payments related to NDS™, Anterios' proprietary platform
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A round-up of news stories in the aesthetic and anti-ageing medicine industry
REGENSCIENTIFIC RECEIVES CE-MARK FOR RENÚ® SOFT TISSUE INJECTABLE IMPLANT
IMPLANT INDICATED FOR LIPOATROPHY, SOFT TISSUE AUGMENTATION, AND MORE
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. 'It is with great excitement and pride that we
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
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."
LATEST ALLERGAN ACQUISITION EXPANDS NEUROTOXIN PIPELINE
delivery technology that enables local, targeted delivery of neurotoxins through the skin without the need for injections. In addition to NDS™, Allergan has acquired global rights to ANT-1207, an investigational topical formulation botulinum toxin type A in development for the potential treatment of hyperhidrosis, acne, and crow's feet lines. The NDS™ platform technology and ANT-1207 add to Allergan's
strong neurotoxin pipeline, with BOTOX® Cosmetic (onabotulinumtoxinA) currently in development for treating forehead lines, masseter hypertrophy, and platysma bands and BOTOX® Therapeutic in development for osteoarthritis and depression. 'Our team at Allergan pioneered
the development and commercialization of BOTOX®, the market-leading neurotoxin used in both medical aesthetics and
therapeutic areas of medicine. This acquisition demonstrates our ability to apply our tremendous scientific leadership in neurotoxins to further extend our already deep neurotoxin pipeline by advancing a new delivery system and formulations that are appealing to both patients and physicians,' said David Nicholson, Executive Vice President and President, Global Brands Research & Development at Allergan.
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