Healthcare Industry News: Coapt Systems
News Release - November 19, 2009
Anika Therapeutics Receives European CE Mark Approval for "ELEVESS Light"Company Expands Aesthetic Franchise with New Product Used to Treat Fine Lines and Wrinkles
Plans European Launch in Early 2010
BEDFORD, Mass.--(HSMN NewsFeed)--Anika Therapeutics, Inc. (Nasdaq: ANIK ), a leader in products for tissue protection, healing and repair based on hyaluronic acid (“HA”) technology, today announced that it has received European CE Mark approval for “ELEVESS™ Light,” the Company’s latest aesthetic product used for the treatment of fine lines and facial wrinkles. ELEVESS Light will be distributed in the European market by the Company’s current aesthetic dermatology distributors.
“This approval expands our aesthetic dermatology product family and paves the way for an early 2010 launch of ‘ELEVESS Light’ in the European Union and other geographies that provide approvals based on the CE mark,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer. “Domestically, we are in discussions with the FDA about the pathway for approval for this new fine-line product.”
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika’s products include ORTHOVISC®, a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek; HYVISC®, a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.; a family of aesthetic dermatology products for facial wrinkles and scar remediation marketed in the U.S. by Coapt Systems, Inc.; AMVISC®, AMVISC® Plus, STAARVISC™-II and Shellgel™ injectable viscoelastic HA products for ophthalmic surgery; INCERT®, an HA-based anti-adhesive for surgical applications; ORTHOVISC® mini a treatment for osteoarthritis targeting small joints and available in Europe; MONOVISC™ a single-injection osteoarthritis product based on Anika’s proprietary cross-linking technology and available in Europe, Turkey, and Canada; and next generation products for joint health and aesthetic dermatology based on the Company’s proprietary, chemically modified HA.
The statements made in this press release which are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective," "expanding," "building," "continue," "progress," “plan,” "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," “expect” and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. These statements also include: (i) planning to launch the new product at the beginning of 2010 in Europe; and (ii) discussions with the FDA about the pathway for approval for the fine-line product domestically. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties and other factors. The Company's actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors including: the risk that (i) the Company's existing distributors or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements, (ii) the Company’s distributors will be unable to achieve meaningful sales levels for ELEVESS Light, (iii) competitive products will adversely impact the Company's product sales, and (iv) the estimated size(s) of the markets which the Company has targeted its products will fail to be achieved Certain other factors that might cause the Company's actual results to differ materially from those in the forward-looking statements include those set forth under the headings "Business," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and on Form 10-Q for the period ended September 30, 2009, as well as those described in the Company's other press releases and SEC filings.
Source: Anika Therapeutics
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