Healthcare Industry News: hyaluronic acid
News Release - December 15, 2006
ORTHOVISC(R) Receives Unique Reimbursement CodeNew Code Simplifies Medicare and Medicaid Reimbursement
WOBURN, Mass., Dec. 15 (HSMN NewsFeed) -- Anika Therapeutics, Inc. (Nasdaq: ANIK ) today announced that its ORTHOVISC® product has been assigned a separate reimbursement code by the Centers for Medicare and Medicaid Services ("CMS"). This move will simplify the current reimbursement process, and improve access to ORTHOVISC, a treatment for osteoarthritis of the knee. The assignment of a reimbursement code removes a barrier to physician utilization of the product for Medicare and Medicaid patients.
The new code for ORTHOVISC will be Q4086 and will be effective starting on January 1, 2007. It reverses a decision to group all products in this category made earlier this Fall. Q-codes have replaced the J-codes for viscosupplementation products. The reimbursement rate will be 106% of ORTHOVISC 's average selling price calculated from data submitted to CMS.
"This decision, which recognizes the differences between marketed hyaluronic acid products, is good news for patients and a positive development for Anika," stated Charles H. Sherwood, Ph.D, Anika's president and chief executive officer.
ORTHOVISC, with a 30 mg dose of HA, contains the highest concentration of HA, which may offer improved pain relief at early, mid and late time points with only three injections. In addition to its effectiveness, ORTHOVISC has the highest safety profile of all HA products on the market.
About Anika Therapeutics, Inc.
Headquartered in Woburn, Mass., Anika Therapeutics, Inc. (http://www.anikatherapeutics.com) 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 products include ORTHOVISC®, a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek and Hyvisc®, a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc. Anika develops and manufactures Amvisc® and Amvisc Plus®, HA viscoelastic products for ophthalmic surgery. It also produces STAARVISC(TM)-II, which is distributed by STAAR Surgical Company and Shellgel(TM) for Cytosol Ophthalmics, Inc.
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," "expected," "opportunities," "will," "may," 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 statements regarding: (i) the company's expectations regarding its prospects for OrthoVisc sales. 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: (i) the company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain clinical data to support a pre-market approval application and/or FDA approval, and/or receive FDA or other regulatory approvals of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the success of the company's efforts to improve the financial performance of its core business; (iii) the company's research and product development efforts and their relative success, including whether the company has any meaningful sales of any new products resulting from such efforts; (iv) the cost effectiveness and efficiency of our manufacturing operations and production planning; (v) the strength of the US economy in which the company operates or will be operating, or (vi) future determinations by the company to allocate resources to products and in directions not presently contemplated. Any delay in receiving any regulatory approvals may adversely affect the company's competitive position. Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved. There is also a risk that (i) the company's existing distributor will not continue to place orders at historical levels or will seek to modify or terminate existing arrangements, (ii) new distribution arrangements, including the agreement with DePuy Mitek pertaining to ORTHOVISC® will not result in meaningful sales of the company's products, (iii) the new Q-code will not have a meaningful impact on ORTHOVISC sales, (iv) the company will be unable to achieve performance and sales threshold milestones in its distribution agreements, (v) competitive products will adversely impact the company's product sales, (vi) the estimated size(s) of the markets which the company has targeted its products will fail to be achieved, (vii) lack of adequate coverage and reimbursement provided by governments and other third party payers for our products and services could have a material adverse effect on our results of operations, or (viii) increased sales of the company's products, including HYVISC®, ORTHOVISC® , or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, or even if such increases occur that such increases will improve gross margins, any of which may have a material adverse effect on the company's business and operations. 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 each of the company's Annual Report on Form 10-K for the year ended December 31, 2005, and its Quarterly Report on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2006 and Current Reports on Form 8-K, as well as those described in the company's other press releases and SEC filings.
Source: Anika Therapeutics
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