Anika Research to expand ORTHOVISC human clinical trials.WOBURN, Mass.--(BUSINESS WIRE)--Nov. 29, 1994--Anika Research Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on Small Cap:ANIK) announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has requested additional human clinical data to complete its review of Anika's Pre-Market Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application for ORTHOVISC, a hyaluronic acid (HA) product for the treatment of temporomandibular joint (TMJ) dysfunction. HA is a naturally occurring biopolymer bi·o·pol·y·mer n. A macromolecule, such as a protein or nucleic acid, that is formed in a living organism. biopolymer any protein or nucleic acid produced by a living organism. found throughout the body that coats, protects and lubricates tissues. The second ORTHOVISC human clinical trial will commence at multiple sites in 1995 and will be co-sponsored by the American Association of Oral and Maxillofacial Surgeons The American Association of Oral and Maxillofacial Surgeons (AAOMS) is the non-profit professional association serving the specialty of oral and maxillofacial surgery, the surgical arm of dentistry. (AAOMS). The data obtained from this study will supplement Anika's PMA, which was accepted for filing by the FDA in December 1992. Anika began its ORTHOVISC clinical trial in 1987. "We are encouraged by the growing support that ORTHOVISC is receiving from the professional community of oral and maxillofacial surgeons. As evidenced by their co-sponsorship of the second human clinical trial, the AAOMS is anxious to offer patients a non-surgical treatment for TMJ dysfunction," said Dr. David A. Swann, Anika's chairman and chief executive officer. ORTHOVISC is designed to be injected into the jaw joint to relieve pain and improve joint function in patients with TMJ dysfunction, a painful and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction condition affecting the joint connecting the lower jaw to the cranium. Approximately three million people in the United States alone seek treatment annually for TMJ dysfunction. "We are enthusiastic about the market potential for ORTHOVISC because there is such a large pool of patients afflicted with jaw pain from TMJ dysfunction that presently do not have an effective non-surgical treatment alternative. We believe that this product is safe and effective and will help those patients to manage their TMJ dysfunction and delay and possibly avoid surgery," he said. Anika is a leader in developing technologically advanced HA-based products. Anika's research and product development program is focused on four areas: ORTHOVISC for temporomandibular joint dysfunction temporomandibular joint dysfunction n. Impaired functioning of the temporomandibular articulation of the jaw. temporomandibular joint dysfunction , OSTEOVISC for osteoarthritis, INCERT for the prevention of post-surgical tissue adhesions and HA oligosaccharides oligosaccharides (ol´igōsak´  rīdz),n. (discrete pieces of HA molecule) for drug delivery and the treatment of cancer and proliferative diseases. CONTACT: Anika Research Inc.
Sean Moran, 617/932-6616
or
Neil G. Berkman Associates
John Hicks, 310/277-5162
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