Anika Therapeutics Receives FDA Approval for Ophthalmic Product; Shellgel to be Marketed by Cytosol Ophthalmics Inc.Business Editors/Health & Medical Writers WOBURN, Mass.--(BUSINESS WIRE)--July 16, 2001 Anika Therapeutics Inc. (Nasdaq:ANIK ANIK Canadian COMSAT ) today announced it has received 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 ) from 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. ) for Shellgel(TM), a hyaluronic acid-based viscoelastic Adj. 1. viscoelastic - having viscous as well as elastic properties natural philosophy, physics - the science of matter and energy and their interactions; "his favorite subject was physics" product designed to protect sensitive eye tissue and maintain eye shape during ophthalmic surgery. Shellgel(TM) will be distributed by Lenior, N.C.-based Cytosol cytosol /cy·to·sol/ (sit´ah-sol) the liquid medium of the cytoplasm, i.e., cytoplasm minus organelles and nonmembranous insoluble components.cytosol´ic cy·to·sol n. Ophthalmics Inc. "This is another step toward broadening our ophthalmic customer base and product offerings," said Douglas R. Potter, chief executive officer. "Cytosol has a presence in this market with its ophthalmic irrigation irrigation, in agriculture, artificial watering of the land. Although used chiefly in regions with annual rainfall of less than 20 in. (51 cm), it is also used in wetter areas to grow certain crops, e.g., rice. products, and this agreement for Shellgel gives us the opportunity for further penetration in the ophthalmic viscoelastic market." About Anika Therapeutics Inc. Anika Therapeutics Inc. (www.anikatherapeutics.com) develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. polymer found throughout the body. In addition to ORTHOVISC(R), a treatment for osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. of the knee (not approved for sale in the United States), Anika markets HYVISC(R) in the United States for the treatment of equine osteoarthritis through Boehringer Ingelheim Vetmedica Inc. and manufactures AMVISC(R) and AMVISC(R) Plus, HA viscoelastic products for ophthalmic surgery, for Bausch & Lomb Surgical. The statements made in this news release that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements involve known and unknown risks, uncertainties and other factors. The words "believe," "will," "would," "expect," "anticipate," "intend," "opportunity," "designed," "seek" and other expressions that are predictions of or indicate future events and trends and that do not constitute historical matters identify forward-looking statements. 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. In particular, the company may be unable to: (i) realize significant revenue from sales of Shellgel(TM), (ii) expand its product franchise in a meaningful way, (iii) achieve meaningful sales of Shellgel(TM), or (iv) obtain further ophthalmic viscoelastic customers. 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 Certain Factors Affecting Future Operating Results" and "Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2000, and the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2001, as well as those described in the company's other news releases and other SEC filings. |
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