Anika Therapeutics Commences Clinical Trial For INCERT-S Anti-Adhesion Therapy.Business Editors/Health/Medical Writers WOBURN, Mass.--(BUSINESS WIRE)--April 20, 2004 Anika Therapeutics, Inc. (Nasdaq:ANIK ANIK Canadian COMSAT ) today announced it has commenced a human pilot clinical trial to test the safety and effectiveness of INCERT(R)-S for the prevention of internal adhesions or scarring following spinal surgery. The trial, which will involve approximately 45 patients, will be conducted at two centers in the United Kingdom, The Wellington Hospital in London and the Royal National Orthopaedic Hospital The Royal National Orthopaedic Hospital NHS Trust (RNOH) provides a comprehensive range of neuro-musculoskeletal health care, ranging from the most acute spinal injury or complex bone tumour to orthopaedic medicine and specialist rehabilitation for chronic back pain sufferers. in Stanmore. INCERT(R)-S is part of a potential family of bioabsorbable, chemically modified hyaluronic acid hyaluronic acid: see mucopolysaccharide. Hyaluronic acid A polysaccharide which is an integral part of the gel-like substance of animal connective tissue; it supposedly serves as a lubricant and shock absorbent in the joints. (HA) therapies in development at Anika. INCERT is designed to act as a barrier to prevent internal tissue adhesion and scarring following spinal, cardiac, pelvic or abdominal surgery. Such adhesions can lead to recurrent back pain, female infertility and intestinal blockage, sometimes necessitating costly second surgeries. Anika's family of potential adhesion prevention products is based on the company's proprietary modified HA technology, which alters the properties of HA to allow for longer duration in the body. By controlling these properties, Anika can design products for optimal performance in the intended application. Designed for spinal surgeries such as discectomy disc·ec·to·my n. The partial or complete excision of an intervertebral disk. Also called discotomy. , laminectomy laminectomy /lam·i·nec·to·my/ (lam?i-nek´tah-me) excision of the posterior arch of a vertebra. lam·i·nec·to·my n. Excision of a vertebral lamina. Also called rachiotomy. or laminotomy, INCERT-S is the first of Anika's potential therapies to be tested in human clinical trials. The gel-like substance is applied to the incision site prior to surgical closure. There are a large number of spinal surgeries worldwide susceptible to the complications of post-surgical adhesions, including approximately 700,000 each year in the United States alone. "Now that our OrthoVisc(R) therapy 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 has been launched in the United States, we are focusing our energies on developing a pipeline of innovative products that will generate sustainable long-term growth for Anika," said Charles H. Sherwood, Ph.D., president and chief executive officer. "Our near-term product strategy centers on therapies derived from chemically modified HA, and commencement of this INCERT-S trial is an important step forward." About Anika Therapeutics, Inc. Headquartered in Woburn, Mass., 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. Anika products include OrthoVisc(R), a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by Ortho Biotech Products, L.P., and Hyvisc(R), a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc. Anika manufactures Amvisc(TM) and Amvisc Plus(TM), HA 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" products for ophthalmic surgery, for Bausch & Lomb. It also produces CoEase(TM), which is marketed by Advanced Medical Optics Advanced Medical Optics, Inc., (NYSE: EYE) (known as AMO) is a global medical device leader focused on the discovery and delivery of innovative vision technologies that optimize the quality of life for people of all ages. , Inc., STAARVISC(TM)-II distributed by STAAR STAAR Second Time Around Aussie Rescue, Inc. (Bryan, TX) STAAR Space Technology Applications Astronomy & Rocket Research (Scottish Rocket Programme) Surgical Company and Shellgel(TM) for 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. 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," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. The statements are based upon the current beliefs and expectations of 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: its ability to successfully commence and/or complete the human pilot clinical trial of INCERT(R)-S or its other products on a timely basis or at all, and that it obtains clinical safety and efficacy data to support any pre-market approval application and/or 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. or other U.S. or foreign regulatory approvals of such products; that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; and the results of its other research and product development efforts and their relative success, including whether the Company is successful in obtaining marketing or distribution arrangements for its products or has any meaningful sales of any new products resulting from such efforts. Even if the Company is successful with INCERT(R)-S or its other products, there can be no assurance that it will be successful with other potential products. 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 each of the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2003 and Current Reports on Form 8-K, as well as those described in the Company's other press releases and SEC filings. |
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