Anika files for European marketing approval for ORTHOVISC; Initiates pivotal U.S. clinical trial for osteoarthritis.WOBURN, Mass.--(BUSINESS WIRE)--May 28, 1996--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) today announced it has filed a Commumautee European (CE) mark registration to market ORTHOVISC as a medical device for the treatment of osteoarthritis with the member states of the European Union. The company also announced today it has accrued the first patients for its pivotal Phase III ORTHOVISC clinical trial in the United States. ORTHOVISC is an ultra-pure, high molecular weight hyaluronic acid product used to relieve pain, reduce inflammation and improve joint function in patients with osteoarthritis. A Notified Body, which is a private third party accredited accredited recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria. accredited herds cattle herds which have achieved a low level of reactors to, e.g. by the National Competent Authorities of the European Commission, will perform a conformity assessment of the ORTHOVISC application to ensure it meets the requirements of the Medical Device Directive (MDD MDD Major depressive disorder, see there ). The MDD establishes design, manufacturing, safety and product performance requirements for medical devices. "Submission of the CE Mark for ORTHOVISC is an important component of our commercialization strategy," said Duffy DuFresne, president of Anika Research. "We intend to work closely with the appropriate European regulatory bodies to streamline these efforts. "In the U.S. we recently received approval from the Food and Drug Administration to commence a pivotal human clinical trial under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and ," DuFresne continued. "These studies will evaluate the utility of ORTHOVISC for the treatment of osteoarthritis of the knee. After compiling sufficient data, we anticipate submitting a Pre-Market Approval application requesting U.S. marketing clearance from the 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. ." The Phase III double blind, placebo controlled trial will include 220 patients with osteoarthritis of the knee, a 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 joint disease characterized by chronic pain, stiffness and loss of motion. The trial will evaluate intra-articular injection of ORTHOVISC for the treatment of osteoarthritis. Hyaluronic acid (HA), a naturally occurring, viscoelastic substance found in the synovial fluid of joints, coats, protects and lubricates the soft tissues. It is estimated that 16 million Americans suffer from some form of osteoarthritis. Separately, the company reported the sudden death of John Casale, vice president of sales and marketing. The company has commenced a search to fill this position. Anika is dedicated to the development and manufacturing of technologically advanced hyaluronic acid products for surgical and therapeutic medical applications. Product development programs include: ORTHOVISC, Anika's lead compound for the treatment of osteoarthritis and temporomandibular joint (TMJ TMJ abbr. temporomandibular joint syndrome Temporomandibular joint pain (TMJ) Pain and other symptoms affecting the head, jaw, and face that are caused when the jaw joints and muscles controlling them don't work ) dysfunction; INCERT for the prevention of surgical adhesions; and HA oligosaccharides oligosaccharides (ol´igōsak´  rīdz),n. for the treatment of cancer. CONTACT: Anika Research Inc. Sean Moran, 617/932-6616 or Pondel, Parsons & Wilkinson Susan Klein, 508/358-4315 Robert Whetstone whetstone, natural or manufactured stone used as an abrasive solid to sharpen tools. It is used dry, with water, or with oil. Such a stone of the finer grade used with oil is usually called an oilstone. , 310/207-9300 |
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