September 22, 2016
BEDFORD, Mass. & NAPLES, Italy–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced four data presentations on HYALOFAST, a biodegradable HA-based scaffold, at the 13th World Congress of the International Cartilage Repair Society (ICRS). The ICRS World Congress, which is being held in Sorrento, Naples, Italy during September 24-27, 2016, is the world’s largest gathering of scientists, clinicians and industry participants focused on clinical cartilage repair and basic cartilage research.
“We’re proud to showcase the results of four recent and important studies evaluating the clinical utility of our biodegradable scaffold, HYALOFAST, before an audience of world-renowned experts in the field of cartilage repair and regeneration. Collectively, the data reinforce the significant advantages HYALOFAST offers over invasive surgical interventions and traditional scaffolds, specifically in terms of ease of use, efficiency and positive treatment outcomes,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer, Anika Therapeutics. “In addition, at our booth this year, we’re excited to debut the HYALOFAST Virtual Simulator, a digital training tool exclusively designed to allow physicians to experience a guided simulation of the entire HYALOFAST procedure in virtual reality.”
HYALOFAST is a non-woven biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used in more than 7,000 patients to date. HYALOFAST is pending regulatory submission in the United States and its ‘FastTRACK’ Phase III trial is currently enrolling patients across the U.S. and Europe.
HYALOFAST Data and Poster Presentations
Sunday, September 25, 2016
1. One-stage Cartilage Repair using Hyaluronic acid-based Scaffold and Mesenchymal Stem Cells (HA-BMAC) Compared to Microfracture: 5 Year FU (Authors: A. Gobbi, G. Whyte, B. Sadlik)
2. Arthroscopic Cartilage Repair using a Hyaluronic Acid-based Scaffold and Activated Bone Marrow-derived Mesenchymal Stem Cells (HA-BMAC) (Authors: G. Whyte, A. Gobbi, B. Sadlik)
3. Medium-term Outcomes of Cartilage Repair using Hyaluronic acid-based Scaffold with Multipotent Stem Cells in Patients Over 45 Years of Age (Authors: A. Gobbi, G. Whyte, M. Castro, B. Sadlik)
Monday, September 26, 2016
1. Hyaluronic acid-based scaffold versus bilayer collagen scaffold in patellofemoral chondral defect repair using dry arthroscopy(Authors: M. Puszkarz, B. Sadlik, A. Gobbi, M. Wiewiorski, B. Gaj, W. Klon, G. Whyte)
Sunday, September 25, 2016
1. Hyalofast: One Step Cartilage Regeneration From Trauma To Early Degenerative Lesions
Moderators: Dr. Francesca Vannini (Rizzoli Institute – Bologna –Italy) and Dr. Boguslaw Sadlik (St. Luke Clinic – Bielsko-Biala –Poland)
Speakers: Dr. Brunella Grigolo (Rizzoli Institute – Bologna –Italy), Prof. Roberto Buda (Rizzoli Institute – Bologna –Italy), Prof. Alberto Gobbi (O.A.S.I. Bioresearch Foundation – Milan –Italy)
Conference Location: Hilton Sorrento Palace, Sorrento – Naples, Italy
Anika Booth: # 6
The ICRS (International Cartilage Repair Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedics medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.
The statements made in the third paragraph of 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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the enrollment of patients in the Hyalofast clinical trial and the U.S. regulatory submission associated with Hyalofast. 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, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products, including for Hyalofast, on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.
For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
For Media Inquiries:
Susan Heins, 864-286-9597