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Press Release

April 28, 2015 at 4:06 PM EDT

Anika Therapeutics Announces Presentation of Seven Abstracts at 12th Annual World Congress of the International Cartilage Repair Society

Research Demonstrates Positive Clinical Outcomes for Hyalofast®

BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing, and repair based on hyaluronic acid (HA) technology, today announced that seven abstracts related to our Hyalofast product are scheduled for presentation at the 12th Annual World Congress of the International Cartilage Repair Society (ICRS)May 8-11, 2015 at the Sheraton Chicago Hotel & Towers in Chicago, Illinois.

The research demonstrates that Anika's HA-based scaffold, Hyalofast, enables patients to naturally regenerate cartilage. Hyalofast is CE Marked in Europe for the entrapment of mesenchymal stem cells in connection with the treatment of chondral and osteochondral lesions, and the product is commercially available in Europe and certain other international markets. Hyalofast can be implanted in an easy, one-step, minimally invasive and cost-effective procedure. During the first quarter of 2015, Anika also filed an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration to conduct a pivotal Phase III clinical trial for Hyalofast.

"The research being presented on Hyalofast highlights the positive clinical outcomes of patients being treated in multiple areas, including the knees and ankles," said Anika President and CEO Dr. Charles H. Sherwood. "The data validates the distinct advantages Hyalofast has over other products as the only HA-based scaffold for regeneration, as well as the safety and effectiveness of the procedure. We look forward to beginning a pivotal Phase III clinical trial planned for the fourth quarter of 2015, and advancing Hyalofast toward commercialization in the United States."

The following abstracts discussing Hyalofast will be presented at ICRS 2015:

  • "Comparison of two matrix membranes on Seeded Bone Marrow-Mesenchymal Stem Cells (BM-MSCs) induced to Chondrocytes capacity," C. Jofre, A. Rojas, E. Narvaez, J. Berendsen, F. Las Heras, R. Mardones.
  • "Arthroscopic Treatment of Osteochondral Lesions of Talus Using Hyaluronic Acid Scaffold Combined with Platelet Rich Growth Factor (Prgf )," M.N. Doral, G. Huri, E. Turhan, G. Donmez, D. Kaya.
  • "Mesenchymal stem cells with Hyaluronan based scaffold: A biological solution for aging cartilage lesions," A. Gobbi, G. Karnatzikos, M. Abhishek.
  • "How mesenchymal cells number impact the outcome in cartilage repair of the ankle: "OneStep" technique with Hyalofast membrane," L. Ramponi, R. Buda, M. Cavallo, S. Giannini, A. Cenacchi, F. Vannini, I. Bonetti, A. Ruffilli.
  • "Is the type of Scaffold Impacting the results of Autologous Bone Marrow Derived Cells Transplantation in Osteochondral Lesions of the Ankle?" F. Vannini, R. Buda, M. Cavallo, L. Ramponi, C. Cavallo, B. Grigolo, S. Giannini.
  • "Treatment of knee cartilage defects with hyaluronan scaffold," K. Slynarski, A. Krzesniak.
  • "Arthroscopic treatment of OCD with using hyaluronic acid based cell-free scaffold and concentration of autologous bone marrow aspirate," M. Bozkurt, M. Akkaya, S. Gursoy, C. Isik.

About ICRS

The International Cartilage Repair Society (ICRS) is a unique forum for international collaboration in cartilaginous tissue research that brings together clinicians, clinical researchers, and basic scientists, engaged or interested in the fields of cartilage biology, imaging, cartilaginous tissue engineering, and translational clinical approaches to the treatment of cartilage pathologies.

About Anika Therapeutics, Inc.

Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops, manufactures, and commercializes therapeutic products for tissue protection, healing, and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's products range from orthopedic/joint health solutions led by Orthovisc® and Monovisc®, treatments for osteoarthritis, to surgical aids in the anti-adhesion and ophthalmic fields. The Company also offers aesthetic dermal fillers for the correction of facial wrinkles. Anika's Italian subsidiary, Anika Therapeutics S.r.l., provides complementary HA products in the orthopedic/joint health and anti-adhesion fields, as well as therapeutics in areas such as advanced wound treatment and ear, nose, and throat care. Its regenerative technology advances Anika's vision to offer therapeutic products and medical solutions that go beyond pain relief to protect and restore damaged tissue.

The statements made in the second and third paragraphs of this press 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. These statements include, but are not limited to, the clinical and commercialization timeframes of Hyalofast and the commercial and clinical advantages of the product. 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 these or other forward-looking statements made by the Company as a result of a number of factors including (i) the Company's ability to successfully commence and/or complete clinical trials of its products, including Hyalofast, on a timely basis or at all, to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications or 510(k) applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products, or 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; (ii) the Company's research and product development efforts and their relative success, including whether the Company has any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of its clinical studies, including the associated regulatory approval applications, its manufacturing operations, and its production planning; (iv) 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; (v) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (vi) the Company's ability to successfully complete its commercialization plans for its products in the U.S. and internationally; (vii) the Company's ability to provide an adequate and timely supply of its products to its customers; (viii) its ability to continue to successfully manage Anika Therapeutics S.r.l.'s business; and (ix) the Company's ability to achieve its growth targets.

Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO
Sylvia Cheung, CFO

Source: Anika Therapeutics, Inc.

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