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Press Release

August 13, 2019 at 8:30 AM EDT

Anika Announces Successful Completion of First Human Surgical Procedure with Injectable HA-Based Bone Repair Therapy

Company to Deploy Hybrid Commercial Strategy to Support U.S.Sales and Distribution

BEDFORD, Mass.--(BUSINESS WIRE)--Aug. 13, 2019-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced the successful completion of the first human surgical procedure with its injectable HA-based bone repair therapy for the treatment of bone voids and other bone defects of the skeletal system caused by trauma or age-related degeneration. The case was performed by Dr. John J. Tierney, an orthopedic surgeon at the New England Baptist Hospital and President of the Greater Boston Orthopedic Center.

“My surgical experience with Anika’s product was very positive, and its ease of use surpassed that of other products I have used,” said Dr. Tierney. “My case went very smoothly, from start to finish, and I have every reason to believe that my patient will recover quickly post-operatively.”

Approximately 900,000 people require treatment for bone voids and other bone defects of the knee, which cause pain and impaired function that can lead to the need for total joint replacement therapy. This therapy combines calcium phosphate, an established precursor to the mineral component of bone, with Anika’s proprietary hyaluronic acid, which enhances flow and tactile feel during administration, to improve ease of use and procedural efficiency.

“Our injectable bone repair therapy is an innovative and easy-to-use treatment option, which is resorbed and replaced by the growth of new bone during the healing process,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “We are excited about this important milestone, and look forward to an initial commercial launch of the product under our hybrid commercial model in September, leveraging our specially-skilled regional sales directors to penetrate the market. We also plan to discuss the benefits of this novel therapy and value of our hybrid commercial strategy at our upcoming analyst and investor day.”

About Anika’s Bone Repair Therapy

Anika’s injectable bone repair therapy is its first surgically-delivered regenerative therapy in the U.S. for bone repair procedures, and it will be launched in September 2019 utilizing the Company’s hybrid commercial model. The therapy is an injectable, HA-based, settable, osteoconductive calcium phosphate bone substitute material, and it is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bony structure. It is provided in a kit with two components (an aqueous solution in a pre-loaded syringe and a dry powder) that must be mixed intra-operatively using the supplied mixing system to form a cohesive paste prior to administration.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, viscosupplements which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the second sentence of the fourth paragraph and the first sentence in the section captioned “About Anika’s Bone Repair Therapy” 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 Company’s plans for the launch of its surgically-delivered bone repair therapy. 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 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) quarterly sales volume variation experienced by the Company, which can make future results difficult to predict and period-to-period comparisons potentially less meaningful; (x) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (xi) 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.

Source: Anika Therapeutics, Inc.

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer

For Media Inquiries:
W2O Group
Sonal Vasudev, 917-523-1418
sonal@w2ogroup.com