Anika
Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue
protection, healing, and repair based on hyaluronic
acid (HA) technology, today announced that it has filed an
Investigational Device Exemption (IDE) with the U.S. Food and Drug
Administration to conduct a pivotal Phase III clinical trial for
Hyalofast, a biodegradable, 3D, HA-based scaffold with autologous bone
marrow aspirate concentrate (BMAC). European clinical data demonstrated
that patients who utilized Hyalofast with BMAC in a one-step
arthroscopic procedure were able to naturally regenerate hyaline-like
cartilage with a minimally invasive and cost-effective procedure.
Hyalofast is CE Marked in Europe for the entrapment of mesenchymal stem
cells in connection with the treatment of chondral and osteochondral
lesions, and it is commercially available in Europe and certain other
international markets.
The Hyalofast pivotal trial, “FastTRACK,” will compare Hyalofast’s
treatment of articular knee cartilage defect lesions to that of a
control microfracture treatment. FastTRACK is a prospective, randomized,
active treatment-controlled, evaluator-blinded, and multi-center study.
Anika expects to enroll 200 patients at up to 30 sites in the United
States and Europe beginning in the fourth quarter of 2015.
“We are excited to progress Hyalofast toward commercialization in the
United States,” said Dr. Charles H. Sherwood, Anika’s President and CEO.
“We have seen very positive clinical outcomes from Hyalofast in the
treatment of knees and ankles internationally, which bodes well as we
advance the product in the clinic domestically. As the only HA-based
scaffold for regeneration, Hyalofast has distinct advantages over other
products constructed of different biomaterials or synthetics. We look
forward to commencing our Phase III pivotal trial later this year.”
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 of the knee, 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 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 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, the commercialization of Hyalofast,
including the Company’s expectations regarding the data to be obtained
in the Phase III pivotal trial, the timing of the Phase III pivotal
trial, 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 our clinical studies, including the associated
regulatory approval applications, our manufacturing operations, and our
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) our ability to
continue to successfully manage Anika Therapeutics S.r.l.’s business;
and (ix) the Company’s ability to achieve its growth targets. 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
"Management's Discussion and Analysis of Financial Condition and Results
of Operations" in the Company's Annual Report on Form 10-K for the year
ended December 31, 2014, as well as those described in the Company's
other press releases and SEC filings.
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