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
or
Sylvia Cheung, CFO
781-457-9000
Source: Anika Therapeutics, Inc.
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