-- Podium Sessions Showcase Studies Comparing
HYALOFAST versus Collagen Scaffold and Microfracture Surgery for
Cartilage Repair --
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 PresentationsSunday, 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)
Company-Sponsored SymposiaSunday,
September 25, 2016
1. Hyalofast: One Step Cartilage Regeneration
From Trauma To Early Degenerative LesionsModerators: 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, ItalyAnika Booth: # 6
About ICRSThe 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.
Forward-Looking Statements
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160922006143/en/
For Investor Inquiries:Anika Therapeutics, Inc.Sylvia Cheung,
781-457-9000Chief Financial OfficerorFor Media Inquiries:Pure
CommunicationsSusan Heins, 864-286-9597
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