Anika Wins CE Mark Approval For ORTHOVISC®-T To Relieve Pain and Restore Function of Tendons Damaged by Chronic Injury
December 19 2016 - 2:00PM
Business Wire
Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated
orthopedic medicines company specializing in therapeutics based on
its proprietary hyaluronic acid “HA” technology, today announced
that it received CE Mark approval for ORTHOVISC-T (sodium
hyaluronate for peritendinous injection), a treatment indicated to
relieve pain and restore function in tendons affected by chronic
lateral epicondylosis. ORTHOVISC-T is designed to provide
lubrication to the site of the damaged tendons to promote tendon
gliding and to provide an environment to support tendon repair.
ORTHOVISC-T is the latest addition to Anika’s product portfolio,
which includes, among other products, HYALOFAST®, a biodegradable,
hyaluronic acid-based scaffold for hyaline-like cartilage
regeneration to treat cartilage injuries and defects. Both
HYALOFAST and ORTHOVISC-T are CE Marked and pending regulatory
submission in the United States.
“We’re excited to announce the timely European approval of
ORTHOVISC-T for the treatment of pain associated with one of the
most common overuse injuries to connective tissues, the condition
commonly described as tennis elbow,” said Charles H. Sherwood,
Ph.D., President and Chief Executive Officer. “The availability of
ORTHOVISC-T not only promises to help millions of people in Europe
find relief from this painful condition, it also expands our global
foothold in orthopedic medicine and provides real-world clinical
experience to inform our path towards regulatory submission in the
U.S.”
ORTHOVISC-T is administered via injection into the site of
injury to relieve pain and restore function of tendons damaged by
chronic injury and overuse, as often seen in tennis elbow.
ORTHOVISC-T consists of a biocompatible, non-animal-derived and
non-inflammatory formulation of hyaluronic acid similar to those
found in the company’s best-selling viscosupplements, ORTHOVISC and
MONOVISC®.
“Degenerative overuse injuries to tendons are a leading cause of
pain and restricted activity, and, until now, treatments were
limited to oral medications, physical and/or occupational therapy,
and corticosteroid injections,” said Peter M. Prokopis, M.D., Hand
and Upper Extremity Specialist at Sports Medicine North, a
Massachusetts-based sports medicine clinic. “ORTHOVISC-T is a
natural and effective solution that not only relieves pain, but
also addresses the source of pain and discomfort and promotes
natural resolution of the symptoms and ultimate recovery.”
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated
orthopedic 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 cartilage 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®, 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 last sentence of the first 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 pendency of
the Company’s regulatory submissions for Hyalofast and Orthovisc-T
in the United States. 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 (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 or 510(k)
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; (x) the Company’s
ability to continue to successfully manage Anika Therapeutics
S.r.l.’s business; 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161219006022/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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