Anika Announces Successful Completion of First Human Surgical Procedure with Injectable HA-Based Bone Repair Therapy
August 13 2019 - 8:30AM
Business Wire
Company to Deploy Hybrid Commercial Strategy to
Support U.S.Sales and Distribution
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190813005218/en/
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
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