Anika To Launch Six FDA-Cleared Sports Medicine and Extremities Products in Third Quarter of 2020
July 20 2020 - 7:00AM
Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated joint
preservation, restoration and regenerative solutions company with
products across the orthopedic early intervention continuum of
care, today announced U.S. Food and Drug Administration (FDA)
clearance and the planned launch of multiple new product
innovations that address the needs of orthopedic and sports
medicine surgeons and their patients seeking to stay active by
overcoming soft tissue damage. Six minimally invasive surgical
devices and instruments have been cleared by the FDA to repair
rotator cuffs, perform arthroscopic knee repairs and treat
arthritis damage in the hand and wrist. The products will be
commercialized through Anika’s recently expanded sales and
marketing team throughout the third quarter of 2020 and mark the
first products launched from the acquisitions of Parcus Medical and
Arthrosurface, which were completed earlier this year.
“Anika has rapidly pivoted to become a dynamic, customer facing
enterprise. The introduction of these innovative technologies is
evidence that the Company is listening to its physician customers
to identify surgeon and patient needs, and has the ability to
develop, gain approvals for and launch a series of new devices and
instruments, even during pandemic conditions,” said Cheryl R.
Blanchard, Ph.D., President and Chief Executive Officer of Anika.
“Commercial success and growth in the sports medicine and joint
preservation and restoration market demands an evolving
understanding of unmet patient needs and the ability to translate
surgeon feedback into designs that are both meaningful and
practical for today’s minimally invasive surgical ecosystem. Anika
is well positioned to launch these exciting innovations, and we
look forward to introducing these new products to our growing
customer base as COVID restrictions ease and elective procedures
resume in the U.S.”
The new products include:
- Knotless AP Suture Anchors, a new family of knotless, drive-in
suture anchors manufactured from a proprietary, bioabsorbable
composite and available in four diameters. These products are used
for rotator cuff repairs in the shoulder and tendon repairs in the
foot and ankle.
- ATLAS, a more anatomical and less invasive arthroplasty
solution to treat arthritis of the CMC joint (thumb).
- Synd-EZ Ti and Synd-EZ SS, knotless solutions to repair
syndesmosis injuries in the ankle. These products are available in
both titanium and stainless steel for compatibility with adjunctive
fixation products.
- Twist PEEK SST, a suture anchor design incorporating fixed
suture tapes to facilitate reproducible knotless double-row rotator
cuff repair.
- 35 PEEK CF Push-In with Tape, a carbon fiber reinforced polymer
anchor that incorporates high-strength suture tape to facilitate
arthroscopic capsulolabral repairs of the shoulder.
- GFS BTB Link, a ligament retention device used with the GFS
Ultimate suspensory fixation device to provide the option to
utilize bone-tendon-bone grafts in ACL and PCL reconstruction.
“Consistent incremental improvements to techniques, tools and
materials are critical in joint preservation surgery, allowing
surgeons to continually refine ways to keep their patients active
and comfortable,” said Anil S. Ranawat, M.D., Hospital for Special
Surgery. “Having worked closely with the Anika team in recent
years, I am impressed with their ability to identify clinical
problems and provide real time solutions for us as practitioners.
Their growing armamentarium of new tools is the most recent example
of this commitment, and I look forward to putting them into
practice.”
About Anika Therapeutics
Anika Therapeutics, Inc. (NASDAQ: ANIK), is a global, integrated
joint preservation, restoration and regenerative solutions company
based in Bedford, Massachusetts. Anika is committed to delivering a
diverse array of products to improve the lives of patients, with a
focus on osteoarthritis pain management, sports medicine and joint
preservation, restoration and regeneration. The Company has close
to three decades of global expertise commercializing innovative
products across the orthopedic early intervention continuum of
care. For more information about Anika, please visit
www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the first and third sentence of the first
paragraph, 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
planned product launches. 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,
especially in light of the evolving landscape around the COVID-19
pandemic. 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 failure
to realize the anticipated benefits of its recently completed
acquisitions; (ii) unexpected expenditures or assumed liabilities
that may be incurred as a result of these acquisitions; (iii) loss
of key employees or customers following the acquisitions or
otherwise; (iv) unanticipated difficulties in conforming business
practices, including accounting policies, procedures, internal
controls, and financial records of the recently acquired companies;
(v) inability to accurately forecast the performance of the
recently acquired companies resulting in unforeseen adverse effects
on the Company’s operating results; (vi) synergies between the
recently acquired companies and the Company being estimates which
may be materially different from actual results; (vii) 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; (viii) 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; (ix) the cost effectiveness and efficiency of the
Company’s clinical studies, manufacturing operations, and
production planning; (x) the Company’s ability to successfully
commercialize its products, in the U.S. and abroad; (xi) the
Company’s ability to provide an adequate and timely supply of its
products to its customers; and (xii) 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.
For Investor Inquiries: Anika Therapeutics, Inc. Sylvia Cheung,
781-457-9000 Chief Financial Officer
investorrelations@anikatherapeutics.com |
For Media Inquiries: W2O Group Rachel Girard, 617-379-6760
rgirard@w2ogroup.com |
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