Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint
preservation company focused on early intervention
orthopedics, today announced the limited market release and the
first surgeries performed using the X-Twist Fixation System.
Christopher E. Baker, M.D., a prominent sports medicine physician
in Tampa, Florida, was the first surgeon to use the X-Twist
Fixation System earlier today.
“The X-Twist is a new addition to the Anika sports
medicine portfolio that brings their anchor
options to the highest standard in orthopedics in the market,” said
Christopher E. Baker, M.D., from the Florida Orthopaedic Institute
in Tampa, Florida. “The instrumentation is easy to use and
intuitive, and fixation is robust. This is an anchor that can be
used both knotless and as a knotted traditional anchor offering a
wide spectrum of options for suture preference, including tape. In
my rotator cuff repairs, this will supplement my medial row anchor
in poor bone quality and will become my primary lateral row anchor.
The X-Twist can easily be used for nearly any soft tissue repair
within the shoulder and throughout the body.”
The X-Twist Fixation System is a platform of suture anchors
designed to be mechanically strong1, easy to use, and support
healing for cases such as rotator cuff repair. The system affords
surgeons a variety of knotless and knotted soft tissue fixation
options in a single anchor platform. The feature-rich design
includes venting intended to support cellular infiltration through
the anchor to promote bony ingrowth; a double helix thread that
allows fast and easy deployment; the ability to support the
surgeon’s preferred combination of multiple sliding suture or tape
configurations; and the unique X-Spline™ drive technology which
provides more torque transfer for easy anchor insertion. In
addition to the shoulder, the X-Twist Fixation System has direct
applications in a variety of procedures, including the foot and
ankle, and other extremities. The system will initially be
available in PEEK.
In May 2022, Anika received 510(k) clearance from the FDA for
the X-Twist Fixation System. The device is a cornerstone product
for Anika’s sports medicine business and will address the needs of
surgeons performing high volume procedures such as rotator cuff
repair and ankle stabilization procedures. Within these procedures,
ease of use and the convenience of an anchor that allows for
multiple suture and tape configurations is highly desirable,
especially in the ambulatory surgery center (ASC), where the
majority of these cases are performed.
“The release of the X-Twist Fixation System is the first of
several Anika products to launch in the US in 2022 and 2023 in the
sports medicine, implant, and regenerative markets. This launch
demonstrates Anika’s commitment and ability to develop, market, and
commercialize products within our expanded $8 billion global market
including joint preservation and restoration, and especially in the
shoulder repair market, which is integral to our growth strategy,”
said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO.
“Anika’s Sports Medicine team, comprised of industry leaders, is
building momentum through this launch and with our recent hardware
augmentation indication for Tactoset, this momentum will only
increase as we execute on our joint preservation strategy.”
In addition to being a meaningful advancement in features and
performance for surgeons, this new suture anchor family provides
further reach for Anika’s Tactoset® Injectable Bone Substitute.
Tactoset’s indications for use include augmentation of hardware,
such as suture anchors, and is an ideal option for rotator cuff
repair in poor bone quality where improved suture anchor fixation
is desired. The strength of Anika’s growing family of rotator cuff
solutions bolsters its competitiveness and market attractiveness in
this key area of clinical and patient need and sets the stage for
additional new product launches into 2023 and beyond.
Anika is initially offering the X-Twist Fixation System in the
US through a limited market release, with a full market release
expected into 2023. Anika expects to introduce the X-Twist Fixation
System internationally in select markets at the time of full market
release.
1 Data on file.
Forward-Looking Statements
This press release may contain 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, concerning the Company's expectations, anticipations,
intentions, beliefs or strategies regarding the future which are
not statements of historical fact, including statements about
surgeon adoption of the T-Twist Fixation System in the future and
about the timing, geographic scope and potential success of new
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. 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)
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.
About AnikaAnika Therapeutics, Inc. (NASDAQ:
ANIK), is a global joint preservation company that creates and
delivers meaningful advancements in early intervention orthopedic
care. Leveraging our core expertise in hyaluronic acid and implant
solutions, we partner with clinicians to provide minimally invasive
products that restore active living for people around the world.
Our focus is on high opportunity spaces within orthopedics,
including osteoarthritis pain management, regenerative solutions,
sports medicine soft tissue repair and bone preserving joint
technologies, and our products are efficiently delivered in key
sites of care, including ambulatory surgery centers. Anika’s global
operations are headquartered outside of Boston, Massachusetts. For
more information about Anika, please visit www.anika.com.
ANIKA, ANIKA THERAPEUTICS, TACTOSET, X-TWIST and the Anika logo
are registered trademarks of Anika Therapeutics, Inc. or its
subsidiaries.
For Investor Inquiries:Anika Therapeutics,
Inc.Mark Namaroff, 781-457-9287Vice President, Investor Relations,
ESG and Corporate Communicationsinvestorrelations@anika.com
For Media Inquiries:GreenoughChristine
Williamson, 617-922-1289Senior Vice
Presidentcwilliamson@greenough.biz
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