Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint
preservation company focused on early intervention
orthopedics, today announced that it has received the final 510(k)
clearance from the FDA for the Integrity™ Implant System. The
system is designed to augment an injured tendon to promote healing
in rotator cuff repair procedures. Clearance of the hyaluronic acid
(HA) based patch component joins the prior 510(k)s received for the
associated fixation devices and instrumentation. The Integrity
implant is a flexible, knitted, HA-based scaffold that provides
improved strength and regenerative capacity over first generation
collagen patches1, and supports regenerative healing through
improved cell infiltration1, tissue remodeling1, and tendon
thickening1.
“The clearance of Integrity is a key milestone in the continued
build-out of Anika’s proprietary HA-based regenerative portfolio
and underscores our commitment to helping surgeons improve outcomes
in rotator cuff repair procedures through biologic healing,” said
Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “Integrity,
named for its structural integrity compared with first-generation
collagen patches, is a key value driver for Anika and was developed
internally using our proprietary HA technology that has
demonstrated differentiated regenerative performance
characteristics. The HA-based patch, together with the
instrumentation and fixation, provide a seamless, efficient, and
elegant rotator cuff repair solution. This clearance opens
significant opportunities in the shoulder and we see future
expansion for this innovative technology in other anatomies.
Integrity enhances the breadth and depth of our regenerative
offering, adding critical mass to a growing portfolio that provides
meaningful solutions to unmet needs in early intervention
orthopedics that restore active living for patients around the
world.”
The Integrity Implant System is comprised of the HA-based patch
implant, fixation implants, and single use arthroscopic delivery
instruments. The patch component of the system is a porous,
flexible construct knitted using HYAFF® fibers and designed to
support cell infiltration and regenerative healing. HYAFF is
Anika’s proven and proprietary esterified HA technology that
resorbs over time as tissue remodels. Integrity is inherently
strong and can be confidently manipulated arthroscopically, which
offers a truly unique and differentiated solution for shoulder
surgeons to treat rotator cuff tears. The Integrity patch implant
is fixed using PEEK bone staples, resorbable PLGA soft tissue
tendon tacks, or suture fixation, as desired, at the site of the
rotator cuff augmentation. The fixation components and
instrumentation are delivered single use and sterile for added
efficiency.
Christopher Baker, MD, of the Florida Orthopedic Institute
commented, “I’m excited to see Anika working to improve the
biologic augmentation market starting with rotator cuff repair.
While some collagen products on the market are showing promising
results with biological incorporation, in animal studies, Integrity
facilitated improved biological healing without the use of animal
collagen, while also providing a scaffold that can add strength to
the construct at the time of implantation. In addition to improving
the patch itself, they have also identified a more streamlined
surgical technique. This product could improve patient outcomes and
reduce the likelihood of future failures of rotator cuff
repair.”
In an independent head-to-head animal study comparing Anika’s
Integrity system and the leading competitive collagen device,
fibroblast infiltration and regularly oriented new collagenous
tissue formation had occurred within the Integrity repair,
demonstrating greater regenerative capacity as early as 12 weeks
post-implantation. At 26 weeks, within the resorbing Integrity
structure, new collagenous tissue infiltration forming a new
network of tendon tissue had occurred. This resulted in the
repaired tendon thickness being nearly 3 times greater than with
the competitive collagen device. Tendon thickness is thought to
improve the local biomechanical environment of the tear by reducing
tendon strain, thus optimizing it’s healing potential3.
Timothy Codd, MD, of the University of Maryland St. Joseph
Medical Center stated, “Building on previous work with biological
augmentation, the new Integrity system will be the next step
forward in improving tendon healing and patient outcomes, with
refined and more precise delivery. With the ability to augment and
improve tendon healing along with increased structural support for
early tendon repairs, Integrity should be the next big advance in
improving patient outcomes in rotator cuff disease.”
The U.S. rotator cuff augmentation market is currently estimated
at $150 million2, growing at a nearly 7% CAGR2 over the next
5-years, representing one of the high opportunity spaces in
orthopedics. The Integrity Implant System continues Anika’s focus
on delivering new, differentiated shoulder solutions, with a
specific focus on the intersection of regenerative solutions and
sports medicine. The Integrity clearance, and upcoming launch,
continues Anika’s release of unique products to support shoulder
surgeons and a portfolio built around rotator cuff disease. Recent
launches include Tactoset with hardware augmentation and with bone
marrow aspirate, the X-Twist suture anchor fixation system, and the
RevoMotion Reverse Shoulder System. These new products allow Anika
to expand deeper into the shoulder market by offering regenerative,
sports medicine, and reconstructive solutions.
Anika expects to commence a limited market release of Integrity
in the United States in the first quarter of 2024 with a full U.S.
market release and expansion into international markets to
follow.
1Data on File
2 2023 SmartTrak
3 Schlegal, T. F., M.D. (2017). Radiologic and clinical
evaluation of a bioabsorbable collagen implant to treat
partial-thickness tears: A prospective multicenter study. Journal
of Shoulder and Elbow Surgery.
https://doi.org/10.1016/j.jse.2017.08.023
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 and Arthrosurface Joint Solutions, 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, HYAFF, INTEGRITY, REVOMOTION,
TACTOSET, X-TWIST, and the Anika logo are trademarks of Anika
Therapeutics, Inc. or its subsidiaries or are licensed to Anika
Therapeutics, Inc. for its use.
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 regarding
the planned launch and future expansion of Integrity, the potential
success of Integrity in improving the treatment of rotator cuff
disease and the potential growth of the rotator cuff augmentation
market. 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.
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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