Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint
preservation company focused on early intervention
orthopedics, today announced that the first surgeries using the
Integrity Implant System were successfully performed by Dr.
Christopher Baker at the Florida Orthopaedic Institute in Tampa,
FL. Integrity, comprised of a hyaluronic acid-based scaffold with
bone and tendon fixation components and single use arthroscopic
delivery instruments, is designed to protect an injured tendon and
promote healing in rotator cuff repair and other tendon procedures.
The system was fully cleared by the FDA in August of 2023. This
marks the beginning of the limited U.S. market release ahead of
schedule that will ramp to a full market release during the first
quarter of 2024.
“The successful first surgeries using Anika’s new Integrity
Implant System mark another key milestone in the build out of our
regenerative product portfolio as we continue to provide
differentiated solutions to surgeons for rotator cuff procedures,”
said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “The
HA-based scaffold, together with the instrumentation and fixation
components, provide a seamless, efficient, and elegant rotator cuff
repair solution. While having a strong implant at time zero is
critically important in rotator cuff repairs, the instrumentation
and delivery are just as important, and we believe we have nailed
it. The feedback received after the procedure exceeded our
expectations highlighting the system’s ease of use and strength of
the HA-based scaffold. We believe that Integrity is truly a game
changer for surgeons and their patients and look forward to
extending this exciting technology to other tendon repairs, for
example, in the foot and ankle.”
The Integrity implant itself is a flexible, knitted, HA-based
scaffold that provides improved dry and wet strength and
regenerative capacity over first generation collagen patches1, and
supports regenerative healing through improved cell infiltration1,
tissue remodeling1, and tendon thickening1. In an independent
head-to-head animal study1 comparing Anika’s Integrity system and
the market leading collagen implant, 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 had occurred, forming a new network of tendon tissue.
This resulted in an average repaired tendon thickness nearly three
times greater than with the market-leading collagen device. The
scaffold component of the Integrity system is a porous, knitted,
flexible construct combining Anika’s proprietary HYAFF® fibers with
polyethylene terephthalate (PET) and is designed to support
cell infiltration and regenerative healing. 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. Integrity is fixated using
PEEK bone staples, resorbable PLGA soft tissue tendon tacks or
suture fixation, as desired, at the site of the rotator cuff
repair. The fixation components and instrumentation are delivered
single-use and sterile for added efficiency.
Christopher Baker, MD, of the Florida Orthopaedic Institute
commented, “The hybrid, multifilament structure provides superior
implant handling and strength when compared to collagen-based
products alone. This combination of materials is comprised of 80%
HYAFF, a hyaluronic acid-based material in clinical use for more
than 20 years, and 20% PET fiber, i.e. surgical suture, which also
has a long and established clinical history. The material and
knitted structure result in a compelling blend of strength and
healing that stands out from other products. The suture material
remaining after full resorption of the HYAFF component is less than
30% of the total amount of suture used in a typical double-row
repair. Handling of the implant has met every expectation that I
had for this new device.”
Timothy Codd, MD, of the University of Maryland St. Joseph
Medical Center stated, “Integrity’s instrumentation, delivery and
surgical technique are a game changer. Securing the implant
laterally first helps ensure proper coverage across the repair site
and the rolling deployment tool provides consistent and repeatable
implant placement.”
The U.S. rotator cuff augmentation market is currently over $150
million2 and is estimated to grow 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 launch of Integrity continues Anika’s release
of differentiated products to support shoulder surgeons and a
portfolio built around rotator cuff disease. Integrity, combined
with recent product launches including X-Twist™ Fixation System,
RevoMotion™ Reverse Total Arthroplasty System, and Tactoset®
Injectable Bone Substitute for hardware augmentation, provide a
truly innovative and comprehensive rotator cuff solution portfolio
that is unmatched in the industry. These solutions position Anika
to be a compelling partner for surgeons and facilities when
treating all types of rotator cuff pathologies.
1Data on File 22023 SmartTRAK
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, ARTHROSURFACE, 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 expansion
of Integrity to treat other tendon repairs, 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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