Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint
preservation company focused on early intervention orthopedics,
today announced that it has completed enrollment of the pivotal
Phase III clinical study for Hyalofast (Hyalofast 15-01) on its
path to achieving FDA approval in the United States.
Hyalofast is a highly differentiated, single-stage, bone
preserving, hyaluronic acid (HA) matrix and its approval would
immediately position Anika as a leader in the regenerative knee
cartilage repair market, which is growing at a 5-year CAGR of 11%
and is expected to reach in excess of $350 million by 20251. Unlike
the current standard of care which requires two surgeries, removal
of autologous cartilage, cell expansion, and subsequent cell
reimplantation at the diseased site, or an alternative product that
requires removing healthy bone to accommodate an implant, Hyalofast
is implanted in just a single surgery following debridement of only
the diseased tissue. In addition to reducing the burden on patients
and the healthcare system, Hyalofast is stocked at the surgical
facility and can simply be pulled off the shelf during surgery when
a cartilage lesion is identified.
“This is an important milestone for Anika, bringing us one step
closer to making Hyalofast available for patients in the United
States,” said Anika’s President and CEO, Cheryl R. Blanchard,
Ph.D. “The knee cartilage repair market in the U.S. is large and
growing and is perfectly aligned with our strategic focus as we
continue to introduce groundbreaking regenerative solutions that
expand our Joint Preservation and Restoration portfolio. We believe
that Hyalofast will drive significant market expansion and further
accelerate our company’s growth in the coming years. We are pleased
that FDA has granted Hyalofast Breakthrough Device Designation and
has agreed to a modular PMA filing, both of which will facilitate
an efficient review process.”
Hyalofast is already marketed in more than 35 countries outside
the U.S. and is truly a game changing treatment for patients with
pain and decreased function caused by cartilage lesions. The U.S.
cartilage repair market has been constrained by the need for
surgeons to perform, and patients to endure, a second surgical
procedure in order to use the product on the market today. The
off-the-shelf, bone-preserving design of Hyalofast allows surgeons
to quickly repair lesions intraoperatively, without the need for a
second costly, invasive surgery.
FDA has granted Anika Breakthrough Device Designation for the
Hyalofast plus autologous bone marrow aspirate concentrate (BMAC)
combination product. The Breakthrough Device Program is a voluntary
program for certain medical devices that are aimed at providing
more effective treatment of life-threatening or irreversibly
debilitating diseases or conditions. It offers Anika the
opportunity to engage with FDA on a prioritized basis to
efficiently address topics as they arise during the premarket
review phase, ultimately enabling patients’ faster access to new
therapies.
The Company has also obtained agreement from FDA to file a
modular PMA submission and expects to file the first module of the
application in 2024. This allows Anika to file product and
manufacturing information while continuing to collect and analyze
clinical data, making the regulatory review process more efficient.
The final module with clinical data is expected to be filed in
2025.
In the U.S., Hyalofast would join Tactoset® Injectable Bone
Substitute in Anika’s regenerative portfolio, as well as other
products in the regenerative pipeline including the HA-based,
arthroscopic patch system. Tactoset is an HA and calcium phosphate
based, biocompatible bone graft substitute that is highly flowable,
easily injectable, settable, and interdigitates into the trabecular
bone architecture with improved handling characteristics compared
to other competitive products. While widely used to treat
insufficiency fractures, it is also indicated for use with the
augmentation of hardware, such as suture anchors.
About Hyalofast
Hyalofast is a biodegradable, resorbable, non-woven scaffold
composed of HYAFF® fibers. HYAFF is Anika’s proprietary solid
form of HA, composed of a benzyl ester of hyaluronic acid. It is
intended as support for the entrapment of mesenchymal stem cells
obtained from autologous bone marrow aspirate concentrate (BMAC)
for the repair of chondral and osteochondral lesions. Hyalofast is
implanted into a cartilage lesion with BMAC and fills the defect
until it is eventually resorbed and replaced by new, hyaline like
cartilage that integrates with the surrounding tissues. Hyalofast
allows for the repair of both chondral and osteochondral lesions
without removing healthy subchondral bone.
Outside the U.S., Hyalofast has been clinically demonstrated to
be safe and effective in medium to long term follow up in the
repair of ankle and knee chondral and osteochondral lesions. Over
40 Hyalofast clinical publications representing greater than 10
years of clinical data show that patients consistently report
reduction in pain and improvement in function of the affected
joint, thus enabling return to their active lifestyle with
substantial pain relief and high satisfaction2. Hyalofast has also
demonstrated a strong safety profile since being placed on the
market outside the U.S. in 2009.
The Hyalofast Phase III 15-01 Study Design
The Hyalofast 15-01 study is a prospective, randomized, active
treatment-controlled, evaluator-blinded multicenter study to
establish the superiority of Hyalofast with autologous bone marrow
aspirate concentrate (BMAC) in the treatment of articular knee
cartilage defect lesions in comparison to microfracture as a
control. The current enrolled study involves 200 subjects
randomized 1:1 versus microfracture with co-primary endpoints being
the % change in KOOS Pain Score from baseline to two years and %
change in IKDC Subjective from baseline to two years. The study,
which began in 2015, was significantly delayed due to the impact
COVID had on new site initiation and elective surgical procedures.
Hyalofast plus BMAC is a device-biologic combination product that
will be subject to a premarket approval application (PMA) under the
jurisdiction of FDA’s Center for Biologics Evaluation and Research
(CBER).
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, HYALOFAST, TACTOSET and the
Anika logo are trademarks of Anika Therapeutics, Inc. or its
subsidiaries or are licensed for use to Anika.
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 the
planned premarket approval filing of Hyalofast with the FDA, the
timing and potential for FDA approval of Hyalofast, the future
commercialization of Hyalofast, the size of or ability for Anika to
compete in the cartilage repair market, and the potential impact to
the growth rate of Anika if and when Hyalofast is approved for sale
in the U.S. 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.
1 SmartTRAK and Anika estimates2 Gobbi A et al. Long-term
Clinical Outcomes of One-Stage Cartilage Repair in the Knee with
Hyaluronic Acid-Based Scaffold Embedded with Mesenchymal Stem Cells
Sourced From Bone Marrow Aspirate Concentrate. Am J Sports
Med. 2019 May 16; Additional data on file.
For Investor Inquiries:
Mark NamaroffAnika Therapeutics, Inc.Vice President, Investor
Relations, ESG and Corporate CommunicationsDirect:
781-457-9287mnamaroff@anika.com
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