Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and
orthopedics company, today announced the full commercial launch of
the WaveForm® A interbody for Anterior Lumbar Interbody Fusion
(ALIF) procedures. The WaveForm A interbody seamlessly integrates
with the company’s Meridian ALIF system for treating patients in
need of fusion due to degenerative disc disease. The proprietary
wave-like design of the WaveForm A interbody provides a balance of
strength, porosity and stability, with a large implant graft
aperture for bone graft material to aid in creating an
osteoinductive environment to optimize supplemental fixation
procedures.
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The 3D printed WaveForm A interbody for
ALIF procedures features a proprietary wave-like design that
provides a balance of strength, porosity and stability, with a
large implant graft aperture for bone graft material. (Photo:
Business Wire)
“Implant design and surface technology play a vital role in the
bone growth process during fusion,” said Dr. Neil Arif Tayyab,
orthopaedic spine surgeon at Girard Orthopaedic Surgeons, in San
Diego, CA. “Newer designs such as the WaveForm A interbody can help
stimulate a better bone growth response and give me greater
confidence that the patient will have a successful fusion.”
The Meridian ALIF system is a modular instrument and implant
system designed to help streamline ALIF procedures by providing
diverse fixation options for single and multilevel ALIFs in a
reduced number of trays. Meridian is compatible with both the
WaveForm A interbody and the company’s Reef™ A interbody featuring
its proprietary NanoMetalene® surface technology and Reef
Topography™. With the launch of WaveForm A, the Meridian system can
more completely address the approximately $200 million dollar ALIF
market segment in the U.S.1
The 3D printed WaveForm A implants feature WaveForm® technology,
a repeating and continuous wave-like structure. WaveForm was
created to withstand high compressive loads while delivering an
endplate porosity that maximizes the potential for early
stabilization2,3. This balance of strength to porosity offers
increased opportunity for bone packing, decreased stiffness profile
and enhanced imaging properties.3
“Our Meridian ALIF system integrates the most advanced
technologies into our surgical sets, minimizing the need for
multiple instrument sets during the procedure,” said Kevin Kenny,
President of Global Spine. “The WaveForm A interbody is an exciting
addition to our portfolio of solutions for ALIF procedures and
enables us to provide a more streamlined option so surgeons can do
more for their patients.”
Advancing Care with ALIF
The ALIF market can be segmented by material into non-3D printed
metal, PEEK (standard and titanium-based advanced surface
technologies), 3D printed metal, and machined bone markets. It is
estimated that more than half of the U.S. ALIF interbody market
today is addressed by PEEK devices. Due to their clinical
advantages, 3D printed and advanced surface technologies-based
interbody devices are expected to grow faster than the overall
interbody market in upcoming years as they take market share from
PEEK devices, ultimately leading to a larger market share than
standard PEEK.4
The WaveForm A interbody and the Meridian ALIF system are
available in the U.S. Learn more about the Company’s interbody
systems here.
1Market research on file. Based off iData Research Inc. 2021
numbers. 2Kelly, Cambre N., et al. "Design and structure–function
characterization of 3D printed synthetic porous biomaterials for
tissue engineering." Advanced healthcare materials 7.7 (2018):
1701095. 3O. Al-Ketan, R. Rowshan, R.K. Abu Al-Rub,
Topology-mechanical property relationship of 3D printed strut,
skeletal, and sheet based periodic metallic cellular materials,
Addit. Manuf. 19 (2018) 167-183. 4Data on file.
About Orthofix
The newly merged Orthofix-SeaSpine organization is a leading
global spine and orthopedics company with a comprehensive portfolio
of biologics, innovative spinal hardware, bone growth therapies,
specialized orthopedic solutions and a leading surgical navigation
system. Its products are distributed in more than 68 countries
worldwide.
The Company is headquartered in Lewisville, Texas and has
primary offices in Carlsbad, CA, with a focus on spine and
biologics product innovation and surgeon education, and Verona,
Italy, with an emphasis on product innovation, production, and
medical education for orthopedics. The combined company’s global
R&D, commercial and manufacturing footprint also includes
facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale,
CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany,
Paris, France, and São Paulo, Brazil.
Forward-Looking Statements
This news release may include forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, and Section 27A of the Securities Act of 1933, as
amended. In some cases, you can identify forward-looking statements
by terminology such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “projects,” “intends,”
“predicts,” “potential,” “continue” or other comparable
terminology. Orthofix cautions you that statements included in this
news release that are not a description of historical facts are
forward-looking statements that are based on the Company’s current
expectations and assumptions. Each forward-looking statement
contained in this news release is subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statement. Applicable risks
and uncertainties include, among others: the ability of newly
launched products to perform as designed and intended and to meet
the needs of surgeons and patients, including as a result of the
lack of robust clinical validation; and the risks identified under
the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, which was
filed with the Securities and Exchange Commission (SEC) on March 6,
2023. The Company’s public filings with the Securities and Exchange
Commission are available at www.sec.gov. You are cautioned not to
place undue reliance on forward-looking statements, which speak
only as of the date when made. Orthofix does not intend to revise
or update any forward-looking statement set forth in this news
release to reflect events or circumstances arising after the date
hereof, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230619449429/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529
Investor Relations Louisa Smith, Gilmartin Group
IR@orthofix.com
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