Orthofix Announces Full Commercial Launch of the WaveForm L Interbody System for Lateral Lumbar Fusion Procedures
06 Novembre 2023 - 1:00PM
Business Wire
Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and
orthopedics company, today announced the full U.S. commercial
launch of the WaveForm® L Lateral Lumbar Interbody System. Designed
for lateral lumbar interbody fusion (LLIF) procedures, the
3D-printed WaveForm L features a porous structure that prioritizes
strength and stability to provide a robust fusion environment.
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The WaveForm® L Lateral Lumbar Interbody
System is designed for lateral lumbar interbody fusion (LLIF)
procedures. The 3D-printed WaveForm L features a porous structure
that prioritizes strength and stability to provide a robust fusion
environment. (Photo: Business Wire)
“Designed to treat the spine safely and reproducibly through
indirect decompression and sagittal alignment restoration, the
WaveForm L features a large core aperture for the placement of bone
graft material to optimize bony fusion throughout the interbody,”
said Dr. Donald Blaskiewicz, Director of Spinal Deformity at St.
Luke’s Boise Medical Center in Boise, Idaho, and faculty at UCSD in
San Diego, CA. “The WaveForm L also has improved imaging
characteristics to aid in radiographic visualization during
intraoperative and postoperative imaging. These combined features
make it one of the best 3D-printed interbodies available.”
WaveForm interbodies are uniquely created with a primary focus
on structure, surface and stability. Constructed from a repeating
wave-like structure, WaveForm L is designed to efficiently
distribute compressive loads and provide high porosity for
optimized stiffness without compromising strength.1,2 At 80 percent
body porosity, WaveForm L provides enhanced imaging characteristics
and increased graft packability, while the optimized 65 percent
endplate porosity of the wave-like structure provides for boney
ingrowth and early mechanical stability.3,4,5
“We are dedicated to providing a comprehensive portfolio of
innovative, procedurally-focused products strategically designed to
work together to drive fusion,” said Kevin Kenny, President of
Orthofix Global Spine. “WaveForm L represents the latest
advancements in proprietary spinal implant technology engineered to
address the many nuances of spinal pathology to meet individual
patient needs, delivering both clinical and economic value to
patients, surgeons and hospital systems.”
Lateral lumbar interbody fusion (LLIF) procedures make up
approximately 20 percent of the interbody device market. The number
of these procedures are projected to continue to increase based on
the rapid growth of titanium-coated PEEK devices and 3D-printed
metal devices. According to 2022 data, the LLIF market is estimated
to be more than $350 million in the U.S.6
- Data on file, TM-0043-22
- Kelly, 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.
- Data on file, TM-0071-23
- Data on file, D0006845
- Kelly, C. N., Wang, T., Crowley, J., Wills, D., Pelletier, M.
H., Westrick, E. R., Adams, S. B., Gall, K., & Walsh, W. R.
(2021). High-strength, porous additively manufactured implants with
optimized mechanical osseointegration. Biomaterials, 279, 121206.
https://doi.org/10.1016/j.biomaterials.2021.121206
- Data on file. Market estimates based off iData 2022 U.S. Market
Report Suite for Spinal Impants and MIS.
About Orthofix
Orthofix and SeaSpine merged in January 2023 to form 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 approximately 68 countries
worldwide.
The Company is headquartered in Lewisville, Texas, where it
conducts general business, product development, medical education
and manufacturing, 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. To learn more, visit Orthofix.com.
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/20231106564293/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529
Investor Relations Louisa Smith, Gilmartin Group
IR@orthofix.com
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