Orthofix Announces Full Commercial Launch of the WaveForm L Interbody System for Lateral Lumbar Fusion Procedures

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

1. Data on file, TM-0043-22
2. 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.
3. Data on file, TM-0071-23
4. Data on file, D0006845
5. 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
6. 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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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.