Orthofix Announces The Full Commercial Launch Of The WaveForm L Interbody System For Lateral Lumbar Fusion Procedures

LEWISVILLE, Texas, November 6, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full commercial launch in the U.S. 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.

“Designed to safely and reproducibly treat the spine via indirect decompression and sagittal alignment restoration, the WaveForm L features a large core opening for the placement of bone graft material to optimize bone fusion throughout the body,” said Dr. Donald Blaskiewicz, director of Spinal Malformation at St. Luke’s Boise Medical Center in Boise, Idaho, and faculty at UCSD in San Diego, CA. “The WaveForm L also has enhanced imaging properties to assist with radiographic visualization during intra- 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 With an 80 percent body porosity, WaveForm L provides improved imaging properties and greater graft packability, while the optimized 65 percent endplate porosity of the wave-like structure provides bone ingrowth and early mechanical stability.^3,4,5

“We are committed to delivering a comprehensive portfolio of innovative, procedurally focused products that are strategically designed to work together to drive fusion,” said Kevin Kenny, president of Orthofix Global Spine. “WaveForm L represents the latest developments in patented spinal implant technology, which is designed to address the many nuances of spinal pathology to meet the individual needs of patients, providing both clinical and economic value to patients, surgeons and hospital systems.”

Lateral lumbar interbody fusion (LLIF) procedures represent approximately 20 percent of the interbody device market. The number of these procedures is expected 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 in the US is estimated at over $350 million.⁶

Data available, 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 available, TM-0071-23
Data available, 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 on iData 2022 US 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 an extensive portfolio of biologics, innovative spine hardware, bone growth therapies, specialty orthopedic solutions and a leading surgical navigation system. The products are distributed in approximately 68 countries around the world.

The company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education and manufacturing, and corporate 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. For more information, visit Orthofix.com.

Forward-Looking Statements

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