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

LEWISVILLE, TEXAS — November 6, 2023 — 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.

“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.