Orthofix Announces 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 number one world spine and orthopedics firm, right now introduced the complete U.S. business launch of the WaveForm^®L Lateral Lumbar Interbody System. Designed for lateral lumbar interbody fusion (LLIF) procedures, the 3D-printed WaveForm L encompasses a porous construction that prioritizes energy and stability to supply a strong fusion setting.

“Designed to deal with the spine safely and reproducibly by oblique decompression and sagittal alignment restoration, the WaveForm L options a big core aperture for the location of bone graft materials to optimize bony fusion all through the interbody,” stated Dr. Donald Blaskiewicz, Director of Spinal Deformity at St. Luke’s Boise Medical Middle in Boise, Idaho, and college at UCSD in San Diego, CA. “The WaveForm L additionally has improved imaging traits to help in radiographic visualization throughout intraoperative and postoperative imaging. These mixed options make it the most effective 3D-printed interbodies accessible.”

WaveForm interbodies are uniquely created with a major give attention to construction, floor and stability. Constructed from a repeating wave-like construction, WaveForm L is designed to effectively distribute compressive masses and supply excessive porosity for optimized stiffness with out compromising energy.^1,2 At 80 % physique porosity, WaveForm L gives enhanced imaging traits and elevated graft packability, whereas the optimized 65 % endplate porosity of the wave-like construction gives for boney ingrowth and early mechanical stability.^3,4,5

“We’re devoted to offering a complete portfolio of progressive, procedurally-focused merchandise strategically designed to work collectively to drive fusion,” stated Kevin Kenny, President of Orthofix International Backbone. “WaveForm L represents the newest developments in proprietary spinal implant know-how engineered to handle the various nuances of spinal pathology to satisfy particular person affected person wants, delivering each scientific and financial worth to sufferers, surgeons and hospital techniques.”

Lateral lumbar interbody fusion (LLIF) procedures make up roughly 20 % of the interbody system market. The variety of these procedures are projected to proceed to extend primarily based on the speedy development of titanium-coated PEEK gadgets and 3D-printed steel gadgets. In response to 2022 information, the LLIF market is estimated to be greater than $350 million within the U.S.⁶

Information on file, TM-0043-22
Kelly, Cambre N., et al. “Design and construction–perform characterization of 3D printed artificial porous biomaterials for tissue engineering.” Superior healthcare supplies 7.7 (2018): 1701095.
Information on file, TM-0071-23
Information on file, D0006845
Kelly, C. N., Wang, T., Crowley, J., Wills, D., Pelletier, M. H., Westrick, E. R., Adams, S. B., Gall, Ok., & Walsh, W. R. (2021). Excessive-strength, porous additively manufactured implants with optimized mechanical osseointegration. Biomaterials, 279, 121206. https://doi.org/10.1016/j.biomaterials.2021.121206
Information on file. Market estimates primarily based off iData 2022 U.S. Market Report Suite for Spinal Impants and MIS.

About Orthofix

Orthofix and SeaSpine merged in January 2023 to type a number one world spine and orthopedics firm with a complete portfolio of biologics, progressive spinal {hardware}, bone development therapies, specialised orthopedic options and a number one surgical navigation system. Its merchandise are distributed in roughly 68 nations worldwide.

The Firm is headquartered in Lewisville, Texas, the place it conducts basic enterprise, product improvement, medical training and manufacturing, and has major places of work in Carlsbad, CA, with a give attention to spine and biologics product innovation and surgeon training, and Verona, Italy, with an emphasis on product innovation, manufacturing, and medical training for orthopedics. The mixed firm’s world R&D, business and manufacturing footprint additionally consists of services and places of work in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Department, MS, Maidenhead, UK, Munich, Germany, Paris, France, and São Paulo, Brazil. To study extra, go to Orthofix.com.

Ahead-Trying Statements

This information launch could embrace forward-looking statements inside the which means of Part 21E of the Securities Trade Act of 1934, as amended, and Part 27A of the Securities Act of 1933, as amended. In some circumstances, you possibly can determine forward-looking statements by terminology akin to “could,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “tasks,” “intends,” “predicts,” “potential,” “proceed” or different comparable terminology. Orthofix cautions you that statements included on this information launch that aren’t an outline of historic info are forward-looking statements which might be primarily based on the Firm’s present expectations and assumptions. Every forward-looking assertion contained on this information launch is topic to dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied by such assertion. Relevant dangers and uncertainties embrace, amongst others: the power of newly launched merchandise to carry out as designed and meant and to satisfy the wants of surgeons and sufferers, together with because of the dearth of sturdy scientific validation; and the dangers recognized underneath the heading “Danger Components” in Orthofix Medical Inc.’s Annual Report on Kind 10-Ok for the fiscal 12 months ended December 31, 2022, which was filed with the Securities and Trade Fee (SEC) on March 6, 2023. The Firm’s public filings with the Securities and Trade Fee can be found at www.sec.gov. You’re cautioned to not place undue reliance on forward-looking statements, which communicate solely as of the date when made. Orthofix doesn’t intend to revise or replace any forward-looking assertion set forth on this information launch to replicate occasions or circumstances arising after the date hereof, besides as could also be required by legislation.