Clinical Study Validates NuVasive Porous Interbody Implant and Synthetic Bone Graft Substitute as Cost-effective Solution for Lateral Lumbar Interbody Fusions

Spine surgeons validated clinical and economic benefits of an entirely synthetic solution in lateral lumbar fusions

SAN DIEGO, July 26, 2022 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the results of the study "Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion?" in the Journal of Neurosurgery: Spine. The study validates entirely synthetic solutions featuring porous interbody implants and bone graft substitute having clinical and economic advantages versus traditional, non-porous interbody implants with premium-priced biologics.

"Having clinically-backed Advanced Materials Science options, from synthetic biologics to porous interbody implants, gives surgeons stronger procedural offerings across the entire spine," said Massimo Calafiore, Chief Commercial Officer at NuVasive. "NuVasive leads with a focus on disruptive innovation—providing not only procedures that are better clinically for both patients and surgeons, but also less expensive for the hospitals we partner with."

The multi-center, retrospective study consisted of 90 patients who underwent lateral lumbar interbody fusions with the combination of a synthetic bone graft substitute, Attrax^® Putty, and a porous titanium interbody implant, Modulus^® XLIF^®. The study found that the use of synthetic biologics and interbody implants with advanced surface technologies resulted in a high rate of effective fusion on CT imaging at 12 months with complete bone bridging in 97.8% of patients, despite the use of a small volume of lower-cost biological material.¹ Often, surgeons rely on premium-priced biologics like recombinant human bone morphogenetic protein-2 (rhBMP-2) to support bone through-growth during a patient's recovery phase.

Attrax Putty is the first and only synthetic bone graft with U.S. Food and Drug Administration indications for thoracolumbar interbody fusion and is also a relatively inexpensive biologic option.¹ Modulus XLIF, part of the Advanced Materials Science^® portfolio, provides a fully porous architecture and favorable environment for bone in-growth,² supporting the less invasive XLIF procedure that is designed to be clinically and economically beneficial.

"I am excited to see outcomes that have been traditionally associated with BMP achieved with cost-effective biologics used in porous interbody cage technology," said Robert Eastlack, M.D., orthopedic spine surgeon at Scripps Health in San Diego and board member of the San Diego Spine Foundation. "The results of this study have created lasting change in our practices, presented huge cost savings and showed significant benefits to the patients."

The results of this study build upon the extensive clinical evidence validating Modulus interbody technology, Attrax Putty and the broader X360 portfolio. Studies show that:

• 90 patients treated at 136 thoracolumbar levels with Modulus XLIF and Attrax Putty showed high rates of success and low rates of complications.¹
• In the only Level I randomized controlled trial of a synthetic bone graft substitute in instrumented posterolateral fusion, Attrax Putty demonstrated non-inferiority to autograft.³
• When used in combination with single-position surgery, Modulus XLIF and Attrax Putty could substantially improve perioperative economics to the hospital through decreased operative time, while meeting postoperative alignment and clinical outcome goals.^4-7

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons and hospitals, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products, the Company's ability to adequately manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.  

¹ Malone H, Mundis Jr., GM, Collier, M, et al. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? J Neurosurg Spine. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070.
² Fogel G, Martin N, Lynch K, et al. Subsidence and fusion performance of a 3D-printed porous interbody cage with stress-optimized body lattice and microporous endplates - a comprehensive mechanical and biological analysis. Spine J 2022;22:1028-37.
³ Lehr AM, Oner FC, Delawi D, et al. Efficacy of a Standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. Spine 2020;45(14):944-51.
⁴ Blizzard DJ, Thomas JA. MIS Single-position lateral and oblique lateral lumbar interbody fusion and bilateral pedicle screw fixation: feasibility and perioperative results. Spine 2017 Jul 12. [Epub ahead of print]
⁵ Rhee JW, Petteys RJ, Anaizi AN, et al. Prospective evaluation of 1-year outcomes in single-level percutaneous lumbar trans facet screw fixation in the lateral decubitus position following lateral trans psoas interbody fusion. Eur Spine J 2015;24(11):2546-54.
⁶ Thomas JA. Single-position lateral lumbar interbody fusion and percutaneous pedicle screw fixation allows for adequate correction of spinal sagittal imbalance. Paper presented at Society for Minimally Invasive Spine Surgery (SMISS) 2016 Annual Forum. Las Vegas, NV, USA.
⁷ Voyadzis JM, Anaizi AN. Minimally invasive lumbar trans facet screw fixation in the lateral decubitus position after extreme lateral interbody fusion: a technique and feasibility study. J Spinal Disord Tech 2013;26(2):98-106.

SOURCE NuVasive, Inc.

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