NuVasive's Simplify Disc Receives FDA Approval for Two-Level Cervical Total Disc Replacement

Rhea-AI Summary

NuVasive, Inc. (NASDAQ: NUVA) announced FDA approval for its Simplify® Cervical Artificial Disc for two-level cervical total disc replacement (cTDR). This landmark approval enhances the growing NuVasive C360 portfolio and signifies strong market potential due to its clinical superiority over traditional anterior cervical discectomy and fusion (ACDF) procedures, with nearly 10% higher overall success rates noted. The Simplify Disc’s innovative design promotes improved patient outcomes and is set to be showcased at the upcoming ISASS Annual Conference.

Positive

• FDA approval for Simplify Disc expands the C360 portfolio.
• Demonstrated clinical superiority over ACDF with nearly 10% higher success rates.
• Increased patient outcomes due to advanced design features.

Negative

• None.

SAN DIEGO, April 6, 2021 /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 NuVasive Simplify^® Cervical Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR).

"This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfolio," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. "There is immense surgeon excitement for this latest edition to our cervical offering, and the expanded two-level indication provides greater opportunities to bring the most clinically effective technology in the cTDR market to more patients."

The Simplify Disc demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level FDA Investigational Device Exemption (IDE) study.¹ In this study, the device proved an overall success rate that was nearly 10% higher when compared to ACDF.¹ Additionally, a greater percentage of patients achieved success in a 15-point Neck Disability Index (NDI) and had no neurological deterioration components in relation to fusion.¹ Overall, the Simplify Disc demonstrates clinical superiority to ACDF¹ and has the highest overall clinical success rate compared to any other approved cervical disc at both one- and two-levels.² It is one of three devices approved for use in two-level cTDR procedures.

"The field of spinal arthroplasty continues to evolve and the Simplify Disc's two-level FDA approval represents another significant milestone in improving the standard of patient care in spine," said Domagoj Coric, M.D., chief of neurosurgery at Atrium Health Carolinas Medical Center in Charlotte, North Carolina. "The Simplify Disc's clinical superiority to ACDF, coupled with its unique design properties, makes it an important tool in how spine surgeons treat cervical radiculopathy."

The Simplify Disc is part of the NuVasive C360™ portfolio, which offers comprehensive, procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion, and cTDR procedures. The device is designed with key performance functions, including:

• Radiologic Design: The disc, uniquely comprised of PEEK on ceramic materials, allows for enhanced visualization through MRI postoperatively compared to alternative devices, a key imaging modality in spine;
• Anatomic Disc Heights: The Simplify Disc is anatomically designed and includes 4mm, 5mm, and 6mm options. The 4mm disc, the lowest disc height in the market,² closely matches the native disc height of a wide range of patients; and
• Physiologic Motion: The proprietary disc design provides unique articulation which allows for a variable center of rotation for each treated level and is designed to closely mimic the motion dynamics of a natural spine segment. The Simplify Disc has the highest NDI success rate compared to any other approved two-level cervical disc.²

NuVasive will feature the Simplify Disc at the upcoming International Society for the Advancement of Spine Surgery (ISASS) 21^st Annual Conference in Miami, Fla. This includes a discussion of the device in a technology session focused on the cervical spine on Thursday, May 13, 2021. In addition, the results of the Simplify Disc's one-level, 24-month, multi-center FDA IDE trial will be shared in a podium presentation on Friday, May 14, 2021.

About NuVasive
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 has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
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 Simplify Cervical Artificial Disc – P200022
² Data on file. Based on review of publicly available materials at the time of this release.

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SOURCE NuVasive, Inc.

FAQ

What is the significance of the FDA approval for NUVA's Simplify Disc?

The FDA approval for the Simplify Disc allows for its use in two-level cervical total disc replacement, expanding NuVasive's market offerings and enhancing treatment options for patients.

How does the Simplify Disc compare to anterior cervical discectomy and fusion procedures?

Clinical studies show the Simplify Disc has nearly 10% higher success rates than traditional ACDF procedures, indicating superior patient outcomes.

What are the key features of the Simplify Disc?

The Simplify Disc features enhanced visualization through MRI, customizable disc heights, and a design that mimics natural spine motion, all contributing to its clinical effectiveness.

When will the Simplify Disc be presented at a conference?

NuVasive will showcase the Simplify Disc at the ISASS 21st Annual Conference, with discussions and presentations scheduled for May 13-14, 2021.