NuVasive Receives Latest CE Mark Approval for Pulse Platform and Starts Global Clinical Evaluations

Rhea-AI Summary

NuVasive (NASDAQ: NUVA) announced CE Mark approval for its Pulse^® platform, marking a significant step in commercialization. This approval allows clinical evaluations in multiple European countries ahead of a global launch planned for later this summer. The Pulse platform integrates various surgical technologies to enhance safety and efficiency in spine surgery. NuVasive aims to leverage this technology in all spine procedures, with demonstrations scheduled at industry events in July 2021.

Positive

• CE Mark approval for the Pulse platform enhances commercialization opportunities.
• Clinical evaluations commence across several European countries.
• Pulse integrates multiple technologies, improving safety and efficiency in spine surgery.
• Expected global launch of Pulse later this summer.

Negative

• None.

SAN DIEGO, June 30, 2021 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, announced today that the Pulse^® platform received CE Mark approval for its latest design update and clinical evaluations are underway in multiple countries throughout Europe.

"The latest CE Mark approval and clinical evaluations are key commercialization milestones for the Pulse platform and further our plan for an expanded global launch later this summer," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. "There is a substantial opportunity for enabling technology adoption in spine surgery, and we are leveraging our expertise in proceduralization to introduce Pulse. This next generation of enabling technology has applications that can be utilized in every spine procedure."

Pulse is a first-of-its-kind technology that integrates radiation reduction,¹ imaging enhancement, rod bending, navigation, intraoperative neuromonitoring, and spinal alignment tools into a single platform. It is currently the only enabling technology platform with the ability for utilization in 100% of spine procedures² and throughout the entire operating room (OR) workflow, allowing surgeons to easily access multiple technologies from a condensed footprint. Pulse is designed to increase safety, efficiency, and procedural reproducibility, while addressing some of the most common clinical challenges in spine surgery.

"In running a comprehensive spine program, I treat patients with a variety of complex spine pathologies and Pulse has utility in every surgical case," said Dr. Jacques Müller-Broich, head of the spine specialty center and spinal orthopedics at University Hospital in Frankfurt, Germany. "The integration of C-arm image stitching and spinal alignment tools provide the ability to measure and correct alignment in real time—something I could not do with prior technologies. I am impressed by the results I am experiencing with Pulse and look forward to continue using this innovative platform in the OR."

Next month, NuVasive will feature the Pulse platform at the following industry events in San Diego:

• Korean American Spine Society (July 1-3, 2021): Visit booth #1 for a demonstration of Pulse and its procedural workflow with X360^®. On July 2, Dr. Stephen Ryu will lead an exclusive Pulse lab at the NuVasive West Coast Experience Center to demonstrate the platform's capabilities and integration with NuVasive's procedural offerings.
• 37^th Annual Meeting of the Section on Disorders of the Spine and Peripheral Nerves (July 28-31, 2021): NuVasive will feature the Pulse platform, X360, and the Simplify^® Cervical Artificial Disc at booth #301. The Company will participate in a special course titled "Novel and Emerging Technologies in Spine Surgery" with leading spine surgeons on July 28 at 1:30 p.m. PT, pre-registration is required. This session will discuss the latest technological advances in spine surgery and include a live demonstration of Pulse.

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.

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¹ Wang TY, Farber SH, Perkins SS, et al. Internally randomized control trial of radiation exposure using ultra-low radiation imaging versus traditional C-arm fluoroscopy for patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion. Spine 2017;42(4);217-23.
² The Pulse platform can be used in every procedure; however, not all modalities are cleared for every procedure. Refer to Pulse system instructions for use.

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SOURCE NuVasive, Inc.

FAQ

What is the significance of the CE Mark approval for NUVA's Pulse platform?

The CE Mark approval signifies that NuVasive's Pulse platform meets European safety and efficacy standards, paving the way for commercialization and clinical evaluations.

When will NuVasive launch the Pulse platform globally?

NuVasive plans for a global launch of the Pulse platform later this summer following its CE Mark approval.

What technologies are integrated into the Pulse platform?

The Pulse platform integrates radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring, and spinal alignment tools.

Where is NuVasive conducting clinical evaluations for the Pulse platform?

Clinical evaluations for the Pulse platform are underway in multiple countries throughout Europe.