NuVasive Receives Latest FDA 510(k) Clearance for Pulse Platform and Announces Commercial Launch

SAN DIEGO, July 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 it received its latest U.S. Food and Drug Administration 510(k) clearance for the Pulse® platform, after receiving CE certification earlier this summer. In addition, the Company announced the commercial launch of Pulse which is now available for sale in targeted global regions.

Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8924251-nuvasive-pulse-fda-clearance-and-launch/

Pulse is an integrated technology platform designed to increase safety, efficiency, and procedural reproducibility of spine surgery. The platform allows surgeons to easily access multiple technologies from a condensed footprint and address some of the most common surgical challenges. It is currently the only enabling technology platform with the ability for utilization in 100% of spine procedures.¹ 

"The Pulse platform launch is an incredible milestone for NuVasive and will help lead the digital transformation of spine surgery. Surgeons are now able to seamlessly work with various technologies to address more clinical challenges in surgery from a single platform—something they could not do before Pulse," said J. Christopher Barry, chief executive officer of NuVasive. "This is the culmination of years of research and development to deliver a platform that helps improve clinical, financial, and operational outcomes. Like we did with XLIF, Pulse is a disruptive technology that has the ability to transform not only the trajectory of NuVasive but the future of spine care for patients."

Benefits for patients, surgeons, and hospitals
The availability and integration of multiple applications in Pulse helps surgeons adopt less invasive and more advanced surgical procedures—which provide benefits to the patient, surgeon, and hospital. The benefits of less invasive surgery are supported by extensive clinical evidence, and include:

• Reduced operating room (OR) time by up to 60 minutes,²
• Savings of nearly $5,000 per patient in hospital costs,^3,4
• Reduced time under anesthesia and lower intraoperative risks,⁵ and
• Reduced length of stay in the hospital.⁶

"This first-of-its-kind platform supports all spine procedure types—from open to less invasive techniques. Pulse is one of the most versatile tools in the spine OR, and the integration of multiple technologies in one platform enhances a surgeon's capabilities to make better, more informed clinical decisions for their patients," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. "I want to thank our NuVasive team and the many surgeons who helped bring Pulse to market and enable better spine surgery."

An integrated technology platform to enable better spine surgery
Pulse integrates multiple technologies into one platform, and its extensible architecture can support future applications, including robotics and smart tools.⁷ Currently, the platform includes:

• Radiation reduction and imaging enhancement: NuVasive's Lessray® technology was designed to increase OR efficiency through streamlined imaging workflow, while also significantly reducing exposure to radiation for everyone in the room.[8] Pulse supports numerous imaging systems, but offers enhanced integration with Siemens' cutting-edge 3D mobile C-arm—the Cios Spin®.
• Navigation: Pulse introduces a procedurally integrated navigation technology that offers the potential to improve screw placement accuracy and minimize radiation.
• Neuromonitoring: This application provides proprietary automated nerve detection with standardized setup and clinically validated alerts[9] to help reduce variability and allow for faster interpretation of neural information.
• Global alignment: NuVasive's Integrated Global Alignment (iGA®) technology offers surgical planning and intraoperative assessment tools to help surgeons correct or restore spinal alignment. Surgeons can later follow up postoperatively to assess the results of the procedure.
• Patient-specific rod bending: NuVasive's spinal rod bending technology, Bendini®, is used to create patient-specific rods that are bent to implant locations. Bendini expedites manual rod manipulation through computer-assisted bend instructions.
• Wireless connectivity: This tool allows seamless connectivity and control of the Pulse platform from all members of the surgical team in the OR—from the surgeon to the C-arm technologist to support staff.

Learn more about Pulse
To learn more about the Pulse platform, visit NuVasive on our website or at upcoming industry events:

• NuVasive's first virtual Innovation Event—click to watch
• 37^th Annual Meeting of the Section on Disorders of the Spine and Peripheral Nerves (July 28-31)
• 2021 American Association of Neurological Surgeons Annual Scientific Meeting (August 21-25)
• Scoliosis Research Society 56^th Annual Meeting (September 22-25)

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.

¹The Pulse platform can be used in every spine procedure; however, not all modalities are cleared for every spine procedure. Refer to Pulse system instructions for use.
²Macario A. What does one minute of operating room time cost? J Clin Anesth 2010;22(4):233-6.
³Shippert RD. A study of time-dependent operating room fees and how to save $100,000 by using time-saving products. Am J Cosmet Surg 2005;22(1):25-34.
⁴Olsen MA, Mayfield J, Lauryssen C, et al. Risk factors for surgical site infection in spinal surgery. J Neurosurg 2003;98(2):149-55.24.
⁵Olsen MA, Nepple JJ, Riew KD, et al. Risk factors for surgical site infection following orthopaedic spinal operations. J Bone Joint Surg Am 2008;90(1):62-9.
⁶Lucio JC, VanConia RB, DeLuzio KJ, et al. Economics of less invasive spinal surgery: an analysis of hospital cost differences between open and minimally invasive instrumented spinal fusion procedures during the perioperative period. Risk Manag Healthc Policy 2012;5:65-74.
⁷Robotics and smart tools are not cleared for use by the FDA.
⁸Wang 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.
⁹Tohmeh AG, Rodgers WB, Peterson MD. Dynamically evoked, discrete-threshold electromyography in the extreme lateral interbody fusion approach. J Neurosurg Spine 2011;14(1):31-7.

View original content:https://www.prnewswire.com/news-releases/nuvasive-receives-latest-fda-510k-clearance-for-pulse-platform-and-announces-commercial-launch-301344986.html

SOURCE NuVasive, Inc.