Initial Pulse Alpha Trial Results Show Extensive Clinical Utility in Nearly all Spine Surgery Cases and Workflow Efficiencies Intended to Reduce Operating Room Time for Surgeon and Patient
SAN DIEGO – September 25, 2018 – NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that live demonstrations of the PulseTM surgical automation platform with integration of the Siemens Healthineers’ Cios Spin* cutting-edge mobile 3D-imaging will be held throughout the North American Spine Society (NASS) 2018 Annual Meeting, September 26-29, 2018.
Upon commercial availability, the Pulse platform will incorporate NuVasive’s neuromonitoring system, NuvaMap® OR surgical planning, rod bending, smart imaging, new 2D- and 3D-navigation, and automation. In addition, Pulse’s wireless connectivity capability effectively creates a hub allowing everyone in the operating room (OR) to access the same information and independently execute various tasks. This enables optimal coordination and information alignment across the OR, and helps drive a more predictable, reproducible surgical experience for the surgeon and their patients. The Pulse all-in-one hardware and software platform will be available for pre-order at the NASS meeting, with anticipated U.S. commercial availability in the second quarter of 2019.
Alpha trial update
Initial Pulse alpha trial results confirm the wide clinical utility of the technology with surgeons leveraging the integrated platform in nearly 100 percent of spinal cases, from general fusion to deformity correction surgeries. In addition, trialing surgeons have reported significant applicability of the platform throughout the entire surgery—gaining surgical efficiencies via real-time feedback to aid in clinical decision making and optimizing OR procedural workflow.
“Pulse’s integrated tools allow for powerful synergies not possible with standalone solutions. This unified ecosystem allows tools that are time-consuming to implement—and therefore, have limited utility—to be used in a much wider variety of cases,” said Dr. Stephen Ryu, neurosurgeon at the Palo Alto Medical Foundation and consulting professor of Electrical Engineering at Stanford University. “Pulse naturally results in a more efficient workflow and is the only ubiquitous, all-in-one, modular technology platform for today’s spine operating room.”
These results positively reaffirm the Company’s strategy behind the Surgical IntelligenceTM ecosystem and in building a roadmap of integrated, modular technologies to deliver safer, faster and smarter surgery.
* Cios Spin from Siemens Healthineers is pending 510(k) clearance, and is not yet commercially available in the U.S.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 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, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually 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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