NuVasive Announces Commercial Launch Of LessRay System Designed To Significantly Reduce Radiation Exposure For Surgeons, Operating Room Staff And Patients

LessRay® launch marks Company’s first capital platform technology release, executing on its strategy to expand footprint in hospital operating room  

SAN DIEGO, CA – Sept. 13, 2017 – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the commercial launch of its LessRay® software technology system. The LessRay system, comprised of a propriety software algorithm and hardware components, is designed to help address over exposure to radiation in hospital operating rooms (O.R.), particularly in the case of minimally invasive spine surgery (MIS).

“The launch of LessRay is a significant milestone for NuVasive, as we begin to sell capital equipment and bring technology advancements into the hospital O.R.,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “With LessRay’s ability to dramatically reduce radiation exposure, as well as its enhanced imaging capability, we are now executing on our imaging and navigation strategy to improve spine surgery productivity and ultimately predictability. Given the healthy pipeline of interest from customers already, the strong demand demonstrates a critical need for a solution like LessRay to address a major safety issue related to radiation facing surgeons and hospital administrators.”

LessRay Benefits
Studies show spine and orthopedic surgeons can receive their lifetime occupational radiation limit within the first 10 years of their career.1 As a result, cancer rates and contraction of cataracts associated with radiation exposure are nearly double that of other surgery practices. LessRay’s proprietary image enhancement technology improves low-dose, low-radiation fluoroscopy (or x-ray) images to have similar diagnostic capabilities as conventional full-dose fluoroscopy images, thereby reducing radiation emission and exposure in the O.R while retaining the high resolution of a full radiation dose shot. Additionally, LessRay has other features to help reduce the number of fluoroscopic shots needed, thus decreasing the overall radiation even further. Results of a recent prospective study2 conducted with patients randomized to which surgical intervals were performed with standard-dose fluoroscopy or fluoroscopy using LessRay, which measurement of radiation emission and exposure showed that radiation exposure of healthcare professionals in the O.R. was between 62 percent and 84 percent lower in the LessRay group compared to the conventional fluoroscopy group.

In addition, radiation exposure and limited imaging capabilities have been barriers to widespread spine MIS adoption, compared to general orthopedic MIS. By dramatically reducing these limitations, LessRay supports the increased adoption of MIS spine surgery and enables the well-documented patient benefits including less blood loss, lower risk of infection, faster recovery time and more. Additional hospital economic benefits include no disruption to current surgical workflow and no additional surgery time needed.

More about LessRay
NuVasive acquired the LessRay propriety software algorithm and technology system in September 2016, and has since improved upon its design. The Company completed robust alpha and beta testing in more than a dozen hospitals where spine surgery is performed, and incorporated trial feedback from surgeons and hospital staff. LessRay units will be sold as a capital sale or lease purchase, with a focus on selling into O.R.’s dedicated to spine surgery first and then proliferating the technology across additional areas of the hospital where this technology also solves a significant need.

Additional LessRay system benefits for spine surgeons and staff that help increase O.R. efficiency include:

  • C-arm tracking: Simplifies localization and target anatomy quickly, accurately and without the unnecessary fluoroscopy time and scouting images.
  • Image stitching: Minimizes surgical workflow interruption by quickly stitching together fluoroscopic images of any spine segment.
  • Angle finder: Minimizes O.R. steps required to obtain crisp endplate shots with fewer fluoroscopic images than traditional C-arm scouting.
  • Alternate view: Improves visualization by making metal instruments invisible or semi-transparent by fading out their obstruction.

“LessRay’s ability to reduce radiation usage is so compelling because it benefits not only the surgeon but also the patient and everyone in the operating room,” said Dr. Stephen Ryu, neurosurgeon at Palo Alto Medical Foundation in Palo Alto, Calif. “LessRay’s additional features that augment the capability of conventional fluoroscopy provide really useful tools for even the simplest surgeries. LessRay’s capability to assist accurate localization of spine levels alone is worth it.”

1 UI Haque M, Shufflebarger HL, O’Brien M, et al, Radiation exposure during pedicle screw placement in adolescent idiopathic scoliosis: is fluoroscopy safe? Spine 2006;31(21):2516-20.

2 Wang TY, Farber SH, Perkins SS, et al.  An internally randomized control trial of radiation exposure using ultra-low radiation imaging (ULRI) versus traditional C-arm fluoroscopy for patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion. Spine 2017;42(4);217-23.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, 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 $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 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, 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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Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
[email protected]

 

Media Contact:
Stefanie Mazer
NuVasive, Inc.
858-320-5243
[email protected]

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