NuVasive and the International Spine Study Group Foundation Announce Expanded Long-Term Partnership with Initiation of Additional Clinical Studies
NuVasive (NASDAQ: NUVA) announced an expanded partnership with the International Spine Study Group Foundation (ISSGF) to initiate two new clinical studies aimed at enhancing patient outcomes in adult spinal deformity surgery. The studies will evaluate minimally invasive surgical techniques and the performance of NuVasive's VersaTie® fixation system. This collaboration builds on a previous five-year study, reinforcing NuVasive's commitment to clinical innovation. The partnership aims to inform better surgical practices and improve patient care through rigorous data collection.
- Continuation of partnership with ISSGF indicates strong collaboration in clinical research.
- New studies can lead to improved surgical outcomes and validation of minimally invasive techniques.
- Potential for data-driven insights that may enhance market positioning and product acceptance.
- None.
SAN DIEGO, March 16, 2021 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, and the International Spine Study Group Foundation (ISSGF) today announced the continuation of their long-term partnership through the launch of two new clinical studies focused on improving patient outcomes in adult spinal deformity surgery.
"NuVasive is excited to extend our partnership with the ISSGF, the premier study group on adult spinal deformity, and to support these breakthrough studies that will inform the future of spine care," said Kyle Malone, vice president of clinical, medical, and regulatory affairs at NuVasive. "This partnership reflects NuVasive's dedication to developing outcome driven innovation through clinical validation for surgeons, providers, and patients."
The NuVasive and ISSGF partnership began in 2015 with a five-year, prospective study to compare the clinical, radiographic, and health-related quality of life outcomes between minimally invasive and open techniques in the treatment of adult spinal deformity. Initial reports from the ongoing study show that minimally invasive surgery (MIS) is a feasible and effective approach for treating adult spinal deformity. Based on this foundation, NuVasive and the ISSGF have expanded their partnership to include two additional clinical studies:
- a 10-year, prospective study evaluating complex adult spinal deformity treated with MIS, including comprehensive clinical and radiographic outcomes, and is now expanded to also include measures of physiology and laboratory data; and
- a prospective, case-controlled analysis of the safety profile, clinical and radiographic outcomes, and implant performance of the NuVasive VersaTie® posterior fixation system used in long posterior spinal fusion constructs for adult patients.
"Our partnership with NuVasive represents a collaborative commitment to better understand the pathology and treatment of adult spinal deformity. Together, we will partner on one of the largest and most granular prospective studies on adult deformity ever performed," said Shay Bess, M.D., president of the ISSGF and orthopedic spine surgeon at Denver International Spine Center in Denver, Colorado. "This study gives us the opportunity to compare data to traditional open surgery, with the goal of informing better surgeon decision making to improve patient care and outcomes."
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
About the International Spine Study Group Foundation (ISSGF)
The ISSGF is a non-profit research foundation comprised of surgeons and scientists dedicated to the advancement of treatment for adults with spinal deformity. Via prospective, multi-center research the ISSGF evaluates methodologies for patient evaluation and treatment techniques to achieve the best possible outcomes. The ISSGF is committed to being internationally recognized for the highest quality published research on improving care and outcomes for adults with scoliosis and spine deformities and validating new spinal deformity surgery techniques.
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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