SAN DIEGO, CA--(Marketwired - May 6, 2014) - NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that it reached a settlement agreement with Cadwell Laboratories, Inc., in a lawsuit involving NuVasive's patented neuromonitoring technology.
NuVasive filed the lawsuit in December 2012 asserting that Cadwell infringed on the Company's patented neuromonitoring technology, including the integration of nerve monitoring technology during lateral approach spine surgery. As part of the settlement reached between the parties, Cadwell has agreed to exit the lateral spine surgery market, and to no longer provide products, services, or support for lateral approach spine fusion surgeries. In addition, certain of Cadwell's future products (that rely on NuVasive patented technology) may be required to openly attribute intellectual property ownership to NuVasive and may require a 5% fee paid to NuVasive.
Alex Lukianov, Chairman and Chief Executive Officer, said, "At NuVasive, we take immense pride in the investments we have made to be a dominant innovator in the spine market, and we intend to aggressively protect those investments. Our neuromonitoring technology is best in class and is central to the facilitation of surgical reproducibility and safety in less invasive spine procedures. I am exceptionally pleased that the solid intellectual property that surrounds our neuromonitoring technology has once again been validated."
The company's neuromonitoring technology was previously validated in litigation between NuVasive and Medtronic. In 2011 a jury verdict awarded monetary damages and back royalty payments to NuVasive in favor of the company's claim that Medtronic's NIM-Eclipse System infringed upon NuVasive's neuromonitoring technology patent.
The NuVasive® proprietary monitoring platform is the only technology that can deliver real-time information and has been clinically validated for more than 10 years and in eight peer reviewed publications. NuVasive spine monitoring has been a valuable component in lateral access surgery, making the XLIF® procedure a reliable and reproducible lateral approach. Today, NVM5 is helping to achieve surgical objectives for all types of spine procedures delivering real-time, actionable information to the surgical team.
NuVasive is an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 4th largest player in the $8.7 billion global spine market.
NuVasive offers a comprehensive spine portfolio of more than 90 unique products developed to improve spine surgery and patient outcomes. The Company's principal procedural solution is its Maximum Access Surgery, or MAS®, platform for lateral spine fusion. MAS provides safe, reproducible, and clinically proven outcomes, and is a highly differentiated solution with fully integrated neuromonitoring, customizable exposure, and a broad offering of application-specific implants and fixation devices designed to address a variety of pathologies.
Having pioneered the lateral approach to spine fusion, NuVasive continues to be at the forefront of the spine industry's shift toward less invasive solutions. The Company's dedication to innovation continues to spawn game-changing technology such as the XLIF Decade™ plate for single-approach fixation through a lateral incision, the PCM® motion-preserving disc for the cervical spine, XLIF® Corpectomy for tumor and trauma, and the Armada® posterior fixation system, which treats adult degenerative scoliosis in a less invasive fashion. The Company has also developed procedurally integrated solutions that completely redefine and improve upon traditional techniques like TLIF, PLIF, Posterior Fixation, and ALIF. NuVasive solutions are increasingly being adopted internationally, as the Company lays the groundwork to continue growing as a global business and to offer industry-leading, Absolutely Responsive customer service to surgeons world-wide. NuVasive is focused on becoming a $1 Billion Start-up™; taking market share by maintaining a commitment to Superior Clinical Outcomes, Speed of Innovation, and Absolute Responsiveness®.
XLIF® is a minimally disruptive surgical procedure performed through the side of the body utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies.
The XLIF® procedure, like any other surgical procedure, is not without risks. Possible complications include, but are not limited to: persistent pain, infection, muscle weakness, vascular injury (injury of the blood vessels), neurologic (nerve or spinal cord) injury, urinary tract infection, stroke, pneumonia, deep vein thrombosis (clotting), and further progression of existing spinal disease. A discussion detailing all potential risks of the XLIF procedure, or any procedure, should take place between patient and physician.
Spine surgeries, including the XLIF® procedure, carry inherent risks and potential complications, which should be discussed between patient and surgeon. Complications vary in severity, including the possibility of death, and can result from surgery in general (e.g., infection or bleeding requiring transfusion), from the approach to the pathology (e.g., vascular, organ or other soft-tissue injury, or injuries to the motor or sensory nerves), spine surgery-related complications (e.g., re-operation required for malpositioned hardware or inadequate decompression), and medical-related issues (e.g., due to other co-morbidities such as diabetes, heart disease, lung disease, use of steroids, and/or smoking).
Complications can also manifest later in the postoperative period, which may require additional procedures (e.g., delayed wound healing, infection, migration or failure of the implants, fracture or settling of the bone, failed fusion).
It is important to reiterate that planning for spine surgery should include detailed discussion between patient and surgeon concerning potential complications associated with current spine surgery treatment options.
The information provided in this press release is for general educational information only. Information you read in this press release cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical or advice as part of this press release. You should also talk to your healthcare professional for diagnosis and treatment.
NuVasive cautions you that statements included in this press 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 minimally disruptive surgical products by spine surgeons, development and acceptance of new products or product enhancements, expansion of our network of sales representatives, and the other risks and uncertainties described in NuVasive's press 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.