NuVasive(R) Announces First Patient in the United States Treated With the PCM(R) Cervical Disc Following FDA Approval
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced that Paul Sawin, M.D., performed the first PCM Cervical Disc surgery on a patient in Orlando, Florida, today. Surgeon proctors, who will instruct upcoming training courses, have started scheduling surgeries now that the new device is available. Surgeon demand for training is strong with courses scheduled to begin next month.
NuVasive received FDA approval for the PCM Cervical Disc in October 2012 after successful completion of a prospective, multicenter randomized investigational device exemption (IDE) clinical trial. The novel device is now being provided to patients and surgeons in the United States as an innovative option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure.
Alex Lukianov, Chairman and CEO of NuVasive, said, "We are very pleased with the initial surgeon interest in this innovative technology. The first U.S. training courses at the NuVasive East and West coast-based facilities are solidly booked. The unique nature of the PCM Cervical Disc and the healthy demand for surgeon training gives us confidence in our expectation for $3.5 million to $5 million in related revenue in 2013. The device is a differentiated, game changing solution for the cervical spine, and marks NuVasive's foray into an exciting, rapidly growing market."
About the PCM Cervical Disc
The PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The device is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation.
The PCM Cervical Disc is composed of cobalt chrome endplates and a central polyethylene core, materials that have a long and well-studied history of use in other orthopedic joint replacements. The broad radius of the polyethylene core allows for unconstrained motion preservation and a broad radius of articulation for coupled motion. The device features a wide footprint to take advantage of the most stable portions of patients' cervical vertebral bodies and offers three different footprint and height options. The superior and inferior endplates also feature three rows of "V-Teeth" which provide short-term fixation until long-term biologic fixation can occur to anchor our motion preserving device.
NuVasive is a medical device company focused on developing minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 4th largest player in the $7.9 billion global spine market. NuVasive's principal product offering is based on its Maximum Access Surgery, or MAS® platform. The MAS platform combines several categories of solutions that collectively minimize soft tissue disruption during spine surgery with maximum visualization and safe, easy reproducibility for the surgeon: a proprietary software-driven nerve avoidance system and intra-operative monitoring support; MaXcess®, a unique split-blade retractor system; a wide variety of specialized implants; and several biologic fusion enhancers. MAS significantly reduces surgery time and returns patients to activities of daily living much faster than conventional approaches. Having redefined spine surgery with the MAS platform's lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF®, NuVasive has built an entire spine franchise. With over 75 products today spanning lumbar, thoracic and cervical applications, the Company will continue to expand and evolve its offering predicated on its R&D focus and dedication to outstanding service levels supported by a culture of Absolute Responsiveness®.
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 that could cause actual growth and results to differ materially include, but are not limited to: the risk that NuVasive's revenue or earnings projections may turn out to be inaccurate because of the preliminary nature of the forecasts and the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability; the uncertain process of seeking regulatory approval or clearance for NuVasive's products or devices, including risks that such process could be significantly delayed; the possibility that the FDA may require significant changes to NuVasive's products or clinical studies; the risk that products may not perform as intended and may therefore not achieve commercial success; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; the risk that additional clinical data may call into question the benefits of NuVasive's products to patients, hospitals and surgeons; and other risks and uncertainties more fully 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.