AUDUBON, Pa., Nov. 30, 2017 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED ), a leading musculoskeletal solutions company, today announced the results of its seven-year clinical trial follow-up that demonstrate superiority of the SECURE-C ® Cervical Artificial Disc over the current standard for the treatment of cervical disc disease, anterior cervical discectomy and fusion (ACDF), based on overall success. SECURE-C ® is designed for disc reconstruction and motion preservation at the operated disc level, unlike traditional motion-eliminating fusion surgery.
“The long-term evidence shown in this study confirms the outstanding results I have seen in my own patients treated with SECURE-C ® ,” said Dr. William Beutler, neurosurgeon at the Pennsylvania Spine Institute. “SECURE-C ® ’s integrated keel is designed for optimal placement and migration resistance, allowing my patients to better maintain their active lifestyles. SECURE-C ® is proven to be a superior treatment option to fusion for patients with cervical disc disease.”
The prospective, randomized Investigational Device Exemption (IDE) trial involved a total of 380 study subjects (240 investigational and 140 control) to compare the safety and effectiveness of SECURE-C ® to ACDF using a cervical plate and structural allograft for patients with intractable symptomatic cervical disc disease (SCDD) at a single level in the cervical spine. At seven years post-surgery, SECURE-C ® patients reported greater overall satisfaction with surgery and exhibited the following:
- Statistically superior composite overall success results (86.3%) compared to ACDF patients (70.0%);
- Greater improvement in pain and function based on the Neck Disability Index (90.4%) versus ACDF patients (86.0%);
- Lower rate of subsequent surgery (4.2%) at the original treated level compared to ACDF patients (15.3%); and
- Lower rate of adjacent level surgery (4.2%) versus ACDF patients (16.0%).
“The seven-year clinical study findings provide further evidence for statistical superiority of SECURE-C ® to ACDF in terms of overall success, bolstering the long term data on cervical arthroplasty,” said Kelly Baker, Ph.D., Senior Vice President of Regulatory and Clinical Affairs. “We are excited to release these findings as Globus continues to bring innovative engineering and superior clinical devices to spine surgeons and their patients.”
Indications The SECURE-C ® Cervical Artificial Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-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 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 SECURE-C ® Cervical Artificial Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the SECURE-C ® Cervical Artificial Disc.
About Globus Medical, Inc. Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com
Safe Harbor Statements All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov . Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
Contact: Dan Scavilla Senior Vice President and Chief Financial Officer Phone: (610) 930-1800 Email: investors@globusmedical.com www.globusmedical.com
