AUDUBON, Pa., Jan. 24, 2019 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, recently announced that the SECURE-C® Cervical Artificial Disc is now covered by Anthem, one of the largest health benefits companies in the United States with close to 40 million medical members and over 73 million lives covered.
Approved by the FDA in 2012, SECURE-C® is designed for reconstruction and motion preservation at the operated disc level, unlike traditional motion-eliminating fusion surgery. A long term, seven-year clinical trial follow-up study published in the prominent International Journal of Spine Surgery demonstrated the superiority of SECURE-C® in terms of overall success, compared to Anterior Cervical Discectomy and Fusion (ACDF), the current standard of care for cervical disc disease.
At seven-year post-operative follow-up, patients treated with SECURE-C® exhibited the following results compared to patients treated with ACDF:
- Statistically superior composite protocol-specified overall success results (86.3% vs. 70.0%)
- Statistically superior composite FDA-defined overall success results (79.2% vs. 63.6%)
- Greater percentage of patients with at least 25% improvement in Neck Disability Index, a measure of pain and function (90.4% vs. 86.0%)
- Lower rate of subsequent surgery at the original treated level (4.2% vs. 15.3%)
- Lower rate of adjacent level surgery (4.2% vs. 16.0%)
“The long term clinical results validate that SECURE-C® creates a significant improvement in patients’ lives over the long term, an important factor in expanding payer coverage,” said Globus Medical’s President, Anthony Williams. “With the addition of Anthem, SECURE-C® is now covered by all major third party payers in every state and strengthens our position for growth in the cervical artificial disc market.”
For more information about SECURE-C®, please visit GlobusMedical.com/SECURE-C.
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:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com
