AUDUBON, Pa., June 13, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the launch of the CREO® Fenestrated Screw System used in the treatment of patients with advanced stage tumors of the thoracolumbar spine. CREO® fenestrated screws, when augmented with the company’s FORTRESS™ radiopaque bone cement, are designed to restore the structural integrity of the spine at vertebral levels affected by metastatic bone disease.
The spine is one of the most common locations for skeletal metastases, accounting for approximately 10% of new cancer diagnoses annually. Advanced stage spinal tumors can result in compression of the spinal cord, pain, fracture, mechanical instability, and neurological deficit. Surgical treatments involving pedicle screw fixation are challenging due to the compromised bone in this patient population.
“Patients with advanced stage tumors may require cement reinforcement due to compromised bone quality,” said Dr. Edwin Ramos, neurosurgeon at The University of Chicago Medicine and Biological Sciences. “The CREO® system allows for cement augmentation after screw placement which integrates seamlessly with a traditional MIS or open pedicle screw technique. This affords a controlled cement delivery and increased stability to help prevent screw loosening that can occur in tumor patients.”
The CREO® Fenestrated Screw System is available with threaded, non-threaded, and MIS screw head options to accommodate surgeon preferences for complex tumor procedures. The screws are cannulated with a series of fenestrations along the shank for targeted cement dispersion, and rigidly attach to specialized instruments for controlled cement delivery.
To learn more about the CREO® Fenestrated Screw System visit www.GlobusMedical.com
Indications
When used for posterior fixation in conjunction with FORTRESS™ or FORTRESS™-Plus bone cement, the CREO® Fenestrated Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit the achievement of fusion. CREO® Fenestrated screws augmented with FORTRESS™ and FORTRESS™-Plus bone cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
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
