Audubon, PA, May 23, 2013: Algea Therapies, a division of Globus Medical Inc. (NYSE: GMED), committed to finding innovative, minimally invasive solutions that treat pain and restore quality of life, today announced the launch of the SHIELD™ Vertebral Compression Fracture (VCF) System, a next generation fracture management and vertebral augmentation platform for patients with vertebral compression fractures.
“We are excited to announce the US launch of the SHIELD™ VCF System, the first vertebral augmentation implant to guide cement flow into the anterior region of the vertebral body, while significantly decreasing overall cement leakage compared to traditional VCF methods. The system features a new surgical technique involving unipedicular cavity creation, and a novel “cement-directing” device, the SHIELD™ implant. With this innovative platform technology, Algea is setting a new standard for safer treatment of vertebral compression fractures,” commented Sean Suh, Senior Group Manager of Algea Therapies.
The SHIELD™ VCF System marks a new level of control in the vertebral body augmentation market. The system is engineered with strategic flow openings designed to give the physician control of cement placement and reduce cement leakage. The system includes the C3 Curved Osteotome, a steerable, unipedicular, curving cavity creator with an adjustable blade. This instrument allows physicians to create a central cavity spanning the sagittal midline for balanced cement augmentation. The C3 Curved Osteotome has the ability to steer and navigate around difficult and damaged anatomy, creating cavities to match the anatomical requirements of each fracture.
Indications for Use
The SHIELD™ VCF System is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 to L5 in the adult spine.
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 Form 10-Q, Form 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.