RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced today the full market launch of the MaxFuse ™ Vertebral Body Replacement System and the Aspect® Anterior Cervical Plate System. Both systems are designed for use in spine fusion and are currently available for U.S. distribution. “The MaxFuse VBR System and the Aspect Anterior Cervical Plate System are two exciting new additions to our spine portfolio,” said Brian K. Hutchison, RTI Surgical president and chief executive officer. “These systems are manufactured in our world-class Marquette, Mich. facility and address important clinical needs in spine fusion.” MaxFuse VBR System The MaxFuse System is used to replace a diseased vertebral body, resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues in the thoracolumbar spine. The device also aids in restoring the height of a collapsed vertebral body. The system is made from PEEK-OPTIMA ®, a unique material selected for its strength, which helps maximize the volume of bone graft that can be placed inside the implant, as well as the graft-endplate apposition which supports the goal of a solid fusion. The system allows surgeons to address a wide range of patient pathologies by offering industry-leading size options in footprints and heights and is designed to optimize fit with the adjacent vertebral bodies, as well as to restore a more normal sagittal balance. RTI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in December 2013. Aspect Anterior Cervical Plate System The Aspect System is a simple, yet versatile anterior cervical plate system designed to meet the varying clinical needs of surgeons performing Anterior Cervical Discectomy and Fusion (ACDF) procedures. The system is used for anterior cervical fixation for degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures, tumor, pseudoarthrosis and failed previous fusion indications. RTI received 510(k) clearance from the FDA for the Aspect system in June 2013.
Aspect temporarily provides resistance to flexion, extension, lateral bending and axial rotation with strength and stiffness in the cervical spine in order to support cervical fusion. The system is able to accommodate semi-constrained, constrained and hybrid constructs in a single set. It offers one through four-level plates, all with large graft visualization windows and a ‘zero-step’ locking mechanism. The locking mechanism is a nitinol spring that has shape-retaining memory, allowing the screw to pass easily without the need for an additional step to engage the locking mechanism. Once the screw is fully seated, the nitinol spring is designed to resist screw back-out. The self-drilling and self-tapping screw designs provide a quick start and excellent bone purchase. The industry-leading drive mechanism design helps ensure the screw is rigid and on-axis during insertion.For more information about the MaxFuse VBR System or the Aspect Anterior Cervical Plate System, or to learn more about RTI Surgical, please visit www.rtisurgical.com. About RTI Surgical Inc. RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to advancing science, safety and innovation, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of Advamed. For more information, please visit http://www.rtix.com/. Forward Looking Statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). In addition, these statements are subject to risks associated with the Pioneer’s financial condition, business and operations and the integration of Pioneer’s business with ours. Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.