RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced today the full market launch of the Streamline ® OCT System. The system is designed to promote fusion of the occipto-cervico-thoracic spine (or occiput-T3). RTI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in March 2014.
The Streamline OCT System is intended for use in the treatment of spinal stenosis, tumors, degenerative disc disease and spondylolisthesis, among others. It allows a rigid construct to be created from occiput toT3 by offering a broad range of implants.
“The Streamline OCT System is another exciting addition to our spine portfolio,” said Brian K. Hutchison, RTI Surgical president and chief executive officer. “We are proud to have a system that offers a range of implants where surgeons can tailor treatment for their patients and provide a more streamlined surgical experience.”
The system is the first to offer a high-angle pedicle screw capable of achieving 60 degrees of angulation in any direction, providing greater intraoperative flexibility and options for screw placement. Streamline OCT also offers a unique occipital plate design that reduces the need for extreme rod bends.Dr. Anthony Lapinsky, board-certified orthopedic surgeon at Premier Orthopaedics and Sports Medicine, Bloomingfield, NJ and a Fellow with the American Academy of Orthopaedic Surgeons, is one of the design surgeons for this system. “The Streamline OCT System, with its unsurpassed modularity, ensures I can manage the variety of clinical challenges I come across in my practice,” said Dr. Lapinsky. “This is due, in large part, to a number of unique implant options, including the highest angle screw on the market.” For more information about the Streamline OCT 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.rtisurgical.com/. Forward Looking Statement 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.
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