ATEC Announces Commercial Launch Of The SafeOp Neural InformatiX System™
Automated Technology Detects Location and Monitors Health of Nerves During Spine Surgery
CARLSBAD, Calif., Nov. 26, 2019 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a medical device company dedicated to revolutionizing the approach to spine surgery, announced today the commercial release of the SafeOp Neural InformatiX System (“SafeOp”), which has been designed to seamlessly integrate critical neural information into ATEC procedural solutions.
The commercial launch of the SafeOp System follows successful alpha evaluations that began earlier this year, and is the last of 12 planned commercial launches for 2019, delivering on ATEC’s commitment to accelerate growth through clinical distinction.
“Today, we are launching the first reflection of the innovation that we expect to deliver through the SafeOp platform: a powerful technology that meets an unmet need for objective, intraoperative neural information during surgery,” said Pat Miles, Chairman and Chief Executive Officer. “SafeOp’s unprecedented combination of nerve identification and nerve health information will be the cornerstone of ATEC clinical distinction. By providing surgeons with the information they require, when they require it, SafeOp profoundly improves the clinical experience in some of spine’s most broadly performed procedures.”
The SafeOp Neural InformatiX System has been engineered with electromyography (EMG) and somatosensory evoked potentials (SSEP) to provide surgeons with actionable information regarding both the location and the health of nerves at risk during surgery. The system integrates seamlessly into operating rooms with a small footprint and wireless connectivity.
Dr. William Taylor, Professor of Neurosurgery at UC San Diego and lateral surgery pioneer, said, “I have been looking for years for a way to monitor the health of the femoral nerve in the lateral approach. SafeOp’s automated SSEP technology is the first to provide real-time feedback about the integrity of that critical neural structure to help surgeons avoid injury and improve outcomes.”
For lateral lumbar procedures, SafeOp’s EMG nerve detection provides information regarding the direction and the proximity of relevant neural anatomy during the surgical approach. In addition to the reliable access afforded with EMG, the system employs real-time SSEP nerve monitoring. Through a combination of cutting-edge signal amplifiers and filters, proprietary waveform classifiers, and predefined parameters, SafeOp SSEP delivers an unparalleled ability to reproducibly monitor nerve health. That capability uniquely equips surgeons with actionable information to assist in mitigating femoral nerve complications, the greatest challenge to the adoption of lateral surgery.
SafeOp also improves the safety and reproducibility of posterior fixation procedures, which encompass roughly 90% of all spine fusions. Integrated into the Invictus™ Posterior Fixation approach, SafeOp’s dynamic EMG technology delivers nerve detection with industry-leading speed and reliability during screw placement, reducing the risk of pedicle breach.
Key Features of the SafeOp Neural InformatiX System and Proprietary Peripheral Devices
- Triggered EMG for Fast, Reliable Nerve Identification
– Proprietary Validated Response Thresholding (VRT) algorithm, designed to deliver industry-leading nerve detection while reducing the incidence of false positive responses
– Industry-leading speed, with stimulation that ramps from below threshold at a frequency 4x faster than competitive systems
– Compelling reliability, as acquired threshold responses are validated with subsequent stimuli for reproducible results
– Visual and audible communication of discrete threshold values
- Saphenous SSEP for Femoral Nerve Integrity Monitoring
– Leverages novel waveform-averaging technology to provide objective, real-time nerve health information
– Actionable SSEP information with audible and visual alerting of response changes, numeric display of SSEP amplitude and latency, and response trend indicators
About Alphatec Holdings, Inc.
Alphatec Holdings, Inc., through its wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a medical device company dedicated to revolutionizing the approach to spine surgery. ATEC designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company markets its products in the U.S. via independent sales agents and a direct sales force.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include references to the Company’s planned commercial launches, product introductions and product integration, surgeon and market acceptance of Company products, solutions and platforms, and the Company’s ability to deliver key product features. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the uncertainty of success in developing new products or products currently in the Company’s pipeline; failure to achieve acceptance of the Company’s products by the surgeon community; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; the Company’s ability to compete with other products and with emerging new technologies; product liability exposure; patent infringement claims; and claims related to the Company’s intellectual property. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate,” “look forward” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. ATEC disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.