ATEC Advances InVictus™ MIS Spinal Fixation System With Commercial Launch Of SingleStep™
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 InVictus Minimally Invasive, or MIS, SingleStep K-wireless implant delivery system. By completely eliminating the requirement for K-wires in a percutaneous pedicle fixation procedure, SingleStep limits the potential complications associated with inadvertent K-wire advancement during traditional minimally invasive pedicle screw placement techniques. SingleStep utilizes an all-in-one driver designed to enhance surgical efficiency without compromising accuracy.
“This release enhances the functionality and distinction of ATEC’s newly-launched InVictus platform with technology that has been engineered to profoundly improve the elegance of percutaneous fixation,” said Pat Miles, Chairman and Chief Executive Officer. “SingleStep enables increased surgeon control of the variables surrounding percutaneous pedicle screw placement. Spine’s new Organic Innovation Machine™ continues to deliver on its commitment to bring meaningful innovation to a market that yearns for it.”
InVictus MIS SingleStep
The commercial release of the InVictus MIS SingleStep implant delivery system follows successful evaluations that began in January 2019.
Compared to a traditional percutaneous technique, InVictus MIS SingleStep is designed to reduce procedural steps, instrument passes, screw insertion time, and fluoroscopy, and completely eliminate guidewire management. SingleStep’s innovative streamlined approach integrates seamlessly with SafeOp neurophysiology to add safety, expedience and increased predictability to percutaneous pedicle screw delivery.
“SingleStep represents an evolutionary leap in percutaneous pedicle screw instrumentation,” stated Tyler G. Smith, M.D. of Roseville Orthopedic Surgery and Sports Medicine in California. “By removing steps in the sequence of targeting and implantation, the result is an elegant system that is faster, safer, and more reproducible. In a word, it is simple. It is easy to make a product different, but the new ATEC has made the approach better.”
Key Features of InVictus MIS SingleStep
The InVictus SingleStep system has been designed to improve surgical outcomes by simplifying minimally invasive pedicle screw placement procedures.
Key features include:
- Limits the potential complications associated with inadvertent guidewire advancement by eliminating the requirement for K-wires;
- Novel ratcheting handle for swift pedicle screw delivery and unprecedented, single instrument-pass functionality;
- Simplified approach reduces procedural steps by 50%, streamlining screw insertion time and potentially reducing reliance on fluoroscopy;
- Steerable stainless steel stylet seamlessly perforates the pedicle; and
- Integration with SafeOp technology reinforces confidence during stylet and screw insertion.
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.
Additional information can be found at www.atecspine.wpengine.com.
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.