First and only commercially available expandable pedicle screw technology designed to optimize fixation and address the clinical challenge of fixation failure in compromised bone
Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, announced today the launch of the InVictus OsseoScrew Expandable Spinal Fixation System.
InVictus OsseoScrew has been designed to be an alternative to the conventional use of cemented fenestrated screws for patients with compromised bone. The system is intended to restore spinal column integrity, even in the absence of fusion, in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. An expansion of the InVictus Posterior Fixation Platform, InVictus OsseoScrew integrates seamlessly with InVictus MIS and Open platforms as well as SafeOp™ Automated EMG.
“InVictus OsseoScrew advances care for patients with compromised bone quality; a testament of ATEC's pursuit of solutions for unmet clinical needs," said Pat Miles, Chairman and Chief Executive Officer. “The system enhances the versatility of InVictus, our industry-leading comprehensive posterior fixation system, and provides surgeons with greater optionality to customize patient care. InVictus OsseoScrew will align well with the level-specific bone density information that EOS will soon be capable of ascertaining, establishing a foundation for the next-generation of ATEC surgical planning.”
With a significant 29 percent increase in pull-out strength compared to standard pedicle screws1, OsseoScrew is engineered to address the clinical challenges of treating patients with compromised bone. In a randomized clinical study In Europe, patients with the system demonstrated clinical fusion and segment stability outcomes comparable to cemented fenestrated screws, while circumventing the risk of perivertebral cement leakage, a frequently occurring complication that can lead to severe complications.2 In the study, OsseoScrew demonstrated a statistically significant lower prevalence of adverse device events at 8%, compared to over 55% for cemented fenestrated screws.3
Christopher DeWald, MD, Assistant Professor and Director of the Spine Deformity Section of Rush University, commented, “InVictus OsseoScrew is a solution for an underserved patient population. The system allows the surgeon a controlled expansion to optimize fixation with improved screw purchase, while helping to minimize the clinical challenge of pedicle screw failure by pull out. It can be elegantly integrated with SafeOp to provide a more predictable technique and reinforce confidence during screw insertion.”
Key Features of InVictus Osseoscrew Expandable Spinal Fixation
- Achieves 29% greater pull-out strength over conventional pedicle screws
- Designed to optimize pedicle fixation with expansion zone location
- Promotes stabilization in patients with compromised bone structures
ATEC, through its wholly owned subsidiaries, Alphatec Spine, Inc., EOS imaging S.A. and SafeOp Surgical, Inc., is a medical device company dedicated to revolutionizing the approach to spine surgery through clinical distinction. ATEC's Organic Innovation Machine™ is focused on developing new approaches that integrate seamlessly with the Company’s expanding AlphaInformatiX Platform to better inform surgery and more safely and reproducibly achieve the goals of spine surgery. ATEC's vision is to become the Standard Bearer in Spine. For more information, visit us at www.atecspine.com
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 many 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 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; 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; 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.
1 Vishnubhotla S, McGarry WB, Mahar AT, et al. A titanium expandable pedicle screw improves initial pullout strength as compared with standard pedicle screws. Spine J 2011;11:777-81.
2 Zhang J, Wang G, Zhang N. A meta-analysis of complications associated with the use of cement-augmented pedicle screws in osteoporosis of spine. Orthop Traumatol Surg Res 2020 Dec 15:102791.
3 Data on file.