Over 500 Initial Surgeries Successfully Performed
Advances Lateral Surgery with a More Predictable, More Reproducible Technique
ATEC Clinical Expertise Enables Complete Reimagining of Requirements for Prone Approach
CARLSBAD, Calif., October 5, 2020. (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 that over 500 prone transpsoas, or PTPTM, surgeries have been successfully performed at multiple sites across the United States. The Company is on track to commercially launch the PTP procedure early in the fourth quarter.
Designed by the team that created the lateral approach for spine fusion, ATEC’s PTP technique leverages the benefits achieved via lateral spine fusion procedures to treat a wide range of patient pathologies. Its principal difference from the standard lateral procedure relies on positioning the patient prone, allowing for a streamlined surgical approach that addresses many of the challenges that have limited adoption of lateral spine fusion. Specifically, the PTP approach minimizes unnecessary patient repositioning, enhances time efficiencies, provides surgeons increased optionality, and more reproducibly achieves spinal alignment objectives. The comprehensive approach seamlessly integrates the PTP Patient Positioning System, the SIGMA-PTP Access System, IdentiTi indication-specific interbody solutions, the InVictus Spinal Fixation System, and importantly, the SafeOp Neural InformatiX System, which objectively monitors the location and the intraoperative health of the lumbar plexus.
“The team that disrupted the spine market with XLIF® has leveraged decades of lateral experience and procedural know-how to revolutionize spine surgery once again,” said Pat Miles, Chairman and Chief Executive Officer. “Where lateral surgery has been one of the fastest growing segments in spine, we estimate that adoption has only reached roughly 30% of surgeons. Prone patient positioning is not only more familiar to spine surgeons, it also enables a consistent orthogonal surgical approach that improves predictability and surgical reproducibility. The result is an approach that is more accessible and capable of addressing the entire market for lumbar surgery, not just lateral fusion procedures.”
Miles continued, “While others repurpose systems designed for something else and validate with cadaveric testing, ATEC’s edge is in the development of procedure-specific solutions that thoughtfully optimize the entire approach. We are applying the learnings from over 500 surgeries to build a successful technique from the ground up. We designed the first-of-its-kind PTP patient positioner to obviate the current arduous and inconsistent practice of taping patients to the OR table for lateral decubitus spine surgery. The PTP positioner exactly situates the patient so that surgeons can maximize the spinal alignment and other anatomic benefits of prone positioning and increase access to challenging L4-L5 levels. We also developed an approach-specific retractor, which attaches robustly to the patient positioner to maintain both the patient and the retractor’s position throughout the surgery. Spine’s greatest lateral expertise is at ATEC, and we are eager to champion an entirely new paradigm for lateral surgery.”
Luiz Pimenta, MD, PhD, ATEC’s Chief Medical Officer and the spine surgeon recognized as the pioneer of the lateral approach affirmed, “PTP is clearly the next step forward for lateral surgery, a conviction that I shared with a surprised audience at last year’s NASS (North American Spine Society) Conference. It brings together the benefits of a less invasive transpsoas (orthogonal)approach with the advantages of an ergonomic prone position. The positioning allows for reproducible single-position surgery that enables surgeons to achieve sagittal alignment goals, the most crucial determinant of long-term spine surgery patient outcomes. With over 500 PTP surgeries performed to date, we have set new standards, fine-tuned the technique and acquired incredible confidence in its potential to meaningfully advance spine fusion surgery.”
PTP technology will be highlighted this week at ATEC’s virtual NASS booth. Please click here , or visit Booth 1525.
The PTP approach was featured in the European Spine Journal, a peer-reviewed publication, in May 2020. Click here to access the article.
About Alphatec Holdings, Inc.
Alphatec Holdings, Inc. (ATEC), 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 through clinical distinction. ATEC’s Organic Innovation Machine is focused on developing new approaches that integrate seamlessly with the SafeOp Neural InformatiX System to safely and reproducibly treat spine’s various pathologies and achieve the goals of spine surgery. Alphatec’s vision is to become the Standard Bearer in Spine. For more information, visit us 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.
Investor/Media Contact:
Tina Jacobsen
Investor Relations
(760) 494-6790
ir@atecspine.com
Company Contact:
Jeff Black
Chief Financial Officer
Alphatec Holdings, Inc.
ir@atecspine.com