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ATEC

Alphatec Holdings, Inc.
NASDAQ · HEALTH CARE · SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
11.36
+0.50 +4.60%
USD · close Oct 22

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How ATEC rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
59%
of sentences unchanged
Added
376
new sentences
Dropped
343
sentences removed
Length
+1,513
words, now 49,268

New in FY2025

  • The sophisticated approaches that we create from the ground up integrate with our expanding InformatiX™ ("IX") platform to objectively inform surgery and achieve the goals of spine surgery more predictably and more reproducibly.
  • Total revenue was $764.2 million for the year ended December 31, 2025, representing an increase of $152.6 million, or 25% compared to $611.6 million for the year ended December 31, 2024.
  • SafeOp became the informational foundation of the Prone TransPsoas (“PTP”) approach, which we developed and launched in 2020 as an advancement designed to address the limitations of first-generation lateral spine surgery.
  • We also acquired EOS® Imaging, a technology platform that enables full-body, calibrated 3D imaging and integrates across the continuum of spine patient care to enhance procedure planning and improve and quantify the assessment of global alignment.
  • Like PTP, these approaches were built from the ground up, fully integrated with SafeOp, and designed to enable single-position surgery across the most commonly treated lumbar levels.
  • In 2025, the EOS Insight platform introduced additional capabilities, including 3D pediatric modeling for detailed assessment of idiopathic scoliosis cases and AutoDensity, an EOS based bone density assessment driven by the EOS Edge imaging and accessed through the EOS Insight portal.
  • The application of our team’s deep spine expertise, coupled with our commitment to advancing the field of spine, has supported continued engagement with surgeons and sales professionals.
  • In addition to our differentiated procedural platforms, including PTP, LTP, EOS and deformity solutions, we have developed comprehensive procedural offerings across cervical, biologics and other traditional spine applications, allowing us to offer a broad portfolio of solutions to our surgeon partners.
  • Since our transformation began in 2018, these efforts have supported continued market share expansion.
  • For the full year 2025, surgical volume grew 22% and average revenue per surgery expanded 4% compared to 2024.
  • The ATEC Experience drove 20% growth in our surgeon user base in 2025.
  • We expect surgeon utilization to continue to increase as we cultivate relationships, partnering with our customers in an increasing number of surgeries and fostering training to inspire partnership in increasingly complex surgeries. 3.
  • We are in the nascent stages of building a profitable international footprint for our surgical implant business focusing on a select few economically attractive markets: Australia, New Zealand and Japan.
  • A column of 33 vertebrae protects the spinal cord and provides the main support for the body.
  • Pain associated with spinal disorders most commonly arises from neural element compression or irritation, including the spinal cord and exiting nerve roots.
  • Such neural compression may result from degenerative changes, disc herniation, deformity, trauma, or other pathological conditions.
  • In addition, structural instability, abnormal motion, deformity, or mechanical failure of spinal elements can contribute to pain and functional impairment, either directly or by exacerbating neural compression.
  • Spine surgery seeks to alleviate pain and restore function by addressing these underlying pathologies.
  • Although surgical intervention in the spine has been performed for decades, published research indicates that outcomes in spine surgery have historically been less predictable and less durable than those observed in many other orthopedic specialties, particularly with respect to reproducibility, long-term durability, and consistency across patient populations.
  • Our procedural offerings are designed to address the underlying causes of spinal pathology by advancing the three fundamental objectives of spine surgery: (1) decompression of neural elements, (2) stabilization of spinal segments, and (3) restoration and maintenance of proper spinal alignment.
  • We believe significant opportunity exists to improve patient outcomes and create value through continued innovation focused on enhancing the predictability, durability, and reproducibility of spine surgery.
  • Our Procedural Solution Our mission to improve outcomes by revolutionizing spine surgery drives a differentiated procedural investment approach.
  • Rather than concentrating primarily on individual implant components, we invest across the broader procedural ecosystem.
  • We focus on developing and integrating technologies intended to enhance clinical predictability and reproducibility, including an expanding informatics platform designed to inform patient care before, during, and after surgery, as well as approach-specific patient positioning and surgical access technologies.
  • Our Technology InformatiX Designed to provide actionable information that controls clinical variables in spine care, our IX™ product platform comprises our EOS imaging system, EOS Insight alignment assessment and surgical planning web/mobile platform, our SafeOp Neural InformatiX System and our navigation-enabled robotics platform ("Valence™").
  • While some IX applications are commercially available, significant development is underway to integrate and interconnect these technologies and bring unprecedented functionalities to market in 2026 and beyond.
  • EOS Insight, an organically developed end-to-end spine care software platform, built around the foundation of EOS Edge™ imaging, was launched in 2024 with additions and improvements released throughout each year.
  • Our SafeOp Neural InformatiX System was the first reflection of the IX product platform.
  • We are currently developing and plan to launch procedure-specific positioners for other procedures in the future.
  • Our current offering includes procedure-specific access systems for PTP, LTP, ALIF, ACDF and TLIF procedures.
  • Available in varying shapes, sizes, and lordosis options, our spinal implants are made from various materials, including allograft, PEEK, porous titanium and 3D printed titanium.
  • Sales and Marketing We market and sell our products through a sales force consisting of exclusive independent sales agents and dedicated employee direct sales representatives.
  • We believe that our most significant competitors are Medtronic (Sofamor Danek), Johnson & Johnson (DePuy Spine), Globus Medical, and others, many of which have substantially greater financial resources than we do.
  • In addition, these companies may have more established distribution networks, entrenched relationships with physicians and experience in developing, launching, marketing, distributing, and selling spinal implant products.
  • As of December 31, 2025, we and our affiliates owned or exclusively licensed 178 issued U.S. patents, 51 pending U.S. patent applications and 268 issued or pending foreign patents.
  • As of December 31, 2025, we and our affiliates owned 35 registered U.S. trademarks and 29 registered trademarks outside of the U.S.
  • These changes include the Budget Control Act of 2011, which resulted in reductions to Medicare payments to providers of 2% per fiscal year, subject to periodic modification or extension by Congress, as well as, the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers, including hospitals and imaging centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
  • Human Capital As of December 31, 2025, we had 913 employees worldwide.
  • Approximately 706 employees were located in the U.S. and 207 employees were located outside of the U.S.
  • Of our U.S. employees, 411 were based in our Carlsbad, California headquarters, covering all of the following functional areas: sales, customer service, marketing, clinical education, advanced manufacturing, quality assurance, regulatory affairs, research and development, human resources, finance, legal, information technology, and administration.

and 336 more.

Gone since FY2024

  • The sophisticated approaches that we create from the ground up integrate with our expanding Alpha InformatiX™ ("AIX") platform to objectively inform surgery and achieve the goals of spine surgery more predictably and more reproducibly.
  • Total revenue was $611.6 million for the year ended December 31, 2024, representing an increase of $129.3 million, or 27% compared to $482.3 million for the year ended December 31, 2023.
  • SafeOp became the informational foundation of the Prone TransPsoas (“PTP”) approach, which we developed and launched in 2020 to advance first-generation lateral spine surgery.
  • We also acquired EOS ® imaging, technology that enables full-body, calibrated, 3D-images that integrate throughout the span of spine patient care to influence procedure planning and improve and quantify the understanding of global alignment.
  • Like PTP, the approaches were built from the ground up and integrated with SafeOp, and are designed to enable single-position surgery for the most commonly treated levels in spine.
  • The application of our team’s deep spine know-how, coupled with our commitment to advancing the field of spine continues to compel surgeons and sales talent to partner with us.
  • That adoption-driven validation has been the source of industry-leading market share expansion since our transformation commenced in 2018.
  • For the full year 2024, surgical volume grew 19% and average revenue per surgery expanded 8.0% compared to 2023.
  • The ATEC Experience drove 18% growth in our surgeon user base in 2024.
  • Over time, we expect surgeon utilization to consistently increase as we cultivate relationships, partnering with our customers in an increasing number of surgeries and fostering training to inspire partnership in increasingly complex surgeries. 3.
  • We are in the nascent stages of building a profitable international footprint focusing on a select few economically attractive markets: Australia, New Zealand and Japan.
  • Looking forward, we intend to gradually expand our footprint in the select geographies.
  • A column of 33 vertebrae, it protects the spinal cord and provides the main support for the body.
  • Pain can be caused when any of the spine’s structures is affected by strain, injury, or disease, and spine surgery seeks to alleviate that pain.
  • While the spine has been surgically intervened upon for decades, research demonstrates that surgical outcomes in spine are generally inferior to surgical outcomes delivered by most other orthopedic specialties, particularly in terms of durability, predictability and reproducibility.
  • Our procedural offerings are designed to treat the various spine pathologies by better achieving the three goals of surgery including: (1) decompression, (2) stabilization, and (3) alignment.
  • We believe there is vast opportunity to create value by innovating to improve surgical outcomes in spine.
  • Our Procedural Solution Our mission to improve outcomes by revolutionizing spine surgery affords a differentiated procedural investment thesis.
  • Unlike most of our peers, we take a holistic approach to the procedures that we bring to market, investing not just in the highest dollar components of the procedure, but in each of the technologies that integrate to enhance clinical predictability and reproducibility of procedural-based approach.
  • Our procedures seamlessly incorporate technology engendered by that thesis, including an expanding informatic ecosystem designed to automatically and objectively inform spine patient care before, during and after surgery, as well as approach-specific, ergonomic patient positioning and surgical access technology.
  • Our Technology Alpha InformatiX Designed to provide actionable information that controls clinical variables in spine care, our AIX™ product platform comprises our EOS imaging system and VEA™ alignment mobile application, our SafeOp Neural InformatiX System and our navigation-enabled robotics platform ("Valence™").
  • While some AIX applications are commercially available, significant development is underway to integrate and interconnect these technologies and bring unprecedented functionalities to market in 2025 and beyond.
  • Insight, an organically developed end-to-end spine care software platform, built around the foundation of EOS Edge™ imaging, was released in 2024.
  • Our SafeOp Neural InformatiX System was the first reflection of the AIX product platform.
  • We also offer procedure-specific access systems, including our Sigma-ALIF Access System which allows for custom anterior abdominal exposure through freehand placement of dissecting blades and connection to a ringed frame.
  • The Sigma-ALIF Access System provides an unobstructed working corridor with custom features to enable an ALIF approach in either supine or lateral decubitus.
  • Available in varying shapes, sizes, and lordosis options, our spinal implants are made from various materials, including allograft, PEEK, and porous titanium.
  • Sales and Marketing We market and sell our products through a sales force consisting of dedicated and non-dedicated independent sales agents and dedicated employee direct sales representatives.
  • We believe that our most significant competitors are Medtronic (Sofamor Danek), Johnson & Johnson (DePuy Spine), Stryker, Globus Medical, and others, many of which have substantially greater financial resources than we do.
  • In addition, these companies may have more established distribution networks, entrenched relationships with physicians and greater experience in developing, launching, marketing, distributing, and selling spinal implant products.
  • As of December 31, 2024, we and our affiliates owned or exclusively licensed 180 issued U.S. patents, 45 pending U.S. patent applications and 250 issued or pending foreign patents.
  • As of December 31, 2024, we and our affiliates owned 33 registered U.S. trademarks and 27 registered trademarks outside of the U.S.
  • Class III devices require PMA before they can be marketed, although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process.
  • The PMA process is generally more complex, costly and time consuming than the 510(k) process.
  • A PMA must be supported by extensive data including, but not limited to, extensive technical information regarding device design and development, preclinical and clinical trials, manufacturing, and labeling information to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device for its intended use.
  • The PMA application must provide valid scientific evidence that demonstrates to the FDA’s satisfaction reasonable assurance of the safety and effectiveness of the device for its intended use.
  • Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive review.
  • If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of the PMA, although in practice, the FDA’s review often takes significantly longer.
  • During this review period, the FDA may request additional information or clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA.
  • Also, during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.

and 303 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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