Centinel Spine Holdco, Inc. CNTL
发行信息
- 价格区间
- 待定
- 发行股数
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- 超额配售
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- 募资额
- $1.00亿
- 发行后总股本
- —
- 流通比例
- —
- 发行费用
- —
- 交易所
- NYSE
公司与限制期
- CEO
- Steven Murray
- 员工
- 138 (as of 06/30/2026)
- 注册州
- DE
- 财年截止
- 12/31
- 锁定期
- 180 天
- 静默期结束
- —
锁定期到期后内部人与早期投资者可以卖出;静默期结束后承销商才会发布研究报告。
业务简介(招股书摘录,英文)
We are a commercial-stage medical technology company with a singular mission to transform spine surgery by advancing motion-preserving solutions for the cervical and lumbar spine. We are exclusively focused on Total Disc Replacement (TDR), which we believe represents a fundamentally different and increasingly important approach to spine surgery compared to traditional fusion techniques that permanently eliminate motion. Our prodisc platform is designed to improve the long-term quality of life for patients suffering from chronic neck and back pain while preserving the spine’s natural movement. As a pure-play company dedicated solely to TDR, we believe our depth of experience, exclusive focus, and long history of clinical success uniquely position us to lead the continued evolution of spine surgery toward solutions designed to preserve motion. Spine disorders are among the most common medical conditions in the United States, with chronic neck and back pain affecting approximately 100 million people each year. Individuals living with degenerative disc disease (DDD) represent a significant subset of this population. Surgical intervention, including spinal fusion and total disc replacement, are commonly performed for patients with DDD. Despite its widespread use, spinal fusion has inherent clinical limitations that we believe can contribute to less favorable outcomes for many patients. Fusion permanently eliminates movement at the treated level or levels of the cervical or lumbar spine, which can reduce patient flexibility and impact their ability to perform certain routine activities. By eliminating movement across one or more levels of the spine, the forces and stresses that would normally be distributed across the entire spinal column are instead concentrated on the adjacent, unfused segments of the spine. This altered motion and increased mechanical load on the adjacent discs may accelerate degeneration at these adjacent levels of the spine, a condition known as adjacent segment disease (ASD). Spinal lumbar fusion procedures are associated with higher rates of postoperative complications compared to TDR (Bai et. Al, Medicine, 2019). In addition, spinal fusion procedures can require longer recovery periods (Perez Albela et al, Spine, 2025), as the bone graft must fully incorporate and solidify to achieve structural stability, which can result in significant time away from work and daily activities and place a considerable burden on patients while contributing to higher indirect healthcare costs. While TDR offers advantages over spinal fusion, some TDR offerings on the market may have drawbacks associated with their design or permitted applications. For example, some TDR implants employ a mobile core, where free translation (or disc movement) may occur upon the application of shear forces, potentially leading to instability. Some TDR implant offerings also utilize materials that may be susceptible to accelerated wear, particle generation, and long-term implant degradation. Other cervical TDR offerings include a narrow range of implant sizes and configurations, and other lumbar TDR offerings include a narrow range of indications (notably lacking FDA-approved two-level lumbar TDR implants), which may limit applicability across patient populations. In addition, we believe that certain surgical instrumentation used by other TDR offerings lacks ease of use, which may result in inconsistent surgical technique, steeper learning curves for adopting surgeons, longer operative times, and an increased risk of inadequate implant positioning. From its inception, we developed the prodisc platform using a first-principles design approach intended to preserve spinal motion in a controlled and durable manner, avoiding both the permanent rigidity of spinal fusion and potential for excessive mobility of discs. The prodisc platform has four core advantages that we believe are essential for durable adoption of TDR: advanced kinematics, durable materials, a broad and configurable implant portfolio, and streamlined instrumentation. The prodisc platform has been developed over more than 35 years as a comprehensive set of systems designed to give surgeons flexibility in addressing patient-specific anatomy, disease severity, and procedural objectives. Our portfolio includes four cervical TDR systems and one lumbar TDR system, all derived from a common motion-preserving design philosophy and supported by streamlined instrumentation. In the United States, our portfolio of five Class III devices is supported by two pre-market approval (PMA) approvals and two Panel-track PMA supplements supported by investigational device exemption (IDE) clinical studies, along with 49 additional PMA supplements, reflecting a long history of successful regulatory execution and continuous product innovation. PMA-designated products require successful human trials and long-term follow-up as opposed to the majority of orthopedic devices, which are approved through the 510(k) pathway. prodisc has received FDA approval for both one-level and two-level procedures across cervical and lumbar indications, making it the only TDR platform with FDA-approved multi-level indications in both regions of the spine. Across the platform, surgeons can select from close to 100 distinct implant configurations spanning fixation methods, endplate geometries, footprint shapes, disc heights, and surgical techniques. We refer to this as our Match-the-Disc philosophy, which we believe supports optimized patient fit, broader surgeon adoption, repeat utilization, and expansion from single-region use to both cervical and lumbar applications within the same clinical practice. Underlying the prodisc platform is our proprietary prodisc CORE Technology, a fixed-core design that is engineered to deliver stable, predictable spinal kinematics while preserving motion at the treated level. This design incorporates a fixed center of rotation and an optimized curvature that is intended to maintain natural movement while avoiding unrestricted or uncontrolled motion that can place excess stress on nearby anatomy. By balancing stability with controlled movement, we believe CORE Technology supports normal spinal biomechanics and consistent implant performance over time. This foundational technology is deployed across our cervical and lumbar systems and is complemented by time-tested implant materials, including cobalt-chromium endplates, ultra-high molecular weight polyethylene inlays, and titanium surface coatings that have been used successfully for decades in spine and large-joint arthroplasty applications. The prodisc platform is supported by what we believe is the most extensive body of peer-reviewed clinical evidence in TDR. More than 300,000 prodisc implantations have been performed worldwide, generating real-world clinical data published in over 590 peer-reviewed clinical papers evaluating outcomes, biomechanics, and long-term performance. This evidence base spans more than 35 years and includes over 60 studies reporting extended long-term follow-up outcomes. Published data demonstrate revision rates of less than 1% for prodisc L TDR over 7 to 21 year follow-up period (Marnay et al., JBJS, 2025), radiographic motion maintenance within a normal functional range in approximately 94% of patients following prodisc L TDR (Zigler JE et al., Spine, 2007), and, in a head-to-head study against spinal fusion, approximately four-fold fewer adjacent-level surgical interventions at seven years following prodisc C TDR compared to spinal fusion (Janssen et al., JBJS, 2015). In addition, TDR studies comparing prodisc L TDR with lumbar fusion demonstrate higher (91% versus 81%) neurological success rates (Zigler JE et al., Spine, 2007) and greater long-term improvement (73% versus 60%) in disability scores (Delamarter et al., JBJS, 2011), and a TDR study comparing multiple lumbar TDR solutions with lumbar fusion showed a 48% relative reduction in the risk of reoperations (Zigler JE et al., Global Spine Journal, 2018). Robust long-term clinical success of prodisc L TDR has also been demonstrated with maintained reductions in disability and pain scores observed through up to 21 years of postoperative follow-up of 1,187 patients with chronic lumbar DDD who underwent lumbar total disc arthroplasty (Marnay et al., JBJS, 2025). We believe the breadth, duration, and consistency of this evidence support physician confidence, payor engagement, and broader adoption of TDR. We believe the evolution of spine surgery toward motion preserving solutions mirrors historical adoption patterns observed in other large orthopedic markets, including knee, hip, and shoulder, where treatment approaches have evolved over time from fusion- or fixation-based procedures to joint-preserving or joint-replacing solutions that restore or preserve motion. In each of these markets, motion-preserving solutions ultimately became the standard of care as patient preference, clinical evidence, surgeon familiarity, and the reimbursement landscape all matured. We believe the spine market is undergoing a similar transition, with increasing acceptance of TDR as a durable, motion-preserving alternative to fusion. We have established a scaled commercial organization dedicated exclusively to TDR, with broad reach across the United States and selected international markets. In the United States, our commercial organization includes 48 sales management and clinical support professionals as of June 30, 2026, supported by more than 400 distributors, enabling engagement with the over 1,500 surgeons that performed a TDR procedure with prodisc in 2025. Internationally, we operate in 35 countries as of June 30, 2026, supported by 11 direct commercial employees and a network of stocking and non-stocking distributors. Our commercial infrastructure is complemented by structured surgeon education programs and targeted direct-to-patient initiatives designed to reduce adoption barriers, expand appropriate patient selection, and support increased utilization across both cervical and lumbar applications. We believe the success of our commercial organization is reflected in the growing number of surgeons who perform TDR with prodisc, as well as the increasing utilization of prodisc among these surgeons. The chart below shows the number of surgeons in the United States who performed at least one TDR procedure with prodisc in the preceding four quarters, as well as high-volume users of prodisc. We define high-volume users as surgeons who performed twelve or more TDR procedures with prodisc over the prior four quarters, which we believe is indicative of deeper platform adoption within a surgeon’s clinical practice. --- Centinel Holdco was incorporated in Delaware on April 24, 2026. Our principal executive offices are located at 900 Airport Road, Suite 3B, West Chester, Pennsylvania 19380, and our telephone number is (484) 887-8810. Our website address is https://www.centinelspine.com.
申购参考 · 获配 vs 开盘买入
不构成申购建议开盘与收盘涨幅为示例输入(非预测),请按自己的情景修改。散户通常很难按发行价获配。
风险清单
- 价格区间可能在路演期间调整,最终以 424B4 定价为准;发行可能推迟或撤回。
- 开盘价常与发行价差距很大;锁定期到期后可能有集中卖出。
本页不构成申购建议,不评分、不给申购结论、不给新股预估上市价。