Here are 1-3 brief analogies for Carlsmed:

• Invisalign for spine implants
• Warby Parker for spine implants

• aprevo AI-enabled Software Solutions: This software utilizes AI algorithms and diagnostic imaging to develop personalized digital surgical plans for spine fusion procedures.
• aprevo Interbody Implants: These are custom-designed interbody implants tailored to each patient's unique pathology and vertebral bone topography for optimal spine fusion.
• aprevo Single-Use Surgical Instruments: These specialized instruments are provided as part of the aprevo Technology Platform to facilitate precise spine fusion surgeries.

Carlsmed (CARL) primarily sells its aprevo Technology Platform to hospitals.

The provided company description does not list the names of specific hospital systems or individual hospitals that are its major customers.

Mike Cordonnier, Co-Founder, President, Chief Executive Officer, and Chairman of the Board

Mike Cordonnier co-founded Carlsmed in 2018. He has over two decades of leadership experience introducing groundbreaking medical technologies across both private and public organizations, including NuVasive, Ellipse Technologies, Zimmer Biomet, Orchid Orthopedics, and X-Spine Systems. He led the commercialization of the PRECICE deformity correction technology for Ellipse Technologies, which was subsequently acquired by NuVasive. Before Ellipse, he was responsible for the development and successful launch of the patient-specific digital dentistry business at Zimmer Biomet.

Leo Greenstein, Chief Financial Officer and Treasurer

Leo Greenstein brings over two decades of strategic financial leadership experience from the surgical device, biotechnology, and oncology diagnostics sectors. Prior to joining Carlsmed, he served as CFO of Tarsus Pharmaceuticals, Inc., where he was instrumental in guiding the company through significant growth and its IPO in October 2020. He is a Certified Public Accountant and a member of the California State Bar.

Niall Casey, Co-Founder, Chief Intellectual Property Officer, and Director

Niall Casey co-founded Carlsmed with Mike Cordonnier in 2018. He possesses extensive expertise in the spine industry, having held technology leadership roles at companies such as Alphatec Spine, Ellipse Technologies, NuVasive, and Johnson & Johnson DePuy Synthes Spine.

Scott Durall, Chief Commercial Officer

Scott Durall has more than 30 years of experience in the medical device industry, with a background that includes leadership positions in sales, marketing, and corporate strategy at companies such as U.S. Surgical.

Jennifer Kamocsay, Chief Legal Officer and Secretary

Jennifer Kamocsay serves as the Chief Legal Officer at Carlsmed and is also the Secretary of the Carlsmed Board of Directors.

The key risks to Carlsmed's business include:

1. Failure to Obtain Timely FDA Clearances for Cervical Products: Carlsmed's planned commercialization of its aprevo Technology Platform for cervical fusion surgery in 2026 is contingent upon obtaining additional FDA clearances for its cervical software platform and personalized plating solutions. The company explicitly states there is "no guarantee that our cervical software platform and our personalized plating solutions will obtain FDA clearance on the expected timeline, or at all." Failure to secure these clearances could significantly delay or prevent entry into the cervical spine fusion market, a key growth area for the company.

2. Uncertainty of CMS X-code Approval for Cervical Procedures: Carlsmed's potential for enhanced reimbursement and market adoption for its cervical spine fusion technology is linked to the proposed CMS ICD-10-PCS ("X-codes") for custom-made anatomically designed fusion devices. These X-codes, if approved, could enable hospitals to receive additional New Technology Add-on Payments (NTAP) of up to $21,125 per procedure. However, the company notes, "there is no guarantee that this proposal will be approved in its current form." Without this premium reimbursement, the financial incentive for hospitals to adopt the aprevo Technology Platform for cervical fusions might be reduced, potentially hindering market penetration and revenue growth in this segment.

3. Challenges in Expanding Surgeon Adoption and Market Penetration: Despite the perceived benefits of the aprevo Technology Platform over traditional spine fusion surgery, Carlsmed faces the ongoing challenge of expanding its surgeon user base. As of June 30, 2025, the company had 199 surgeon users compared to an estimated 4,000 surgeons across the United States whose patients could benefit from the technology. Successfully growing this user base and overcoming the inertia associated with established traditional surgical methods is crucial for achieving its estimated $13.4 billion total addressable market in the United States and driving sustained revenue growth.

The total addressable market for Carlsmed's aprevo Technology Platform in the United States is approximately $13.4 billion. This estimate is based on the projected 445,200 lumbar fusion surgeries in the United States in 2025 and the company's current average selling price.

• Commercialization of the aprevo Technology Platform for cervical spine fusion surgeries: Carlsmed expects to commercialize its aprevo Technology Platform for cervical spine fusion surgeries in 2026, following successful completion of the first in-human personalized cervical procedure in July 2025 and FDA 510(k) clearance for its aprevo interbody implants for cervical interbody fusion surgeries in November 2024.
• Expansion of the surgeon user base and increased utilization in lumbar spine fusion: The company sees ample opportunity to grow its surgeon user base, noting an increase from 103 surgeon users as of March 31, 2024, to 177 as of March 31, 2025, and from 116 to 199 surgeon users as of June 30, 2025. This indicates continued market penetration and adoption of their aprevo Technology Platform for lumbar spine fusion.
• Potential favorable reimbursement for cervical spine fusion surgeries through CMS X-codes: In April 2025, CMS announced proposed ICD-10-PCS (X-codes) for custom-made anatomically designed fusion devices for cervical spine fusion surgeries. If approved, these X-codes could make hospitals eligible for NTAP of up to $21,125 per cervical spine fusion procedure, which is expected to drive surgeon adoption and patient access.
• Expansion into strategic international markets: While currently focused on the U.S. market, Carlsmed plans to engage in market access initiatives for strategic international regions, opening up new geographical markets for its aprevo Technology Platform.

Share Repurchases

• Carlsmed has no history of share buybacks.

Share Issuance

• Carlsmed completed its Initial Public Offering (IPO) in July 2025, offering 6,700,000 shares of common stock at an initial public offering price of $15.00 per share.
• The gross proceeds from the IPO were approximately $100.5 million, before deducting underwriting discounts, commissions, and other offering expenses.
• Underwriters were granted a 30-day option to purchase up to an additional 1,005,000 shares of common stock at the initial public offering price.

Inbound Investments

• In March 2024, Carlsmed raised $52.5 million in venture capital funding through a Series C round co-led by B Capital and U.S. Venture Partners.
• The company's Initial Public Offering in July 2025 also served as a significant inbound investment, raising over $100 million and materially strengthening its financial position for growth investments.