CARL

Company Overview — What Does CARLSMED, INC. Do?

We are a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. We are focused on becoming the standard of care for spine fusion surgery. The aprevo Technology Platform consists of artificial intelligence (“AI”)-enabled software solutions, and interbody implants that we custom design for each patient’s unique pathology and vertebral bone topography, and single-use surgical instruments (the “aprevo Technology Platform”). The aprevo Technology Platform was designed to address the limitations of traditional spine fusion surgery and aims to optimize patient outcomes and reduce the need for revision surgeries. By providing personalized surgical plans and interbody implants for custom vertebral fit that are powered by AI-enabled, outcomes-based algorithms, the aprevo Technology Platform supports surgeons in achieving proper spinal alignment for patients with degenerative disc disease (“DDD”), which can improve clinical outcomes and reduce the likelihood of revision surgeries. We currently market the aprevo Technology Platform for lumbar spine fusion surgery, and we are further developing the aprevo Technology Platform for use in cervical spine fusion surgeries, which we expect to commercialize in 2026. DDD is the progressive breakdown of spinal discs that are interposed between vertebrae to provide mobility and shock absorption. The disease occurs naturally with age and can be accelerated by factors such as injury, repetitive loading, obesity, or genetic predisposition. Adult spinal deformity (“ASD”) is a more severe form of DDD and is a condition where the spine has systematic structural abnormalities and/or abnormal curvature often affecting multiple levels of the spine. These conditions often cause a loss of disc height and spine function, and lead to chronic pain, disability, and other chronic spinal pathologies, significantly impacting patients’ lives. As the conditions progress and patients experience debilitating pain or disabilities, surgical intervention may become necessary. One study estimated that the overall prevalence of diagnosed DDD was 27.3% for individuals over the age of 65, and increased with age (Parenteau et al., 2021). Non-surgical interventions are typically the first line of treatment for DDD and are aimed at managing symptoms and slowing disease progression without invasive procedures. When non-surgical treatments fail to alleviate debilitating symptoms or disabilities, surgical interventions may become necessary. The most common surgical intervention and current standard of care is traditional spine fusion, which we define as a spine fusion procedure with stock implants that are fixed in size and shape. According to the SmartTRAK Report, there will be approximately 445,200 lumbar fusion surgeries and approximately 372,600 cervical fusion surgeries performed in the United States in 2025. Despite its wide adoption, we believe traditional spine fusion surgery has several limitations and can lead to poor clinical outcomes. First, traditional spine fusion often lacks robust pre-operative planning, relying on two-dimensional (“2D”) imaging without advanced tools, such as three-dimensional (“3D”) modeling. This limits the surgeon’s ability to plan for optimal correction. Second, the stock implants that are used during surgery are largely symmetric in shape and only come in pre-defined dimensions, which often fail to match the unique anatomy of each patient and can lead to unpredictable alignment. During the surgery, the surgeon must visually choose the correct stock implant from dozens of options, which involves a prolonged trialing process, and which we believe elevates the risk of secondary complications. Finally, post-operatively, there is no integrated means for reconciling achieved outcomes against surgical objectives and utilizing these insights systematically to improve future surgical plans. As a result of these limitations, traditional spine fusion surgery can fail to achieve proper alignment, leading to post-operative complications and increasing the likelihood of revision surgery. Recent publications on traditional spine fusion report rates of revision surgery for mechanical complications between 14% and 32% over a mean postoperative period of one to two years in ASD patients (Kent et al., 2024). We believe that these limitations and poor clinical outcomes not only impair patients’ health and quality of life but also impose a significant economic burden on the healthcare system with the direct and indirect costs of a revision surgery frequently exceeding $100,000 (Raman et al., 2018). The aprevo Technology Platform represents an end-to-end, integrated digital technology platform designed to deliver better surgical results, reduce the need for revision surgery, and improve long-term outcomes. The aprevo Technology Platform is the first available solution to provide personalized digital surgical plans and the accompanying aprevo interbody implants that are tailored to each patient’s unique pathology and vertebral bone topography. Our pre-operative planning software utilizes standard-of-care diagnostic imaging in combination with our AI-enabled algorithms to develop personalized digital surgical plans, allowing us to design aprevo interbody implants for each patient’s unique pathology and anatomy. Additionally, the aprevo Technology Platform supports the collection of post-operative data to inform our digital surgical planning process. The aprevo Technology Platform is 510(k) cleared by the U.S. Food and Drug Administration (“FDA”) and commercially available in the United States for lumbar interbody fusion surgeries. Procedures using our aprevo interbody implants are covered by Medicare, Medicare Advantage, and commercial payors; these are generally mapped to MS-DRG codes that provide for premium reimbursement for most spine fusion surgeries that utilize aprevo interbody implants relative to those that use stock implants. We believe this also helps drive surgeon adoption while also supporting patient access to our patient-centric technology. While our current commercial focus is on the U.S. market, we plan to engage in market access initiatives for strategic international regions. We are also developing our aprevo Technology Platform for use in cervical spine fusion surgeries, and in July 2025 successfully completed the first in-human personalized cervical procedure in the United States using our aprevo Technology Platform. In November 2024, we received FDA 510(k) clearance for our aprevo interbody implants for cervical interbody fusion surgeries after previously receiving FDA Breakthrough Device Designation for this technology. In 2025, we plan to continue to build our aprevo Technology Platform for cervical fusion procedures by pursuing additional clearances for advancements to our cervical software platform and our personalized plating solutions. However, 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. Assuming we get the necessary additional clearances, we expect to commercialize the aprevo Technology Platform for cervical fusion surgery in 2026. In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced proposed ICD-10-PCS (“X-codes”) for the use of custom-made anatomically designed fusion devices for cervical spine fusion surgeries. While there is no guarantee that this proposal will be approved in its current form, if approved in the CMS Final Rule, these X-codes will identify claims that are eligible for hospitals to receive NTAP of up to $21,125 per cervical spine fusion procedure. We estimate there is a total addressable market of approximately $13.4 billion for our aprevo Technology Platform in the United States, based on our current average selling price and the approximately 445,200 lumbar fusion surgeries that are expected to be performed in the United States in 2025, according to the SmartTRAK Report. Our total addressable market is the total overall revenue opportunity that we believe is available for the aprevo Technology Platform in the United States if we achieve 100% market share for lumbar fusion surgeries and is not a representation that we will achieve such market share. We estimate there are approximately 4,000 surgeons across the United States whose patients could benefit from using the aprevo Technology Platform (Moore et al., 2021). As of March 31, 2025, 177 surgeon users had completed one or more procedures using the aprevo Technology Platform, compared to 103 surgeon users as of March 31, 2024. As of June 30, 2025, 199 surgeon users had completed one or more procedures using the aprevo Technology Platform, compared to 116 surgeon users as of June 30, 2024. We believe this suggests ample opportunity to grow our surgeon user base and further penetrate the market by capturing more surgeons across the United States. --- We market and sell the aprevo Technology Platform to hospitals through a combination of our direct sales team and independent sales agents. Our direct sales team consists of Area Business Directors, Regional Sales Directors, Account Managers, and Strategic and National Account leadership, who are primarily responsible for selling the aprevo Technology Platform to surgeons and working with hospitals to secure product approval. They are also responsible for recruiting independent sales agents that cover each surgery, generating leads, and training clinics. We plan to grow our commercial infrastructure, including both our direct sales team and our number of independent sales agents, and expand various market access initiatives, including utilizing medical education programs and surgeon training at top academic institutions. A large body of evidence supports the clinical benefits of the aprevo Technology Platform for spine fusion, including seven peer-reviewed clinical data publications and 12 peer-reviewed clinical data abstracts. Across the various studies and publications, the aprevo Technology Platform has shown favorable results in two of the most critical success measures in spine fusion surgery: (1) achieving proper post-operative alignment and (2) obviating the need for revision surgery due to implant related complications. We continue to develop our growing base of clinical and patient reported outcomes to serve as evidence of the aprevo Technology Platform’s value to all key stakeholders, including patients, clinicians, hospitals, and payors. For example, we are currently conducting a 338-patient study, our COMPASS Registry, to track clinical outcomes from procedures using the aprevo Technology Platform in both DDD and ASD patients. Based on interim data from the first 67 ASD patients in our COMPASS Registry, these patients demonstrated improved alignment and reduced mechanical complications post-operatively, with a revision rate of 1.5% at one-year follow-up that were attributable to mechanical complications unrelated to the aprevo interbody implant (Kent et al., 2024). We have experienced sequential quarterly and annual revenue growth driven primarily by growth in our surgeon user base and increased utilization by our existing surgeon users. Our principal executive offices are located in Carlsbad, CA. CARLSMED, INC. (CARL) is classified as a micro-cap stock in the Healthcare sector, specifically within the Medical Equipment industry. The company is led by CEO Michael Cordonnier and employs approximately 100 people, headquartered in CARLSBAD, California. With a market capitalization of $257M, CARL is one of the notable companies in the Healthcare sector.

CARLSMED, INC. (CARL) Stock Rating — Avoid (April 2026)

As of April 2026, CARLSMED, INC. receives a Avoid rating with a composite score of 30.1/100 and 1 out of 5 stars from the Blank Capital Research quantitative model.CARL ranks #4,069 out of 4,446 stocks in our coverage universe. Within the Healthcare sector, CARLSMED, INC. ranks #712 of 838 stocks, placing it in the lower half of its Healthcare peers. The rating is generated by a multi-factor model that weighs quality (30%), momentum (25%), value (15%), investment (10%), stability (10%), and short interest (10%).

CARL Stock Price and 52-Week Range

CARLSMED, INC. (CARL) currently trades at $9.11. The stock lost $0.61 (6.3%) in the most recent trading session. The 52-week high for CARL is $17.19, which means the stock is currently trading -47.0% from its annual peak. The 52-week low is $10.65, putting the stock -14.5% above its annual trough. Recent trading volume was 113K shares, suggesting relatively thin trading activity.

Is CARL Overvalued or Undervalued? — Valuation Analysis

CARLSMED, INC. (CARL) carries a value factor score of 23/100 in the Blank Capital model, signaling premium valuation that prices in significant future growth. The price-to-book ratio stands at 2.63x, versus the sector average of 2.75x. The price-to-sales ratio is 1.29x, compared to 1.66x for the average Healthcare stock.

At current multiples, CARLSMED, INC. trades at a premium to most Healthcare peers. This elevated valuation may be justified if the company can sustain above-average growth rates and profitability, but it also creates downside risk if earnings disappoint expectations.

CARLSMED, INC. Profitability — ROE, Margins, and Quality Score

CARLSMED, INC. (CARL) earns a quality factor score of 34/100, signaling below-average profitability metrics relative to the broader market. The return on equity (ROE) is -119.9%, compared to the Healthcare sector average of -43.5%, which is below typical expectations for high-quality companies. Return on assets (ROA) comes in at -91.1% versus the sector average of -33.1%.

On a margin basis, CARLSMED, INC. reports gross margins of 75.3%, compared to 71.5% for the sector. The operating margin is -60.5% (sector: -66.1%). Net profit margin stands at -58.7%, versus -58.7% for the average Healthcare stock. Revenue growth is running at 98.4% on a trailing basis, compared to 10.6% for the sector. Profitability is below benchmark levels, which may reflect industry headwinds, elevated reinvestment, or structural challenges.

CARL Debt, Balance Sheet, and Financial Health

CARLSMED, INC. has a debt-to-equity ratio of 16.0%, compared to the Healthcare sector average of 32.0%. The low leverage indicates a conservative balance sheet with significant financial flexibility. The current ratio is 8.87x, indicating strong short-term liquidity. Total debt on the balance sheet is $15M. Cash and equivalents stand at $115M.

CARL has a beta of 1.53, meaning it is more volatile than the broader market — a $10,000 investment in CARL would be expected to move 53.4% more than the S&P 500 on any given day. The stability factor score for CARLSMED, INC. is 31/100, suggesting elevated price swings that may be unsuitable for conservative portfolios.

CARLSMED, INC. Revenue and Earnings History — Quarterly Trend

In TTM 2026, CARLSMED, INC. reported revenue of $51M and earnings per share (EPS) of $-2.12. Net income for the quarter was $-30M. Gross margin was 75.3%. Operating income came in at $-31M.

In FY 2025, CARLSMED, INC. reported revenue of $51M and earnings per share (EPS) of $-2.12. Net income for the quarter was $-30M. Gross margin was 75.3%. Operating income came in at $-31M.

In Q3 2025, CARLSMED, INC. reported revenue of $13M and earnings per share (EPS) of $-0.40. Net income for the quarter was $-9M. Gross margin was 75.9%. Operating income came in at $-9M.

In Q2 2025, CARLSMED, INC. reported revenue of $12M and earnings per share (EPS) of $-1.47. Net income for the quarter was $-7M. Gross margin was 73.4%. Operating income came in at $-7M.

Over the past 4 quarters, CARLSMED, INC. has demonstrated a growth trajectory, with revenue expanding from $12M to $51M. Investors analyzing CARL stock should weigh these quarterly trends alongside the valuation and quality metrics discussed above.

CARL Dividend Yield and Income Analysis

CARLSMED, INC. (CARL) does not currently pay a dividend. This is common among smaller companies in the Medical Equipment industry that prefer to reinvest cash flows into business expansion rather than returning capital to shareholders. Income-focused investors looking for Healthcare dividend stocks may want to explore other Healthcare stocks or use the stock screener to filter by dividend yield.

CARL Momentum and Technical Analysis Profile

CARLSMED, INC. (CARL) has a momentum factor score of 24/100, signaling weak relative price performance. Stocks with low momentum scores have historically tended to continue underperforming in the near term. The investment factor score is 25/100, which measures capital allocation efficiency and asset growth patterns. The short interest score of 47/100 reflects moderate short selling activity.

CARL vs Competitors — Healthcare Sector Ranking and Peer Comparison

Within the Healthcare sector, CARLSMED, INC. (CARL) ranks #712 out of 838 stocks based on the Blank Capital composite score. This places CARL in the lower half of all Healthcare stocks in our coverage universe. Key competitors and sector peers include ASTRAZENECA PLC (AZN) with a score of 61.4/100, Sol-Gel Technologies Ltd. (SLGL) with a score of 56.6/100, VIEMED HEALTHCARE, INC. (VMD) with a score of 53.4/100, Innoviva, Inc. (INVA) with a score of 52.7/100, and JOHNSON & JOHNSON (JNJ) with a score of 51.7/100.

Comparing CARL against the S&P 500 benchmark is also instructive for understanding relative performance. Investors can view the full CARL vs S&P 500 (SPY) comparison to assess how CARLSMED, INC. stacks up against the broader market across all factor dimensions.

CARL Next Earnings Date

No upcoming earnings date has been announced for CARLSMED, INC. (CARL) at this time. Check the earnings calendar for the latest scheduling updates across all stocks in our coverage universe.

Should You Buy CARL? — Investment Thesis Summary

The quantitative profile for CARLSMED, INC. suggests caution. The quality score of 34/100 flags below-average profitability. The value score of 23/100 indicates premium valuation. Momentum is weak at 24/100, a headwind for near-term performance. High volatility (stability score 31/100) increases portfolio risk.

In summary, CARLSMED, INC. (CARL) earns a Avoid rating with a composite score of 30.1/100 as of April 2026. The rating is derived from the Blank Capital Research methodology, which combines six factor dimensions into a single quantitative ranking. Investors should consider these quantitative signals alongside their own fundamental research, risk tolerance, and investment time horizon before making buy or sell decisions on CARL stock.

Related Resources for CARL Investors

Explore more research and tools: CARL vs S&P 500 comparison, top Healthcare stocks, stock screener, our methodology, quality factor explained, value factor explained, momentum factor explained. Compare CARL head-to-head with peers: CARL vs AZN, CARL vs SLGL, CARL vs VMD.