Second quarter 2026 revenue of $18.9 million, representing 57% growth year-over-year

Full year 2026 revenue guidance raised to $74 million to $78 million

CARLSBAD, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) ("Carlsmed" or the "Company"), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today reported financial results for the second quarter ended June 30, 2026.

"Our second quarter 2026 results reflect the growing momentum of aprevo$(R)$ procedures and further progress on our path to profitability," said Mike Cordonnier, Chairman and Chief Executive Officer. "We delivered 57% revenue growth year-over-year, expanded gross margins by 340 basis points, and grew our trained surgeon user base by more than 60% over the prior year. We continue to see strong volume growth across lumbar and cervical aprevo(R) procedures, with continued advancements in our proprietary digital production system enabling scalability ahead of strong market demand. We believe the recent CMS ruling -- which takes effect on October 1, 2026, and provides new and enhanced hospital reimbursement for the aprevo(R) lumbar procedure -- positions us well for ongoing growth in the years to come."

Recent Business Highlights

   -- Surgeon adoption grew significantly, with total trained surgeon users up 
      over 60% year-over-year, led by strong engagement from early-career and 
      post-fellowship surgeons 
 
   -- CMS Inpatient Prospective Payment System (IPPS) rule for fiscal year 2027 
      recently finalized to include three new MS-DRG codes and favorable 
      reimbursement for inpatient aprevo(R) lumbar procedures, a significant 
      milestone towards expanding access for Medicare patients 
 
   -- aprevo(R) cervical completed second full quarter of commercialization, 
      now representing approximately 10% of quarterly revenue, with surgeon 
      training on the platform expanding significantly since last quarter 
 
   -- Raised full-year 2026 revenue guidance to a range of $74--$78 million, 
      over 50% growth at the midpoint versus full-year 2025, reflecting strong 
      volume trends and a robust pipeline 

Second Quarter 2026 Financial Results

   -- Revenue was $18.9 million for the second quarter of 2026, a 57% increase 
      compared to $12.1 million in the second quarter of 2025. 
 
   -- Gross profit for the second quarter of 2026 was $14.5 million compared to 
      $8.9 million for the second quarter of 2025. Gross margin was 76.8% for 
      the second quarter of 2026, compared with 73.4% in the second quarter of 
      2025. 
 
   -- Operating expenses were $25.6 million for the second quarter of 2026, 
      compared with $15.4 million for the second quarter of 2025, which 
      consisted of: 
 
          -- Research and development expenses of $6.0 million for the second 
             quarter of 2026, compared with $4.2 million for the second quarter 
             of 2025. 
 
          -- Sales and marketing expenses of $11.9 million for the second 
             quarter of 2026, compared with $7.9 million for the second quarter 
             of 2025. 
 
          -- General and administrative expenses of $7.6 million for the second 
             quarter of 2026, compared with $3.3 million for the second quarter 
             of 2025. 
 
   -- Net loss was ($10.5) million for the second quarter of 2026, compared to 
      a ($6.8) million net loss for the second quarter of 2025. 
 
   -- Adjusted EBITDA was ($8.6) million for the second quarter of 2026, 
      compared to ($6.2) million for the second quarter of 2025. 
 
   -- Cash and cash equivalents, restricted cash, short-term investments, and 
      marketable securities were $89.3 million as of June 30, 2026. 

2026 Financial Outlook

   -- Revenue for the full year 2026 is expected to be in the range of $74 to 
      $78 million, representing growth of over 50% at the midpoint of the range 
      over 2025. This compares to prior guidance of $72 to $77 million. 

Webcast & Conference Call Details

Carlsmed will host a conference call and concurrent webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time), to review the Company's performance. A live webcast of the conference call will be available in the Events & Presentations section of the Company's investor website at investors.carlsmed.com. A replay will be archived on the Company's website following completion of the call.

Non-GAAP Financial Measures

This press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles ("GAAP"), including adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Carlsmed's financial measures presented in this press release that are calculated and presented in accordance with GAAP.

The Company calculates adjusted EBITDA as net income (loss), as adjusted to exclude, as applicable, (i) net interest income (expense), (ii) income tax expense (benefit), (iii) depreciation expense from property and equipment (iv) amortization expense from long-lived assets, (iv) stock-based compensation expense and (v) change in fair value of warrant liabilities.

This non-GAAP measure is presented because management believes it allows investors to view the Company's performance in a manner similar to the method used by management to evaluate financial performance for both strategic and annual operating planning. Management believes that to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of adjusted EBITDA, in addition to considering the Company's GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of the Company's ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare the Company's period-over-period results.

The non-GAAP financial measures used by Carlsmed may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Carlsmed's financial results prepared and reported in accordance with GAAP. This non-GAAP measure should not be construed as an inference that the Company's future results will be unaffected by unusual or non-recurring items. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned "Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA" later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers.

About Carlsmed

Carlsmed is a 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.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects, including statements about Carlsmed's growth prospects and future performance, the ability of Carlsmed to achieve profitability in the near term or at all, the scalability of Carlsmed's business, the level of demand for Carlsmed's products, the impact of the recent CMS ruling on Carlsmed's business , the revenue ranges presented in our 2026 Financial Outlook, and other statements containing the words "anticipate, " "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "likely," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption "Risk Factors" in the Carlsmed's Annual Report on Form 10-K on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed's views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed's views as of any date subsequent to the date of this press release.

Investor Relations

IR@Carlsmed.com

Media