Third quarter 2026 revenue of $21.6 million, representing 65% growth year-over-year

Full year 2026 revenue guidance raised to $78 million to $80 million

CARLSBAD, Calif., Nov. 10, 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 third quarter ended September 30, 2026.

“The third quarter represented strong execution against our long-term strategy as we delivered 65% revenue growth and advanced our leadership position in AI-enabled personalized surgery as we grew our surgeon user base by more than 60% over the prior year,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “We broadened our personalized surgery platform, strengthened our leadership team, and secured new inpatient CMS reimbursement for our aprevo® lumbar spine fusion procedure. Taken together with our differentiated, capital-light model, these accomplishments reinforce our foundation for sustainable, profitable long-term growth as we head into 2027.”

Recent Business Highlights

  • CMS Inpatient Prospective Payment System (IPPS) rule for fiscal year 2027 became effective October 1, 2026, with increased reimbursement for inpatient aprevo® lumbar procedures
  • Launched aprevo® Lumbar Bi-lateral Posterior System in October, which the Company estimates addresses approximately 30,000 U.S. lumbar fusion procedures annually
  • Further strengthened leadership team to drive productivity, scale, and patient-centric innovation with the promotion of Jeff Bertolini to Chief Operating Officer, the appointment of Rich Heppenstall as Chief Financial Officer, and the addition of Tony Jarc, Ph.D., as Chief Product and AI Officer
  • Raised full-year 2026 revenue guidance to a range of $78 million to $80 million, over 56% growth at the midpoint versus full-year 2025

Third Quarter 2026 Financial Results

  • Revenue was $21.6 million for the third quarter of 2026, a 65% increase compared to $13.1 million in the third quarter of 2025.
  • Gross profit for the third quarter of 2026 was $16.7 million compared to $9.9 million for the third quarter of 2025. Gross margin was 77.3% for the third quarter of 2026, compared with 75.9% in the third quarter of 2025.
  • Operating expenses were $29.4 million for the third quarter of 2026, compared with $19.0 million for the third quarter of 2025, and included $2.8 million in expenses related to executive transition costs and the expected resolution of certain legal matters. Operating expenses consisted of:
    • Research and development expenses of $6.4 million for the third quarter of 2026, compared with $4.4 million for the third quarter of 2025.
    • Sales and marketing expenses of $13.0 million for the third quarter of 2026, compared with $9.6 million for the third quarter of 2025.
    • General and administrative expenses of $10.0 million for the third quarter of 2026, compared with $4.9 million for the third quarter of 2025.
  • Net loss was ($12.2) million for the third quarter of 2026, compared to ($8.5) million for the third quarter of 2025.
  • Adjusted EBITDA was ($7.3) million for the third quarter of 2026, compared to ($8.2) million for the third quarter of 2025.
  • Cash and cash equivalents, restricted cash, short-term investments, and marketable securities were $80.3 million as of September 30, 2026.

2026 Financial Outlook

Revenue for the full year 2026 is expected to be in the range of $78 million to $80 million, representing growth of over 56% at the midpoint. This compares to prior annual revenue guidance of $74 to $78 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 EBITDA, adjusted EBITDA, adjusted net loss and adjusted net loss per share. 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 EBITDA as net income (loss), adjusted to exclude: (i) net interest (income) expense, (ii) income tax expense (benefit), (iii) depreciation expense from property and equipment, and (iv) amortization expense from long-lived assets. We define “Adjusted EBITDA” as EBITDA adjusted to exclude (i) stock-based compensation expense, (ii) acquisition and transaction costs, (iii) acquired intangible asset amortization and impairments, (iv) restructuring and cost reduction initiatives, (v) executive transition costs, (vi) legal settlements net of proceeds from insurance in excess of legal fees, (vii) changes in fair value of warrant liabilities and gains and losses on debt extinguishments or modifications, and (viii) non-operating investment gains and losses. 

We define “Adjusted Net Loss” as net loss, adjusted to exclude: (i) acquisition and transaction costs, (ii) acquired intangible asset amortization and impairments, (iii) restructuring and cost reduction initiatives, (iv) executive transition costs, (v) legal settlements net of proceeds from insurance in excess of legal fees, (vi) change in fair value of warrant liabilities and gains and losses on debt extinguishments or modifications, and (vii) non-operating investment gains and losses. We define “Adjusted Net Loss Per Share” as Adjusted Net Loss divided by the weighted-average number of shares of common stock outstanding during the period, adjusted to exclude shares that were accelerated upon executive severance. Each item excluded in a period is separately identified and quantified in the reconciliation that follows. 

These non-GAAP measures are presented because management believes they allow 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 non-GAAP metrics, in addition to considering the Company’s GAAP financial measures. 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. These non-GAAP measures 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. Reconciliations of EBITDA and adjusted EBITDA, as well as Adjusted Net Loss and Adjusted Net Loss Per Share, are reported in this press release to the most comparable GAAP measure for the respective periods and appears in the table captioned “Reconciliation of GAAP Net Loss to Adjusted EBITDA” and “Reconciliation of GAAP Net Loss to Adjusted Net Loss Per Share” respectively. 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, our expectations regarding potential market size, Carlsmed’s ability to continue improving our products and technology and to develop new 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 Carlsmed’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent Quarterly Reports on Form 10-Q 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
Marketing@Carlsmed.com

   
CARLSMED, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
(unaudited)
  
             
    Three Months Ended
September 30,		     Nine Months Ended
September 30,		  
    2026     2025     2026     2025  
Revenue   $ 21,554     $ 13,074     $ 56,610     $ 35,346  
Cost of sales     4,889       3,147       12,978       8,914  
Gross profit     16,665       9,927       43,632       26,432  
Operating expenses:                        
Research and development     6,380       4,445       17,598       11,755  
Sales and marketing     13,004       9,610       35,221       24,218  
General and administrative     9,982       4,907       23,826       11,715  
Total operating expenses     29,366       18,962       76,645       47,688  
Loss from operations     (12,701 )     (9,035 )     (33,013 )     (21,256 )
Other income (expense):                        
Interest expense     (316 )     (380 )     (940 )     (1,100 )
Interest income     772       954       2,502       1,670  
Change in fair value of warrant liabilities     —       (65 )     —       (335 )
Total other income (expense), net     456       509       1,562       235  
Net loss     (12,245 )     (8,526 )     (31,451 )     (21,021 )
Deemed dividend to preferred stockholders     —       —       —       (584 )
Net loss attributable to common stockholders   $ (12,245 )   $ (8,526 )   $ (31,451 )   $ (21,605 )
                         
Net loss   $ (12,245 )   $ (8,526 )   $ (31,451 )   $ (21,021 )
Other comprehensive loss:                        
Unrealized loss on available-for-sale debt securities     (21 )     —       (38 )     —  
Total other comprehensive loss     (21 )     —       (38 )     —  
Total comprehensive loss   $ (12,266 )   $ (8,526 )   $ (31,489 )   $ (21,021 )
                         
Net loss per share attributable to common stockholders, basic and diluted   $ (0.45 )   $ (0.40 )   $ (1.16 )   $ (2.15 )
Weighted-average number of common shares used to compute basic and diluted net loss per share     27,303,162       21,081,330       27,104,729       10,051,623  

   
CARLSMED, INC.
CONDENSED BALANCE SHEETS
(in thousands, except for share and par value amounts)
(unaudited)
  
             
    September 30, 2026     December 31, 2025  
Assets            
Current assets:            
Cash and cash equivalents   $ 35,945     $ 85,793  
Restricted cash     100       100  
Short-term investments     24,000       24,000  
Marketable securities     20,262       —  
Accounts receivable, net of allowances of $1,495 and $1,653, as of September 30, 2026, and December 31, 2025, respectively     16,884       11,362  
Inventory     2,987       1,845  
Prepaid expenses and other current assets     5,377       3,573  
Total current assets     105,555       126,673  
Property and equipment, net     3,611       1,487  
Operating lease right-of-use assets     5,707       1,826  
Other assets     397       134  
Total assets   $ 115,270     $ 130,120  
             
Liabilities and Stockholders’ Equity            
Current liabilities:            
Accounts payable   $ 3,311     $ 4,481  
Accrued liabilities     6,766       3,287  
Accrued compensation     7,371       5,760  
Short-term operating lease liabilities     789       752  
Total current liabilities     18,237       14,280  
Long-term portion of term loan, net     15,400       15,346  
Long-term operating lease liabilities     5,596       1,316  
Other long-term liabilities     363       309  
Total liabilities     39,596       31,251  
Commitments and contingencies            
             
Stockholders’ equity:            
Preferred stock, $0.00001 par value; 10,000,000 shares authorized and zero shares issued and outstanding as of September 30, 2026, and December 31, 2025     —       —  
Common stock, $0.00001 par value; 600,000,000 shares authorized, 27,387,646 shares issued and outstanding as of September 30, 2026; 600,000,000 shares authorized, 26,664,243 shares issued, and 26,604,505 shares outstanding as of December 31, 2025     —       —  
Additional paid-in capital     207,968       199,674  
Accumulated deficit     (132,256 )     (100,805 )
Accumulated other comprehensive loss     (38 )     —  
Total stockholders’ equity     75,674       98,869  
Total liabilities and stockholders’ equity   $ 115,270     $ 130,120  

RECONCILIATION OF GAAP NET LOSS
TO ADJUSTED EBITDA
(unaudited)
 
                       
    Three Months Ended September 30,       $     %    
      2026       2025       Change     Change    
(in thousands, except percentages)                                
Net loss   $   (12,245 )   $   (8,526 )   $   (3,719 )     43.6   %
Interest (income) expense       (456 )       (574 )       118     (20.6 ) %
Income taxes       —         —         —       **    
Depreciation and amortization       126         82         44       53.7   %
EBITDA       (12,575 )       (9,018 )       (3,557 )     39.4   %
Stock-based compensation       2,466         704         1,762       250.3   %
Executive transition costs       2,390         —         2,390       **    
Legal settlements       450         —         450       **    
Change in fair value of warrant liabilities       —         65         (65 )     (100.0 ) %
Adjusted EBITDA   $   (7,269 )   $   (8,249 )   $   980       (11.9 ) %

    Nine Months Ended September 30,       $     %    
      2026       2025       Change     Change    
(in thousands, except percentages)                                
Net loss   $   (31,451 )   $   (21,021 )   $   (10,430 )     49.6   %
Interest (income) expense       (1,562 )       (570 )       (992 )   174.0   %
Income taxes       —         —         —       **    
Depreciation and amortization       355         183         172       94.0   %
EBITDA       (32,658 )       (21,408 )       (11,250 )     52.6   %
Stock-based compensation       6,366         1,137         5,229       459.9   %
Executive transition costs       2,390         —         2,390       **    
Legal settlements       450         —         450       **    
Change in fair value of warrant liabilities       —         335         (335 )     (100.0 ) %
Adjusted EBITDA   $   (23,452 )   $   (19,936 )   $   (3,516 )     17.6   %

**Prior year amount was $0, percentage change not meaningful

 
RECONCILIATION OF GAAP NET LOSS
TO ADJUSTED NET LOSS PER SHARE
(unaudited)
           
    Three Months Ended September 30,   $ %
    2026   2025   Change Change
(in thousands, except share, per share amounts, and percentages)  
Net loss $ (12,245 ) $ (8,526 ) $ (3,719 ) 43.6   %
Executive transition costs   2,390     —     2,390   **    
Legal settlements   450     —     450   **    
Change in fair value of warrant liabilities   —     65     (65 ) (100.0 ) %
Adjusted Net Loss   (9,405 )   (8,461 )   (944 ) 11.2   %
                         
Weighted average common shares outstanding   27,303,162     21,081,330     6,221,832   29.5   %
Less: Accelerated shares from executive transition   (959 )   —     (959 ) **    
Adjusted weighted average common shares outstanding   27,302,203     21,081,330     6,220,873   29.5   %
                         
Adjusted Net Loss Per Share $ (0.34 ) $ (0.40 ) $ 0.06   (15.0 ) %

    Nine Months Ended     September 30,   $ %
    2026   2025   Change Change
(in thousands, except share, per share amounts, and percentages)  
Net loss $ (31,451 ) $ (21,021 ) $ (10,430 ) 49.6   %
Executive transition costs   2,390     —     2,390   **    
Legal settlements   450     —     450   **    
Change in fair value of warrant liabilities   —     335     (335 ) (100.0 ) %
Adjusted Net Loss   (28,611 )   (20,686 )   (7,925 ) 38.3   %
                         
Weighted average common shares outstanding   27,104,729     10,051,623     17,053,106   169.7   %
Less: Accelerated shares from executive transition   (323 )   —     (323 ) **    
Adjusted weighted average common shares outstanding   27,104,406     10,051,623     17,052,783   169.7   %
                         
Adjusted Net Loss Per Share $ (1.06 ) $ (2.06 ) $ 1.00   (48.5 ) %

**Prior year amount was $0, percentage change not meaningful


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