Carlsmed Reports Third Quarter 2025 Financial Results and Raises Full-Year Guidance

Rhea-AI Summary

Carlsmed (Nasdaq: CARL) reported Q3 2025 revenue of $13.1M, a 98% year‑over‑year increase, gross margin of 75.9%, and cash and equivalents of $115.5M as of September 30, 2025. The company raised full‑year 2025 revenue guidance to $49.0–$50.0M (≈80%–84% growth vs. 2024) and shortened aprevo implant lead times to 8 business days. CMS NTAP reimbursement for aprevo cervical procedures took effect Oct 1, 2025; commercial launch expected early 2026 and >50 cervical procedures completed in clinical evaluation. Carlsmed amended its debt facility to increase availability to $50M and extended maturity and interest‑only period.

Positive

• Q3 revenue of $13.1M (+98% YoY)
• Raised 2025 revenue guidance to $49.0–$50.0M (80%–84% growth)
• Gross margin at 75.9% in Q3 2025
• Reduced aprevo lead time to 8 business days beginning October
• CMS NTAP for aprevo cervical effective Oct 1, 2025 and >50 procedures

Negative

• Operating expenses increased to $19.0M in Q3 (from $12.6M)
• Net loss widened to $8.5M in Q3 2025
• Adjusted EBITDA loss of $8.2M in Q3 2025

Insights

Financial Results Analyst

Strong revenue growth and raised guidance offset by rising operating losses; cash runway appears healthy.

Revenue accelerated to $13.1 million in Q3, up 98% year‑over‑year, and management raised full‑year revenue guidance to $49.0 to $50.0 million, signaling execution against scaling plans. Gross margin improved to 75.9%, which coupled with expanding surgeon adoption (up >70% YoY) supports higher unit profitability as volumes grow.

Operating expenses rose to $19.0 million in Q3, widening the GAAP net loss to ($8.5) million and Adjusted EBITDA loss to ($8.2) million; these show continued investment in commercialization. Key items to watch over the next 6–12 months are actual revenue delivery versus the raised guidance, trajectory of operating expenses, and the company’s cash burn relative to the reported $115.5 million cash balance.

Medical Device Commercialization Expert

NTAP approval and early clinical uptake materially improve commercialization prospects for cervical platform.

CMS NTAP reimbursement effective October 1, 2025 for the cervical aprevo® product removes a major reimbursement barrier and supports a commercial launch expected in early 2026. The press release reports >50 cervical procedures completed and a reported two‑year data point showing a 75% reduction in revision surgery versus a matched cohort, which if reproducible will ease hospital adoption and payer conversations.

Execution risks remain: conversion from clinical evaluation to broad commercial use, surgeon training, and supply lead‑time consistency (now within eight business days) will determine uptake over the next 12–18 months. Monitor NTAP real‑world reimbursement implementation, physician adoption rates after launch, and any published peer‑review of the two‑year revision reduction data within that horizon.

Third quarter revenue of $13.1 million, representing 98% growth YoY 

Raising full year 2025 revenue guidance to $49 million - $50 million

CARLSBAD, Calif., Nov. 06, 2025 (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, 2025. 

"We delivered another strong quarter with 98% revenue growth year-over-year, expanded gross margins to 76%, increased surgeon users by more than 70% year-over-year, and reduced lead times to within 8 business days. These achievements demonstrate the incredible momentum and speed at which we are scaling while maintaining operational excellence,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “With NTAP reimbursement for cervical procedures secured and more than 50 patients treated in our clinical evaluation, we are tracking toward launching our cervical spine platform early next year to bring our transformative digital surgery approach to an even broader patient population.”

Recent Business Highlights   

• Reduced lead time for our aprevo^® interbody implants to hospitals to within eight business days of surgical plan approval beginning October (from 10 business days exiting Q2 2025 and 20 business days in Q3 2024)
• CMS New Technology Add-On Payment (NTAP) went into effect on October 1, 2025, for aprevo^® cervical procedures; commercial launch is expected in early 2026. To date, over 50 cervical aprevo procedures have been successfully completed by more than a dozen spine surgeons as part of our clinical evaluation program
• Data presented at the Scoliosis Research Society Annual Meeting in September demonstrated a 75% reduction in revision surgery at a two-year time point for aprevo^® versus a patient matched cohort
• Executed an amendment in October to our existing debt facility, increasing maximum availability to $50 million and extending the maturity date and interest-only payment period
• Announced the appointment of Jennifer Kamocsay as Chief Legal Officer and Secretary. Ms. Kamocsay brings more than a decade of corporate legal experience as counsel across the life science and technology sectors
  

 Third Quarter 2025 Financial Results

• Revenue was $13.1 million for the third quarter of 2025; a 98% increase compared to $6.6 million for the third quarter of 2024
• Gross profit for the third quarter of 2025 was $9.9 million compared to $4.8 million for the third quarter of 2024. Gross margin was 75.9% for the third quarter of 2025, compared with 72.8% for the third quarter of 2024  
• Operating expenses were $19.0 million for the third quarter of 2025, compared with $12.6 million for the third quarter of 2024, which consisted of:
  • Research and development expenses of $4.4 million for the third quarter of 2025, compared with $4.0 million for the third quarter of 2024 
  • Sales and marketing expenses of $9.6 million for the third quarter of 2025, compared with $6.6 million for the third quarter of 2024 
  • General and administrative expenses of $4.9 million for the third quarter of 2025, compared with $1.9 million for the third quarter of 2024 
• Net loss was ($8.5) million for the third quarter of 2025, compared to a ($7.8) million net loss for the third quarter of 2024  
• Adjusted EBITDA loss was ($8.2) million for the third quarter of 2025, compared to ($7.7) million for the third quarter of 2024 
• Cash and equivalents were $115.5 million as of September 30, 2025 
  

2025 Full Year Financial Outlook 

• Revenue for the full year 2025 is expected to be in the range of $49.0 to $50.0 million, representing growth of 80% to 84% over 2024. This compares to prior guidance of $45.5 to $47.5 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 third quarter 2025 performance. To access the webcast, please use the following link, which will provide you with dial-in details: https://edge.media-server.com/mmc/p/y7ki9icwCarlsmed Third Quarter 2025 Earnings Conference 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 (i) net interest expense and income, (ii) income tax expense (benefit), (iii) depreciation and amortization expense, (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 has limitations as an analytical tool and 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 Statement 

Any statements in this press release about future expectations, plans and prospects, including statements about the Carlsmed’s ability to scale the impact of its aprevo^® technology platform and advance its personalized spine surgery platform to transform patient outcomes and drive long-term growth, Carlsmed’s current expectation of commercially launching aprevo^® cervical in the United States in 2026, the number ranges presented in our 2025 Full Year 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 Registration Statement on Form S-1 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 
Caroline Corner, PhD 

IR@Carlsmed.com 

Media 
LeAnn Burton 
Senior Director Brand Marketing 
LBurton@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,
		2025				2024				2025				2024
Revenue		$	13,074			$	6,590			$	35,346			$	17,757
Cost of sales			3,147				1,792				8,914				4,733
Gross profit			9,927				4,798				26,432				13,024
Operating expenses:
Research and development			4,445				4,035				11,755				11,289
Sales and marketing			9,610				6,622				24,218				15,092
General and administrative			4,907				1,918				11,715				6,068
Total operating expenses			18,962				12,575				47,688				32,449
Loss from operations			(9,035)				(7,777)				(21,256)				(19,425)
Other income (expense):
Interest expense			(380)				(402)				(1,100)				(943)
Interest income			954				394				1,670				920
Change in fair value of warrant liabilities			(65)				(28)				(335)				(89)
Total other income (expense), net			509				(36)				235				(112)
Net loss and comprehensive loss			(8,526)				(7,813)				(21,021)				(19,537)
Deemed dividend to preferred stockholders			—				(592)				(584)				(592)
Net loss attributable to common stockholders		$	(8,526)			$	(8,405)			$	(21,605)			$	(20,129)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.40)			$	(2.06)			$	(2.15)			$	(4.97)
Weighted-average number of common shares used to compute basic and diluted net loss per share			21,081,330				4,088,553				10,051,623				4,046,210

CARLSMED, INC.

CONDENSED BALANCE SHEETS

(in thousands, except for share and par value amounts)
(unaudited)

		September 30, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents		$	115,373			$	40,125
Restricted cash			100				100
Accounts receivable, net of allowances of $1,601 and $1,239, as of September 30, 2025 and December 31, 2024, respectively			11,296				6,766
Inventory			1,340				995
Prepaid expenses and other current assets			3,356				1,365
Total current assets			131,465				49,351
Property and equipment, net			1,187				260
Operating lease right-of-use assets			1,986				1,644
Other assets			225				569
Total assets		$	134,863			$	51,824
Liabilities, Convertible Preferred Stock, and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable		$	2,672			$	2,412
Accrued liabilities			3,186				2,687
Accrued compensation			4,409				3,270
Short-term operating lease liabilities			661				449
Total current liabilities			10,928				8,818
Long-term portion of term loan, net			15,440				15,414
Long-term operating lease liabilities			1,513				1,317
Warrant liabilities			32				457
Other long-term liabilities			290				222
Total liabilities			28,203				26,228
Commitments and contingencies (Note 9)
Series A convertible preferred stock, $0.00001 par value; zero and 4,902,814 shares authorized, issued, and outstanding, and zero and $13,767 liquidation preference as of September 30, 2025 and December 31, 2024, respectively			—				13,578
Series B convertible preferred stock, $0.00001 par value; zero and 4,393,481 shares authorized, zero and 4,335,051 shares issued and outstanding, and zero and $30,000 liquidation preference as of September 30, 2025 and December 31, 2024, respectively			—				29,801
Series C convertible preferred stock, $0.00001 par value; zero and 4,910,500 shares authorized, zero and 4,890,123 shares issued and outstanding, and zero and $52,500 liquidation preference as of September 30, 2025 and December 31, 2024, respectively			—				52,847
Stockholders’ equity (deficit):
Preferred stock, $0.00001 par value; 10,000,000 and zero shares authorized, zero shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively			—				—
Common stock, $0.00001 par value; 600,000,000 and 21,835,801 shares authorized, 26,652,775 and 4,234,798 shares issued, and 26,584,077 and 4,139,219 shares outstanding as of September 30, 2025 and December 31, 2024, respectively			—				—
Additional paid-in capital			198,852				541
Accumulated deficit			(92,192)				(71,171)
Total stockholders’ equity (deficit)			106,660				(70,630)
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)		$	134,863			$	51,824

RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA

(unaudited)

		Three Months Ended September 30,											$				%
			2025					2024					Change				Change
(in thousands, except percentages)
Net loss		$		(8,526)			$		(7,813)			$		(713)				9.1%
Interest (income) expense				(574)					8					(582)			**
Income taxes				—					—					—				—
Depreciation and amortization				82					33					49				148.5%
EBITDA				(9,018)					(7,772)					(1,246)				16.0%
Stock-based compensation				704					66					638				966.7%
Change in fair value of warrant liabilities				65					28					37				132.1%
Adjusted EBITDA		$		(8,249)			$		(7,678)			$		(571)				7.4%

		Nine Months Ended September 30,										$					%
		2025					2024					Change					Change
(in thousands, except percentages)
Net loss		$		(21,021)			$		(19,537)			$		(1,484)				7.6%
Interest (income) expense				(570)					23					(593)			**
Income taxes				—					—					—				—
Depreciation and amortization				183					108					75				69.4%
EBITDA				(21,408)					(19,406)					(2,002)				10.3%
Stock-based compensation				1,137					153					984				643.1%
Change in fair value of warrant liabilities				335					89					246				276.4%
Adjusted EBITDA		$		(19,936)			$		(19,164)			$		(772)				4.0%

** Change not meaningful

FAQ

What were Carlsmed (CARL) third quarter 2025 results?

Carlsmed reported Q3 2025 revenue $13.1M, gross margin 75.9%, and net loss $8.5M.

How did Carlsmed change full‑year 2025 guidance on November 6, 2025?

The company raised 2025 revenue guidance to $49.0–$50.0M, up from prior $45.5–$47.5M.

What does the Oct 1, 2025 NTAP decision mean for CARL?

CMS NTAP for aprevo cervical procedures became effective Oct 1, 2025, supporting reimbursement ahead of a planned early‑2026 commercial launch.

How much cash did Carlsmed hold at September 30, 2025?

Carlsmed reported $115.5M in cash and equivalents as of September 30, 2025.

Did Carlsmed change its debt facility in October 2025?

Yes — an amendment increased maximum availability to $50M and extended the maturity and interest‑only period.

What clinical evidence did Carlsmed report regarding aprevo outcomes?

Data presented at the Scoliosis Research Society showed a 75% reduction in revision surgery at two years versus a matched cohort.