UPDATE - Carlsmed® Reports Second Quarter 2025 Financial Results

Rhea-AI Summary

Carlsmed (NASDAQ:CARL), a medical technology company specializing in AI-enabled personalized spine surgery solutions, reported strong Q2 2025 financial results. Revenue reached $12.1 million, marking a 99% year-over-year growth. The company achieved a gross margin of 73.4% and reported a net loss of $6.8 million.

Key highlights include the successful completion of their first personalized cervical spine surgery using the aprevo® technology platform, and receiving CMS New Technology Add-On Payment (NTAP) reimbursement for aprevo® cervical procedures. The company maintains a strong financial position with $33.5 million in cash and recently raised $93.5 million through their IPO in July 2025.

Looking ahead, Carlsmed projects full-year 2025 revenue between $45.5-47.5 million, representing 67-75% growth over 2024.

Positive

• Revenue grew 99% year-over-year to $12.1 million in Q2 2025
• Strong gross margin of 73.4% in Q2 2025
• Successful IPO raising $93.5 million in net proceeds
• Received CMS New Technology Add-On Payment approval for cervical procedures
• Completed first personalized cervical spine surgery using aprevo® platform
• Projected strong full-year revenue growth of 67-75% for 2025

Negative

• Net loss increased to $6.8 million in Q2 2025 from $6.3 million in Q2 2024
• Operating expenses increased 41% to $15.4 million
• Gross margin declined from 75.0% to 73.4% due to expedited production fees
• Increased expenses across R&D, sales and marketing, and administrative functions

Insights

Healthcare Technology Financial Analyst

Carlsmed reported strong 99% YOY revenue growth to $12.1M, though expenses are outpacing revenue with continued net losses.

Carlsmed's Q2 2025 results showcase impressive commercial momentum with revenue reaching $12.1 million, representing 99% year-over-year growth. This substantial growth stems from increased adoption of their aprevo® AI-enabled personalized spine surgery platform, demonstrating strong market penetration in the personalized medical device space.

The gross margin of 73.4% remains healthy despite a slight decline from 75.0% in Q2 2024, primarily due to expedited production costs. This margin level is still quite favorable for a medical technology company, suggesting efficient manufacturing processes despite the scaling challenges.

However, the company continues to operate at a loss with net losses of $6.8 million for the quarter, slightly higher than the $6.3 million loss in the same period last year. Operating expenses increased substantially to $15.4 million from $10.9 million, growing at a faster rate (41%) than gross profit. This indicates the company is heavily investing in growth initiatives, particularly in sales and marketing ($7.9 million, up 61%) to drive adoption.

The recent IPO has significantly strengthened Carlsmed's financial position, with $93.5 million in net proceeds providing substantial runway for continued expansion. With $33.5 million in cash as of quarter-end (pre-IPO), and the additional capital raised, the company appears well-funded to pursue its growth strategy.

The full-year revenue guidance of $45.5-47.5 million represents 67-75% year-over-year growth, suggesting management expects continued strong commercial performance but at a somewhat moderated pace compared to Q2's 99% growth. The successful expansion into cervical spine procedures and securing CMS New Technology Add-On Payment reimbursement are significant operational achievements that should support future growth.

Medical Device Innovation Expert

Carlsmed's AI-enabled spine technology is gaining rapid market adoption with new cervical spine applications expanding their addressable market.

The 99% year-over-year revenue growth demonstrates exceptional market validation for Carlsmed's aprevo® AI-enabled personalized spine surgery platform. This technology represents a significant advancement in spinal surgery, moving beyond standardized implants to patient-specific devices designed using artificial intelligence.

The successful completion of the first personalized cervical spine surgery using their technology platform marks a critical expansion beyond their established lumbar fusion market. Cervical spine procedures represent an entirely new revenue stream with substantial market potential when it launches in 2026. The technology's ability to secure CMS New Technology Add-On Payment (NTAP) reimbursement for these cervical procedures, effective October 1, 2025, is particularly significant as it removes a key adoption barrier in the US healthcare system.

The company's focus on artificial intelligence as evidenced by increased R&D investment in AI initiatives positions them at the forefront of the personalized medical device revolution. Their COMPASS registry completion suggests they're building a proprietary clinical outcomes database that could further refine their AI algorithms and strengthen their competitive moat.

The CEO's statement that they're becoming "the new standard of care in spine fusion surgery" is supported by their rapid adoption metrics. The fact that revenue growth is driven by procedure volume rather than price increases ("average revenue per procedure flat between these periods") indicates genuine market penetration and clinical acceptance rather than pricing power.

While the gross margin decreased slightly to 73.4% due to expedited production costs, this reflects growing pains typical of rapidly scaling medical device companies rather than fundamental business model issues. As they continue to scale, production efficiencies should improve, potentially restoring or even improving margins.

Q2’25 revenue of $12.1 million, 99% YOY growth

Full year revenue guidance of $45.5M - $47.5M

CARLSBAD, Calif., Aug. 28, 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 second quarter ended June 30, 2025.

“Our strong commercial performance was driven by the continued adoption of our highly differentiated AI-enabled aprevo^® technology platform and growing recognition of its ability to deliver more favorable patient outcomes than legacy devices,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “Building upon our momentum in personalized lumbar fusion surgery, in July we successfully completed the first personalized cervical spine surgery using our aprevo^® technology platform, launching in 2026. We enter the second half of 2025 well positioned for continued scale as we become the new standard of care in spine fusion surgery.”

Second Quarter Financial Results & Recent Highlights

• Revenue was $12.1 million for the second quarter of 2025; a 99% increase compared to $6.1 million for the second quarter of 2024. This increase was driven by the increased number of surgical procedures utilizing the aprevo^® technology platform in the second quarter of 2025, with average revenue per procedure flat between these periods.
• Gross profit for the second quarter of 2025 was $8.9 million compared to $4.6 million for the second quarter of 2024, due to our increased revenue. Gross margin was 73.4% for the second quarter of 2025, compared with 75.0% for the second quarter of 2024; this decrease was primarily driven by expedite production fees charged by our contract manufacturer in the second quarter to meet customer timing requirements.
• Operating expenses were $15.4 million for the second quarter of 2025, compared with $10.9 million for the second quarter of 2024.
  • Research and development expenses were $4.2 million for the second quarter of 2025, compared with $4.0 million for the second quarter of 2024. This increase was primarily driven by higher personnel costs to support product development and artificial intelligence initiatives, partially offset by lower prototype and materials costs and reduced COMPASS registry costs following enrollment completion in second half of 2024.
  • Sales and marketing expenses were $7.9 million for the second quarter of 2025, compared with $4.9 million for the second quarter of 2024. This increase was primarily driven by personnel additions and variable sales expenses associated with our revenue growth, as well as an increase in marketing expenses.
  • General and administrative expenses were $3.3 million for the second quarter of 2025, compared with $2.0 million for the second quarter of 2024. This increase was primarily due to personnel additions to support business growth and costs associated with the transition to being a publicly traded company, including associated legal, accounting, and other professional fees.

• Net loss was $6.8 million for the second quarter of 2025, compared to a $6.3 million net loss for the second quarter of 2024.
• Adjusted EBITDA loss was $6.2 million for the second quarters of 2025 and 2024.

• Cash and cash equivalents were $33.5 million as of June 30, 2025. The Company received $93.5 million of net proceeds, after deducting underwriting discounts and commissions and before other additional offering expenses, from its initial public offering in July 2025.
• The first personalized cervical spine surgery using the AI-enabled aprevo^® technology platform was performed.
• aprevo^® cervical procedures received CMS New Technology Add-On Payment (NTAP) reimbursement, in effect October 1, 2025.
  
  

2025 Full Year Financial Outlook

• Revenue for the full year 2025 is expected to be in the range of $45.5 million to $47.5 million, representing growth of 67% to 75% over 2024.
  
  

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 second quarter and first half of 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/y7ki9icw.

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 June 30,								Six Months Ended June 30,
		2025				2024				2025				2024
Revenue		$	12,083			$	6,081			$	22,272			$	11,167
Cost of sales			3,214				1,519				5,767				2,941
Gross profit			8,869				4,562				16,505				8,226
Operating expenses:
Research and development			4,160				3,998				7,310				7,254
Sales and marketing			7,869				4,873				14,608				8,470
General and administrative			3,342				2,010				6,808				4,150
Total operating expenses			15,371				10,881				28,726				19,874
Loss from operations			(6,502	)			(6,319	)			(12,221	)			(11,648	)
Other income (expense):
Interest expense			(363	)			(325	)			(720	)			(541	)
Interest income			336				428				716				526
Change in fair value of warrant liabilities			(237	)			(61	)			(270	)			(61	)
Total other income (expense), net			(264	)			42				(274	)			(76	)
Net loss and comprehensive loss			(6,766	)			(6,277	)			(12,495	)			(11,724	)
Deemed dividend to preferred stockholders			—				—				(584	)			—
Net loss attributable to common stockholders		$	(6,766	)		$	(6,277	)		$	(13,079	)		$	(11,724	)
Net loss per share attributable to common stockholders, basic and diluted		$	(1.47	)		$	(1.55	)		$	(2.94	)		$	(2.91	)
Weighted-average number of common shares used to compute basic and diluted net loss per share			4,589,717				4,053,063				4,445,384				4,024,815

CARLSMED, INC. CONDENSED BALANCE SHEETS (in thousands, except for share and par value amounts) (unaudited)
		June 30, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents		$	33,472			$	40,125
Restricted cash			100				100
Accounts receivable, net of allowances of $1,576 and $1,239, as of June 30, 2025 and December 31, 2024, respectively			9,711				6,766
Inventory			1,068				995
Prepaid expenses and other current assets			1,841				1,365
Total current assets			46,192				49,351
Property and equipment, net			972				260
Operating lease right-of-use assets			2,144				1,644
Other assets			3,962				569
Total assets		$	53,270			$	51,824
Liabilities, Convertible Preferred Stock, and Stockholders’ Deficit
Current liabilities:
Accounts payable		$	2,581			$	2,412
Accrued liabilities			3,219				2,687
Accrued compensation			3,113				3,270
Short-term operating lease liabilities			571				449
Total current liabilities			9,484				8,818
Long-term portion of term loan, net			15,431				15,414
Long-term operating lease liabilities			1,705				1,317
Warrant liabilities			727				457
Other long-term liabilities			267				222
Total liabilities			27,614				26,228
Commitments and contingencies (Note 9)
Series A convertible preferred stock, $0.00001 par value; 4,902,814 shares authorized, issued, and outstanding, and $13,767 liquidation preference as of June 30, 2025 and December 31, 2024			13,578				13,578
Series B convertible preferred stock, $0.00001 par value; 4,393,481 shares authorized, 4,335,051 shares issued and outstanding, and $30,000 liquidation preference as of June 30, 2025 and December 31, 2024			29,801				29,801
Series C convertible preferred stock, $0.00001 par value; 6,028,243 and 4,910,500 shares authorized, 6,007,866 and 4,890,123 shares issued and outstanding, and $64,500 and $52,500 liquidation preference as of June 30, 2025 and December 31, 2024, respectively			65,350				52,847
Stockholders’ deficit:
Common stock, $0.00001 par value; 23,679,694 and 21,835,801 shares authorized, 4,681,414 and 4,234,798 shares issued, and 4,603,756 and 4,139,219 shares outstanding as of June 30, 2025 and December 31, 2024, respectively			—				—
Additional paid-in capital			593				541
Accumulated deficit			(83,666	)			(71,171	)
Total stockholders’ deficit			(83,073	)			(70,630	)
Total liabilities, convertible preferred stock, and stockholders’ deficit		$	53,270			$	51,824

RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA (unaudited)
		Three Months Ended June 30,											$				%
			2025					2024					Change				Change
(in thousands, except percentages)
Net loss		$		(6,766	)		$		(6,277	)		$		(489	)			7.8		%
Interest (income) expense				27					(103	)				130				(126.2	)	%
Income taxes				—					—					—				—
Depreciation and amortization				61					35					26				74.3		%
EBITDA				(6,678	)				(6,345	)				(333	)			5.2		%
Stock-based compensation				258					52					206				396.2		%
Change in fair value of warrant liabilities				237					61					176				288.5		%
Adjusted EBITDA		$		(6,183	)		$		(6,232	)		$		49				(0.8	)	%

		Six Months Ended June 30,										$						%
		2025					2024					Change					Change
(in thousands, except percentages)
Net loss		$		(12,495	)		$		(11,724	)		$		(771	)			6.6		%
Interest (income) expense				4					15					(11	)			(73.3	)	%
Income taxes				—					—					—				—
Depreciation and amortization				101					75					26				34.7		%
EBITDA				(12,390	)				(11,634	)				(756	)			6.5		%
Stock-based compensation				433					87					346				397.7		%
Change in fair value of warrant liabilities				270					61					209				342.6		%
Adjusted EBITDA		$		(11,687	)		$		(11,486	)		$		(201	)			1.7		%

FAQ

What was Carlsmed's (CARL) revenue growth in Q2 2025?

Carlsmed reported $12.1 million in revenue for Q2 2025, representing a 99% increase compared to $6.1 million in Q2 2024.

How much did Carlsmed raise in their IPO in July 2025?

Carlsmed raised $93.5 million in net proceeds from their initial public offering in July 2025, after deducting underwriting discounts and commissions.

What is Carlsmed's revenue guidance for full-year 2025?

Carlsmed expects full-year 2025 revenue to be between $45.5 million to $47.5 million, representing growth of 67% to 75% over 2024.

What was Carlsmed's gross margin in Q2 2025?

Carlsmed's gross margin was 73.4% in Q2 2025, compared to 75.0% in Q2 2024, with the decrease primarily due to expedited production fees.

What recent regulatory approval did Carlsmed receive for their aprevo® technology?

Carlsmed received CMS New Technology Add-On Payment (NTAP) reimbursement approval for aprevo® cervical procedures, effective October 1, 2025.