Full Press Release Details
Neurosurgery Navigation & Therapy Grew 59% to $5.4 Million
SOLANA BEACH, CA / ACCESS Newswire / October 28, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its third quarter ended September 30, 2026.
"Throughout 2026 we have continued to make substantial strategic progress in building our comprehensive drug delivery ecosystem, adding new biopharma partners, and assisting existing partners progress through the regulatory process globally," commented Joe Burnett, President and CEO at ClearPoint Neuro. "The acceleration of our financial performance in the third quarter was driven by our core organic clinical product revenue, as well as our biologics and drug delivery revenue both returning to double-digit growth. The 36% revenue growth outpaced operating expense growth of 23% in the third quarter, as the completion of the IRRA flow product integration has enabled improved operating leverage. Our current cash balance of $46.2 million provides us with additional confidence to fund our product pipeline which now includes AI Derived Planning and Simulation, Neuro Navigation in the MRI and Operating Room, Laser Therapy and Access, IRRA flow CSF management, Robotic Surgery, Focused Ultrasound, as well as our comprehensive drug delivery ecosystem including pre-clinical and clinical services. This unmatched portfolio and partnership advantage will make us the premier therapy enabling company in the cranial neurosurgery space for many years to come."
The Company now estimates revenue in 2026 to be between $48.0 million and $50.0 million.
Financial Results - Quarter Ended September 30, 2026
Total revenue was $12.1 million for the three months ended September 30, 2026, and $8.9 million for the three months ended September 30, 2025, which represents an increase of $3.2 million, or 36%.
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 11% to $4.9 million for the three months ended September 30, 2026 from $4.4 million for the three months ended September 30, 2025. This increase is primarily attributable to higher revenue from services performed at ClearPoint Advanced Laboratories.
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint and IRRA flow systems, increased 59% to $5.4 million for the three months ended September 30, 2026, from $3.4 million for the same period in 2025. The increase is driven primarily by additional revenues due to sales of the IRRA flow product, which the Company acquired in connection with its acquisition of IRRAS in the fourth quarter of 2025.
Capital equipment and software revenue, consisting of sales of ClearPoint and IRRA flow reusable hardware and software and related services, increased 68% to $1.7 million for the three months ended September 30, 2026, from $1.0 million for the same period in 2025 primarily due to an increase in placements of ClearPoint navigation capital and software, IRRA flow control units, and Prism laser units.
The Company achieved a gross margin of 58% on its sales for the three months ended September 30, 2026, and a gross margin of 63% in the same period in 2025. The decrease in gross margin is primarily due to overhead costs at the new ClearPoint Advanced Laboratories facility and additional amortization expense of acquired intangible assets, partially offset by a decrease in other cost of revenue, for the three months ended September 30, 2026, as compared to the same period in 2025.
Operating expenses were $13.4 million for the three months ended September 30, 2026, compared with $10.9 million for the same period in 2025, an increase of 23%. The increase was mainly driven by the IRRAS acquisition in November 2025, primarily through higher personnel costs resulting from the expansion of our clinical and sales teams, as well as increased occupancy costs, and travel costs.
At September 30, 2026, the Company had cash and cash equivalents totaling $46.2 million as compared to $45.9 million at December 31, 2025, with the increase resulting from the net proceeds of $22.0 million from the at-the-market equity offering program, partially offset by the use of $20.1 million in cash for operating activities.
¹ Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under award number R01CA307001. A total of $633,819, or 100 percent of the first-year project budget, is financed with federal funds. No non-governmental funds are included in the approved budget. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Investors and analysts are invited to listen to a live broadcast review of the Company's third quarter 2026 results on Wednesday, October 28, 2026 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=cPBDKSsR . Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until November 27, 2026, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/ .
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com .
Statements in this press release and in the teleconference referenced above concerning the Company's plans, growth and strategies may include forward-looking statements within the meaning of the federal securities laws, including the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding: the Company's 2026 revenue guidance and other expectations regarding future financial performance, liquidity and capital resources; the expected adoption and growth of the Company's neurosurgery navigation and therapy products, including IRRA flow and laser therapy, and its capital equipment and software placements; the growth of the Company's biologics and drug delivery business, including preclinical services at ClearPoint Advanced Laboratories; the regulatory progress of the Company's biologics and drug delivery partners; the expansion of the Company's laser therapy program into spine; the development of the Company's product pipeline; and other statements of management's expectations, beliefs, plans, estimates or projections relating to the future. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "potential," "may," "will," "should," "could" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements.
Factors that could cause actual results to differ materially include, among others: the Company's ability to achieve broader market adoption of its products and services; the timing and outcome of its biologics and drug delivery partners' clinical trials and regulatory submissions; the Company's ability to maintain and expand its partner relationships; the risk that ClearPoint Advanced Laboratories may not achieve or maintain GLP compliance or generate revenue on anticipated timelines; the integration of acquired businesses, including IRRAS; changes in government regulation, reimbursement and funding; competition; supply chain disruptions; the Company's ability to fund its operations and service its indebtedness; and general economic, market and geopolitical conditions. For a more detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q, including the "Risk Factors" sections therein. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investor Relations: Danilo D'Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 [email protected]
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