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ClearPoint Neuro Reports Third Quarter 2025 Results

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ClearPoint Neuro (NASDAQ:CLPT) reported third quarter 2025 results on November 6, 2025, with Q3 revenue of $8.9M, a 9% increase year‑over‑year, and cash of $38.2M as of September 30, 2025.

Key operational updates include the new ClearPoint Advanced Laboratories (CAL) becoming operational, FDA 510(k) clearance for PRISM Laser compatibility with 1.5T MRI, a prototype Robotic Neuro‑Navigation System demo, regulatory clearances in 34 countries, activation of 5 new customers, and a signed agreement to acquire IRRAS Holdings.

The company achieved a 63% gross margin, reaffirmed full‑year 2025 revenue guidance of $36.0M–$38.0M, and expects combined 2026 pro forma revenue with IRRAS of $54.0M–$60.0M.

ClearPoint Neuro (NASDAQ:CLPT) ha riportato i risultati del terzo trimestre 2025 il 6 novembre 2025, con Q3 revenue of $8.9M, in aumento del 9% rispetto all'anno precedente, e cash of $38.2M al 30 settembre 2025.

Gli aggiornamenti operativi chiave includono l'avvio operativo del nuovo ClearPoint Advanced Laboratories (CAL), l'FDA 510(k) clearance per la compatibilità del PRISM Laser con 1.5T MRI, una demo del prototipo del Robotic Neuro‑Navigation System, autorizzazioni regolamentari in 34 paesi, l'attivazione di 5 nuovi clienti e un accordo firmato per acquisire IRRAS Holdings.

L'azienda ha ottenuto un margine lordo del 63%, ha confermato la guidance per il 2025 di ricavi di $36.0M–$38.0M e prevede ricavi pro forma combinati nel 2026 con IRRAS di $54.0M–$60.0M.

ClearPoint Neuro (NASDAQ:CLPT) informó los resultados del tercer trimestre de 2025 el 6 de noviembre de 2025, con ingresos del Q3 de 8,9 millones de dólares, un aumento del 9% interanual, y efectivo de 38,2 millones de dólares al 30 de septiembre de 2025.

Las actualizaciones operativas clave incluyen que el nuevo ClearPoint Advanced Laboratories (CAL) ya está operativo, la aprobación 510(k) de la FDA para la compatibilidad del PRISM Laser con 1.5T MRI, una demo del prototipo del Sistema de Navegación Neuronal Robótica, autorizaciones regulatorias en 34 países, la activación de 5 nuevos clientes y un acuerdo firmado para adquirir IRRAS Holdings.

La empresa logró un margen bruto del 63%, reafirmó la guía de ingresos para todo el año 2025 de 36.0M–38.0M dólares, y espera ingresos pro forma combinados para 2026 con IRRAS de 54.0M–60.0M dólares.

ClearPoint Neuro (NASDAQ:CLPT)는 2025년 11월 6일 2025년 3분기 실적을 발표했으며 3분기 매출 890만 달러, 전년 대비 9% 증가, 2025년 9월 30일 기준 현금 3820만 달러를 기록했습니다.

주요 운영 업데이트로는 신규 ClearPoint Advanced Laboratories (CAL)의 가동 시작, 1.5T MRI와의 PRISM 레이저 호환성에 대한 FDA 510(k) 승인이 포함되며, 프로토타입 로봇 신경 내비게이션 시스템의 시연, 34개국의 규제 승인을 포함하고, 5명의 신규 고객 확보, 그리고 IRRAS Holdings 인수에 대한 합의 서명을 들 수 있습니다.

회사는 63%의 총이익률를 달성했고, 2025년 전체 매출 가이던스를 $36.0M–$38.0M로 재확인했으며, IRRAS와의 2026년 결합 프로 포마 매출은 $54.0M–$60.0M로 예상합니다.

ClearPoint Neuro (NASDAQ:CLPT) a publié les résultats du troisième trimestre 2025 le 6 novembre 2025, avec un chiffre d'affaires du T3 de 8,9 M$, en hausse de 9 % sur un an, et une trésorerie de 38,2 M$ au 30 septembre 2025.

Les principales mises à jour opérationnelles incluent la mise en service du nouvel ClearPoint Advanced Laboratories (CAL), l’autorisation 510(k) de la FDA pour la compatibilité du PRISM Laser avec un IRM 1,5T, une démonstration d’un prototype du système de navigation neuronale robotisée, des autorisations réglementaires dans 34 pays, l’activation de 5 nouveaux clients et un accord signé pour acquérir IRRAS Holdings.

L’entreprise a réalisé une marge brute de 63%, a réaffirmé la prévision de revenus pour l’ensemble de l’année 2025 de 36,0–38,0 M$ et s’attend à des revenus pro forma combinés en 2026 avec IRRAS de 54,0–60,0 M$.

ClearPoint Neuro (NASDAQ:CLPT) meldete die Ergebnisse des dritten Quartals 2025 am 6. November 2025, mit Q3-Umsatz von 8,9 Mio. USD, einem Anstieg von 9 % gegenüber dem Vorjahr, und cash von 38,2 Mio. USD zum 30. September 2025.

Zu den wichtigsten operativen Aktualisierungen gehören die Inbetriebnahme des neuen ClearPoint Advanced Laboratories (CAL), die FDA 510(k)-Freigabe für die PRISM-Laser-Kompatibilität mit 1,5T-MRI, eine Prototyp-Demonstration des Robotic Neuro‑Navigation System, regulatorische Freigaben in 34 Ländern, die Aktivierung von 5 neuen Kunden und eine unterzeichnete Vereinbarung zum Erwerb von IRRAS Holdings.

Das Unternehmen erzielte eine Bruttomarge von 63%, bestätigte die Umsatzprognose für das gesamte Jahr 2025 von 36,0M–38,0M USD und erwartet kombinierte pro-forma Umsätze im Jahr 2026 mit IRRAS von 54,0M–60,0M USD.

ClearPoint Neuro (NASDAQ:CLPT) أبلغت عن نتائج الربع الثالث من عام 2025 في 6 نوفمبر 2025، مع إيرادات الربع الثالث 8.9 مليون دولار، بزيادة قدرها 9% على أساس سنوي، ونقدية 38.2 مليون دولار حتى 30 سبتمبر 2025.

تشمل التحديثات التشغيلية الرئيسية الإطلاق الفعّال لـ ClearPoint Advanced Laboratories (CAL)، وموافقة FDA 510(k) على توافق PRISM Laser مع أجهزة MRI 1.5T، عرض بروتوكولي لنظام الملاحة العصبية الروبوتي، وت won تصاريح تنظيمية في 34 دولة، وتفعيل 5 عملاء جدد، واتفاقية موقّعة لشراء IRRAS Holdings.

حققت الشركة هامش إجمالي قدره 63%، وأعادت تأكيد توجيه الإيرادات لعام 2025 بأكمله بين 36.0M–38.0M دولار، وتتوقع إيرادات مزيجية للشركة لعام 2026 مع IRRAS بين 54.0M–60.0M دولار.

Positive
  • Revenue +9% year‑over‑year to $8.9M in Q3 2025
  • Gross margin 63% in Q3 2025, up from 60% year‑ago
  • CAL facility operational with ~5x prior preclinical capacity
  • PRISM 1.5T clearance opens ~50% of US neuro LITT market
  • Cash $38.2M as of Sept 30, 2025 (up from $20.1M at 12/31/2024)
Negative
  • Operating expenses increased to $10.9M in Q3 2025, up 9% year‑over‑year
  • Used $11.8M cash for operating activities year‑to‑date through Sept 30, 2025
  • Decrease in product revenue due to timing of partner trials
  • $20M additional funding access is conditional on closing the IRRAS acquisition

Insights

ClearPoint shows revenue growth, operational expansion, and regulatory wins that materially improve commercialization capacity.

ClearPoint grew third-quarter revenue to $8.9 million, a 9% year-over-year rise, reported a 63% gross margin, and held $38.2 million in cash as of September 30, 2025. The company activated five new customers, supports over 60 biopharma partners, and placed its new ClearPoint Advanced Laboratories facility into service. The FDA 510(k) for 1.5T compatibility and the Robotic Neuro-Navigation prototype extend the addressable procedural settings and device catalog.

Key dependencies and risks include partner trial timing, integration of the announced IRRAS acquisition, and realization of higher-margin GLP work at CAL; management cites narrowed full-year revenue guidance of $36.0 million to $38.0 million and projects combined 2026 revenue with IRRAS of $54.0 million to $60.0 million. Operating expenses rose to $10.9 million in Q3, so cash runway hinges on converting pipeline services and closing financings tied to the IRRAS transaction. Monitoring near-term milestones matters: first 1.5T PRISM installations in Q4 2025, CE Mark timing in the second half of 2026, completion and closing of the IRRAS deal, and booked study volume for CAL in 20262027

Watch metrics that will confirm commercial traction: sequential quarterly revenue versus the narrowed guidance range, the pace of customer activations converting into recurring disposable sales, preclinical contract bookings for CAL, and successful integration of IRRAS to expand commercial reach. These items should clarify whether the company can sustain margin improvement and approach the management-stated path to breakeven within the stated planning horizon.

Site Readiness Continues for Specialized Treatment Centers Envisioned to Support a Growing Number of Cell and Gene Therapy Trial Patients and Later Commercialization

SOLANA BEACH, CA / ACCESS Newswire / November 6, 2025 / 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, 2025.

Third Quarter Highlights

  • Continued to provide supply, development, and strategic support to more than 60 active biopharma partners, including nine partner programs accepted for FDA expedited review, with many partners sharing updates on their scientific and regulatory progress at the 2025 ESGCT Annual Congress in Seville, Spain;

  • Completed transition to the new Pre-clinical CRO Facility named ClearPoint Advanced Laboratories (CAL) located in Torrey Pines, California, which became operational and already began running preclinical studies early in Q4 2025;

  • Announced the development and demonstration of the Company's prototype Robotic Neuro-Navigation System, which is being designed to enable the ClearPoint Neuro Navigation software to operate the KUKA LBR Med Robotic Arm to support all minimally invasive cranial surgical procedures including cell and gene therapy infusions, laser catheter placement, biopsy workflows, deep brain stimulation, and stereotactic EEG lead placements;

  • Received FDA 510(k) clearance expanding compatibility of the ClearPoint PRISM Laser Therapy System with 1.5T MRI guidance in addition to the previously cleared 3T MRI guidance, opening up more than 50% of the existing market for neuro LITT;

  • Announced several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan, bringing the total number of international clearances for key therapy delivery products to 34 countries worldwide;

  • Announced a signed agreement for the acquisition of IRRAS Holdings, Inc., which will expand the Company's footprint into the neurocritical care space and allow the Company to leverage an expanded commercial channel;

  • Activated 5 new global customers in the third quarter;

  • Reported quarterly revenue of $8.9 million, a 9% year-over-year increase compared with the third quarter of 2024 and reaffirmed the prior 2025 full year forecast narrowing the expected revenue range to between $36.0 million and $38.0 million; and

  • Reported cash and cash equivalents totaling $38.2 million as of September 30, 2025.

"This is one of the most exciting times in the history of our company as we make progress across all four of our existing growth pillars and announce a plan to evolve them in line with our latest strategic direction," commented Joe Burnett, President and CEO of ClearPoint Neuro. "We are laying the groundwork for realizing the full potential of ClearPoint Neuro as we enable our 60 plus biopharma partners to progress through the regulatory process in the United States and beyond. The scientific data emerging from several of our cell and gene therapy partners who have been selected for expedited review by the FDA has been encouraging. As we have seen from recent news, the regulatory pathway and timelines for our biopharma partners remain areas of active learning. We at ClearPoint Neuro recognize the urgency of bringing transformative therapies to patients in need and remain focused on collaborating with our partners to support their development, while also remaining committed to the highest standards of quality, safety, and consistency in therapy delivery. To advance this effort, we plan to activate additional sites to support cell and gene therapy trials and eventual commercialization with our drug delivery ecosystem. Our highest priority with the neurosurgical community is to work hand-in-hand with our biopharma partners and to identify the first 35-40 specialized treatment centers which can add 5,000 patients a year in capacity. We believe that this added site capacity using ClearPoint Neuro's technology is crucial to standardize delivery and create consistency across sites for these new-to-world cell and gene therapies. The intent is that these experienced clinical trial sites will become the commercial deployment sites of the future, all using the ClearPoint Neuro ecosystem for MRI, CT, and Robotic Navigation, a portfolio of cannula-based routes-of-administration, quality control infusion modeling and monitoring, and expert clinical support. We believe that commercial drug delivery is the largest future revenue stream for ClearPoint Neuro, and we have only just begun to unlock its full potential."

"However, our excitement does not begin and end with these future cell and gene therapy launches," continued Mr. Burnett. "Our existing four pillars of growth, which will also be evolved to include IRRAS upon the closing of the acquisition, will give ClearPoint Neuro access to an existing total market valued at more than $0.5 billion, and a practical portfolio that we believe will allow us to increase our market share in each and every one of those pillars."

"In Pillar One, Biologics and Drug Delivery, we achieved a huge milestone of activating our new ClearPoint Advanced Laboratories facility (CAL). In Q3, the team focused on setting up the new facility, establishing the foundation, writing protocols, and obtaining the various necessary certifications. We have now completed our first preclinical study for a pharmaceutical sponsor at the new facility, showing that we are officially open for business. This new facility, located in the Torrey Pines biotech region, has three potential growth vectors that we expect to monetize over the coming years as CAL allows us to 1) add capacity for much larger studies, approximately five times our prior capacity, 2) perform higher value/higher margin GLP studies including pivotal toxicology studies, and 3) offer additional services to biopharma partners increasing the potential offerings and comprehensiveness of the facility. For perspective, we have already bid out studies for 2026 and 2027 that reflect the expanded scope and greater sophistication of our new facility, which in turn results in higher value offerings for the Company. This is a huge success for the entire team to get the new facility running in such a short period of time. We expect our Biologics and Drug Delivery revenue to drive double digit growth in the fourth quarter and expand further in 2026 and 2027."

"In Pillars Two and Three, Neurosurgery Navigation and Laser Therapy, we have continued the successful full market releases for new products, which, like in Pillar One, are designed to increase share in these existing markets. Our ClearPoint 3.0 software has now been installed at more than 50 centers in the United States and is enabling ClearPoint Neuro procedures to be performed in both the MRI suite and the operating room using CT, all with the same system. In total, we activated five new customers in the quarter. Our PRISM Laser Therapy system just received FDA clearance expanding to compatibility with 1.5 Tesla powered magnets, opening up approximately 50% of the neuro LITT market in the United States. We expect the first installations of the 1.5 Tesla labeled product in the fourth quarter. Both 1.5T and 3.0T PRISM Laser Therapy systems have also been submitted for CE Mark approval which we expect in the second half of 2026. We also unveiled a prototype of our proprietary Robotic Neuro-Navigation System that is being designed to support all minimally invasive cranial procedures, including cell and gene therapy infusions, laser catheter placement, biopsy workflows, deep brain stimulation, and stereotactic EEG lead placements, which will make ClearPoint Neuro the only company with one software platform that can deploy navigation in three different arenas: MRI, iCT, and Robotics. This prototype received excellent early development feedback at the 75th Annual Congress of Neurological Surgeons (CNS) in Los Angeles this past month."

"In addition to advancing our existing pillars of growth, we are expanding our presence beyond the United States, with regulatory clearances now spanning 34 countries, including recent approvals in Canada, Taiwan, and Hong Kong. By making it possible for our biopharma partners to standardize and simplify every possible aspect of the surgical workflow for delivering their therapies across many geographies, we hope to reduce barriers to adoption and give our partners' therapies improved chances to succeed on a global stage."

"With the announcement of the signing of our agreement to acquire IRRAS Holdings, Inc., we expect to introduce a new fourth pillar of growth. This fourth pillar will be focused on cranial irrigation and aspiration, and will allow us to enter the substantial intracranial hemorrhage market with a potentially disruptive product in the EVD space, and gain scale by effectively doubling the size of our commercial organization. We believe that, across our evolved four growth pillars, we will have a credible path to cash breakeven and profitability without including our largest potential market of commercial cell and gene therapies in the years ahead."

Business Outlook

The Company reaffirmed its full-year guidance, narrowing the expected revenue range to between $36.0 million and $38.0 million.

Based on management's current forecasts for ClearPoint Neuro's business and our assessment of the IRRAS business, the total 2026 combined revenue for the two companies is expected to be in the range of $54.0 to $60.0 million. As with all forward-looking statements, this estimate is subject to revision based on updated information, including that arising through the post-closing integration of IRRAS. Our guidance for future financial performance is 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.

Financial Results - Quarter Ended September 30, 2025

Total revenue was $8.9 million for the three months ended September 30, 2025, and $8.1 million for the three months ended September 30, 2024, which represents an increase of $0.7 million, or 9%.

Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials, stayed relatively consistent at $4.4 million for the three months ended September 30, 2025 and 2024. Service and other revenue increased $0.7 million due to new studies performed for our partners in the three months ended September 30, 2025, offset by a decrease in product revenue due to timing of the pharmaceutical partners' clinical and preclinical trials.

Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 20% to $3.4 million for the three months ended September 30, 2025, from $2.9 million for the same period in 2024. The increase is driven by higher sales of Prism Laser Therapy, and the introduction of our 3.0 operating room navigation software, which has positively impacted procedural volumes in the operating room during the three months ended September 30, 2025, compared to the same period in 2024.

Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, increased 25% to $1.0 million for the three months ended September 30, 2025, from $0.8 million for the same period in 2024 due to an increase in the sale of hardware and rental revenue.

The Company achieved a gross margin of 63% on its sales for the three months ended September 30, 2025, as compared to 60% in the same period in 2024. The increase in gross margin was primarily due to higher margins on biologics and drug delivery service revenue and mix of product sold for the three months ended September 30, 2025, as compared to the same period in 2024.

Operating expenses were $10.9 million for the three months ended September 30, 2025, compared with $10.0 million for same period in 2024, an increase of 9%. The increase was mainly driven by higher product and software development costs, professional services fees, and personnel-related expenses, including share-based compensation, as we increased headcount to fuel the expansion of the research and development, clinical, and support organizations.

At September 30, 2025, the Company had cash and cash equivalents totaling $38.2 million as compared to $20.1 million at December 31, 2024, with the increase resulting from the net proceeds of the note payable and stock offering of $32.0 million, partially offset by the use of $11.8 million in cash for operating activities.

On November 5, 2025, the Company entered into an agreement to access an additional $20.0 million in funding under its existing note financing arrangement with Oberland Capital, conditioned upon the closing of the Company's transaction to acquire IRRAS Holdings, Inc., and other customary closing conditions. The Company expects to use the additional funding to support integration activities, enhance working capital, and fund new growth initiatives for the combined business operations.

Teleconference Information

Investors and analysts are invited to listen to a live broadcast review of the Company's 2025 third quarter results on Thursday, November 6, 2025 at 5:00 p.m. Eastern time (2:00 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=60S23gGB . 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 December 4, 2025, 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/.

About ClearPoint Neuro

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.

Forward-Looking Statements

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 context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the Company's belief about the outcome of regulatory interactions with respect to its biotech Partners' therapies, the timing of commercialization of such therapies, and the market potential for such therapies; the continued development and commercial potential of the Company's proprietary Robotic Neuro-Navigation platform System; the size of total addressable markets or the market opportunity for the Company's products and services, including for the PRISM Laser Therapy System and the Company's preclinical CRO facility; the consummation of IRRAS Holdings, Inc. transaction and the market potential for IRRAS products; the anticipated adoption of the Company's products and services for use in the delivery of gene and cell therapies; the Company's expectations for revenues, operating expenses, and management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. 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. Particular uncertainties and risks include those relating to: the Company's biotech Partners' risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech Partners' therapies; the limitation or modification of the FDA's eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the Company's biotech Partner's continued use of the Company's products and services in their delivery of gene and cell therapies; the Company's ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company's ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; risks inherent in the research, development, and regulatory approval of the Company's new products; the future market for preclinical services and the investment required to expand such services, which could divert resources from the Company's other business operations; the possibility that the closing of the IRRAS transaction is delayed or does not occur at all because conditions to the transaction are not obtained or satisfied on a timely basis or at all; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company's failure to integrate IRRAS into its business in accordance with expectations; deviations from the expected market potential of the IRRAS products; diversion of management's attention on the IRRAS proposed transaction; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's research and development programs; the ability of the Company to manage the growth of its business; and the Company's ability to attract and retain its key employees. For a 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. 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.

Contact:
Investor Relations:
Danilo D'Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com

CLEARPOINT NEURO, INC.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except for share and per share data)

For the Three Months Ended September 30,

2025

2024

Revenue:
Product revenue

$

5,361

$

5,474

Service and other revenue

3,500

2,648

Total revenue

8,861

8,122

Cost of revenue

3,261

3,275

Gross profit

5,600

4,847

Research and development costs

3,452

3,315

Sales and marketing expenses

3,838

3,549

General and administrative expenses

3,586

3,141

Operating loss

(5,276

)

(5,158

)

Other income (expense):
Other expense, net

(64

)

(11

)

Interest (expense) income, net

(543

)

209

Net loss before income taxes

(5,883

)

(4,960

)

Income tax expense

(8

)

(14

)

Net loss

$

(5,891

)

$

(4,974

)

Net loss per share attributable to common stockholders:
Basic and diluted

$

(0.21

)

$

(0.18

)

Weighted average shares outstanding:
Basic and diluted

28,427,574

27,591,623

For the Nine Months Ended September 30,

2025

2024

Revenue:
Product revenue

$

16,649

$

14,053

Service and other revenue

9,912

9,566

Total revenue

26,561

23,619

Cost of revenue

10,273

9,259

Gross profit

16,288

14,360

Research and development costs

10,660

9,060

Sales and marketing expenses

11,691

10,673

General and administrative expenses

11,056

8,725

Operating loss

(17,119

)

(14,098

)

Other income (expense):
Other expense, net

(112

)

(32

)

Interest (expense) income, net

(472

)

646

Net loss before income taxes

(17,703

)

(13,484

)

Income tax expense

(51

)

(44

)

Net loss

$

(17,754

)

$

(13,528

)

Net loss per share attributable to common stockholders:
Basic and diluted

$

(0.63

)

$

(0.50

)

Weighted average shares outstanding:
Basic and diluted

28,137,528

26,840,119

 

CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(in thousands, except for share and per share data)

September 30,

2025

December 31,

(Unaudited)

2024

ASSETS
Current assets:
Cash and cash equivalents

$

38,221

$

20,104

Accounts receivable, net

4,000

4,713

Inventory, net

6,583

6,863

Prepaid expenses and other current assets

2,525

1,683

Total current assets

51,329

33,363

Property and equipment, net

2,114

2,005

Operating lease, right-of-use assets

5,955

3,086

Other assets

959

735

Total assets

$

60,357

$

39,189

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable

$

723

$

1,340

Accrued compensation

3,516

4,885

Other accrued liabilities

1,748

1,450

Operating lease liabilities, current portion

347

557

Contract liabilities, current portion

1,719

2,121

Total current liabilities

8,053

10,353

Operating lease liabilities, net of current portion

6,195

3,011

Contract liabilities, net of current portion

769

436

Long-term note payable, net

29,203

-

Other long-term liabilities

263

-

Total liabilities

44,483

13,800

Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at September 30, 2025 and December 31, 2024

-

-

Common stock, $0.01 par value; 90,000,000 shares authorized at September 30, 2025 and December 31, 2024; 28,428,176 and 27,617,415 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

284

276

Additional paid-in capital

224,714

216,483

Accumulated deficit

(209,124

)

(191,370

)

Total stockholders' equity

15,874

25,389

Total liabilities and stockholders' equity

$

60,357

$

39,189

 

CLEARPOINT NEURO, INC.
Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)

For the Nine Months Ended September 30,

2025

2024

Cash flows from operating activities:
Net loss

$

(17,754

)

$

(13,528

)

Adjustments to reconcile net loss to net cash flows from operating activities:
Allowance for credit losses (recoveries)

217

(507

)

Depreciation and amortization

565

740

Share-based compensation

6,199

5,204

Payment-in-kind interest

490

-

Amortization of debt issuance costs and original issue discounts

60

51

Amortization of lease right of use assets, net of accretion in lease liabilities

821

692

Increase (decrease) in cash resulting from changes in:
Accounts receivable

497

(157

)

Inventory, net

(16

)

434

Prepaid expenses and other current assets

(696

)

88

Other assets

(192

)

(40

)

Accounts payable and accrued expenses

(1,251

)

1,373

Lease liabilities

(716

)

(635

)

Contract liabilities

(69

)

(1,422

)

Net cash flows from operating activities

(11,845

)

(7,707

)

Cash flows from investing activities:
Purchases of property and equipment

(473

)

(12

)

Net cash flows from investing activities

(473

)

(12

)

Cash flows from financing activities:
Proceeds from offerings of common stock, net of offering costs

3,263

16,183

Proceeds from issuance of note payable, net of financing costs and discount

28,653

-

Repayment of 2020 senior secured convertible note

-

(10,000

)

Proceeds from stock option exercises

49

21

Payments for taxes related to net share settlement of equity awards

(1,661

)

(340

)

Proceeds from issuance of common stock under employee stock purchase plan

311

288

Net cash flows from financing activities

30,615

6,152

Net change in cash, cash equivalents and restricted cash

18,297

(1,567

)

Cash, cash equivalents and restricted cash, beginning of period

20,104

23,140

Cash, cash equivalents and restricted cash, end of period

$

38,401

$

21,573

Cash and cash equivalents

38,221

21,573

Restricted cash included in other assets, non-current

180

-

Total cash, cash equivalents and restricted cash

$

38,401

$

21,573

SUPPLEMENTAL CASH FLOW INFORMATION
Cash paid for:
Income taxes

$

69

$

41

Interest

$

490

$

480

SOURCE: ClearPoint Neuro, Inc.



View the original press release on ACCESS Newswire

FAQ

What were ClearPoint Neuro (CLPT) Q3 2025 revenue and cash balances?

ClearPoint reported Q3 2025 revenue of $8.9M and cash and cash equivalents of $38.2M as of Sept 30, 2025.

What guidance did ClearPoint Neuro (CLPT) give for full‑year 2025 and pro forma 2026?

The company reaffirmed 2025 revenue guidance at $36.0M–$38.0M and expects combined 2026 revenue with IRRAS of $54.0M–$60.0M.

How does the FDA 510(k) clearance announced Nov 6, 2025 affect ClearPoint Neuro (CLPT)?

FDA clearance expands PRISM Laser compatibility to 1.5T MRI, opening roughly 50% of the US neuro LITT market.

What is the ClearPoint Advanced Laboratories (CAL) update from ClearPoint Neuro (CLPT)?

CAL in Torrey Pines is operational, has begun preclinical studies, and offers about five times previous study capacity.

What acquisition did ClearPoint Neuro (CLPT) announce and what is its immediate condition?

ClearPoint signed an agreement to acquire IRRAS Holdings; an additional $20M financing is conditioned on closing the transaction.
Clearpoint Neuro Inc

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