AI Earnings Predictions for ClearPoint Neuro Inc. (CLPT)

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Exhibit 99.1

ClearPoint Neuro Reports Third Quarter 2026 Results

Neurosurgery Navigation & Therapy Grew 59% to $5.4 Million

SOLANA BEACH, CA, 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.

Third Quarter 2026 Highlights

• Reported third quarter revenue of $12.1 million, representing 36% overall growth, including the recently acquired IRRAflow Portfolio;

• Neurosurgery navigation and therapy, which includes navigation, laser, drill and IRRAflow products, increased 59% to $5.4 million in the quarter;

• Achieved record capital equipment and software revenue of $1.7 million, representing 68% growth in the quarter, including the recently acquired IRRAflow equipment;

• Increased biologics and drug delivery revenue to $4.9 million, an 11% year-over-year increase;

• First formal BLA was submitted by one partner for the treatment of Huntington’s Disease;

• ClearPoint is an industry partner in a five-year, $2.98 million competitively awarded NCI R01, led by Dartmouth Health to advance MR-guided laser therapy for spinal metastases.¹ The program runs from benchtop through large subject validation to a clinical trial, using the ClearPoint Prism system. ClearPoint contributes technical, software development, and procedural expertise. This is early-stage research that supports our spine LITT roadmap;

• Received net proceeds of $22.0 million from the at-the-market equity offering program; and

• Reported cash and cash equivalents of $46.2 million as of 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 IRRAflow 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, IRRAflow 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.”

Business Outlook

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 IRRAflow 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 IRRAflow 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 IRRAflow 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, IRRAflow 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

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EX-99.1

Exhibit 99.1

ClearPoint Neuro Reports Second Quarter 2026 Results

Positive BioPharma Partner Regulatory Progress and Early Success in Focused Ultrasound Technology Platform Expansion

SOLANA BEACH, CA, August 3, 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 second quarter ended June 30, 2026.

Second Quarter 2026 Highlights

• Reported second quarter revenue of $10.9 million, representing 18% overall growth, including the recently acquired IRRAflow Portfolio; Biologics and Drug Delivery Revenue declined 15% in the quarter, primarily due to a decrease in products shipped to biopharma customers supporting new trial initiations compared to the second quarter a year ago. This decline was partially offset by growth in preclinical service revenue in the quarter. As of July 2026, the ClearPoint Advanced Laboratories (CAL) facility is now in the Company’s possession and new services revenue is expected to return the Biologics and Drug Delivery segment to growth in the third quarter;

• Multiple biopharma partners recently received positive feedback from the FDA on their potential BLA submissions, as well as other global regulatory progress, leading us to believe that additional cell and gene therapies could become available commercially by the end of 2027;

• The Company expects 10-15 clinical trials using ClearPoint Neuro technology to be enrolling patients in the next 18 months, along with approximately 10 partner clinical trial data readouts;

• The Company has entered into multiple statements of work for preclinical services at CAL, including our first statement of work involving GLP services, which we expect to complete in the first half of 2027;

• Both our in-development Robotic platform and Harmony 1.0 software were showcased at multiple neurosurgery trade shows in the second quarter; feedback from more than 50 surgeons reinforced our strategy and provided essential user input;

• Announced plans to enter the focused ultrasound market via a partnership with the SONOCARE Lab at Sungkyunkwan University, South Korea, alongside the successful intravenous delivery of tracers across the blood-brain barrier in a preclinical model using the ClearPoint Neuro prototype system; and

• Positive regulatory news has re-activated the need for commercial drug delivery readiness in 2027 leading to a reorganization of the Company’s commercial structure which began in Q2 with an emphasis on installed base expansion and clinical case support.

“Establishing ClearPoint Neuro as the leading neuro cell and gene therapy delivery company has been our number one priority for the last 10 years. Over that time, we have pivoted the company vision, invested more than $200 million, built our unique ecosystem, and earned more than 60 active biopharma partners, many of whom have programs which are now under FDA expedited review,” commented Joe Burnett, President and CEO at ClearPoint

Neuro. “Exciting news over the past few months from our partners, global regulatory bodies, and our own product development teams have only furthered that conviction.”

“First, the FDA recently reversed their guidance on a number of rare disease decisions, once again opening the door for potential partner BLA submissions later this year. This timing could yield commercial approvals as early as 2027, and as a key product and service provider to our partners, we need to ensure that we are ready. This regulatory news, combined with the planned initiation of larger phase III trials, has elevated the priority to invest in building our clinical capacity so that the ClearPoint installed base and our clinical support team are not a bottleneck. We believe the next 18 months will only increase the need for capable sites as we expect between 10 and 15 clinical trials to be enrolling, and approximately 10 data readouts to be presented, creating informative news flow on almost a monthly basis. It is important to note that progress toward commercial cell and gene therapy delivery is not just a U.S. phenomenon, and expanding our global footprint is included in these activities.”

“Second, we are now in possession of the ClearPoint Advanced Laboratories, or the ‘CAL’, our preclinical lab facility in Torrey Pines. Importantly we have now signed our very first statement of work for an IND enabling study involving GLP services at the CAL and we expect it to be performed in the first half of 2027.”

“Third, we announced a 10-year focused ultrasound drug delivery partnership with the SONOCARE Lab at Sungkyunkwan University in South Korea, supported by preclinical proof-of-concept results demonstrating successful delivery of tracers across the blood-brain barrier. In parallel, our in-development ClearPoint Neuro robotic platform continued to advance and received valuable

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