ClearPoint Neuro Announces Promising Results from Brain Tumor Laser Therapy Study to be Presented at the CNS Annual Meeting in Los Angeles

Rhea-AI Summary

ClearPoint Neuro (NASDAQ:CLPT) reported encouraging Phase I-II results for the ClearPoint Prism Neuro Laser Therapy System from a 14‑patient study at Skåne University Hospital (NCT05296122) in Lund, Sweden, to be presented at the CNS Annual Meeting in Los Angeles Oct 13-15, 2025.

Key findings: improved survival versus matched open‑surgery controls, a median ablation time of 6.5 minutes, a safe and reproducible workflow, and no device‑related events reported.

Positive

• Study showed improved survival versus matched open‑surgery controls
• Median ablation time of 6.5 minutes
• No device‑related events reported in the 14‑patient cohort

Negative

• Small cohort of 14 patients limits generalizability
• Product usage may not be approved or cleared in all markets

Insights

Clinical Device Research Analyst

Phase I–II data in 14 glioblastoma patients show encouraging safety and survival signals, but evidence remains early and limited.

ClearPoint Prism reported a small cohort (n=14) study showing improved survival versus matched open‑surgery controls, a median ablation time of 6.5 minutes, and no device‑related events. The study was co‑funded by the company and led at Skåne University Hospital (NCT05296122), which supports feasibility and a reproducible intraoperative workflow for minimally invasive laser ablation in high‑grade glioma cases.

The primary business mechanism is clearer procedural efficiency and a safety profile that could lower procedural risk and expand use of image‑guided laser ablation. Key dependencies and risks include the small sample size, early phase design, sponsor co‑funding, and lack of randomized, larger‑scale efficacy data; these limit confidence in durability and generalizability of the survival signal. The announcement states product usage may not be approved in all markets, which affects near‑term adoption.

Concrete items to watch: publication of full study data and methodology, any peer‑reviewed survival statistics and adverse‑event tables, follow‑up durations, and plans for randomized or larger trials and regulatory filings; also note the device will be displayed at the CNS meeting on October 13-15, 2025, and the release date October 7, 2025.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 7, 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 results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy. The study cohort comprised fourteen patients ages 18-80years with primary and recurrent glioblastoma and grade 4 astrocytoma, tumors which are among the most challenging to treat.

The study (NCT05296122) was led by Dr. Peter Siesjö, sponsored by CLS AB, and co-funded by the Company. Findings from the study are encouraging and demonstrated:

• Improved survival compared to matched open surgery controls

• Safe¹, feasible, and reproducible workflow

• Median ablation time: 6.5 minutes.

"For patients facing limited options and an otherwise invasive procedure, these initial results suggest meaningful potential for minimally invasive laser therapy in neuro-oncology," commented Chris Osswald, PhD, Director and Global Segment Leader for Laser Therapy. "We're proud to be part of a solution that prioritizes precision, safety, accessibility, and patient outcomes. The fast, simple, and predictable workflow of ClearPoint Prism enables physicians to improve patient care today and may lay the groundwork for healthcare systems to build capacity and expertise in cell and gene therapy workflows that will transform tomorrow."

The ClearPoint Prism technology will be on display at the 75^th Annual Congress of Neurological Surgeons (CNS) in Los Angeles October 13-15, 2025.²

¹ No device-related events or complications reported.
² Product usage represented may not be approved or cleared in all markets.

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

This press release contains forward-looking statements within the context of the federal securities laws, including the Company's expectation for the future performance and market of its products and services and for cell and gene therapies, and its expectation that the laser therapy workflow may apply to provide training or capabilities for cell and gene therapy applications.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: 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; future revenue from sales of the Company's products and services; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company's products and services in their delivery of therapies; the Company's ability to maintain its current relationships with biologics and drug delivery partners or enter into new relationships with such partners; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company's ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company's ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of the Company's new products and the new products of its biologics and drug delivery partners. More detailed information on these and additional factors that could affect the Company's actual results are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's Quarterly Report on Form 10-Q for the three months ended June 30, 2025, both of which have been filed with the Securities and Exchange Commission. The Company does not assume any obligation to update these forward-looking statements.

Contact Information

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

SOURCE: ClearPoint Neuro, Inc.

View the original press release on ACCESS Newswire

FAQ

When will ClearPoint Neuro present the Prism laser therapy results and where?

Results will be presented at the 75th CNS Annual Meeting in Los Angeles, Oct 13-15, 2025.

What were the key clinical findings for CLPT's ClearPoint Prism in the Phase I-II study?

The study reported improved survival versus matched open‑surgery controls, a median ablation time of 6.5 minutes, and no device‑related events.

Where was the ClearPoint Prism study (CLPT) conducted and what is the trial ID?

The study was conducted at Skåne University Hospital in Lund, Sweden and is registered as NCT05296122.

How many patients were included in the ClearPoint Prism study reported by CLPT?

The study cohort comprised 14 patients aged 18–80 with primary and recurrent glioblastoma and grade 4 astrocytoma.

Did the ClearPoint Prism study report any device‑related complications?

No device‑related events or complications were reported in the study cohort.

What does the CLPT study mean for regulatory availability and market use?

The company noted that product usage may not be approved or cleared in all markets, so availability will vary by jurisdiction.

What is the immediate investor implication of CLPT's Prism study results?

The results are an early clinical readout showing safety and feasibility, which may inform future trials and commercialization steps but do not guarantee regulatory approval.