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
[email protected]
(888) 287-9109 ext. 3

SOURCE: ClearPoint Neuro, Inc.