Clinical Laserthermia Systems AB (CLS) (Nasdaq First North Growth Market:CLS-B), a provider of tools for precise tissue ablation using heat generated by laser light, said on Wednesday that it has submitted a CE-marking application for its ClearPoint Prism Neuro Laser Therapy System, seeking regulatory approval for use in Europe with 1.5T and 3.0T magnetic resonance imaging (MRI) guidance in neurosurgical procedures.

This application follows CLS's 2024 ISO certification under the European Medical Device Regulation and the successful completion of a clinical study at Skåne University Hospital assessing the safety and feasibility of MRI-guided laser interstitial thermal therapy (LITT) for glioblastoma.

The ClearPoint Prism System, commercialised globally with ClearPoint Neuro Inc, combines laser ablation technology with MRI guidance and neuro-navigation to enable minimally invasive treatment of brain lesions.

Patients in the clinical study showed increased median survival compared with a matched control group undergoing open surgery, and the study confirmed the safety and feasibility of the LITT platform.

With CE marking, CLS plans to launch the system commercially in European hospitals and neurosurgical centres, expanding access to minimally invasive brain lesion treatment.

Dan J. Mogren, CEO of CLS, described the application as a strategic step to broaden the company's market presence outside the US market.

Regulatory approval through CE marking is expected in the second half of 2026.