Clinical Laserthermia Systems AB (publ) announced that the recruitment of patients to the clinical study, sponsored by CLS and co-funded by ClearPoint Neuro Inc, at Skane University Hospital in Sweden is now completed. In the study a total of 14 patients with glioblastoma have been treated with MR-guided laser ablation. The study is a single-center, non-randomized prospective study with the aim of evaluating the safety and feasibility of minimally invasive MRI-guided laser ablation (also named as Laser Interstitial Thermal Therapy or LITT) of tumor tissue in patients with gliob lastoma.

Glioblastoma is the most common and most aggressive form of malignant brain tumor in adults. The first five patients in the study were all diagnosed with recurrent glioblastoma. In May 2023 the study was expanded with up to ten additional patients.

Patients with primary, inoperable glioblastoma were also included in the study at that time. In total, 14 patients have now undergone treatment with laser ablation and in all cases the procedure could be performed safely and according to plan. The team at Skane University Hospital used the CLS system for neurosurgery, which is commercialized under the brand name ClearPoint Prism Neuro Laser Therapy System, in combination with the ClearPoint Neuro Navigation System, to perform the treatments.

Specialists from ClearPoint Neuro's European team and from CLS were present and provided application and product support during the study. When the follow-up of the last patient is complete, in about three months, the results will be compiled, and a manuscript submitted to a scientific medical journal. The results are also planned to be used as part of an upcoming application for CE marking of the system for use in neurosurgery on the European market.

In early June, a full market launch of the ClearPoint Prism Neuro Laser Therapy System was initiated in the US through CLS? partner ClearPoint Neuro Inc.