Recruitment of Glioblastoma Patients to the CLS-sponsored Clinical Study at Skåne University Hospital is now Completed

Lund, Sweden – Clinical Laserthermia Systems AB (publ) (CLS or the "Company") today announces that the recruitment of patients to the clinical study, sponsored by CLS and co-funded by ClearPoint Neuro Inc, at Skåne 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 glioblastoma. 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 Skåne 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.

Professor Peter Siesjö, who is principal investigator of the study comments, "The treatment system used for surgical intervention and navigation in the MR camera worked excellently in the completed clinical study. The benefits are obvious for the patients with less invasive interventions and shorter treatment times. For the healthcare system, the method provides the opportunity to offer treatment in cases where conventional surgery it not possible or suitable".

Regarding the future significance of the study, Peter Siesjö says the following: "As the workflow for laser ablation in the MR camera improves, and the duration of the intervention thereby decreases, the demand will increase. Laser ablation of primary and secondary brain tumors as well as epileptic foci and radiation necrosis is better for both the patient and the healthcare system. For the patient, the procedure is less invasive with a lower risk of complications, shorter treatment time and faster recovery, and for the healthcare system, the method probably means a more precise and effective treatment."

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.

For more information, please contact:


Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)

Tel: +46 – (0)705 – 90 11 40


E-mail: dan.mogren@clinicallaser.com

About CLS

Clinical Laserthermia Systems AB (publ), develops and sells TRANBERG®|Thermal Therapy System and ClearPoint Prism Neuro Laser Therapy System with sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy. The products are marketed and sold directly or through partners for image-guided laser ablation and are used in studies for treatment with imILT®, the company's interstitial laser thermotherapy for immune stimulating ablation with potential abscopal treatment effect. CLS is headquartered in Lund, Sweden, with subsidiaries in Germany, the United States and a marketing company in Singapore. CLS is listed on Nasdaq First North Growth Market under the symbol CLS B. Certified adviser (CA) is FNCA Sweden AB.

For more information about CLS, please visit the Company's website: www.clinicallaser.se