Lund, Sweden, October 7th, 2025 - Clinical Laserthermia Systems AB (publ) ("CLS") today announces positive results from a clinical safety study on laser ablation, performed using CLS proprietary LITT platform in patients with malignant brain tumor, conducted at Skåne University Hospital.
Patients with recurrent malignant brain tumor that were treated with Laser Interstitial Thermal Therapy (LITT) had increased median survival compared to a matched control group treated with open surgery. The study's primary objective - to investigate whether the CLS proprietary LITT platform was safe and feasible in the treatment of brain tumors - was successfully achieved. Among the 14 patients enrolled in the study, only eight neurologic or cognitive adverse events were reported, and most of these were transient.
"We are very pleased that the neurosurgeons who conducted the study found our system for neuro LITT procedures to be easy to use and that it performed very well. And even if this is a small study, it's very satisfying to see that the results are this good," commented Dan J. Mogren, CEO of CLS.
The patients in the study suffered from recurrent (11 patients) or newly diagnosed glioblastoma (3 patients). Glioblastoma is the most aggressive form of brain tumor and accounts for 51% of malignant brain tumors. It has a poor prognosis due to resistance to treatment and a high rate of recurrence. If left untreated, the median survival is between 2 and 4 months.
"For patients with glioblastoma, having a minimally invasive option instead of open surgery is an important step forward. This may also provide new treatment options for many inoperable patients. It's less demanding for patients and makes treatment easier to go through," commented Peter Siesjö, associate professor in neurosurgery and principal investigator of the study.
The study, that was conducted by neurosurgeons at Skåne University Hospital, was sponsored by CLS and co-funded by ClearPoint Neuro, Inc. The laser ablations were guided by 3T MR imaging and neuro navigation was performed using ClearPoint® Neuro Navigation System, ClearPoint Neuro Inc.
Results from the study will be presented at the 75th Congress of Neurological Surgeons (CNS) Annual Meeting, a premier neurosurgery conference held at the Los Angeles Convention Center 11-15 October, expecting over 3,000 delegates. https://www.cns.org/poster-search?id=3560
The study is registered at clinicaltrials.gov with trial number: NCT05296122.
CLS proprietary LITT platform features Non-cooled simple-to-setup Laser Applicators, for a wide range of anatomical targets in the brain, and Thermoguide Workstation for MR thermometry, providing the highest refresh rate and image resolution on the market. CLS LITT platform for Neuro applications is cleared by U.S FDA and marketed in the US as ClearPoint PRISM® Neuro Laser Therapy System by ClearPoint Neuro Inc.
For more information, please contact:
Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)
Phone: +46 (0) 70-590 11 40
E-post: 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 through partners for image-guided laser ablation. 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
