Lund, Sweden - September 4th, 2025 - Clinical Laserthermia Systems AB (publ) ("CLS" or "the Company") today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for expansion of the labeling of ClearPoint Prism® Neuro Laser Therapy System.
In addition to the existing clearance for use with 3.0 Tesla (3.0T) magnetic resonance imaging (MRI) guidance, the system is now also cleared for use with 1.5T MRI guidance.
The expanded clearance significantly broadens the accessibility of the Prism Neuro Laser Therapy System for U.S. hospitals and patients, as approximately half of all MRI-guided neurosurgical procedures are performed using 1.5T scanners. The approval thereby more than doubles* the addressable U.S. market for Neuro Laser Interstitial Thermal Therapy (Neuro LITT) procedures.
"This FDA clearance is a pivotal milestone for CLS and our partner Clearpoint Neuro. By expanding compatibility to 1.5T MR scanners, we are unlocking access to minimally invasive laser ablation therapy for a much larger number of patients and hospitals across the U.S. This is a major step in our mission to enable broader adoption of Neuro LITT procedures and to support physicians with safe, effective, and image-guided solutions for treating patients with severe neurological conditions", commented Dan J. Mogren, CEO of CLS.
The ClearPoint Prism® Neuro Laser Therapy System is marketed and sold in the U.S. exclusively by Clearpoint Neuro, Inc., under the companies' global partnership agreement. The expanded labeling is expected to accelerate adoption and clinical use of Neuro LITT procedures, enabling hospitals with both 3T and 1.5T MRI scanners to treat a larger range of patients.
*Moser E, Laistler E, Schmitt F and Kontaxis G (2017) Ultra-High Field NMR and MRI-The Role of Magnet Technology to Increase Sensitivity and Specificity. Front Phys. 5:33. doi: 10.3389/fphy.2017.00033.
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 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
This disclosure contains information that CLS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 04-09-2025 17:01 CET.