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Est. tid*
2026-02-20 08:30 Bokslutskommuniké 2025
2025-11-14 08:30 Kvartalsrapport 2025-Q3
2025-08-22 - Kvartalsrapport 2025-Q2
2025-06-30 - X-dag ordinarie utdelning CLS B 0.00 SEK
2025-06-27 - Årsstämma
2025-05-16 - Kvartalsrapport 2025-Q1
2025-02-21 - Bokslutskommuniké 2024
2024-10-31 - Kvartalsrapport 2024-Q3
2024-10-21 - Extra Bolagsstämma 2024
2024-08-23 - Kvartalsrapport 2024-Q2
2024-06-28 - Årsstämma
2024-05-29 - Kvartalsrapport 2024-Q1
2024-05-17 - X-dag ordinarie utdelning CLS B 0.00 SEK
2024-04-25 - Split CLS B 200:1
2024-02-23 - Bokslutskommuniké 2023
2023-11-17 - Kvartalsrapport 2023-Q3
2023-08-25 - Kvartalsrapport 2023-Q2
2023-06-29 - Årsstämma
2023-06-22 - X-dag ordinarie utdelning CLS B 0.00 SEK
2023-06-08 - Extra Bolagsstämma 2023
2023-05-25 - Kvartalsrapport 2023-Q1
2023-02-23 - Bokslutskommuniké 2022
2022-11-22 - Extra Bolagsstämma 2022
2022-11-17 - Kvartalsrapport 2022-Q3
2022-08-25 - Kvartalsrapport 2022-Q2
2022-06-29 - X-dag ordinarie utdelning CLS B 0.00 SEK
2022-06-28 - Årsstämma
2022-05-19 - Kvartalsrapport 2022-Q1
2022-02-24 - Bokslutskommuniké 2021
2021-11-18 - Kvartalsrapport 2021-Q3
2021-08-24 - Kvartalsrapport 2021-Q2
2021-06-29 - X-dag ordinarie utdelning CLS B 0.00 SEK
2021-06-28 - Årsstämma
2021-05-19 - Kvartalsrapport 2021-Q1
2021-03-31 - Extra Bolagsstämma 2021
2021-02-26 - Bokslutskommuniké 2020
2020-11-19 - Kvartalsrapport 2020-Q3
2020-08-26 - Kvartalsrapport 2020-Q2
2020-06-12 - X-dag ordinarie utdelning CLS B 0.00 SEK
2020-06-11 - Årsstämma
2020-05-28 - Kvartalsrapport 2020-Q1
2020-02-28 - Bokslutskommuniké 2019
2019-11-21 - Kvartalsrapport 2019-Q3
2019-08-22 - Kvartalsrapport 2019-Q2
2019-06-12 - X-dag ordinarie utdelning CLS B 0.00 SEK
2019-05-17 - Årsstämma
2019-05-16 - Kvartalsrapport 2019-Q1
2019-03-18 - Extra Bolagsstämma 2019
2019-02-14 - Bokslutskommuniké 2018
2018-11-22 - Kvartalsrapport 2018-Q3
2018-08-23 - Kvartalsrapport 2018-Q2
2018-06-20 - Årsstämma
2018-06-14 - X-dag ordinarie utdelning CLS B 0.00 SEK
2018-05-24 - Kvartalsrapport 2018-Q1
2018-05-18 - Extra Bolagsstämma 2018
2018-02-22 - Bokslutskommuniké 2017
2017-11-16 - Kvartalsrapport 2017-Q3
2017-07-17 - Kvartalsrapport 2017-Q2
2017-06-28 - X-dag ordinarie utdelning CLS B 0.00 SEK
2017-06-27 - Årsstämma
2017-05-18 - Kvartalsrapport 2017-Q1
2017-01-31 - Bokslutskommuniké 2016
2017-01-20 - Extra Bolagsstämma 2017
2016-11-17 - Kvartalsrapport 2016-Q3
2016-08-18 - Kvartalsrapport 2016-Q2
2016-06-16 - Årsstämma
2016-05-19 - Kvartalsrapport 2016-Q1
2016-02-21 - Bokslutskommuniké 2015
2015-11-19 - Kvartalsrapport 2015-Q3
2015-08-20 - Kvartalsrapport 2015-Q2
2015-06-12 - X-dag ordinarie utdelning CLS B 0.00 SEK
2015-06-11 - Årsstämma
2015-05-21 - Kvartalsrapport 2015-Q1
2015-02-23 - Bokslutskommuniké 2014
2014-11-14 - Kvartalsrapport 2014-Q3
2014-08-20 - Kvartalsrapport 2014-Q2
2014-06-18 - X-dag ordinarie utdelning CLS B 0.00 SEK
2014-06-17 - Årsstämma
2014-05-22 - Kvartalsrapport 2014-Q1
2014-02-24 - Bokslutskommuniké 2013
2013-11-22 - Kvartalsrapport 2013-Q3
2013-09-19 - Extra Bolagsstämma 2013
2013-08-20 - Kvartalsrapport 2013-Q2
2013-06-10 - X-dag ordinarie utdelning CLS B 0.00 SEK
2013-06-07 - Årsstämma
2013-05-24 - Kvartalsrapport 2013-Q1
2013-02-25 - Bokslutskommuniké 2012
2012-11-23 - Kvartalsrapport 2012-Q3
2012-08-24 - Kvartalsrapport 2012-Q2
2012-06-08 - X-dag ordinarie utdelning CLS B 0.00 SEK
2012-06-07 - Årsstämma
2012-04-20 - Kvartalsrapport 2012-Q1
2012-01-09 - Bokslutskommuniké 2011
2012-01-04 - Extra Bolagsstämma 2012
2011-11-21 - Kvartalsrapport 2011-Q3
2011-09-26 - Kapitalmarknadsdag 2010
2011-08-22 - Kvartalsrapport 2011-Q2
2011-06-10 - Årsstämma
2011-05-20 - Kvartalsrapport 2011-Q1
2011-02-24 - Bokslutskommuniké 2010
2010-11-24 - Kvartalsrapport 2010-Q3
2010-08-25 - Kvartalsrapport 2010-Q2
2010-05-28 - X-dag ordinarie utdelning CLS B 0.00 SEK
2010-05-26 - Kvartalsrapport 2010-Q1
2010-02-26 - Bokslutskommuniké 2009
2009-11-30 - Kvartalsrapport 2009-Q3

Beskrivning

LandSverige
ListaFirst North Stockholm
SektorHälsovård
IndustriMedicinteknik
Clinical Laserthermia Systems är verksamt inom medicinteknik. Bolagets vision är att utveckla och effektivisera behandlingen av solida cancertumörer, där bolaget är försäljare av sterila patientkit. Produkterna används i diverse cancerbehandlingar som vid behandling av malignt melanom, samt cancer i lungor, lever och bukspottkörtel. Bolaget grundades år 2006 och har sitt huvudkontor i Lund.
2025-09-04 17:00:47

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.