Clinical Laserthermia Systems, together with its partner ClearPoint Neuro, announces FDA submission to expand the labeling of ClearPoint Prism® to include 1.5 T MRI guidance

Lund, Sweden – Clinical Laserthermia Systems AB (publ) (CLS), a leading developer of image-guided laser ablation systems, announces the submission of its 510(k) application to the U.S. Food and Drug Administration (FDA) for expanding the indication of ClearPoint Prism to also include 1.5 T MRI guidance.

This submission is a result of and marks a key milestone in CLS’s strategic partnership with ClearPoint Neuro, Inc., and will expand the labeling of ClearPoint Prism to include both 3.0 T and 1.5 T MRI guidance on its labeling.

“The expanded indication of ClearPoint Prism, once cleared by US-FDA, will more than double the addressable U.S neuro LITT market, which we believe will significantly increase our revenue potential. It also creates the foundation for global expansion, offering a solution for all clinically relevant MRI scanners”, said Dan J. Mogren, CEO of CLS.

“We have already seen rapid adoption across functional and oncological neurosurgical LITT procedures with our current 3.0 T labeling, and we believe that achieving clearance for 1.5 T will unlock the remaining neuro LITT market in the United States that we do not have access to today,” commented Joe Burnett, President and CEO of CLPT.

For more information, please contact:

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

Phone: +46 (0) 70-590 11 40

E-post: [email protected]

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