CLS partner ClearPoint Neuro receives FDA 510(k) clearance for Prism Bone Anchor Accessory enabling operating room placement of laser applicators

Lund, Sweden, April 30, 2024 – Clinical Laserthermia Systems AB (publ) (“CLS” or “the Company”) today congratulates its partner ClearPoint Neuro on receiving 510(k) clearance for its Prism Bone Anchor Accessory, expanding the use of ClearPoint Prism Neuro Laser Therapy System beyond the MRI into the operating room.

The introduction of the Prism Bone Anchor Accessory for use with the ClearPoint Prism Neuro Laser Therapy System and commercially available stereotactic systems allows for placement of laser applicators also in the operating room.

“The 510(k) clearance of the Prism Bone Anchor is a significant milestone in the roll out of the ClearPoint Prism Neuro Laser Therapy System on the U.S market, and I congratulate ClearPoint Neuro on this achievement. Introducing the Prism Bone Anchor significantly expands the addressable market for the ClearPoint Prism Neuro Laser Therapy System supplied by CLS. We look forward to continuing our collaboration with ClearPoint Neuro to deliver in-demand products and to further expand the addressable market.” said Dan J. Mogren, CEO of CLS.

The ClearPoint Prism Neuro Laser Therapy System is currently in limited market release at selected academic medical centers across the United States.

For further information, please contact:

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

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

E-mail: [email protected]

CLS

Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy Systems, including Thermoguide Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. The products are marketed for image-guided laser ablation and used in studies for treatment with imILT®, the Company’s interstitial laser thermotherapy for immunostimulant ablation with potential abscopal effects. CLS is headquartered in Lund and has subsidiaries in Germany, the US and Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B. The Certified Advisor (CA) is FNCA Sweden AB.

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