CLS announces enrollment completion of initial phase of CLS-sponsored glioblastoma laser ablation study with the ClearPoint Prism™ Neuro Laser Therapy System at Skåne University Hospital
Lund, Sweden –Clinical Laserthermia Systems AB (publ) (CLS), today announced that all five patients have been safely treated in the clinical study at Skåne University Hospital (SUS).
The aim of the study is to evaluate safety and feasibility of using minimally invasive MRgLITT in brain, for ablation of tumor tissue in patients diagnosed with glioblastoma. In the study, the team at Skåne University Hospital utilized CLS’s latest thermal therapy product branded ClearPoint Prism™ Neuro Laser Therapy System, in combination with ClearPoint® Neuro Navigation System, to perform the MRg LITT procedure using a streamlined one-room, one-team workflow.
The study targets patients with tumors that would have been difficult to reach using traditional methods like open surgery or radiation. Before study closure and compilation of study data, the patients will be followed up for three months.
“We are very happy with how the clinical study is conducted at SUS, to investigate how CLS products can offer an alternative for patients where the risks with traditional surgery are too great,” stated Dan J. Mogren, CEO of Clinical Laserthermia Systems AB. “One major benefit compared to traditional surgery is that the patients generally can leave the hospital already two days after the procedure.”
In 2022 CLS received 510(k) clearance by the FDA for the PRISM system, for use in neurosurgery, in the United States. ClearPoint Neuro has exclusive global rights to commercialize the ClearPoint Prism Neuro Laser Therapy System from CLS for neuro applications.
CLS, ClearPoint Neuro and Skåne University Hospital have agreed to continue the successful collaboration until 2024 and have received approval from the Swedish competent authority to extend the clinical study protocol for up to 10 additional glioblastoma patients to gain further experience, and to gather data for market approvals in countries outside of the USA.
Skåne University Hospital has previously published a press release informing about the benefits laser ablation brings for the patients. An English version is available here:
MRI-guided laser surgery – new help for brain tumour patients - Skåne University Hospital (skane.se)
The information was submitted for publication, through the agency of the contact person set out below on May 2, 2023.
For more information, please contact:
Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)
Phone: +46 (0)705 90 11 40
E-mail: dan.mogren@clinicallaser.com
About 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, Tel: +46 8 528 00 399. E-mail: info@fnca.se.
For more information about CLS, please visit the Company's website: clinicallaser.se.