CLS and Skåne University Hospital enter a clinical trial agreement to evaluate MR-guided Laser Interstitial Thermal Therapy (LITT) for glioblastoma ablation
Clinical Laserthermia Systems AB (publ) (CLS), which develops advanced innovative products for high-precision image guided laser ablation, announces that it has entered into an agreement with Skåne University Hospital to sponsor a clinical trial evaluating the safety and feasibility of magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) for ablation of glioblastoma lesions, using the CLS TRANBERG® Thermal Therapy System with Thermoguide™ Workstation. Approval for this trial has been obtained from the Swedish Medical Product Agency.
The single-center, single-arm prospective study will investigate the safety and feasibility of using a minimally invasive MR guided laser-based procedure to remove as much of the glioblastoma lesion as possible in five patients.
“I am more than pleased to announce this clinical collaboration with Skåne University Hospital within the field of neurosurgery. The collaboration includes a clinical investigation studying the safety and feasibility of using our TRANBERG® Thermal Therapy System with Thermoguide™ Workstation in MR guided LITT treatment in five patients with glioblastoma. It is also CLS start on collecting clinical evidence allowing us to apply for a class III CE-mark expansion of our sterile disposable TRANBERG® laser applicators for use in ablation of brain lesions”, says Dan J. Mogren, acting CEO of CLS.
About brain tumors and glioblastoma
Glioblastoma is the most aggressive type of brain tumor. About 50 000 new cases are reported each year in Europe and US combined, most of them progress despite treatment. Although intensive research and drug development is done and ongoing for the treatment of this disease, it remains almost incurable. Localization of the tumor may limit the use of traditional surgery and other local treatment options and are therefore deemed unsuccessful.
About Skåne University Hospital
As the third largest hospital in Sweden, Skåne University Hospital offers a full range of highly specialised care, research and education. Skåne University Hospital has units in both Malmö and Lund, where a total of 12,000 employees belonging to more than 100 different professions and occupations work. We provide highly specialised care, and we are the national specialised medical care centre in four areas. Research at Skåne University Hospital is closely tied to point-of-care treatment and done in co-operation with Lund University. We teach and supervise students who will eventually become our colleagues in the future. Students of all professional categories (physiotherapists, registered nurses, social workers, doctors, practical nurses, etcetera) receive their clinical training (VFU) with us.
This information is information that CLS AB is obliged to make public pursuant to the EU Market Abuse
Regulation. The information was submitted for publication, through the agency of the contact person set out below, on February 9th, 2022 at 08:30 CET.
Contact information:
Dan J. Mogren, Acting CEO, Clinical Laserthermia Systems AB (publ)
Tel: +46 – (0)705 – 90 11 40
E-mail: dan.mogren@clinicallaser.com
About CLS and TRANBERG
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. All components of the TRANBERG®|Thermal Therapy Systems have received EU-wide regulatory approval as medical devices (CE-marked class II) for the treatment of soft tissue lesions. CLS is developing its systems to get CE-mark class III for disposable TRANBERG laser applicators to be used in brain as well as expanding the current CE-mark for treatment with imILT®, the Company's interstitial laser thermotherapy for immunostimulatory ablation with potential abscopal effect. 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: 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 09-02-2022 08:30 CET.