University Hospital Magdeburg obtains the “Go” for the Investigator Initiated Trial on focal laser ablation treatment of localized prostate cancer, with the TRANBERG[®] Thermal Therapy System
Lund, Sweden, 24 June, 2021 – Clinical Laserthermia Systems (publ) and Otto-von-Guericke-University Magdeburg, Medical faculty have obtained approval from the ethics committee, and from the responsible Competent Authority (BfArM), in Germany regarding the previously announced IIT targeting focal laser ablation treatment of prostate cancer.
CLS and the Otto-von-Guericke-University Magdeburg, Medical faculty as the sponsor and with the KKS Magdeburg as sponsor representative (Coordinating Center of clinical studies) have since October last year an agreement regarding an IIT of MRI-Ultrasound fusion guided focal laser ablation treatment of prostate cancer, up to Gleason 7a (3+4), using CLS’ TRANBERG® Thermal Therapy System for high-precision, minimally invasive interventions. Within the scope of the trial 10 patients with localized prostate cancer will receive focal laser ablation treatment. The follow-up time after treatment will be 12 months and the total duration time of the study is expected to be 18 months. This clinical trial is expected to start recruiting the third quarter 2021, which means that the estimated end time for the trial is 2023.
“I am happy to announce that all formal approvals for our clinical collaboration with Otto-von-Guericke-University Magdeburg, Medical faculty, are now in place. MRI-Ultrasound fusion guided focal laser ablation treatment of prostate cancer is a strategically important area for CLS and our TRANBERG Thermal Therapy System. I’m looking forward to see our system being put to work by the urology experts at the University of Magdeburg”, says Dan Mogren, acting CEO at CLS.
“My team and I are very excited to start the enrollment in this trial soon with MRI-Ultrasound fusion guided focal laser ablation treatment of prostate cancer using the innovative technology presented by the CLS TRANBERG system. Prostate cancer is today the most common cancer diagnose in men. To evaluate new treatment alternatives for this group of patients is most relevant”, says Prof. Dr.med. Martin Schostak, Head of Urology at the University Hospital Otto-von-Guericke-University Magdeburg.
Otto-von-Guericke-University Magdeburg is one of the most important universities in Germany and its medical department is ranked among the top 15 in Germany. The Urology department is a strong and important player in focal therapy of prostate cancer.
The information was submitted for publication, through the agency of the contact person set out below, on June 24, 2021 at 10:00 CET.
Dan J. Mogren, acting CEO, Clinical Laserthermia Systems AB (publ)
Ph: +46 – (0)705 – 90 11 40
E-mail: dan.mogren@clinicallaser.com
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy System, 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 for treatment with imILT®, the Company's interstitial laser thermotherapy with potential immunostimulatory 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: www.clinicallaser.se