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Radboud University Medical Center in Nijmegen, the Netherlands, has initiated an Investigator Initiated Trial (IIT) studying MR-guided FLA in localized prostate cancer using the CLS TRANBERG® products

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Lund, Sweden, 18 February, 2022 – Radboud University Medical Center (Radboudumc) in Nijmegen in the Netherlands has obtained approval from its ethics committee for its Investigator Initiated Trial (IIT) to evaluate the safety and feasibility of magnetic resonance guided focused laser ablation (MRgFLA) as a focal therapy treatment for localized prostate cancer in low to intermediate risk patients, using the TRANBERG® Thermal Therapy System with Thermoguide™ Workstation.

“I am very pleased that the Minimally Invasive Image-Guided Intervention Center (MAGIC) at Radboudumc, a leading European center in diagnosis and treatment of prostate cancer, has chosen to collaborate with CLS in this clinical investigation into the safety and feasibility of MR guided FLA as a focal therapy treatment of patients with localized prostate cancer, using our TRANBERG® products that integrates with their MR-scanner and robotic system for procedure imaging, navigation and monitoring of the entire procedure”, says Lars-Erik Eriksson, Deputy CEO of CLS.

My team is looking forward to this clinical study in collaboration with CLS within our clinical trial on magnetic resonance (MR) guided focused laser ablation (MRgFLA) as a focal therapy treatment for localized low to intermediate risk prostate cancer”, says Professor Jurgen Fütterer from MAGIC at Radboudumc. “The study will investigate a minimally invasive MR guided laser ablation procedure, to remove the index tumor that is confined to the prostate gland. With this new technology of CLS, that fully integrates with our MR-scanner and robotic system for accessing the prostate, the MR-guided procedure is performed using a much less invasive approach, compared to surgery, while still offering a high degree of precision and accuracy during instrument positioning and tumor ablation.”

 

About localized prostate cancer

About 1,700,000 new cases per year of localized prostate cancer are reported worldwide. Although the landscape of prostate cancer treatment shows several treatment options, there is still an important unmet need for patients who progressed to intermediate risk stage. The currently available surgical options show significant risks and side effects related to urinary and erectile functions and quality of life.

 

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 18, 2022 at 16:45 CET.

 

Contact information:

Lars-Erik Eriksson, CFO and Deputy CEO, Clinical Laserthermia Systems AB (publ)

Tel: +46 – (0)702 – 90 33 00E-mail: lars-erik.eriksson@clinicallaser.com

 

 

About CLS and TRANBERG system 

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: www.clinicallaser.se

 

About MAGIC and Radboud University Medical Center

The Minimally Invasive Image-Guided Intervention Center (MAGIC) is part of the Department of Medical Imaging of Radboud University Medical Center in Nijmegen, the Netherlands. The MAGIC-group has its roots in MRI-guided diagnosis and treatment of prostate cancer and is chaired by Prof. dr. Jurgen Fütterer. He is Interventional radiologist and is full professor at University of Twente and at the Radboud University Medical Center. He published extensively on MRI in prostate cancer in various journals and book chapters. Together with dr. Joyce Bomers he introduced and implemented MR-guided oncological prostate interventions such as MR-guided cryoablation, Focal Laser Ablation (FLA) and TULSA in the Radboudumc. They were closely involved in the development of a complete MR-compatible remote controlled manipulator to assist during in-bore prostate biopsy procedures. Nowadays, they have a broad experience in MRI-guided diagnostics and interventions for localized prostate cancer.

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