CLS and University Hospital Magdeburg launch clinical trial regarding focal laser ablation treatment of localized prostate cancer

Irvine, CA, October 12, 2020 – Clinical Laserthermia Systems (publ) and Otto-von-Guericke-University Magdeburg, Medical faculty are entering into an agreement regarding an Investigator Initiated Trial (IIT) targeting 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. Previously this year, CLS announced that University Hospital Magdeburg had evaluated the TRANBERG system in an MR-guided LITT procedure for treatment of small liver metastases and tumors. More than twenty patients were treated under the evaluation program. The evaluation was successful with no treatment related side effects and the hospital will continue to use CLS products for its LITT procedures. CLS and University Hospital Magdeburg is now expanding its collaboration which is managed by CLS’ German subsidiary, CLS GmbH.

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 in December 2020, which means that the estimated end time for the trial is 2022.

“I am very pleased to announce this enhanced collaboration with University Hospital Magdeburg in Germany, and to get the opportunity to work together with this skilled team to get valuable user experience and collect solid clinical data from prostate treatment with the TRANBERG Thermal Therapy System. This study supports CLS’s strategy to continue to build clinical evidence for our products in the FLA/LITT space. This is the path to secure clinical relevance and enable a strong commercial development for the company,” says Lars-Erik Eriksson, CEO at CLS.

CLS will co-fund the study and also supply its disposable products. The TRANBERG laser unit is already installed at the hospital. Recruitment of patients will start after the formal approval from the responsible ethics committee and the responsible Competent Authorithy (BfArM) in Germany is according to the German Law to conduct clinical trials with medical devices.   Otto-von-Guericke-University Magdeburg was founded after the unification of Germany, and is one of the important universities in the country. 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. 

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This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.

The TRANBERG®|Thermal Therapy System has not yet received market clearance for immune stimulating interstitial laser thermotherapy (imILT®) by the Food and Drug Administration (FDA) in the United States of America (USA).

Company contact:
Michael Magnani, Managing Director
P: +1 949-504-5440
E: michael.magnani@clinicallaser.com

Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG® |Thermal Therapy System including specially designed sterile disposable products minimally invasive treatment of cancerous tumors, in accordance with regulatory approvals in EU and USA. The products are marketed for image-guided laser ablation (FLA, LITT) and for treatment with imILT®, the company’s interstitial thermotherapy with a potentially immune stimulating effect. CLS is headquartered in Lund, Sweden and has subsidiaries in Germany and Irvine, CA. CLS is listed Nasdaq First North Growth Market under the ticker CLS B. Certified Adviser (CA) is FNCA Sweden AB, Ph: +46 8 528 00 399. E-mail: info@fnca.se. Further information is available on www.clinicallaser.se.