CLS and University Hospital Magdeburg Begin Study of MRI-Ultrasound, Fusion-Guided Focal Laser Ablation Treatments of Prostate Cancer
Investigator Initiated Trial Receives “Go” for Minimally Invasive Prostate Cancer Treatment using the TRANBERG® Thermal Therapy System
IRVINE, Calif., July 07, 2021 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation systems, today announced that its collaboration regarding an Investigator Initiated Trial (IIT) with Otto-von-Guericke-University Magdeburg, Medical faculty has obtained approval from the ethics committee, and from the responsible Competent Authority (BfArM), in Germany. CLS and the Magdeburg medical team will now proceed with the previously announced IIT regarding MRI-Ultrasound, fusion-guided focal laser ablation treatment of prostate cancer.
Within the scope of the trial 10 patients with localized prostate cancer up to Gleason 7a (3+4), will receive focal laser ablation treatment using CLS’ TRANBERG® Thermal Therapy System and accessories for high-precision, minimally invasive interventions. The follow-up time after treatment will be 12 months.
“CLS is excited to be working with Magdeburg University Hospital to conduct studies and produce vital data regarding how precisely and effectively our new generation of products works together with MRI-Ultrasound, fusion-guidance to treat prostate tumors in patients,” says Dan Mogren, Acting CEO of CLS. “Fusion-guided biopsies are an increasingly preferred method to detect prostate cancer based on its accuracy and minimally invasive recovery benefits. We believe a successful study outcome will help us refine our focal laser ablation therapy to more easily treat early stage prostate cancer in a clinic or office setting.”
“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.
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG® |Thermal Therapy System including specially designed sterile disposable products for the minimally invasive ablative treatments of soft tissues and 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 on 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: email@example.com. Further information is available on www.clinicallaser.se.
The TRANBERG®|Thermal Therapy System has not yet received market clearance for immune stimulating interstitial laser thermotherapy (imILT®) or its Thermoguide thermometry software by the Food and Drug Administration (FDA) in the United States of America (USA).
Company contact: Clinical Laserthermia Systems AB Dan J. Mogren, Acting CEO T: +46 – (0)705 – 90 11 40 E: firstname.lastname@example.org Company Contact: CLS Americas: Michael Magnani, Managing Director T: +1 949-504-5440 E: email@example.com Media Contact: TopSpin Communications Joe Waldygo, President P: +1 480-363-8774 E: firstname.lastname@example.org