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CLS Conducts In-Vivo Laser Ablation Studies for Neuro and Prostate using TRANBERG Thermal Therapy System with Thermoguide

IRVINE, Calif. and LUND, Sweden, May 22, 2020 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS) today announced it is conducting new in-vivo precision laser ablation treatment studies for neuro and prostate using its TRANBERG Thermal Therapy System with Thermoguide thermometry software. The company is also currently preparing its application for 510(k) clearance from the American Food and Drug Administration (FDA) for the U.S. market.
Recent dialog between CLS and the FDA has brought about new information. Most notably, the demand for preclinical data is now more extensive than the company initially expected, primarily for products to be used in neuro applications, but also for use in other indications. This quarter, CLS will initiate preclinical studies in neuro and prostate scheduled to last throughout the year.In April 2020, CLS obtained EU approval and an EC Certificate for the TRANBERG System, Thermoguide software and related products to be marketed and sold in Europe for indications such as prostate cancer, brain tumors, and epilepsy.CLSa??s current expected timeline for filing its application for 510(k) clearance with the FDA is estimated to take place during the first half of 2021. The timeline and plan could be affected by the ongoing Covid 19 pandemic and travel restrictions within the U.S. and EU.A a??We now have a detailed overview of the FDAa??s latest requirements, which have been previously difficult to foresee. This enables us to recalibrate and align our resources towards the access and organisations necessary for carrying out the work with, among other things, the preclinical studies,a?? says Stephan Dymling, CTO at CLS. a??Our goal is to begin executing the new plan at the highest pace and productivity the current situation and the prerequisites allow.a??
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