IRVINE, Calif. and MIAMI, Jan. 31, 2023 (GLOBE NEWSWIRE) -- CLS Americas, a leading provider of office-based, focal laser ablation systems in the US urology market, today announced the full twenty patients have been safely treated in the previously announced Phase I clinical study titled, “Targeted MRI/US Fusion Transperineal Laser Ablation of Low-to-Intermediate Risk Prostate Cancer.” The study utilizes CLS’s TRANBERG® Thermal Therapy System in combination with the Focalyx® Fusion medical device for treatment organization, planning, image fusion, and real-time image guidance during the high-precision, focal laser ablation (FLA) treatment. The study is being conducted by Urological Research Network, LLC, a Florida-based, not-for-profit clinical research organization.
In the US, over one million prostate biopsies are performed every year leading to a diagnosis of prostate cancer for almost 250,000 men. Focal laser ablation of prostate tumors has demonstrated high levels of precision and accuracy with low risk of side effects, such as erectile dysfunction and urinary incontinence.
“CLS Americas is very pleased with the preliminary results indicating patients experiencing little to minor quality of life side effects following the FLA procedure with the CLS TRANBERG laser system,” stated Michael Magnani, President of CLS Americas. “Our principal investigator, Dr. Fernando J. Bianco, was able to effectively and efficiently perform minimally invasive MR/Fusion, image-guided, focal laser ablation of prostate tumors in an office setting. This milestone represents the exciting potential to treat more patients with less discomfort, enabling faster recovery times, and significantly reducing the risk of unwanted side effects.”
“The TRANBERG laser system provides a higher degree of precision and control over the ablation shape, size, and margin than cryotherapy or other focal therapies I’ve worked with and seen,” stated Dr. Fernando J. Bianco, principal investigator, Urological Research Network, LLC. “Additionally, I found the TRANBERG laser system to be very easy and intuitive to operate in conjunction with the Focalyx Fusion real-time, image guidance and treatment planning system. The procedure workflow for FLA is very similar to other office based procedures routinely being performed by urologists, such as fusion-guided prostate biopsies and cryoablation of the prostate.”
Recent Company Video Highlights
CLS Americas is currently expanding its commercial market development for the TRANBERG focal laser ablation system and has two informational videos available to view and download.
1.) TRANBERG DEMO – Fusion-Guided Focal Laser Ablation.
2.) FOCAL 2022 Conference - TRANBERG & FOCALYX Presentation.
TRANBERG™ Thermal Therapy System
The TRANBERG™ Thermal Therapy System can be configured for MR/US fusion-guided procedures using real-time tissue temperature measurements for precise therapy and ablation control. It includes a desk-top mobile laser unit, innovative non-cooled laser applicators, tissue temperature probes, and procedure-specific accessories. The TRANBERG system can be deployed in either a transperineal or transrectal approach.
About CLS Americas
Clinical Laserthermia Systems Americas Inc, based in Irvine, CA, is responsible for the sales, commercial development, operations and clinical support for the TRANBERG® Thermal Therapy System and accessories for the US urology market. The powerful system provides minimally invasive, high precision, focal laser ablation using MR or MR US Fusion for image guidance and has received FDA clearance in the US for soft tissue ablation, such as prostate tumors.
CLS Americas is a subsidiary of Clinical Laserthermia Systems AB (publ) headquartered in Lund, Sweden. which has subsidiaries in Germany, the US and Singapore. For more information about CLS, please visit the Company's website: www.clinicallaser.com.
