CLS Americas and HALO Precision Diagnostics Announce 25 Patient Post-Market Study to Evaluate CLS’s TRANBERG Thermal Therapy System

2023-02-08

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IRVINE, Calif. and INDIAN WELLS, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems Americas, Inc. (CLS), a leading provider of office-based, focal laser ablation (FLA) systems for urologists, and HALO Precision Diagnostics, Inc. (HALO), today announced a Letter of Intent to evaluate the safety and short term efficacy of CLS’s TRANBERG® Thermal Therapy System for treating low-to-medium risk prostate cancer patients with FLA therapy outside of a hospital setting. HALO will conduct an initial post-market study treating up to twenty-five (25) patients at one or more of its HALO Ambulatory Surgery Centers. Upon completion of its evaluation, HALO and CLS will enter into discussions regarding HALO’s acquisition of the CLS TRANBERG Laser System for use in some of its nationwide system of approximately 16 clinics. 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 excited to begin this initial collaboration with HALO Precision Diagnostics to bring our minimally invasive, image-guided FLA treatment to patients in the convenience of their local urology doctor’s office or clinic,” said Michael Magnani, President of CLS Americas, Inc. “We share a common goal with HALO to enable and deliver a safe and effective treatment of prostate cancer that also helps preserve a patient’s quality of life.” “HALO Precision Diagnostics is pleased to announce a formal relationship and initial post-market study with CLS to evaluate its TRANBERG Laser for treating patients with image-guided, laser focal therapy,” stated Bernadette M. Greenwood, Chief Research Officer, HALO Precision Diagnostics, Inc. “CLS has a strong track record of safety and innovation with its TRANBERG system and a history of successful clinical studies with leading academic and research institutions in the US and EU. We look forward to working with their team to help more patients access focal therapy.” 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 HALO Precision Diagnostics HALO Precision Diagnostics changes patient lives and outcomes through early detection of the leading causes of death with precision diagnostics. We accomplish this with a personalized diagnostic ensemble including advanced imaging, genomics, non-invasive liquid biomarkers, and community-based data at scale combined with deep learning algorithms. By optimizing all these solutions under the HALO Precision Diagnostics platform, we provide rapid, precise, actionable results to enable life-changing treatments by physicians for their patients. About CLS Americas, Inc. 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, focal laser ablation treatments 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: m. CLS Americas Contact: Phone: +1 (949) 504-5440, E-mail: contact-us@clinicallaser.com. Company Contact: CLS Americas: Michael Magnani, President P: +1 (949) 504-5440 E: michael.magnani@clinicallaser.com Media Contact: CLS Americas TopSpin Communications Joe Waldygo, President P: +1 (480)363-8774 E: joe@topspinpr.com Company & Media Contact: HALO Precision Diagnostics Bernadette M. Greenwood, MSc, RT (R) (MR) Chief Research Officer, HALO DIAGNOSTICS, PhD Candidate, Radboud Research Institute P: (760) 776-8989 E: Bernadette@HALODX.com