CLS Americas Announces 2nd Order of TRANBERG™ Focal Laser Ablation Accessories Placed by the National Institutes of Health Clinical Center

2024-04-09
上市批准
CLS’s Single-Use, Sterile Instruments to be used in Research Study - MRI/Ultrasound Fusion-Guided FLA of Prostate Tissue and Prostate Cancer LOS ANGELES, April 09, 2024 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems Americas, Inc. (CLS), a leading provider of office-based, focal laser ablation (FLA) systems for urologists, today announced it has received its second order from the National Institutes of Health Clinical Center (NIHCC) for its TRANBERG™ Thermal Therapy System accessories. This order of single-use sterile instruments includes introducers, temperature probes, and unique, non-cooled laser applicators that will be used to assess the clinical utility of CLS’s TRANBERG™ Thermal Therapy System towards MRI/Ultrasound fusion-guided focal laser ablation (FLA) of prostate tissue and prostate cancer in male patients. The order falls under the previously announced research collaboration agreement between NIHCC and its parent company, Clinical Laserthermia Systems AB, based in Sweden. 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. “This second order of our TRANBERG Focal Laser Ablation accessories enables our continued collaboration with the NIH to evaluate our TRANBERG laser for image-guided, focal therapies to treat prostate cancer,” said Michael Magnani, President of CLS Americas. “CLS’s relationship goal with the NIH and its study is to demonstrate positive results that focal laser ablation can offer patients safe and effective alternatives to traditional prostate cancer treatments without the unwanted side effects.” 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. A TRANBERG FLA Animation Video of the system and procedure is available to watch. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit . About CLS Americas, Inc. Clinical Laserthermia Systems Americas Inc, based in Los Angeles, 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 510(k) 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: . 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 Media Contact: NIH Clinical Center Justin Cohen, MS, MA Chief, Office of Communications & Media Relations (OCMR) P: +1 (301).402.6202 E: justin.cohen@nih.gov
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