CLS Americas Inc, a subsidiary of Clinical Laserthermia Systems AB, today announced the company's  TRANBERG® Thermal Therapy System (https://clinicallaser.se/products/tranberg-thermal-therapy-system/) will be used by Focalyx Technologies, developer of image-guided fusion target devices, to conduct a 20-patient, Phase I clinical study titled, "Targeted MRI/US Fusion Transperineal Laser Ablation of Low-to-Intermediate Risk Prostate Cancer." The study will utilize the Focalyx® Fusion (https://www.focalyx.com/en/focalyx-fusion) medical device for treatment planning, image fusion, real-time image guidance during treatment, and CLS's TRANBERG® Thermal Therapy System for high-precision, focal laser ablation. Other instruments will be used during the procedure as well. The study will be conducted by Urological Research Network, LLC (https://research.surgery/), a Florida-based not-for-profit clinical research organization in The USA.

"CLS is extremely pleased to begin this important clinical study with Dr. Fernando J. Bianco, who is the, Investigator In-Chief for the Urological Research Network" stated Michael Magnani, president of CLS Americas Inc. "Dr. Bianco is widely recognized as a pioneer of fusion target therapies in the office setting under local anesthesia and respected throughout the international medical community as an innovative urologic oncologist. He began his comprehensive MRI-US, Transperineal Fusion program in 2013 and since then has performed over 2,500 biopsies and 1,000 fusion target cryoablations in the office setting. We believe this upcoming study will provide strong results showing the safety, efficacy, and effectiveness of treating prostate cancer tumors in an outpatient urology clinic or office setting."

In the US, over a million prostate biopsies are performed every year identifying almost 250,000 men with prostate cancer. These patients need emergent therapies as alternatives to the standard treatments that often carry long term harmful side effects. CLS is actively recruiting and working with clinical and commercial partners to enable high precision, minimally invasive targeted fusion laser ablation of prostate cancer tumors to be performed under local anesthesia in an office setting or clinic as well as hospitals.

"The role of practical and safe delivery of heat-based tissue ablation applied to malignancies is growing, it's happening among kidney, lung, and hepatic tumors," said Dr. Bianco. "We welcome the expansion of ablation energies that can be applied through the perineal skin in an office setting under local anesthesia as novel potential tools in our fight against prostate cancer. However, while I believe there is a tremendous opportunity for laser ablation, it first requires rigorous scientific scrutiny. This trial represents a first solid step in that direction."

CLS History & Experience - Image-Guided, Focal Laser Ablation of Prostate Tumors

CLS's TRANBERG® Thermal Therapy Systems with its accessories have been used to treat hundreds of prostate tumor patients in the US and EU using MRI guidance. The safety and diagnostic accuracy of fusion-guided prostate biopsies are well documented with strong global market growth. The treatment process and workflow for MR/US, fusion-guided focal laser ablation of prostate cancer tumors are very similar to the fusion-guided biopsy process with a similar recovery time for the patient.

High Precision Thermal Therapy System

The TRANBERG® Thermal Therapy System has been developed for image-guided, high-precision soft tissue thermal therapy and ablation procedures. The system can be configured for MR, CT-US, and MR-US, fusion-guided procedures using tissue temperature feedback for precise therapy and ablation control. It includes a desk-top mobile laser unit, innovative non-cooled laser applicators, external tissue temperature probe sensors, and procedure-specific accessories. Its non-cooled, laser fiber technology optimizes heat distribution, eliminates the need for external cooling, and helps reduce procedure times.

Focalyx® Fusion

Focalyx® Fusion (https://www.focalyx.com/en/focalyx-fusion) is an innovative image fusion medical device. It originated at the University College of London Computational Biology program and has been further developed by Focalyx® Technologies, a Miami-based medical device manufacturing company. The Focalyx® Fusion allows the integration of an MRI diagnostic and treatment plan from magnetic resonance imaging with real-time ultrasound. The contour of the prostate is introduced, and the two silhouettes are superimposed. The result is a highly accurate 3D image of the patient's gland, in which it is possible to locate suspicious lesions with high precision using a GPS-like system. The diagnosed lesion is then ablated safely while preserving the prostate without jeopardizing sexual and urinary functions.

Company Contact:

CLS Americas Inc.

Michael Magnani, President

T: +1 (949) 504-5440

E: michael.magnani@clinicallaser.com

Media Contact:

CLS Americas Inc.

TopSpin Communications

Joe Waldygo, President

P: +1 (480)363-8774

E: joe@topspinpr.com

Company/Media Contact

Focalyx, LLC

Dr. Alessandra Pluchino, COO

T: +1 (888) 636-2259

E: apluchino@smartblate.com

Company/Media Contact

Urology Research Network

Dr. Fernando Bianco

Investigator In-Chief

T: +1 (786) 431-2014

E: fusionprotocol@research.surgery

About CLS and the TRANBERG® product portfolio

Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG® Thermal Therapy Systems, including ThermoguideTM Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. All components of the TRANBERG® Thermal Therapy Systems have received EU-wide regulatory approval as medical devices (CE-marked class II) for the treatment of soft tissue lesions. CLS is developing its systems to get CE-mark class III for disposable TRANBERG® laser applicators to be used in brain as well as expanding the current CE-mark for treatment with imILT®, the Company's interstitial laser thermotherapy for immunostimulatory ablation with potential abscopal treatment effect. CLS is headquartered in Lund and has subsidiaries in Germany, the US and Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B. The Certified Advisor (CA) is FNCA Sweden AB, Tel: +46 8 528 00 399.E-mail:info@fnca.se.

The use of TRANBERG® Thermal Therapy System for immune stimulating interstitial laser thermotherapy (imILT®) and the ThermoguideTM thermometry software has not yet received market clearance by the Food and Drug Administration (FDA) in the United States of America (USA).

For more information about CLS, please visit the Company's website: www.clinicallaser.com

This disclosure contains information that CLS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 29-03-2022 14:00 CET.