CLS Americas and URN Announce First Patient Treated in Clinical Study “Targeted MRI/ US Fusion Transperineal Laser Ablation of Low-to-Intermediate Risk Prostate Cancer”

Minimally Invasive, Outpatient Treatment Designed for Office or Clinic

IRVINE, Calif. and MIAMI, April 20, 2022 (GLOBE NEWSWIRE) — CLS Americas, a subsidiary of Clinical Laserthermia Systems AB, today announced the first patient has been safely treated in its recently announced 20-patient, 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 planning, image fusion, and real-time image guidance during the high-precision, focal laser ablation 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. These patients are demanding 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 focal laser ablation of prostate cancer tumors to be performed under local anesthesia in an office setting or clinic.

“CLS is excited to achieve this significant milestone in our clinical study with Dr. Bianco and his team at URN,” stated Michael Magnani, president of CLS Americas. “The procedure went as planned and the patient was able to leave a short while after with minimal discomfort. An MRI performed immediately after the procedure indicated the tumor was precisely and successfully ablated using our TRANBERG system under fusion image guidance by the Focalyx^® platform. We look forward to completing this trial as we continue developing our commercialization and clinical partnerships.”

“Current treatment options for patients with prostate cancer leave much to be desired by the patient,” said Dr. Fernando J. Bianco, Investigator In-Chief for the Urological Research Network. “Patients today are largely either observed (active surveillance) or receive radical therapies such as radiation or undergo a surgery to completely remove their prostate. Existing focal therapy technologies, while promising, still expose patients to unacceptably high risks of complications such as erectile dysfunction or urinary incontinence. I believe that focal laser ablation provides the precision to successfully treat the cancerous lesions while offering patients a superior side effect profile.”

Dr. Fernando 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 has since performed over 2,500 biopsies and 1,000 fusion target cryoablations in the office setting.

CLS History & Experience – Image-Guided, Focal Laser Ablation of Prostate Tumors
CLS’s TRANBERG^® Thermal Therapy System 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 is very similar to the fusion-guided biopsy process with a similar procedure related 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 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. Therefore, patients can maintain their quality of life.

About CLS and the TRANBERG^® product portfolio
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG^® Thermal Therapy Systems, including Thermoguide™ 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.

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

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

CONTACT: Company Contact:
CLS Americas:
Michael Magnani, President
T: +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
Focalyx, LLC
Dr. Alessandra Pluchino, COO
T: +1 (888) 636-2259
E: apluchino@focalyx.com

Company/Media Contact
Urology Research Network
Dr. Fernando Bianco
Investigator In-Chief
T: +1 (786) 431-2014
E: fusionprotocol@research.surgery