CLS Americas & Focalyx Present Integrated Fusion-Guided Focal Laser Ablation Solution at FOCAL 2022 Conference

Combined Products Enable Minimally-Invasive, High Precision Laser Focal Therapy of Prostate Tumors in an Office or Clinic

LOS ANGELES, Sept. 23, 2022 (GLOBE NEWSWIRE) — CLS Americas, a subsidiary of Clinical Laserthermia Systems AB, and Focalyx Technologies, developer of image-guided fusion target devices, today announced the companies will exhibit and demonstrate their respective TRANBERG™ Thermal Therapy System for focal laser ablation and Focalyx® Fusion medical device at the FOCAL 2022 Conference being held September 22-24, 2022 in Los Angeles. The conference theme is, ”Frontiers in Oncologic Prostate Care and Ablative Local Therapy.”

The TRANBERG™ System is designed to work with multiple MR/US fusion image guidance systems for precise and accurate tumor ablation in a minimally invasive, outpatient setting. Compared to other focal therapies, focal laser ablation therapy has demonstrated higher levels of precision and accuracy with lower risk of side effects, such as erectile dysfunction and urinary incontinence.

“CLS Americas is excited to demonstrate our new office-based, fusion-guided, focal Laser Ablation solution to FOCAL 2022 attendees in conjunction Focalyx Technologies and Urological Research Network,” stated Michael Magnani, president of CLS Americas. “The treatment process and workflow is very similar to the workflow for fusion-guided, transperineal prostate biopsies and cryoablations. This reduces the learning curve for urologists already familiar with these procedures.”
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 have shown to carry long term harmful side effects.

“Some current treatment options for prostate cancer tumors expose patients to unacceptably high complications rates for erectile dysfunction or urinary incontinence,” said Dr. Fernando J. Bianco, Investigator-In-Chief for the Urological Research Network. “Based on my clinical trial experience with CLS’s TRANBERG laser, I believe that partial gland fusion focal laser ablation provides the precision to successfully treat the cancerous lesions while offering patients a superior side effect profile.”

CLS Americas & Focalyx Technology Lunch Presentation
Dr. Fernando J. Bianco, Investigator In-Chief for the Urological Research Network, a Florida-based, not-for-profit clinical research organization, will discuss his experience conducting his ongoing 20-patient, Phase I clinical study using the TRANBERG and Focalyx systems titled, “Targeted MRI/US Fusion Transperineal Laser Ablation of Low-to-Intermediate Risk Prostate Cancer.”

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 has been used in hundreds of tumor laser ablation procedures in patients with localized prostate cancer in the US and EU using an in-bore, MRI-guided procedure. With the safety and diagnostic accuracy of MR/US fusion-guided transperineal prostate biopsy being well documented, this outpatient office procedure and technology are seeing a strong global adoption. CLS is leveraging its in-bore MR experience and applying it to MR/US, fusion-guided transperineal procedures and technology to perform focal laser ablation of prostate tumors with the TRANBERG^® Thermal Therapy System. CLS is helping reduce the ‘focal therapy learning curve’ to provide more patients with the added benefit of a safe, fast and precise tumor ablation procedure.

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, or 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. The TRANBERG system can be deployed in either a transperineal or transrectal approach. 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^TM 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 for the US market: www.clinicallaser.com.

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