Clinical Laserthermia Systems

CLS’s TRANBERG® Thermal Therapy System and the Focalyx® Fusion image-guidance system will initially be offered to urology clinics under a Mobile Service Provider (MSP) Agreement that includes consumable accessories, training, and on-site clinical and technical support to physicians and staff during procedures.

Focalyx currently serves centers for diagnosis and treatment of Prostate Cancer in Boston, Connecticut, Miami, New York, Ohio and Pennsylvania with plans to expand to also serve centers in Atlanta, Chicago, Houston and Los Angeles.

"CLS is exited to enter into this co-marketing agreement with Focalyx. It will enable the companies to jointly expand the commercial availability and technical support for the integrated treatment system consisting of TRANBERG Thermal Therapy System and Focalyx Fusion. We look forward to even more prostate cancer patients receiving treatment with our unique image-guided focal laser ablation technology," says Dan J. Mogren, CEO Clinical Laserthermia Systems.

“Fusion-guided focal laser ablation is a safe and effective minimally invasive treatment for low-to-intermediate risk prostate cancer that offers patients a lower risk of unwanted side effects such as erectile dysfunction or urinary incontinence. This is made possible because the TRANBERG laser system used under Focalyx image guidance provides a higher degree of precision and control over the ablation shape, size, and margin than cryotherapy or other focal therapies I’ve worked with and seen,” stated Dr. Fernando J. Bianco, CEO of Focalyx, LLC.

In his role as principal investigator at Urological Research Network, LLC, Dr. Bianco has safely treated twenty patients over the past year in the previously announced Phase I clinical study titled, “Targeted MRI/US Fusion Transperineal Laser Ablation of Low-to-Intermediate Risk Prostate Cancer.” 

About  Focalyx®

Focalyx via it’s exclusive client, is the provider of the Focalyx® Fusion Device, the only platform tailored for Diagnosis with Focalyx Bx and Treatment with FocalyxTx  to precisely diagnose and destroy cancer within the prostate while sparing healthy tissue. The Focalyx® Fusion Device is 510(k) cleared for the fusion/registration of MRI and transrectal ultrasound (TRUS) images of the prostate during a transperineal biopsy or therapy procedure. For more information, visit www.focalyx.com.

The information was submitted for publication, through the agency of the contact person set out below on 28 August 2023.

For more information, please contact:


Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)

Phone: +46 (0)705 90 11 40
E-mail: dan.mogren@clinicallaser.com

About CLS

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. The products  are  marketed  for  image-guided  laser  ablation  and  used in studies for  treatment  with  imILT®, the  Company's interstitial laser thermotherapy for immunostimulant ablation with potential abscopal effects. 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: clinicallaser.se