Clinical Laserthermia Systems Announces Initiation of Prostate Cancer Clinical Study in collaboration with U.S based HALO Diagnostics

Lund, Sweden – November 7, 2023 – Clinical Laserthermia Systems AB (publ) (“CLS” or “the Company”) today announces that their US subsidiary CLS Americas and US based HALO Diagnostics, a leader in precision diagnostics and image-guided therapies (HALO Dx), has entered an agreement to initiate a clinical study using the TRANBERG Thermal Therapy System to perform image-guided focal laser ablation (FLA) of low-to-intermediate risk prostate cancer in 25 patients.

Data from these patients treated over the next 6-8 months will be entered into a patient registry where their long-term follow up will be monitored and conducted. The CLS TRANBERG System provides safe and effective focal laser ablation of low-to-medium risk prostate tumors, while also preserving healthy tissue to minimize the risk of unwanted side effects such as ED and urinary incontinence.

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.

“CLS is pleased to collaborate with Dr. Scionti and HALO Diagnostics for this clinically significant study regarding the efficacy of treating prostate cancer using image-guided focal laser ablation in an ASC,” stated Michael Magnani, president of CLS Americas. “We look forward to providing clinical support and collaborative assistance to Dr. Scionti with the new TRANBERG treatment. This study is a continuation of our long-standing collaborative research with HALO and will contribute further evidence to support the precise cancer control and quality of life benefits offered by FLA.”

"Entering into this study collaboration with HALO Diagnostics represents a significant milestone for CLS on our path towards establishing the TRANBERG portfolio in the U.S as a superior product for FLA in the focal treatment of patients diagnosed with localized prostate cancer. To CLS, HALO Diagnostics’ extensive experience and comprehensive platform for personalized diagnostics is of particular interest and adds value to our collaboration," says Dan J Mogren, CEO of CLS AB.

For more information, please contact:

Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)
Phone: +46 (0) 70-590 11 40
E-mail: dan.mogren@clinicallaser.com

About HALO Diagnostics

For more information about HALO Diagnostics and their prostate program, please visit http://www.halodx.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.

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