Feasibility and outcome data from the study is presented in the peer-reviewed scientific article "MR-guided Transrectal Focal Laser Ablation for Localized Low- and Intermediate Risk Prostate Cancer: Initial Outcomes Using an Integrated Laser Ablation System" by Y Wimper et al. published in Journal of Vascular and Interventional Radiology.  

In summary, technical success was achieved in 10 out of 10 patients with low to intermediate risk prostate cancer, and median tumor coverage was 100%. Two out of 10 patients had a residual and recurrent disease at the treatment site during follow-up which aligns with results from previous studies on MRgFLA.

No significant changes in urinary or sexual function were reported 12 months after treatment. These results indicate that MRgFLA using the TRANBERG system has the potential to achieve the goal of focal therapy, i.e. good oncological control without the treatment-related morbidities associated with radical whole-gland therapies, which include incontinence (9-18%) and erectile dysfunction (87-94%).

Furthermore, the authors point out that laser ablation may provide several advantages over other energy sources in the treatment of prostate cancer as prostatic tissue naturally has a high optical absorption rate. The benefits of near-real time MR-guidance and the use of Thermoguide software that allow for precise placement of the laser applicator and accurate estimation of the treatment effects are also highlighted.

In the conclusion the authors state that "MRI-guided FLA in patients with low-to-intermediate risk PCa using an integrated system was feasible and safe and indicates promising short-term oncological and functional outcomes".

"This is the first clinical publication to report data from treatment of prostate cancer patients inside the MR suite using our TRANBERG system and Thermoguide Workstation, says Kristian Waldeck, VP Medical Affairs at CLS. "We are delighted about the promising results and would like to extend a big thank you to the clinical team in Nijmegen and congratulate them on this pioneering work".

Literature reference:

Wimper Y, te Molder LPW, Sedelaar JPM, Bomers JGR, Overduin CG, Fütterer JJ, MR-guided Transrectal Focal Laser Ablation for Localized Low- and Intermediate Risk Prostate Cancer: Initial Outcomes Using an Integrated Laser Ablation System., Journal of Vascular and Interventional Radiology (2025), doi: https://doi.org/10.1016/j.jvir.2025.01.043

About localized prostate cancer

About 1,700,000 new cases per year of localized prostate cancer are reported worldwide. Although the landscape of prostate cancer treatment shows several treatment options, there is still an important unmet need for patients who progressed to intermediate risk stage. The currently available surgical options show significant risks and side effects related to urinary and erectile functions and quality of life.

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 CLS

Clinical Laserthermia Systems AB (publ), develops and sells TRANBERG®|Thermal Therapy System and ClearPoint Prism Neuro Laser Therapy System with sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy. The products are marketed and sold through partners for image-guided laser ablation and are used in studies for treatment with imILT®, the company's interstitial laser thermotherapy for immune stimulating ablation with potential abscopal treatment effect. CLS is headquartered in Lund, Sweden, with subsidiaries in Germany, the United States and a marketing company in Singapore. CLS is listed on Nasdaq First North Growth Market under the symbol CLS B. Certified adviser (CA) is FNCA Sweden AB.

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