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Regulatory press release

CLS and Exact Imaging renew their Memorandum of Understanding regarding a commercial collaboration in the field of micro-ultrasound guided focal laser ablation

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Clinical Laserthermia Systems AB (publ) (CLS) and Canadian Exact Imaging (https://www.exactimaging.com/united-states) have renewed and adjusted the Memorandum of Understanding (MoU), which the parties previously entered into, regarding a commercial collaboration in the field of focal laser ablation. Under the MoU the parties will evaluate how the companies' respective products can be combined and used in micro-ultrasound guided focal therapy (FLA/LITT) in patients with localized prostate cancer.

- Both parties wish to set a new focus on the collaboration and have therefore decided to renew the MoU. Together we will execute clinical tests in the U.S and in Europe regarding prostate cancer treatment. TRANBERG Thermal Therapy System is optimized for MR guided therapy procedures, but MR scanners are not available in all hospitals and traditional ultrasound equipment is often not enough to guide an ablation treatment. Exact Imaging's 29 MHz micro-ultrasound platform, ExactVu, is a cost-effective solution with high-quality, high-resolution, real-time imaging. From the clinical tests we aim to collect relevant data to support a possible joint product offer for micro-ultrasound guided laser ablation treatment in prostate, says Dan Mogren, CCO at CLS.

- We are excited about the upcoming clinical tests and the product evaluation. If the clinical tests are successful and advance to the commercial selling stage, Exact Imaging's worldwide distribution partner, EDAP TMS, would handle the commercial part of the collaboration with CLS, says Randy AuCoin, President and CEO of Exact Imaging.

CLS markets and sells TRANBERG® | Thermal Therapy System (http://clinicallaser.com/tranberg/thermal-therapy-system/) for image guided FLA on the US and European markets. Image guided means that the physician uses magnetic resonance images (MRI) or ultrasound images, for example, to identify targets, guide placement of instruments and for monitoring of the FLA treatment. Exact Imaging is a world leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate. ItsExactVu™ (https://www.exactimaging.com/united-states/exactvu-micro-ultrasound-system) platform is today used primarily for image guidance during targeted prostate biopsy procedures.

CLS estimates that the total addressable market (USA / EU / Japan) for image guided focal therapy of benign prostatic hyperplasia (BPH) and localized prostate cancer amounts to approximately 500,000 treatments per year.

More about Exact Imaging www.exactimaging.com

This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.

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