CLS and Exact Imaging Sign a Memorandum of Understanding (MoU) to Enter into a Commercial Collaboration on Image Guided Focused Laser Ablation of Disease in Prostate

LUND, Sweden and TORONTO, June 4, 2018 /PRNewswire/ - Clinical Laserthermia Systems AB (CLS) (publ) and Exact Imaging have signed a memorandum of understanding to enter into a commercial collaboration. With a product, jointly optimized for high resolution micro-ultrasound guided focused laser ablation (FLA), the goal is to offer the urologic market a superior solution for image guided focal therapy in patients with localized prostate cancer and BPH.

CLS markets and sells 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 the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate. Its ExactVu™ platform is today used primarily for image guidance during targeted prostate biopsy procedures.

"The intended collaboration will strengthen both companies' product offerings, expand the addressable market and further increase focus on sales. Ultrasound equipment is available today at almost all hospitals. However, we believe the 29 MHz ExactVu system, Exact Imaging's micro-ultrasound platform, dramatically increases the user's ability to see diseased tissue, to correctly place CLS instruments and most importantly, to better monitor the FLA treatment itself. The intention is to offer the urologic market the safest, most complete and cost-effective solution for focal therapy of prostate cancer and BPH," says Dan Mogren, CCO at CLS.

CLS and Exact Imaging have signed the MoU with the aim of entering into a commercial collaboration during 2018, where the parties will market and sell a jointly optimized product for micro-ultrasound guided FLA treatment in prostate.

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. CLS products are currently included in a clinical study at Toronto General Hospital in Toronto, Canada. The study investigates image guided FLA of localized prostate cancer. The study is conducted at the hospital's initiative and comprises 25 patients.

About Exact Imaging

Exact Imaging (www.exactimaging.com) is the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging's ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and being an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and specifically target biopsies at those areas. For the minority of cases where MRI might assist (i.e., prior negative biopsies), FusionVu™ is the micro-US/MRI fusion application operating on the ExactVu micro-ultrasound platform enabling cognitive (using Cognitive Assist™) and MRI fusion guided by real-time micro-ultrasound resolution. The ExactVu micro-ultrasound system has received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).

About Clinical Laserthermia Systems

Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG®|Thermal Therapy System including its specially-designed sterile disposable products for safe, gentle and effective treatment of soft tissue such as cancerous tumors. The products are marketed for image-guided laser ablation and for treatment with immuno-stimulating interstitial laser thermotherapy, imILT®. The company, which is headquartered in Lund Sweden and has a subsidiary in Boston, MA, is listed on Nasdaq First North under the ticker CLS B. Certified Adviser is Västra Hamnen Corporate Finance. Further information is available on www.clinicallaser.se.

The TRANBERG®|Thermal Therapy System has not yet received market clearance for immune stimulating interstitial laser thermotherapy (imILT®) by the Food and Drug Administration (FDA) in the United States of America (USA).

SOURCE Exact Imaging

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