Elekta MR-linac functionality and CE mark update (Correction)

STOCKHOLM, November 10, 2017 – Elekta (EKTA-B.ST) has decided to add additional functional imaging capabilities to its MR-linac (Unity) and to spend more time on validating its linac control system in order to offer clinicians the unparalleled opportunities of its high field strength from the first release. Consequently, CE mark for Unity is currently expected during the first half of 2018 instead of the end of 2017.

During 2017, Elekta successfully unveiled Unity in both Europe and the U.S. A first-in-man-study at the University of Utrecht and studies at other university hospitals confirmed the technical accuracy and safety of the MR-linac. These studies also confirmed the capability of the system to precisely deliver the treatment while simultaneously acquiring high quality images.

Feedback has been overwhelmingly positive in general and, in particular, potential customers with MR experience have emphasized the aspect of the diagnostic high field 1.5 Tesla MRI component. The system is not only capable of faster anatomical imaging at the same time as the treatment, compared to low field MR components offered by competing systems, but it also enables the MR-linac to perform functional imaging. This is a prerequisite for dose painting, where higher doses of radiation are deposited into the more active areas of tumors. To enable this functionality, Elekta decided to add additional functional imaging features also called diffusion weighted imaging from the first commercial release of Unity.

For Elekta, the safety and accuracy of the MR-linac are paramount. Elekta has therefore built a next generation linac control system to handle the advanced capabilities offered by the high field MR information. This control system will become the most advanced solution for high-precision radiation therapy and Elekta has decided to take the time needed for its validation. This will ensure that the Company is optimally prepared for the potential of dynamic on-line adaptive treatments, which may have more demanding performance requirements.

Elekta CEO, Richard Hausmann, comments: “Although development and final testing of Unity is progressing well, I decided to take a bit more time because I want to be certain that the high field strength of our solution can be optimally used from the first release. Our system will not only offer clinical staff the highest possible contrast between lesions and organs in real time, but also functional information on a cellular level, like tissue perfusion and permeability, also called diffusion, eventually enabling dose painting as the method of choice. I am looking forward to demonstrating Unity during the Radiological Society of North America meeting in Chicago, later in November and to the wider MR community as well.”

The interest in Elekta’s system and the list of potential customers continues to grow. The target to generate orders for 75 systems before the end of 2019 will remain.

No financial effect is expected on the performance of the current fiscal year 2017/18 and the installation of pilot and research systems will not be interrupted.

Elekta MR-linac (Unity) is a work in progress and not available for sale or distribution.

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This is information that Elekta AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 07:45 CET on November 10, 2017. (REGMAR)

About Elekta

Elekta is proud to be the leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. Our advanced, effective solutions are created in collaboration with customers, and more than 6,000 hospitals worldwide rely on Elekta technology. Our treatment solutions and oncology informatics portfolios are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, and to drive cost efficiency in clinical workflows. Elekta employs 3,600 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm www.elekta.com

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For further information, please contact

Gert van Santen, Group Vice President Corporate Communications, Elekta AB
Tel: +31 653 561 242,
E-mail: gert.vansanten@elekta.com
Time zone: CET: Central European Time

Tobias Bülow, Director Financial Communications, Elekta AB
Tel: +46 722 215 017,
E-mail: tobias.bulow@elekta.com
Time zone: CET: Central European Time