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EBR Systems Inc. (EBR) is a medical device company that has developed the smallest inside the heart wireless and leadless cardiac pacing device, WiSE®, in the world. Leads are the primary cause of device failure with implanted cardiac pacing devices.

Heart failure is a significant public health problem with an estimated prevalence in 2020 of 6.9 million people in the U.S., and around 64 million people worldwide. The Company believes that WiSE® is the only way to provide heart failure patients with leadless cardiac resynchronisation therapy (CRT). CRT is the clinically proven and accepted standard of care for treating patients suffering moderate to severe heart failure due to dyssynchrony. WiSE® enables CRT to be delivered to patients who are unable to receive CRT from a traditional lead based system or are at high risk from an upgrade procedure. Without effective CRT these patients have a very poor clinical prognosis, poor quality of life and reduced life expectancy.

WiSE® is able to deliver CRT without leads by using Ultrasonic Energy from a subcutaneous source to power the receiver electrode inside the heart. The absence of a battery allows the receiver electrode to be approximately 5 to 6% of the size of the other leadless pacemakers, slightly larger than a grain of rice.

The Company is currently conducting its SOLVE pivotal clinical trial that is expected to complete patient recruitment in H1 2022. This trial is expected to provide headline data in H2 2022 to support an application in H1 2023 for FDA approval of WiSE®. EBR has compelling human clinical data, CE Mark and FDA Breakthrough Device Designation status which underpins the confidence in the clinical and commercial pathway. Endpoints in the SOLVE pivotal trial have been achieved in three previous studies conducted by EBR.

The Company is anticipating WiSE® could receive FDA approval and launch commercially in the U.S. in H2 2023. EBR has an initial addressable market opportunity of approximately US$2.1 billion with initial adoption to be driven by sites participating in the SOLVE clinical trial for currently untreatable and high risk patients. In the future, EBR intends to broaden its target markets by expanding the use of WiSE® into other patient groups and clinical applications. EBR estimates that the total addressable market can grow to approximately US$7.1 billion.

Listing date 24 November 2021 11:00 AM AEDT ##
Company contact details https://ebrsystemsinc.com/
Principal Activities EBR Systems, Inc. (Company) is a pre revenue, medical device company that is focused on developing and bringing to market, devices to treat patients with certain types of heart failure. The Company has patented technologies that can provide clinical advantages over technology currently available from incumbent companies.
Issue Price USD 1.08
Issue Type CHESS Depositary Interests 1:1
Security code EBR
Capital to be Raised $110,000,000
Expected offer close date 05 November 2021
Underwriter Bell Potter Securities Limited, Morgans Corporate Limited and Wilsons Corporate Finance Limited (Joint Underwriters/Lead Managers).
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