• Release Date: 23/05/23 08:39
• AGM
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• Release Date: 26/04/23 08:25
• Summary: Quarterly Activities/Appendix 4C Cash Flow Report

Following is a brief extract from today's release that has also encouraged me to take a small start up position.

ASX ANNOUNCEMENT:

14 March 2022 Leadless Pacemakers included in SOLVE-CRT IDE Clinical Trial Key Highlights:

The US FDA (Food & Drug Administration) has agreed for EBR to include leadless (wireless) pacemakers as a co-implant in the pivotal SOLVE-CRT IDE clinical trial

If approved for final labelling during the PMA application, the opportunity to pair leadless pacemakers with the WiSE® CRT System to deliver cardiac resynchronisation therapy (CRT) potentially expands EBR’s initial addressable market by US$400m in 2024

SOLVE-CRT remains on track to complete enrolment for interim analysis by H1 2022 

US FDA approves EBR’s wireless pacemakers:

Brief Notes from Prospectus (IPO Nov 21)

EBR is a United States-based company that operates in the medical technology sector, primarily focusing on implantable, wireless cardiac pacing devices. EBR’s only product is its patented wireless pacemaker – WiSE. WiSE is an implantable, cardiac pacing device able to provide stimulation to endocardial (inside the heart) heart tissue for the correction of heart rhythm conditions without requiring the use of leads. The product takes a different approach from current wireless pacemakers in the market. Rather than having an onboard power source, the electrode used with WiSE is remotely powered using Ultrasonic Energy. This allows the receiver electrode, which is implanted in the heart muscle tissue to provide therapeutic electrical stimulation, to be approximately 5-6% of the size of the other wireless pacemakers, slightly larger than a grain of rice. Wise is currently in the final stages of clinical trails to gain regulatory approvals with the US. EBR anticipates FDA approval in H2 2023.

Risks

·      Regulatory approvals

·      Delays in regulatory approvals

·      New technology and competition

Target Market

Company’s initial target markets of the U.S., Germany, France, the U.K., Australia, Benelux and Scandinavia. 

Competition

·      Medtronic (Ireland)

·      Abbott (U.S.),

·      Boston Scientific Corporation (U.S.)

The three above account for 92.4% of the market