EBR Systems is due for approval of their Wise CRT on or before April 12 (Alllegedly (have to say that after the OPT results))

There doesn't seem to be too much interest for EBR on here, they have almost doubled in share price over the past 3-4 months leading into approval,

Their Wise CRT doesn't compete directly against current options, it offers a leadless left ventricle pacing solutions where lead based have failed.

Looks to be a good longterm opportunity if they can pull it off with potential to expand to being the primary option for treatment rather than the backstop when lead based solutions have too many issues.

Have fumbled round with some valuation estimates but they haven't put too much info forward to work with and I think they are targeting a slower rollout focused on places that have been involved with trials.

Interesting with this one it appears to be more physician led rather than hey we have a new product that's better than the others please buy it.

Anyone have any thoughts on this as far as potential valuation based around the upcoming launch?

Disc Held RL & SM

• 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