EBR Systems: ASX: EBR
EBR Systems is often compared to Cochlear. Although they focus on different areas of the body, the similarities between the two companies are apparent. Both provide highly technical products that tackle specialised problems for which there are no alternative solutions.
EBR Systems was listed on the ASX on 21 November 2021, with its CDIs priced at AUD 1.08. The current market capitalisation is around AUD 500 million, trading at approximately AUD 1.20
EBR Systems has developed a product called WISE CRT, a device that provides patients with wireless endocardial cardiac resynchronisation therapy. For those not involved in the medical field, I will break everything down
EBR systems are part of Cardiac Rhythm Management. These devices monitor heart rhythms and deliver shocks to the heart tissue as needed to ensure a regular heartbeat. There are three main types of devices:
- Pacemakers: These stimulate the heart to contract when it becomes too slow or irregular
- Defibrillators: Deliver an electric shock to reset the heart rhythm when shockable rhythms occur.
- CRT Devices: Synchronises contractions on both sides of the heart
The WISE CRT system addresses pacing-induced heart failure, also known as dysynchronous heart failure. Approximately 30% of patients with a pacemaker in the right ventricle develop pacing-induced heart failure within five years.
The treatment for this condition is Cardiac Resynchronisation Therapy (CRT), which involves pacing both sides of the heart to synchronise contractions and improve heart efficiency. Currently, only wired biventricular pacing options are available for CRT. The left-sided lead must be placed in the coronary sinus that runs along the outside of the left ventricle. It is not possible to place larger items in the left ventricle due to the risk of thrombus formation. Additionally, current wireless pacemakers are too large, and wired pacemakers carry a significantly higher risk of stroke.
The therapeutic benefits of Cardiac Resynchronisation Therapy (CRT) are clear and widely accepted, with a reported 59% improvement in function at six months, as well as enhancements in heart function and quality of life. However, there are limitations to traditional wired CRTs. Approximately 5% of patients face challenges in placing leads in the coronary sinus, and 2-6% of leads may fail, shift position, or encounter other issues. Additionally, about 30% of patients who receive CRT are classified as non-responders.
In cases where upgrades are needed, the lead typically connects to the original pacemaker. Unfortunately, for patients with wireless pacemakers who develop pacing-induced heart failure, the only option for treatment is WISE CRT.
The Initial CRT Indications for WISE CRT:
- Patients Unable to Receive Regular CRT: This includes individuals who are unable to use existing lead-based systems.
- Acute Lead Failure: Occurs in about 5% of cases where an effective lead cannot be placed in the coronary sinus (CS) due to anatomical or disease-related issues.
- Chronic Lead Failure: Affects 2-6% of patients whose existing CRT leads have been switched off, rendering the leads ineffective.
- High-Risk Upgrades: Refers to patients who are considered too high risk for lead upgrades.
A growing market is emerging for people with wireless pacemakers. The primary wireless pacemaker currently in use is the Medtronic Micra implant; approximately 200,000 of these devices have been implanted since their approval. There are around 60,000 potential patients for the WISE CRT devices, as these are the only options for upgrading to Cardiac Resynchronisation Therapy (CRT). This estimate assumes that 30 per cent of patients with a wireless pacemaker develop desynchrony heart failure. Additionally, the Abbott Aveir implant was approved in 2023, while Boston Scientific’s Empower device is currently seeking FDA approval.
The Market
Considering the initial market for CRT, the total addressable market (TAM) is approximately $2.1 billion. As clinical trials progress and indications expand, such as for totally wireless, this therapy has the potential to become the first-line treatment for CRT.
The WISE CRT offers a solution to a group of patients who previously had no options. EBR systems have applied for some interesting US Medicare programs for reimbursement, which I will cover in my next post.
None of this is investment advice. I am not a financial advisor; it is the culmination of my research that I use to inform my investment decisions. No recommendations will ever be made. Please do your own due diligence before making an investment decision.
Investing in Health 