EBR Systems

JOHN MCCUTCHEON

PRESIDENT & CEO

(ASX:EBR)

◾ Company Name: EBR Systems ◾ Company ASX code: EBR ◾ Key areas: Leadless pacemakers, heart failure ◾ Key Personnel: Allan Will, Chairman | John McCutcheon, President & CEO | Frank Hettmann, CFO ◾ Locations: Sunnyvale, California ◾ Market Cap as of 15/09/22: $129.55M ◾ 52 Week share price as of 15 September: $0.330 - $1.095 ◾ Company Website: ebrsystemsinc.com

COMPANY PROFILE

As many as half of patients with traditional pacemakers undergoing cardiac resynchronisation therapy (CRT) either don’t benefit from treatment, or develop issues related to the wires leading to the heart.

It’s an issue that remains poorly addressed, and Australian-listed medtech EBR Systems is determined to drive better patient outcomes.

To that end, EBR Systems invented the WiSE® CRT System, which uses a proprietary wireless technology to deliver pacing stimulation directly to the inside of the left ventricle of the heart.

Designed to address the persistent limitations of current CRT systems, WiSE® provides a more customised, patient-specific solution.

Traditional artificial cardiac pacemakers generate electrical pulses delivered by electrodes to the chambers of the heart, causing the targeted chambers to contract and pump blood.

They are commonly used by patients suffering from heart problems, such as those suffering from heart failure, in which the heart is unable to pump enough blood to meet the body’s demands.

Heart failure afflicts more than 25 million people across the world, however there are limitations to CRT, which requires the insertion of wires into the left and right ventricles of the heart.

“WiSE® is the world’s first and only inside-the-heart leadless cardiac pacing device for heart failure,” says Allan Will, chairman of EBR.

“Traditional CRT devices use wires to deliver energy to the heart; however, many patients are unable to receive effective CRT because their anatomy or disease prevents the use of these wires.

“WiSE® provides an alternative solution by providing leadless CRT to patients who would otherwise suffer poor prognosis.”

It’s working, too. A prospective, multi-center, non-randomised study of 35 patients who previously failed conventional CRT demonstrated hugely promising results.

Patients were treated with the WiSE® CRT System at six leading clinical centers in Europe and evaluated 30 days and six months after treatment; 97 per cent achieved cardiac resynchronisation within a month and 85 per cent reported ongoing clinical benefits after six months.

The company is now focused on the SOLVE-CRT trial, which it needs to successfully pass in order to submit the device to the FDA.

Enrolment has been completed for the trial, which will evaluate the safety and efficacy of WiSE® in heart failure patients who are classified as acute lead failures, chronic lead failures, high-risk upgrades, or leadless upgrades.

“The completion of interim enrolment for the pivotal SOLVE trial is a significant milestone and value catalyst,” says president and CEO John McCutcheon.

“We remain confident that we will achieve the six-month primary endpoints, resulting in a successful pivotal trial and the basis for FDA approval. Our confidence is underpinned by outcomes from previous clinical trials of WiSE® , which have exceeded the performance endpoints set for the SOLVE trial.”

Excitingly for the company, there is little in the way of competition in the field, giving EBR unprecedented access to an initial global addressable market of $3.6 billion in 2024.

“WiSE® is the only device that can potentially support the upgrade of patients currently implanted with a leadless right ventricle pacemaker, which solves a significant unmet need by providing a solution to patients with no other upgrade options,” says McCutcheon.

“We have come a long way since our IPO late last year, further de-risking the business and strengthening EBR’s investment proposition, and we are wellfunded with $115 million in cash as of 2Q 2022.”

KEY INVESTMENT HIGHLIGHTS

JULY 1, 2022: EBR completes interim enrolment in pivotal SOLVE-CRT IDE clinical trial. JULY 1, 2022: EBR secures 5-year US$50M growth capital facility with a leading venture debt provider Runway Growth Capital. AUGUST 29, 2022: Clinical Study Demonstrating Feasibility of WiSE® in Left Bundle Branch Area Pacing published in Heart Rhythm Journal.