EBR Systems: Aussie Medtech Ready to Disrupt $3.6B Heart Failure Market with Leadless Pacemaker

Andrew Shute, Senior Vice President of Business Development at EBR Systems, is confident that his Australian medical device company is poised to make a significant impact on the global cardiac rhythm management market. The focus? A novel leadless pacemaker designed to revolutionise treatment for heart failure patients. After years of development and rigorous clinical trials, EBR Systems is on the cusp of receiving crucial FDA approval, paving the way for a rapid commercialisation strategy in the lucrative US market.

Speaking at a recent industry meeting, Shute highlighted the company’s unique position. “We’ve developed a novel device, the world’s only leadless pacemaker designed specifically to treat heart failure,” he stated. While the cardiac rhythm management market is dominated by giants like Medtronic, Abbott, and Boston Scientific, Shute asserts EBR isn’t in direct competition. Instead, he sees their technology as complementary, addressing a critical unmet need within the existing treatment paradigm.

The initial total addressable market (TAM) at launch is estimated at a substantial $US3.6 billion in the US alone. This target demographic comprises heart failure patients who have previously failed to achieve therapeutic benefits from traditional lead-based cardiac synchronisation therapy (CRT). Shute anticipates this market will grow as they expand indications and enter additional international markets.

EBR Systems’ journey to market has been underpinned by two critical pillars: compelling clinical data and the FDA’s coveted Breakthrough Device Designation. This designation has fostered a direct and informal communication channel with the FDA, significantly streamlining the regulatory process. The company has successfully navigated key milestones, including the submission of its final PMA module last August, completion of the 100-day meeting in December, and passing the pre-approval inspection in January.

The FDA’s Breakthrough Device Designation also provides a crucial advantage on the commercialisation front, automatically granting EBR Systems access to two key reimbursement schemes in the US: NTAP and TPT. These schemes are expected to secure an average selling price (ASP) of $US45,000 per system. This favourable reimbursement environment means EBR doesn’t need to sell a vast number of systems to achieve significant revenue milestones; just 2,200 systems would translate to $US100 million in revenue.

Addressing a Critical Unmet Need in Heart Failure

EBR Systems operates within the CRT segment of the cardiac rhythm management market, targeting heart failure patients suffering from ventricular dyssynchrony – where the left and right ventricles beat out of sync. The therapy aims to restore this synchrony through simultaneous pacing.

A critical issue in traditional cardiac pacing, highlighted by Shute, is “pacing-induced heart failure.” Approximately 100% of patients receiving a standard pacemaker or defibrillator develop ventricular dyssynchrony due to stimulation of only the right side of the heart. Within four years, around 30% of these patients progress to pacing-induced heart failure, necessitating an upgrade to CRT.

The Achilles’ heel of traditional cardiac rhythm management over the past 50-60 years has been the leads (wires) that deliver electrical impulses to the heart. These leads are prone to failure mechanisms such as migration, fracture, and acting as conduits for infection, with endovascular infections carrying a mortality rate of around 30%. The broader market has been moving towards leadless solutions to address these limitations.

While leadless pacemakers exist for bradycardia (slow heart rate), EBR Systems’ device is unique. “EBR has developed the only leadless pacemaker able to pace the left ventricle for heart failure,” Shute explained. Existing leadless pacemakers are significantly larger (20 times) and, if implanted in the left ventricle, would pose a thrombogenic risk, leading to stroke. In contrast, EBR Systems’ electrode undergoes complete endothelialisation, eliminating this clot formation risk.

This distinct indication means EBR is not directly competing with other leadless pacemakers. In fact, the company sees them as complementary: “Even 30% of patients who receive a leadless pacemaker will develop that pacing-induced heart failure I mentioned earlier, and we provide the only means to upgrade those patients to CRT in that event.” This creates a symbiotic relationship, where greater adoption of other leadless pacemakers will expand EBR’s future market.

Compelling Clinical Data and Strategic Commercialisation

The company’s pivotal clinical trial results, presented at the Heart Rhythm Society meeting in May 2023 and subsequently published in JAMA Cardiology, demonstrated a phenomenal 16.4% reduction in left ventricular end-systolic volume – a key measure of heart efficiency. Studies consistently show that a 10% reduction in this volume significantly improves both mortality and quality of life. This compelling clinical data has garnered strong support from key opinion leaders globally. Professor Betts from Oxford University Hospital aptly summarised the need, stating that “without [EBR Systems’ device], these heart failure patients will be relegated to progressive deterioration of their condition and repeated hospitalizations.”

The US remains the primary target market due to strong engagement from key opinion leaders and its concentrated hospital landscape. Approximately 2,000 hospitals implant CRT devices in the US, but 50% of the market lies within the top 250 hospitals, making it an efficient target for EBR Systems’ direct salesforce. The company has already secured procedure codes and interim payment tariffs with CMS (Centers for Medicare & Medicaid Services) and, critically, became the first technology accepted onto CMS’s TPT reimbursement pathway, which is limited to a maximum of five new technologies per year.

Initial commercialisation will involve a limited market release, focusing on clinical trial sites, aiming for a sustainable utilisation rate of two implants per hospital per month. This will be followed by a broader rollout to additional high-volume sites with strong physician engagement. EBR Systems is building out a direct salesforce of high-performing reps specialising in introducing new technology, and has recently announced the lease on a new, four-times larger facility to expand manufacturing capabilities and meet future demand.

Looking ahead, EBR Systems plans to expand its TAM beyond its initial launch, with two new clinical studies commencing in Australia and the UK. The “TLC” (Totally Leadless CRT) study will support the transition from treating previously failed patients to newly diagnosed heart failure patients, further broadening the market for this innovative Aussie medtech. Shute confirmed that the company anticipates TPT and NTAP reimbursement in place by October 1st, paving the way for commercialisation and a significant leap in heart failure treatment.