• EBR announces positive results of its pivotal SOLVE-CRT trial at Heart Rhythm 2023 in US
  • EBR latest ASX biotech company to achieve a key catalyst, opening door to US$2.5 billion market
  • Company now working on regulatory and commercialisation timelines and reckons they remain intact

The latest ASX biotech to achieve a key catalyst this year is medical device company EBR Systems (ASX:EBR)  which was up ~10% on Monday after announcing positive results of its pivotal SOLVE-CRT (SOLVE) trial at key conference in the US.

The abstract presentation, titled Safety and Efficacy of a Leadless Ultrasound-Based Cardiac Resynchronization Pacing System in Heart Failure – Results from the SOLVE-CRT Study,  was presented in the Late Breaking Clinical Trials sessions at Heart Rhythm 2023 by co-principal investigator Dr Jagmeet P. Singh.

This year held in New Orleans, the conference is the Heart Rhythm Society’s (HRS) annual meeting and the premier global electrophysiology conference, attracting the largest gathering of heart rhythm professionals globally.

The study met both its efficacy and safety endpoints with statistical significance, allowing the study to conclude, and importantly, providing clinical validation of leadless pacing with the Wireless Stimulation Endocardially (WiSE) WiSE CRT system.

WiSE is the only left ventricle in-the-heart leadless system for Cardiac Resynchronisation Therapy (CRT).

In terms of efficacy, based on 100 patients at six months, the improvement in heart function, as measured by the reduction in left ventricular end systolic volume (LVESV), came in at -16.4%, a -7.1% absolute improvement from the prespecified -9.3% hurdle rate.

Regarding safety, based on 183 patients at six months, the percentage of patients without device or procedure-related complications was 80.9%, better than the prespecified 70% hurdle rate.

EBR said all other outcomes analysed to date have been concordant with these results showing significant improvement in reversing heart failure symptoms and improving physiology.


Culmination of decades of research

EBR chairman Allan Will was thrilled and immensely proud of the entire EBR team for achieving this positive trial result.

“This represents the culmination of decades of diligent research and development and teamwork, enabling us to deliver what we did today,” he said in an announcement.

“The SOLVE trial not only demonstrates the ability of our device to provide safe and effective cardiac resynchronisation therapy but also validates EBR’s technology as a key treatment for those suffering from cardiac arrhythmia.

“This breakthrough will significantly improve the lives of countless patients currently suffering from this disorder.”

EBR president and CEO John McCutcheon said he was incredibly encouraged by all aspects of the top-line data presented with the data exceeding pre-specified regulatory primary efficacy and safety endpoints, paving the way for regulatory approval.

“The results validate our novel approach for delivering CRT and treating heart arrhythmia in heart failure patients,” he said.

“We are eager to advance our commercialisation strategy and will continue to work with the FDA to deliver a seamless pathway forward to approval.

“We look forward to leveraging our established partnerships and presence in the US to drive initial sales growth, targeting a US$2.5 billion market and improving patient outcomes for those with no other treatment options.”


Next step is FDA approval

With the SOLVE-CRT trial now concluding,  the focus turns to regulatory and commercialisation timelines, which EBR said remain intact.

In its announcement EBR said a manuscript will be submitted to a medical journal for peer-review and publication.

EBR said it will continue to progress its regulatory agenda and is aiming to finalise its pre-market approval (PMA) submission to the FDA in Q1 CY24, paving the way for US Food and Drug Administration (FDA) approval.

The company has forecast a target product launch date of H2 CY24.

“EBR has maintained significant engagement with the FDA, which includes gaining prior approval for the trial re-design to include a single-arm only treatment phase and the FDA granting the WiSE device a Breakthrough Device Designation,” the company said.

EBR said it was well funded to support its commercialisation objectives with substantial cash reserves of US$56.6 million (A$84.31 million as of March 2023) and a growth capital facility with Runway Growth Finance.

The company said in light of the positive trial results, EBR now has the option to draw down on the US$20 million second tranche of this facility.

EBR will now mobilise to execute its clear and targeted commercialisation strategy, focused on four patient groups in the US market including acute lead failure, high risk upgrades, leadless upgrades and chronic lead failure,  representing a combined market opportunity of US$2.5 billion per annum.

EBR said it looks forward to bringing this ground-breaking technology to patients, which in many cases have no other treatment option, providing a better quality of life for those suffering from heart failure.

Popping the champagne

Morgan’s healthcare analyst Scott Power, who has been anticipating release of the EBR pivotal trial data at the Heart Rhythm conference, said it was certainly a day to pop open the champagne not only for the company but also ASX biotech companies, which are continuing to have a good run of achieving catalysts in 2023.

Among those companies is Neuren Pharmaceuticals (ASX:NEU), which achieved US FDA approval for a drug to treat Rett Syndrome. The drug is now being rolled out in the US.

Another catalyst was for ImpediMed (ASX:IPD) after the US National Comprehensive Cancer Network (NCCN) released a new set of guidelines, which included the use of bioimpedance spectroscopy (BIS) as an objective measurement tool to identify early signs of lymphoedema for the first time.

Predictive diagnostics and bio-analytical services company Proteomics International Laboratories (ASX:PIQ) also recently announced it had inked an exclusive licence agreement with Sonic Healthcare USA, a division of Sonic Healthcare (ASX:SHL).

The agreement is for the use and commercialisation of PIQ’s PromarkerD predictive test for diabetic kidney disease in the US.

“We are very happy and it’s a great result with the primary and secondary endpoints being exceeded, which means the clinical side of the business has been de-risked,” Power said.

He said EBR may now become of interest as a takeover target for larger med device companies like Medtronic, Boston Scientific or Abbott Vascular.

“They’re the three major players that operate in the heart failure space,” Power said.

“It’s a terrific result and continues our run of companies hitting these major milestones like Neuren, ImpediMed and Proteomics.

“Now we can add EBR to the list.”

Power said given the favourable SOLVE-CRT results and impending regulatory approval, Morgans view EBR as well placed to build a profitable medical device business in the CRT space.

Morgans maintains its speculative Buy recommendation but has increased its 12-month target price from 96.5 cents to $1.55.


The EBR share price today: