EBR reports milestone quarter, final FDA review for WiSE CRT system

EBR reports milestone quarter, progressing US regulatory pathway for its WiSE CRT system
The company submitted its final module of PMA application to US FDA in August and a substantive review is now underway
EBR has also completed a $50 million capital raise to accelerate its WiSE US commercialisation strategy

Special Report: Medtech EBR has reported a milestone quarter underpinned by submission of the final module of its premarket approval application to the US FDA for its WiSE CRT system.

In August, EBR Systems (ASX:EBR) submitted the final module of its premarket approval (PMA) application for its WiSE CRT (cardiac resynchronisation therapy) system to the US Food and Drug Administration (FDA).

WiSE holds the distinction of being the world’s first leadless pacemaker for the heart’s left ventricle.

The PMA application for WiSE underwent an initial review by the regulatory body to confirm administrative completeness and adequacy of the technical elements. The PMA was then accepted for a substantive review in September.

EBR said the PMA application included extensive technical documentation and comprehensive clinical data from all clinical trials to date, including its pivotal SOLVE-CRT trial, which successfully met its primary efficacy and safety endpoints.

The substantive review is now underway and that involves comprehensive evaluation, feedback and information requests prior to an approval decision.

It includes:

A Bioresearch Monitoring audit to ensure the quality and integrity of EBR’s clinical trial study data, and to ensure test subjects that took part in investigations were protected from undue hazard or risk
A Pre-approval Inspection to confirm EBR’s manufacturing, processing and packing procedures comply with quality system regulations, and that the facility can consistently produce devices that meet the approved specifications

EBR said WiSE’s ‘Breakthrough Device’ designation facilitated prioritised review and enhanced communication with the FDA.

The company anticipates FDA approval in Q1 2025 and is preparing for a 2025 commercial launch, targeting a significant US market opportunity that represents US$3.6bn.

“We’ve had a significant milestone quarter, marked by our final PMA submission and the FDA’s commencement of their substantive review,” president and CEO John McCutcheon said.

“We are now in the final stages of our regulatory approval process, aiming for approval in Q1 2025.”

$50m capital raise to accelerate commercialisation

In September EBR launched a fully underwritten Institutional placement and entitlement offer to raise $50m to ensure funding to accelerate its commercialisation strategy and drive US market adoption in 2025.

The institutional placement and accelerated institutional entitlement offer raised $45.8m and completed on September 20. The $4.2m retail entitlement offer concluded on October 10.

EBR said funds raised would be used to primarily support commercialisation activities, manufacturing scale-up and ongoing research and development.

The company plans to leverage its established partnerships and presence in the US to drive initial sales.

EBR will targeting US sites that participated in its pivotal SOLVE-CRT trial and other high-volume sites.

The medtech closed the quarter with US$36.4m (~A$52.6m) in cash and US$37.8m (A$54.6m) in investments.

Raising profile of WiSE and EBR

In August, study results of SOLVE-CRT were published in the Journal of the American Medical Associate (JAMA) Cardiology, which reinforces the trial’s clinical significance.

In July 2024, management attended the high-profile 18th Bioshares Biotech Summit held in Fremantle, Western Australia.

EBR also completed an Australian roadshow from September 30 to October 2, updating institutional and retail investors on the regulatory approval process, commercialisation pathway, recent JAMA publication, capital raising and outlook.

US reporting company status

EBR is now a US public reporting company and ASX-listed entity.

In July the company filed a Form 10 Registration with the US Securities and Exchange Commission (SEC) for the Registration of Securities, which was declared effective on September 30.

EBR said it had now been granted waivers from several ASX Listing Rules, reducing the need for dual periodic reporting.

This article was developed in collaboration with EBR Systems, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.