US FDA completes initial filing review of EBR’s PMA application, determines it contains all required information to proceed to a substantive review
PMA application will now be evaluated determine effectiveness and safety of the WiSE CRT System (WiSE)
EBR anticipates approval in Q1 CY25 and remains on track for commercial launch
Special Report: EBR Systems has announced the US Food and Drug Administration (FDA) has accepted its final premarket approval (PMA) application for the WiSE CRT System, which holds the distinction of being the world’s first leadless pacemaker for the heart’s left ventricle.
EBR Systems (ASX:EBR) has announced the FDA has formally accepted its PMA application for WiSE and it will now progress to a substantive review.
EBR announced at the end of August it had submitted the final module for the PMA application, which was subject to a 45-day FDA-mandated filing period to confirm administrative completeness and ensure that the technical elements of the application were adequate for substantive review. The FDA took only 30 days from the final module submission to provide this confirmation, rather than the full 45-day allowable period, which bodes well for an expedited review.
Roughly the size of a cooked grain of rice, EBR’s ground-breaking WiSE technology employs proprietary wireless techniques to administer pacing stimulation directly to the heart’s left ventricle and overcome problems associated with current standard of care.
The device consists of more than 100 meticulously assembled miniature electrical components, each delicately arranged by hand before being compacted into its cylindrical rice grain-like shape.
Key assessments in substantive review
EBR said the substantive review is a comprehensive evaluation process of the full PMA application, with key assessments including:
Bioresearch Monitoring (BIMO) audit – ensures the quality and integrity of EBR’s clinical trial study data and confirms that test subjects were protected from undue risk
Pre-Approval Inspection (PAI) – confirms EBR’s manufacturing, processing, and packing procedures comply with Quality System regulations, ensuring the facility can consistently produce devices meeting the approved specifications.
During the substantive review, the FDA will provide feedback and request responses from the company before a decision regarding the approvability of WiSE.
EBR’s PMA application includes extensive technical documentation and comprehensive clinical data from all clinical trials to date, including data from the pivotal SOLVE-CRT trial, which successfully met its primary efficacy and safety endpoints.
Results of the SOLVE -CRT trial were released at the Heart Rhythm Society’s May 2023 conference.
Additionally, the company released positive results from the SOLVE randomised sub-study in September 2023, further reinforcing conclusions from the primary study.
Results of the SOLVE-CRT for WisE were recently published in the prestigious journal JAMA Cardiology.
JAMA Cardiology is a leading journal for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide.
On track for commercial launch in 2025
WiSE has been designated a Breakthrough Device, allowing EBR to receive prioritised review and interactive communication with the FDA.
The company anticipates FDA approval in Q1 CY2025, remaining on track for commercial launch in CY2025.
EBR recently announced a fully underwritten institutional placement and entitlement offer to raise $50m.
The company said the funding would provide sufficient cash runway through the FDA approval process and support the early commercialisation and revenue growth phase.
‘Closer to US commercialisation’
EBR president and CEO John McCutcheon said it was a significant milestone for the company that its PMA application had progressed to substantive review by the FDA, effectively moving into the final stages of its regulatory timeline
“The FDA moved quickly through this step, which could have taken up to 45 days,” he said.
“This significant milestone brings us even closer to commercialisation and to making available our life-changing WiSE technology to heart failure patients in need.”
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.
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