EBR Systems Inc (ASX:EBR) – which is developing the world’s only wireless cardiac pacing device for heart failure – has ticked off another important step in its progress towards entering the US$3.6 billion US market, submitting its final Premarket Approval (PMA) module to the US Food and Drug Administration.
And given the usual FDA review cycle parameters, the company anticipates approval of its WiSE CRT (Cardiac Resynchronization Therapy) System to be granted in the first quarter of CY2025, for a commercial launch sometime in the same year.
Because WiSE has been designated a ‘Breakthrough Device’, it will receive prioritised review and interactive communication with the FDA throughout the PMA process, which will involve an initial FDA-mandated filing period, followed by a substantive review which will evaluate the full PMA application.
President & Chief Executive Officer John McCutcheon said EBR was delighted to have reached this milestone.
“This submission is the result of years of effort and collaboration between our clinical, regulatory, and engineering teams,” he said.
“With this application, we are now one step closer to making WiSE available to physicians for their patients across the United States.
“If approved, this PMA package will allow us to launch WiSE in 2025. We look forward to sharing further updates as we progress through the regulatory review process.”
EBR shares moved up on the news, and at 13:53 AEST, they were trading at $1.23: a rise of 10.36% since the market opened.