Acutus Medical, Inc. (AFIB) Q1 2023 Earnings Call

Investor webinar replay

Replay transcript excerpt

Our next question comes from William Polunovic at Concordia Genuity. William, your line is open. Hey, it's Sean. I'm for Bill tonight. Thanks for taking our questions, and congrats on the quarter. If I could just start just on the update to the timing for AccuBlade. I know you called up second half, but any specific timing for the approval? How should we think about the launch and then the plans for a limited market release? How long could that be? Thanks. Thanks for the question, John. So as we said in our last call, our guidance for the full year contemplated Accublate approval in the second half of the year. So that expectation is unchanged from what we had shared in March. As a reminder, obviously because Accublate is already approved and used outside the United States and has been on the market in Europe since March of 2021, the way we would approach a limited market release is probably a little bit different than if this were a completely new to market product. So we will start with obviously our highest utilization accounts as it relates to primary targets for AccuBlate and those accounts that have given us feedback where the integration of an ablation catheter is critical to growing their AccuMap procedures from where we sit today or toward adoption in additional additional categories. But we would, obviously, as you know, there will be a process by which we have to go through that committee approval, very consistent with when you launch any other new product. So, our current outlet contemplates a fairly modest contribution from AccuBlate in 2023. The one thing I would also just remind you of, as we had submitted AccuBlate in October of last year. The average PMA review time at the FDA is running right now between 330 and 350 calendar days, so if you use that...