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Apyx Medical reports preliminary Q4 revenue $12.1M-$12.5M, consensus $13.5M
The Fly

Apyx Medical reports preliminary Q4 revenue $12.1M-$12.5M, consensus $13.5M

"Although global sales in our Advanced Energy segment showed improvement over the third quarter, our fourth quarter revenue results reflect continued business disruption related to the Medical Device Safety Communication," said Charlie Goodwin, president and CEO. "Specifically, while global Advanced Energy sales increased more than 40% on a sequential basis, the pace of recovery in global generator sales was slower than what our guidance had assumed. With that said, Apyx continues to lead the way in ensuring the safe and effective use of our technology. Our team continued to make progress in educating existing and potential customers about the strong safety and efficacy profile of our products, including raising awareness of the additional 510(k) clearances that we secured in 2022. Importantly, we also continued to engage with the Food & Drug Administration ("FDA") on our proposed regulatory submission for a new clinical indication demonstrating the safety of our Renuvion(R) technology when used after liposuction. We received the FDA’s formal feedback on the related pre-submission request in December and expect to submit a request for 510(k) clearance by the end of January. We continue to believe the receipt of 510(k) clearance for this new clinical indication would directly address the remaining limitations of the Medical Device Safety Communication."

Published first on TheFly

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