Shareholder Investigation of Apyx Medical

Apyx Medical Corporation (APYX) Accused of Misleading Investors

According to the filed complaint for alleged violations of the Securities Exchange Act of 1934 between August 1, 2018 and April 1, 2019, in August 2018, of Apyx Medical Corporation (APYX) announced that it had completed enrollment in its clinical study evaluating Renuvion and represented that the results would support its 510(k) submission to the FDA. Throughout December 2018 and January 2019, Apyx highlighted the submission of the 510(k) application as a milestone. The truth was revealed in February 2019 when White Diamond Research released a report alleging that Apyx’s clinical study on the use of J-Plasma for dermal resurfacing may have missed its endpoints. On this news, Apyx’s shares fell nearly 25% to close at $6.40 per share on February 21, 2019. On April 1, 2019, Apyx revealed it had withdrawn its 510(k) application for regulatory clearance of J-Plasma in dermal resurfacing procedures, citing concerns raised by the FDA. It also revealed that the clinical study had missed its primary efficacy endpoint. On this news, Apyx shares plummeted over 35% to close at $4.46 per share on April 2, 2019.

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