Lawsuit Overview
Settlement Overview
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July 21, 2020 - The court preliminarily approved the settlement.
July 9, 2020 - A stipulation and agreement of settlement was entered by the parties.
March 11, 2020 - The court denied the defendants' motion to dismiss.
October 3, 2019 - A motion to dismiss the amended complaint was filed.
September 3, 2019 - An amended complaint was filed with the court.
April 17, 2019 - An investor in shares of Apyx Medical Corporation (NASDAQ: APYX) filed a lawsuit in the U.S. District Court for the Middle District of Florida over alleged violations of Federal Securities Laws by Apyx Medical Corporation in connection with certain allegedly false and misleading statements made between August 1, 2018, and April 1, 2019.
Clearwater, FL based Apyx Medical Corporation f/k/a/ Bovie Medical Corporation, a medical technology company, manufactures and sells medical devices in the cosmetic and surgical markets worldwide. Apyx Medical Corporation reported that its annual Total Revenue rose from $10.23 million in 2017 to $16.68 million in 2018 and that its Net Loss of $5.06 million in 2017 turned into a Net Income of $64 million in 2018.
On February 21, 2019, White Diamond Research released a report alleging that a clinical study on the use of the Company’s J-Plasma for dermal resurfacing may have missed its endpoints.
Then, on April 1, 2019, Apyx Medical Corporation announced that it had withdrawn its 510(k) application for the use of J-Plasma for dermal resurfacing, citing concerns raised by the FDA. Apyx Medical Corporation revealed that the FDA had questioned the device’s clinical results, which differed greatly from two of the investigational centers used in the study, as well as the potential impact certain protocol deviations.
Moreover, Apyx Medical Corporation disclosed that the clinical study did not meet its primary efficacy endpoint. Shares of Apyx Medical Corporation (NASDAQ: APYX) declined to as low as $3.55 per share on April 2, 2019.
According to the complaint the plaintiff alleges on behalf of purchasers of Apyx Medical Corporation (NASDAQ: APYX) common shares between August 1, 2018, and April 1, 2019, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between August 1, 2018, and April 1, 2019, the Defendants made false and/or misleading statements and/or failed to disclose that the clinical study on the use of J-Plasma for dermal resurfacing had not met its primary efficacy endpoint, that, as a result, the clinical study did not support the Company’s application for regulatory clearance, that, as a result, the Company was unlikely to receive regulatory approval of J-Plasma for dermal resurfacing, and that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis.