The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Middle District of Florida on behalf of those who acquired Apyx Medical Corporation ("Apyx" or the "Company") (NASDAQ: APYX) securities during the period from August 1, 2018 through April 1, 2019 (the "Class Period"). Investors have until June 17, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
The lawsuit alleges that Apyx failed to disclose to investors: (i) that the clinical study on the use of J-Plasma for dermal resurfacing had not met its primary efficacy endpoint; (ii) that, as a result, the clinical study did not support the Company's application for regulatory clearance; and (iii) that, as a result, the Company was unlikely to receive regulatory approval of J-Plasma for dermal resurfacing.
On April 1, 2019, Apyx announced that it had withdrawn its 510(k) application for Renuvion, a patented surgical device for use in dermal surgical procedures, citing concerns raised by the FDA. Apyx 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 of certain protocol deviations.
On this news, shares of Apyx fell $2.49 per share, approximately 35.8%, to close at $4.46 on April 2, 2019.
If you acquired Apyx securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at email@example.com, or by filling out the contact form at the link below, to discuss your rights or interests with respect to these matters without any cost to you.