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Apyx announced on March 14, 2022, that it has been notified by the FDA that the Agency intends to post a Medical Device Safety Communication related to the Company’s Advanced Energy products.
“Based on our initial interactions with the FDA, we believe the Agency’s MDSC will pertain to the use of our Advanced Energy products outside of their FDA-cleared indication for general use in cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures,” said Charlie Goodwin, President and CEO.
Goodwin added: “While we are aware that some of our products are being used by physicians for dermal resurfacing procedures, for which our products do not have a cleared indication, we do not and will not promote the use of our products..."
On this news, the Company’s stock fell by 40.6%, to close at $5.88 per share on March 14, 2022.
Taking into account all the facts and statements of the Company's management, there is reason to believe that they have not properly, timely and in full disclosed that a significant number of Apyx’s Advanced Energy products were used for off-label indications and such off-label uses led to an increase in the number of medical device reports filed by Apyx reporting serious adverse events. As a result, the Company was reasonably likely to incur regulatory scrutiny which in turn most probably would hurt Company's business and financials.
Failure to Disclose,
Shock Event Date
14 March 2022