Apyx Medical Corporation (APYX) Used its Products for Off-Label Indications
A shareholder filed a class action on behalf of all persons or entities that purchased or otherwise acquired Apyx Medical Corporation (NASDAQ: APYX) securities between May 12, 2021 and March 11, 2022, for violations of the Securities Exchange Act of 1934. Apyx claims to be an advanced energy technology company with products in the cosmetic and surgical markets. Nearly 80% of its revenue is derived from the Advanced Energy segment.
According to the complaint, during the class period, defendants failed to disclose to investors that a significant number of Apyx’s Advanced Energy products were used for off-label indications and that 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 would adversely impact its financial results.
On March 14, 2022, Apyx disclosed that the FDA would be posting a Medical Device Safety Communication (“MDSC”) related to the Company’s Advanced Energy Products. The Company further disclosed that “[b]ased 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.” On this news, the Company’s stock fell $4.02, or over 40%, to close at $5.66 per share on March 14, 2022.
Next Steps: If you acquired shares of Apyx Medical Corporation securities between May 12, 2021 and March 11, 2022, you have until August 5, 2022, to ask the court to appoint you lead plaintiff for the class. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.