Investigation
03/14/2022
Initial Lawsuit
06/06/2022
Lawsuit Progression
08/05/2022
Did the company mislead investors regarding the use of its advanced energy products (Plasma/RF Handpiece and Plasma Generators) outside of their FDA-cleared indication for general use? The products were indicated in “cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.”
This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.
A lawsuit was subsequently filed. We will update this post as it unfolds.
03/14/2022
The U.S. Food and Drug Administration (FDA) issues a warning for consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures.
“Specifically, the FDA is warning against the use for procedures intended to improve the appearance of the skin through dermal resurfacing (a procedure on the skin to treat wrinkles) or skin contraction (a procedure under the skin that can be performed either alone or in combination with liposuction to achieve skin effects, such as “tightening”).”
“The Renuvion/J-Plasma device is FDA cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. The use of this device has not been determined to be safe or effective for any specific procedure intended to improve the appearance of the skin.”
Stock Impact
| Close | Previous close | Price variation | Percentage variation |
|---|---|---|---|
| $5.88 | $9.9 | $-4.02 | -40.61% |
A shareholder filed this securities class action on behalf of persons and entities that purchased or otherwise acquired Apyx Medical Corporation securities between May 12, 2021 and March 11, 2022, inclusive.
According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors:
(1) that a significant number of Apyx’s Advanced Energy products were used for off-label indications;
(2) that such off-label uses led to an increase in the number of medical device reports filed by Apyx reporting serious adverse events;
(3) that, as a result, the company was reasonably likely to incur regulatory scrutiny;
(4) that, as a result of the foregoing, the company’s financial results would be adversely impacted; and
(5) that, as a result of the foregoing, defendants’ positive statements about the company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses