Shares of Apyx Medical (APYX 5.88%), a medical device company focused on the cosmetics market, are being slammed Tuesday. The stock was down 46% as of 1:22 p.m. EST after the company announced that it was voluntarily withdrawing its application for regulatory clearance of its J-Plasma/Renuvion product. The device is designed to be used during dermal-resurfacing procedures.
Apyx Medical announced that the decision was made after a meeting with the FDA regarding the submission. Specifically, the FDA stated that it had concerns about the 55-patient, multi-center trial that the company conducted to justify regulatory approval. The agency noted that the results from one of the three investigational centers in the study were vastly better than those from other two. FDA officials asked numerous questions about how protocol deviations that occurred at that center might have impacted the results.
Apyx's management team stated that it was committed to working with the FDA to address their concerns as soon as possible, but that they could not provide investors with a timeline on resubmission. Traders are thrashing the company's stock in response.
2019 is turning out to be a rough year for Apyx's investors. Just a few weeks ago, the company found itself on the receiving end of a short-seller report. The stock largely recovered from that event, but Tuesday's regulatory fiasco will be a bitter pill for shareholders to swallow.
Getting a product through the FDA approval process is hard enough when everything goes according to plan, let alone when your primary study gets called into question. Since there isn't a clear path forward for this business at this time, I plan to ignore this company's stock, and focus my attention on more promising opportunities.