Apyx Medical Corp. (NASDAQ: APYX) shares dropped sharply on Tuesday after the company announced that it has voluntarily withdrawn its application for premarket notification 510(k) regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures.
However, the firm noted that it will continue to work with the U.S. Food and Drug Administration (FDA) relative to the development of a new 510(k) submission. Currently, Apyx cannot provide a timeline for resubmission, but it intends to do so after further discussions with the FDA.
Apyx originally filed to market and sell Renuvion Cosmetic Technology for dermal resurfacing procedures.
In the course of its review of Apyx’s submission, the FDA raised a number of questions and concerns related to superior clinical results from one investigational center as compared to the other two investigational centers in the study. The FDA also questioned the potential impact of protocol deviations at this investigational center, including the prophylactic use of methylprednisolone in all but five subjects treated.
Shawn Roman, vice president of research and development for Apyx Medical, commented:
The IDE study results show good progress towards being able to eventually demonstrate the efficacy of our Renuvion Cosmetic Technology as more than 90% of subjects in the study experienced an improvement in appearance as assessed by investigators, and the independent photographic reviewers were able to correctly identify post treatment photographs in more than 97% of subjects. Unfortunately, we experienced a larger than expected range of clinical outcomes in the study due primarily to the inconsistent application of treatment time on tissue among investigators at the three centers.
Shares of Apyx were last seen down over 44% at $3.86, in a new 52-week range of $3.84 to $8.89. The consensus price target is $11.00.
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