Apyx Medical (NYSE:APYX), formerly known as Bovie Medical, said late yesterday that it has voluntarily withdrawn the FDA 510(k) clearance application for its J-Plasma/Renuvion device seeking a dermal resurfacing indication.
The Clearwater, Fla.-based company submitted a new 510(k) clearance application seeking new indications for the Renuvion system in December.
The application came supported by by data from a 55-patient, multi-center, single arm, evaluator-blind prospective investigational device exemption study of the system exploring its ability to reduce facial wrinkles and rhytides, Apyx Medical said.
The study, however, did not meet its primary efficacy endpoint, a comparison of the proportion of subjects with a greater than or equal to 1-score improvement on the Fitzpatrick Wrinkle and Elastosis Scale at 3-months. The company hoped to achieve a 75% success rate, but only 62% of subjects showed an improvement of 1 or more on the scale.
Apyx Medical said that in reviewing the submission, the FDA had concerns over clinical results from one investigational center being superior to the other two centers in the study. The federal watchdog was also concerned about the potential impact of protocol deviations at the superior center which included the prophylactic use of methylprednisolone in all but 5 subjects.
“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,” R&D VP Shawn Roman said in a prepared statement.
The company said that it does not have a timeline for resubmission, but that it intends to resubmit after further discussions with the FDA.
“We have been involved in productive and positive interactions with the agency and they have been very engaged throughout the process. They were understandably focused on the performance versus our stated primary endpoint, the variability in treatment outcomes across the three centers and the protocol deviations identified at one investigational center. After consultation with the agency in late-March, we withdrew our application on March 29, 2019 as we were unlikely to be able to resolve the issues raised within the agency’s congressionally mandated MDUFA 90-day review period that would have otherwise ended on April 1, 2019. Apyx Medical is committed to collaborating with the agency to gain a better understanding of their concerns, which the company plans to address in a new IDE supplement to obtain further data with uniform treatment applications across all investigational sites to support a new 510(k) regulatory clearance to market and sell Renuvion cosmetic technology for dermal resurfacing procedures. We are actively engaged with the agency to determine what additional data, studies and analyses may be required to support a new submission and an indication for use in dermal resurfacing procedures. In the interim, we continue to focus our 2019 commercial efforts on our initial clinical indication in the U.S. cosmetic surgery market, where Renuvion is used as a subdermal coagulator. With more than 400,000 liposuction procedures performed in the U.S. each year, this represents a compelling annual addressable market opportunity of more than $170 million,” prez & CEO Charlie Goodwin said in a press release.