Apyx Medical Corp. Provides Update on the Premarket Notification 510(k) Submission to the U.S. Food & Drug Administration (FD...
April 01 2019 - 4:05PM
Business Wire
Provides Preliminary First Quarter 2019
Revenue Results and Reaffirms 2019 Revenue Outlook
Apyx Medical Corporation, formerly known as Bovie Medical
Corporation, (NASDAQ:APYX) (the “Company”), a maker of
medical devices and supplies and the developer of J-Plasma®, a
patented surgical product marketed and sold under the Renuvion®
Cosmetic Technology brand in the cosmetic surgery market, today
announced it has voluntarily withdrawn its application for
premarket notification 510(k) regulatory clearance of
J-Plasma/Renuvion for use in dermal resurfacing procedures. The
Company will continue to work with the U.S. Food and Drug
Administration (the “Agency”) relative to the development of a new
510(k) submission. At the present time, the Company cannot provide
a timeline for resubmission but intends to do so after further
discussions with the Agency.
As previously disclosed, on December 19, 2018, the Company filed
a premarket notification 510(k) for regulatory clearance for a new
clinical indication to market and sell Renuvion Cosmetic Technology
for dermal resurfacing procedures. The application was supported by
data from a multi-center, single arm, evaluator-blind prospective
investigational device exemption (IDE) study evaluating the safety
and efficacy of J-Plasma/Renuvion technology for the reduction of
facial wrinkles and rhytides, which was conducted at three
investigational centers and consisted of 55 patients. The primary
efficacy endpoint was the comparison of the proportion of subjects
(i.e., the percentage of treatment responders) with a ≥ 1-score
improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at
the 3-month follow-up visit, as compared to baseline, as determined
by at least 2 out of 3 blinded Independent Photographic Reviewers
(IPRs). The primary safety endpoint was the adverse event rate and
duration for a period of 3 months following the procedure.
The IDE study yielded no serious adverse events, however, the
study did not meet the primary efficacy endpoint, as only 62% of
subjects were deemed to have experienced a ≥ 1-score improvement on
the FWS at the 3-month follow-up visit, whereas the study protocol
and statistical analysis plan included 75% success criteria.
In the course of its review of the Company’s submission, the
Agency 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
Agency also questioned the potential impact of protocol deviations
at this investigational center including the prophylactic use of
methylprednisolone in all but five subjects treated.
“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,” said
Shawn Roman, Vice President of R&D for Apyx Medical.
“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.”
“We have been involved in productive and positive interactions
with the Agency and they have been very engaged throughout the
process,” said Charlie Goodwin, President and Chief Executive
Officer of Apyx Medical. “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.”
Mr. Goodwin continued: “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.
Finally, we announced preliminary revenue expectations for the
first quarter of 2019 in this afternoon’s press release which
reflect strong growth of 65% - 71% year-over-year, and we have
reaffirmed our 2019 revenue guidance expectations of total revenue
growth in the range of 50% - 56% year-over-year, driven primarily
by 53% to 61% growth in our Advanced Energy business this
year.”
Preliminary First Quarter 2019 Revenue
Summary:
- Total Q1 revenue from continuing
operations in a range of approximately $5.6 to $5.8 million, up
approximately 65% to 71% year-over-year.
- Advanced Energy revenue of
approximately $4.3 million to $4.4 million, up approximately 64% to
67% year-over-year, driven by strong Renuvion sales.
- OEM revenue of approximately $1.3
million to $1.4 million, up approximately 69% to 82%
year-over-year.
2019 Revenue
Outlook:
The Company is reaffirming fiscal year 2019 revenue guidance
of:
- Total revenue in the range of $25.0
million to $26.0 million, representing growth of 50% to 56%
year-over-year, compared to total revenue from continuing
operations of $16.7 million in fiscal year 2018.
- Total revenue guidance continues to
assume:
- Advanced Energy revenue in the range of
approximately $20.0 million to $21.0 million, representing growth
of 53% to 61% year-over-year, compared to Advanced Energy revenue
of $13.7 million in fiscal year 2018. The Advanced Energy revenue
range continues to assume that US growth is only driven by
contributions from Renuvion sales related to its use as a subdermal
coagulator following liposuction procedures and that international
growth is driven primarily by utilization-related demand, in
existing international markets only.
- OEM revenue of approximately $5.0
million, representing growth of 38% year-over-year, compared to
$3.6 million for fiscal year 2018. The OEM revenue range continues
to assume contributions from the Company’s electrosurgical
disposables and accessories supply agreement with Symmetry Surgical
of approximately $2.5 million for the full year 2019 period,
compared to approximately $0.6 million in fiscal year 2018.
About Apyx Medical
Corporation:
Apyx Medical Corporation (formerly Bovie Medical Corporation) is
an advanced energy technology company with a passion for elevating
people’s lives through innovative products in the cosmetic and
surgical markets. Known for its innovative Helium Plasma
Technology, Apyx is solely focused on bringing transformative
solutions to the physicians and patients it serves. The company’s
Helium Plasma Technology is marketed and sold as Renuvion® in the
cosmetic surgery market and J-Plasma® in the hospital surgical
market. Renuvion offers plastic surgeons, fascial plastic surgeons
and cosmetic physicians a unique ability to provide controlled heat
to the tissue to achieve their desired results. The J-Plasma system
allows surgeons to operate with a high level of precision and
virtually eliminating unintended tissue trauma. The Company also
leverages its deep expertise and decades of experience in unique
waveforms through original equipment manufacturing (OEM) agreements
with other medical device manufacturers. For further information
about the Company and its products, please refer to the Apyx
Medical Corporation website at www.ApyxMedical.com.
Cautionary Statement on Forward-Looking
Statements:
Certain matters discussed in this release and oral statements
made from time to time by representatives of the Company may
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and the Federal
securities laws. Although the Company believes that the
expectations reflected in such forward-looking statements are based
upon reasonable assumptions, it can give no assurance that its
expectations will be achieved.
Forward-looking information is subject to certain risks, trends
and uncertainties that could cause actual results to differ
materially from those projected. Many of these factors are beyond
the Company’s ability to control or predict. Important factors that
may cause actual results to differ materially and that could impact
the Company and the statements contained in this release can be
found in the Company’s filings with the Securities and Exchange
Commission including the Company’s Report on Form 10-K for the year
ended December 31, 2018 and subsequent Form 10-Q filings. For
forward-looking statements in this release, the Company claims the
protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995.
The Company assumes no obligation to update or supplement any
forward-looking statements whether as a result of new information,
future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20190401005837/en/
Westwicke Partners on behalf of Apyx Medical CorporationMike
Piccinino, CFA443-213-0500investor.relations@apyxmedical.com
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