HOUSTON, May 17, 2019 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology licensed
from The University of Texas on behalf
of the MD Anderson Cancer Center ("MD Anderson"), today provided an
update on its application for FDA clearance and addressed a recent
anonymous article published on SeekingAlpha.com.
"We know there is a lot of focus on whether or not, and when,
Soliton can achieve FDA clearance to market its new Rapid Acoustic
Pulse (RAP) technology," commented Dr. Chris Capelli, President and CEO of
Soliton. "So, we would like to provide some insight regarding
where we stand in this process. We submitted our request for
marketing clearance, referred to as a "510(k)," in March of this
year. The targeted time period for review of a 510(k)
application is 90 days. This means we should be receiving
feedback from the FDA before the end of this month.
Importantly, we have not been notified that our application must be
converted to a "De Novo" process, the approval of which can take
considerably longer to secure. While we cannot be certain
that our application will continue as a 510(k) or that our
application will eventually be cleared, we are now cautiously
optimistic that our RAP device could be cleared sooner than we have
been estimating."
Dr. Capelli continued, "While we normally don't comment on
matters relating to our stock price, we are aware that the posting
of an article by an anonymous author on SeekingAlpha.com has
coincided with a precipitous drop in our stock price. Given
that this article contains numerous misstatements of fact, we feel
compelled to comment on the most egregious of those misstatements
to ensure that investors are not further misled. The
following recites a few of the misleading claims made in this
article, followed by the factual reality:
CLAIMED: Remeditex has dumped every position that it
has filed that it held on sec.gov. And they were smart decisions,
as they all turned out to be dogs and are trading at a fraction
today of what they traded at when Remeditex had its position. Will
Remeditex follow this pattern and dump its entire position of SOLY?
We believe it will.
FACTUAL: Mr. Brett
Ringle, President of Remeditex, responded, "This statement
is patently false. We continue to hold our positions in a
number of publicly traded portfolio companies. We believe
strongly in the underlying science and ultimate potential of
Soliton. Our commitment to Soliton is evidenced by our
investing over $27 million and having
stuck by the Company throughout its existence. In fact, we
even participated in the IPO. We always carefully analyze our
portfolio companies and we are convinced that Soliton has a bright
future and we will continue to be a part of that future."
CLAIMED: The company is years from having an FDA approved
product.
FACTUAL: We have said in our filings and press releases
that we expect clearance of our device by end of this year.
However, as described above, it appears that we may receive notice
back from the FDA regarding our 510(k) application this
month. While we cannot be sure, we are cautiously optimistic
that our device may be cleared sooner than the Company previously
indicated.
CLAIMED: Right now, they don't even have a finished
product to submit to the FDA.
FACTUAL: Only fully engineered, tested and documented
finished products can be successfully submitted for FDA clearance,
which is what we have done. Future generation products are
intended to incorporate planned improvements. Our Generation 3
RAP device we expect to offer in our nationwide launch will have
significant changes from the Generation 2 device that we intend to
offer in our initial market launch, which in turn will have
significant changes from the Generation 1 device we have submitted
for FDA review and clearance. We expect the changes made to our
device from Generation 1 to Generation 2 will necessitate the
filing of an additional 510(k) before being launched. We cannot be
certain that the changes we deem appropriate to make to the
Generation 3 RAP device prior to the nationwide launch will not
require another 510(k) filing.
CLAIMED: SOLY's study results are only shown on its
website, and not in a peer reviewed journal, which makes the data
less legitimate.
FACTUAL: Our clinical trial results were peer reviewed
and published via the American Society For Laser Medicine &
Surgery (ASLMS), one of the most respected bodies in laser
medicine. Our device was also awarded "Best in Show" by the
ASLMS.
CLAIMED: Zimmer also recommends using ZWave for cellulite
treatment. So, what exactly is new or original in SOLY's RAP
technology?
FACTUAL: Soliton's RAP shockwaves are 50 times
faster (rise and fall time of peak pressure wave), 10 times higher
in pressure and 4 times faster in repetition rate (click this link
to see a direct comparison of the two devices:
https://www.soliton.com/acoustic-shockwave/) than Zimmer
ZWave. Eight patent families and 68 issued and pending
patents distinguish the unique attributes of Soliton RAP that we
believe make it unlike any other acoustic pulse device
available. The repetition rate combined with the rapid rise
and fall times alone are carefully designed to exploit the
relaxation time and susceptibility to shear waves of the cellular
and other structures we target. We are the only device we
know of with this capability other than "focused" acoustic devices,
which can't cover enough area to be practical for indications like
tattoo removal and cellulite reduction and can result in
significant heat and pain.
Dr. Capelli concluded, "We would encourage investors to consider
the source. These misleading claims, which appear to have led
to significant financial loss to some of our shareholders come from
an anonymous source identified only as a short-seller, someone who
stands to benefit by instilling fear in those who may not know
better. This is so egregious that we feel compelled to
explore all potential options against the perpetrators, including
legal and regulatory. Regardless, long after this
short-seller, who believes they face no consequences for their
tortious misstatements, profits from those who are misled, we will
continue to stand in the full light of day by our claims, cautions
and actions. For those who have not been misled, we thank you
for you continued support and encouragement. We believe
firmly that Soliton has tremendous potential and we remain
committed to realizing that potential on your behalf."
About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and
proprietary platform technology licensed from MD Anderson. The
Company's first planned commercial product is designed to use rapid
pulses of designed acoustic shockwaves in conjunction with existing
lasers to reduce the number of treatment visits to remove unwanted
tattoos (RAP device). In addition, higher energy versions of
acoustic pulse devices are in early stages of development for
potential stand-alone treatment of cellulite and other
indications. Both products are investigational and are not
available for sale in the United
States.
For more information about the Company, please
visit: http://www.soliton.com
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. Forward-looking statements in this press
release include, without limitation, the ability of Soliton's
acoustic shockwave device to receive marketing clearance from the
FDA. These statements relate to future events, future expectations,
plans and prospects. Although Soliton believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. Soliton has attempted to identify
forward-looking statements by terminology including ''believes,''
''estimates,'' ''anticipates,'' ''expects,'' ''plans,''
''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,''
''might,'' ''will,'' ''should,'' ''approximately'' or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. These statements are only
predictions and involve known and unknown risks, uncertainties, and
other factors, including those discussed under in our SEC filings,
including under the heading "Item 1A. Risk Factors" in the Form
10-K for year ended December 31, 2018
we filed with the SEC and updated from time to time in our Form
10-Q filings and in our other public filings with the SEC. Any
forward-looking statements contained in this release speak only as
of its date. Soliton undertakes no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
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SOURCE Soliton, Inc.