HOUSTON, March 27, 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 announced
that its 510(k) application for premarket clearance filed with the
U.S. Food and Drug Administration ("FDA") for its first generation
Rapid Acoustic Pulse ("RAP") tattoo removal device has cleared the
agency's acceptance review. The application now moves to a
substantive review. The device is indicated as an accessory to
the 1064 nm Q-Switched (pulsed) laser for black ink tattoo
removal on the arms, legs and torso in Fitzpatrick Skin Type I-III
individuals. Clinical trials have demonstrated that using the
Company's RAP device, in conjunction with a Q-Switched laser,
allows for multiple passes of laser treatment in a single treatment
session. The current standard of care for tattoo removal is to
use a Q-Switched laser to ablate the tattoo ink particles into
pieces small enough for the body's natural processes to remove
them, that independent studies have shown require on average ten or
more office visits to achieve acceptable results. In our own
clinical trial using the RAP device in conjunction with a
Q-Switched laser, patients experienced 75% to 100% removal of their
tattoos in just three office visits.
![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 accelerate the removal of unwanted tattoos (RAP device). (PRNewsfoto/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 accelerate the removal of unwanted tattoos (RAP device). (PRNewsfoto/Soliton, Inc.)](https://mma.prnewswire.com/media/837601/Soliton_Logo.jpg)
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Dr. Christopher Capelli,
president and CEO of Soliton, said, "We are very pleased with the
progress of our premarket notification through the FDA review
process." Dr. Capelli continued, "Having found that our
submission contained all the necessary elements and information, we
look forward to the substantive review and FDA clearance of the RAP
device."
"We are excited about the prospects for our RAP technology as we
enter the tattoo removal segment—estimated to be approximately
$4.8 billion annually by
2023. And, we expect our higher energy version of this new
technology will eventually take us into additional, and potentially
bigger aesthetics markets. Because our technology relies upon
replaceable cartridges for each treatment, we believe our business
model will benefit from recurring revenue, allowing Soliton to
share in the volume growth in the aesthetic category expected in
the coming years," said Dr. Capelli.
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 accelerate the removal of 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 RAP to
accelerate tattoo fading or fat removal and/or to reduce cellulite,
whether future clinical trials related to the acceleration of
existing fat removal technologies and cellulite are successful, the
ability of Soliton's RAP to receive FDA clearance, and the ability
of Soliton's higher energy device to be proven safe and effective
in other aesthetic procedures. 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 "Risk
Factors" in the Form 1-A we filed with the SEC on February 13, 2019. 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.
CONTACT:
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Joe Dorame, Joe
Diaz & Robert Blum
|
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Lytham Partners,
LLC
|
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602-889-9700
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soly@lythampartners.com
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SOURCE Soliton, Inc.