HOUSTON, May 28, 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 it has received clearance from the U.S. Food & Drug
Administration ("FDA") to market its Rapid Acoustic Pulse ("RAP")
device for tattoo removal. The device is indicated as an
accessory to the 1064 nm Q-Switched laser for black ink tattoo
removal on the arms, legs and torso in Fitzpatrick Skin Type I-III
individuals.
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"Receiving clearance from the FDA, while inline with our
expectations, is nonetheless gratifying and validating,
representing a bedrock for the commercialization plan of our RAP
technology," commented Dr. Chris
Capelli, President, CEO and co-founder of Soliton.
"This clearance to market allows us to begin the transition from
R&D to expanded product development and commercialization
within the tattoo removal segment.
Development of our breakthrough shockwave device, which was
recently awarded "Best in Show" by the American Society for Laser
Medicine and Surgery (ASLMS), has taken us over 5 years and more
than $25 million in research and
development to create. This required collaborating with a
wide range of industry-leading experts, including engineers
responsible for the Space Shuttle ignition system, scientists
specializing in the plasma physics involved in nuclear fusion and
physicysts specializing in acoustic engineering.
Our device, which is now covered by 8 patent families with 68
patents issued or pending, safely converts 3,000 volts at 3,000
amps (9,000,000 watts of power) into finely-controlled acoustic
shockwaves at a rate of up to 100 pulses per second through our
replaceable treatment cartridge. While this is a significant amount
of power being converted into an acoustic pulse, it is extremely
brief in time, with both a very short rise time and a similarly
short fall time. This results in microscopic mechanical
disruption to the targeted cellular level structures and vacuoles.
Importantly, the negative pressure component of each acoustic pulse
is attenuated so therapy can be provided without creating the
cavitation, heat or collateral tissue damage that would give the
patient the sensation of significant pain. As a result,
Soliton's RAP technolocy can provide meaningful results with little
potential for bruising or other treatment related downtime.
In the clinical trials submitted to the FDA as part of the
510(k) application that was just cleared, we demonstrated that our
RAP device can enable tattoo removal in just 2-3 office visits. In
contrast, a separate independent study of 397 tattoo owners,
demonstrated that the standard of care laser-only method required
10 or more office visits to achieve acceptable results.
Taking into consideration that the tattoo removal industry is
estimated to grow to approximately $4.8
billion annually by 2023, we are eager to further our
commercialization plans and move towards our launch and revenue
generation as early the first half of 2020.
Importantly, this FDA clearance represents only the first of
many indications we are pursuing with our RAP technology. We
believe our RAP technology offers the potential for significant
breakthrough treatments in a variety of aesthetic market segments.
We look forward to building upon this initial FDA clearance in
combination with compelling results from various clinical trials in
these other aesthetic segments to advance the influence of our RAP
technology."
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 the Soliton RAP
technology to prove safe and effective for our targeted indications
and to achieve FDA clearance for this technology. 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.