HOUSTON, March 21, 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 filed for 510(k) premarket clearance with the U.S. Food
and Drug Administration ("FDA") for its first generation Rapid
Acoustic Pulse ("RAP") tattoo removal device. 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. 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, resulting in accelerated fading in comparison to
stand-alone laser treatment.
The current standard of care for tattoo removal is to use a
Q-switched (pulsed) laser to ablate the tattoo ink particles into
pieces small enough for the body's natural processes to remove
them. Unfortunately, this current method is highly inefficient,
requiring up to 10 or more office visits to achieve acceptable
results. A clinical trial has demonstrated that using our Rapid
Acoustic Pulse ("RAP") device in conjunction with a Q-switched
laser has the potential to produce similar results in just 2 to 3
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, "The submission of our 510(k)
application for premarket clearance of our RAP device represents an
important step in the commercialization of our products. We will be
operating in a large industry segment that seeks the solutions our
technology offers in terms of speed of tattoo removal and the
potential for higher operating margins for the professional
practices that adopt the RAP technology."
"Our strategy is a razor/razorblade model with consumable
products for single-use applications, generating recurring revenue
that should allow Soliton to share in the volume growth that is
expected in the coming years," continued Dr. Capelli. "We believe
this business model will serve the Company and our shareholders
well as we enter into the tattoo removal segment – estimated to be
approximately $4.8 billion annually
by 2023 – and eventually into additional aesthetics markets. We are
excited about the prospects for expanding the use of our RAP
technology to address new markets and other aesthetic
issues."
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,
and whether future clinical trials related to the
acceleration of existing fat removal technologies and cellulite are
successful. 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
|
|
Lytham Partners,
LLC
|
|
602-889-9700
|
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soly@lythampartners.com
|
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SOURCE Soliton, Inc.