HOUSTON, April 29, 2021 /PRNewswire/ -- Soliton,
Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology, today
announced the U.S. Food and Drug Administration ("FDA") clearance
of the Company's special 510(k) for modifications to its RESONIC™
device.
"We were thrilled to receive this clearance as it marks the last
significant hurdle to our ability to initiate our commercial launch
of the improved RESONIC device in the second quarter," stated
Brad Hauser, Soliton CEO and
President. "Our discussions with our target dermatologists and
plastic surgeons on our Rapid Acoustic Pulse (RAP) technology have
been very well received and there is strong enthusiasm for an
effective and efficient patient experience for tattoo removal and
cellulite treatment with the RESONIC device over the coming
months."
The RESONIC device utilizes the RAP technology to deliver safe
and effective tattoo removal and cellulite treatment and now
includes an autoloading cartridge and an improved user interface.
These modifications are geared towards providing for a more
seamless user experience. The special 510(k) application was
submitted to the FDA on March 31,
2021.
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About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and
proprietary platform technology licensed from The University of Texas on behalf of MD Anderson Cancer
Center. The Company's first FDA cleared commercial product,
RESONIC™, will use rapid pulses of acoustic shockwaves for the
treatment of cellulite and as an accessory to lasers for the
removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in
bringing RESONIC to the market. The Company believes this "Soliton"
method has the potential to lower tattoo removal costs for
patients, while increasing profitability to practitioners, compared
to current laser removal methods. The Company also believes the
technology will provide the first non-invasive acoustic technology
to target the underlying causes of dimples and ridges in cellulite.
Soliton is investigating potential additional capabilities of the
RAP technology. The device is currently cleared in the United States only for use in tattoo
removal and cellulite.
For more information about the Company, please visit:
http://www.soliton.com
Forward-Looking Statements
This press release includes 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 statements involve
risks and uncertainties. These statements relate to future events,
future expectations, plans and prospects. Forward-looking
statements in this release include, but are not limited to, our
ability to successfully launch the RESONICTM technology.
Although Soliton believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
actual results or outcomes may prove to be materially different
from the expectations 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,'' "would,"
''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 in our filings with the
Securities and Exchange Commission ("SEC"), including under the
heading " Risk Factors" in our most recently filed Form 10-K filed
with the SEC and as updated in our Form 10-Q filings and in our
other 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.
DC:82293768.2
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SOURCE Soliton, Inc.