HOUSTON, March 11, 2020 /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
U.S. Food and Drug Administration ("FDA") clearance of the
Company's Special 510(k) Premarket Notification regarding its
Generation II Rapid Acoustic Pulse ("RAP") device.
"The FDA clearance of our Generation II RAP device marks yet
another milestone on Soliton's path towards commercialization,
specifically this year's strategic launch for tattoo removal,"
stated Christopher Capelli, MD,
founder, President and CEO of Soliton. "We initially intend to
provide this generation of the device to approximately 20-25 of the
top dermatologists within the United
States and look forward to the resulting physician feedback
and market data regarding cartridge utilization."
The Generation II RAP device delivers the same tattoo-removal
technology as the Generation I device but is slightly modified for
improved ease of use in the physician's office. The Generation II
RAP device constitutes the underlying technology of the RAP device
that will be deployed in the strategic U.S. tattoo removal
commercial launch planned for mid-2020. Similar technology
was utilized in the Company's pivotal cellulite and proof of
concept keloid scar trials. Only the tattoo removal
indication was reviewed by the FDA in this submission and cleared
for marketing.
The Special 510(k) filing was submitted to the FDA on
February 10, 2020 and states the
device is indicated as an accessory to the 1064 nm Q-Switched laser
for black ink tattoo removal in Fitzpatrick Skin Type I-III
patients. 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.
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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 FDA cleared commercial product will use rapid
pulses of acoustic shockwaves as an accessory to lasers for the
removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in
bringing the Rapid Acoustic Pulse ("RAP") device 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.
Soliton is investigating potential additional capabilities of the
RAP technology in clinical and preclinical testing, including the
potential to improve the appearance of cellulite by creating
mechanical stress at the cellular level and inducing significant
collagen growth and the potential to treat keloid and hypertrophic
scars by targeting the stiffened environment in the intracellular
matrix.
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 to launch its
product in mid-2020. 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, 2019
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.