HOUSTON, Feb. 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
that it has filed for Special 510(k) Premarket Notification with
the U.S. Food and Drug Administration ("FDA") for its Generation II
Rapid Acoustic Pulse ("RAP") device.
![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. (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). 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. (PRNewsfoto/Soliton, Inc.)](https://mma.prnewswire.com/media/871205/Soliton_Logo.jpg)
The Generation II RAP device delivers the same tattoo-removal
therapy 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 limited U.S. commercial launch planned
for mid-year 2020. Although, similar technology was utilized
in the Company's pivotal cellulite and proof of concept keloid scar
trials, only the tattoo removal indication will be reviewed by the
FDA in this submission and enabled during this initial launch.
The Special 510(k) filing states the device is indicated as an
accessory to the 1064 nm Q-Switched laser for 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.
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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 receive
clearance of the Special 510(k) and to launch its product in
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, 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.