HOUSTON, Dec. 18, 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
its Rapid Acoustic Pulse ("RAP") device successfully completed the
IEC 60601 safety testing being conducted at SGS, the world's
leading inspection, verification, testing and certification
company. The testing was led by a team at Sanmina Corporation, a
leading electronics manufacturing services provider.
This safety testing is a requirement of the supplemental 510(k)
filing for the Company's RAP device for tattoo removal, improvement
in the appearance of cellulite, keloid (scarring) and additional
pipeline indications. The tests are intended to insure that devices
meet standard safety metrics to protect users and patients. The
supplemental 510(k) filing will provide an update to Soliton's
current FDA 510(k) clearance, which was received in May 2019 for tattoo removal, with respect to the
step changes made to the device to improve usability in the
field.
Dr. Chris Capelli, Soliton's
President, CEO and co-founder, commented, "We are pleased, but not
surprised by the safety testing results of our RAP device. The
safety of our second generation device mirrors that of our first,
and these results reinforce this. We look forward to submitting
this safety data in early 2020, simultaneous with the Special
510k filing of our second generation
RAP device. This step is an important one in our plans to
commercialize the device being launched for tattoo removal to a
select and limited number of dermatologists in mid-2020."
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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 submit the
safety data for the second generation RAP device in early 2020, and
to commercialize the device being launched for tattoo removal to a
select and limited number of dermatologists 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, 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.