HOUSTON, July 8, 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 will release the cumulative 26-week patient data from
its cellulite proof of concept clinical trial on Monday, July 15, 2019. As the Company has
previously announced, the proof-of-concept clinical trial studied
the safety and efficacy of a new version of its acoustic shockwave
device for the treatment of moderate to severe cellulite. The
results from the 26-week assessment are being presented at The
Aesthetics Show in Las Vegas on
July 12, 2019.
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"We were excited and encouraged by the initial patient results
we saw when the trial treatments were completed," said Chris Capelli, Soliton President, Chief Science
Officer and co-founder. "Those initial results suggested that
Soliton has the potential for a new approach to treating
cellulite. Our excitement has continued to grow as we have
tracked the patient responses to the treatment and we look forward
to presenting what will be 26 weeks of data on July 15. This
data forms the foundation for the protocol development for our
recently announced expanded pivotal Clinical Cellulite Trial to
launch later this summer."
Cellulite affects up to 90% of women and over a billion dollars
per year is spent on treatment in the U.S. In the
proof-of-concept trial, the Soliton Rapid Acoustic Pulse ("RAP")
device was applied to the surface of the patients' skin for a
single 20-minute, non-invasive treatment. The treatments
required no anesthesia, caused no bruising, swelling or infection,
and were evaluated by the trial participants as a "0" on a pain
scale of 0-10 in 97% of the treatments. None of the patients
experienced any post-treatment downtime. The proof-of-concept trial
was conducted by Dr. Michael S.
Kaminer at SkinCare Physicians in Boston in collaboration with Elizabeth L. Tanzi, MD FAAD of Capital Laser and
Skin Care in Chevy Chase, MD.
Both Drs. Kaminer and Tanzi serve on the Company's Scientific
Advisory Board. The Soliton device used in this trial has not
been reviewed or cleared by the FDA for marketing and, accordingly,
none of the information in this press release is intended to
promote the sale or use of the device. The device is
investigational and is not available for sale in the United States.
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 preclinical testing, including the potential to
assist existing fat reduction technology in the reduction of fat as
well as improving the appearance of cellulite by creating
mechanical stress at the cellular level and inducing significant
collagen growth.
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's
acoustic shockwave device to reduce cellulite in the proof of
concept clinical trial. 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.