HOUSTON, July 25, 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 the company has identified a third site as well as the
supervising physician for its upcoming expanded pivotal Cellulite
Trial. The site joins two previously identified sites in what
is anticipated to be a four-site trial.
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The expanded Cellulite Clinical Trial builds upon a
proof-of-concept trial conducted earlier this year. Subjects
will be treated at Chicago Cosmetic Surgery and Dermatology with
treatment supervised by Omer
Ibrahim, MD FAAD and Carolyn I.
Jacob, MD FAAD, both Board Certified Dermatologists.
The data from the patients treated in Chicago will be added to the data from
patients treated at Capital Laser in Chevy Chase, MD and at SkinCare Physicians in
Boston.
Dr. Chris Capelli, President, CEO
and co-founder of Soliton, commented, "This pivotal cellulite trial
will ultimately take place in 4 sites located in major cities
across the country, and will enroll up to 75 patients. The
study is designed to support our submission to the U.S. Food and
Drug Administration."
Cellulite affects up to 90% of women and over a billion dollars
per year is spent on treatment in the U.S. Results from our
initial proof of concept clinical trial suggest the potential for a
new approach to treating cellulite. 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 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 a larger clinical
trial or to receive FDA clearance for the cellulite indication, and
the ability of Soliton to commence such larger clinical trial
within the next few months. 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.