HOUSTON, July 10, 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 an additional site and
supervising physician for its upcoming expanded pivotal Cellulite
Trial. The site is the second of four planned sites for the pivotal
trial.
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The proof-of-concept trial was conducted by Dr. Michael S. Kaminer at SkinCare Physicians in
Boston in collaboration with Dr.
Elizabeth L. Tanzi of Capital Laser
and SkinCare in Chevy Chase, MD.
The expanded Cellulite Clinical Trial will now include subjects
treated at SkinCare Physicians, supervised by Dr. Kaminer, added to
the subjects being treated at Capital Laser. Drs. Kaminer and Tanzi
are members of the Company's Scientific Advisory Board.
Dr. Chris Capelli, President, CEO
and co-founder of Soliton, commented, "We are thrilled to be
partnering with Dr. Kaminer on the pivotal trial designed to
support our submission to the U.S. Food and Drug Administration. We
anticipate it ultimately will take place in four sites located
across the country and will enroll up to 75 patients."
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 locate new sites and to recruit new
patients to commence such larger clinical trial on a timely basis.
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.