HOUSTON, July 1, 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 partnered with a Maryland-based site as well as the supervising
physician for its upcoming expanded pivotal Cellulite Trial.
The trial builds upon the proof-of-concept trial conducted earlier
this year.
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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. Dr. Tanzi will supervise the treatment of
patients occurring in the expanded Cellulite Clinical Trial at
Capital Laser. Three additional trial sites and supervising
physicians are in discussions at this time.
Dr. Chris Capelli, President, CEO
and co-founder of Soliton, commented, "This pivotal cellulite trial
is being designed to support our submission to the U.S. Food and
Drug Administration. It ultimately will take place in 4 sites
located across the country and enroll up to 75 patients. Dr.
Tanzi and Dr. Kaminer are amongst the country's leading physicians
and researchers."
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.