HOUSTON, Nov. 5, 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 pivotal cellulite trial has been completed, with all
required patients having been successfully treated across the four
clinical sites.
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"With the successful completion of all 67 required patients, our
defined regulatory path remains on track as we prepare for the
follow-up site visits," said Dr. Chris
Capelli, President, CEO and co-founder of Soliton. "We
are immensely grateful to all the patients who participated and for
the effort and speed with which the four sites completed enrollment
and treatment. Having successfully treated all patients, we
are one step closer to bringing a non-invasive treatment for
the reduction of cellulite to the market."
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 in the pivotal study required no
anesthesia, caused no bruising, swelling or infection, and were
evaluated by the trial participants as an average of 2.4 on a pain
scale of 0-10. None of the patients experienced any post-treatment
downtime.
Based on biopsies from our own animal studies, Soliton's RAP
device appears to be capable of selective disruption of the
fibrotic septa that contribute to the appearance of
cellulite. The new discovery, referred to as "acoustic
subcision," helps explain the recent proof-of-concept trial results
showing an improvement in the appearance of cellulite following use
of the Company's RAP device.
[ To read a detailed description of acoustic subcision, read
page 10 of our shareholder letter here:
https://www.soliton.com/shareholder-letter-2019 ]
Together with the device's demonstrated ability to stimulate new
collagen production in animal models, this represents what the
Company believes is a potentially important new way to treat
cellulite and improve the appearance of the skin. 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 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 of Soliton to
complete the pivotal cellulite trial, the ability of Soliton's
acoustic shockwave device to prove safe or effective in reducing
cellulite in the pivotal clinical trial, and to receive FDA
clearance for the cellulite indication. 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.