HOUSTON, Sept. 24, 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 has surpassed 75% of the required patients to be treated in
its pivotal cellulite trial.
More than 75% of the 60 required prospective patients have been
successfully treated across the four clinical sites in the pivotal
trial.
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Dr. Chris Capelli, President, CEO
and co-founder of Soliton, commented, "We are greatly
encouraged by the progress of our cellulite trials. We look
forward to continued execution and providing results upon
completion." Dr. Capelli continued, "We expect the results of
this study to form the basis of our application with the FDA for
clearance in cellulite reduction and hope to be filing this
application during the first half of 2020."
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.
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 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 to
complete the pivotal cellulite trial during 2020, 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.