HOUSTON, Nov. 12, 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 begun the first follow-up visits for patients in its
pivotal cellulite trial.
------------------------
Join our more than 200K fans here to
follow the Company: https://soly-investors.com
------------------------
Dr. Chris Capelli, President, CEO
and co-founder of Soliton, commented, "The start of the
follow-up visits is a significant milestone. We are hopeful
that the results from our pivotal trial will be as strong as those
seen in our proof-of-concept study in cellulite. This
would support the filing of our 510(k) application with the FDA for
the treatment of cellulite, which we expect to occur in the first
half of 2020. With the planned limited launch of our device
in 2020 for the indication of tattoo removal, regulatory clearance
for this new indication would put us on track to expand nationally
and internationally with two indications in 2021."
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 patient's 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, the ability of Soliton to
file the 510(k) application with the FDA for the treatment of
cellulite in the first half of 2020 and to receive FDA clearance
for the cellulite indication, and the ability of Soliton to expand
nationally and internationally with two indications in 2021. 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.
View original
content:http://www.prnewswire.com/news-releases/soliton-announces-first-follow-up-visit-conducted-in-the-pivotal-cellulite-clinical-trial-300956009.html
SOURCE Soliton, Inc.