HOUSTON, Aug. 6, 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 completed their site initiation visit for
the first site to be included in its upcoming expanded pivotal
Cellulite Trial. Site initiation visits are for initial
clinical staff training and protocol reviews with the staff in
advance of patient treatments. The company also announced
that patient enrollment for the trial has been initiated at the
initial trial site.
Join our more than 200K fans here
to follow the Company: https://soly-investors.com
The initial training, site visit and enrollment were completed
at Chicago Cosmetic Surgery and Dermatology with treatment
supervised by Omer Ibrahim, MD FAAD
and Carolyn I. Jacob, MD FAAD, both
Board Certified Dermatologists. Site initiation visits at the three
additional trial sites will be conducted over the next six
weeks. Patient enrollment will occur concurrently.
Dr. Chris Capelli, President, CEO
and co-founder of Soliton, commented, "The completion of these
important steps in the clinical trial process moves Soliton closer
to the treatment of enrolled patients in this pivotal cellulite
trial. We look forward to completing site visits and
enrollment at the other trial sites and initiating patient
treatments at each site in the very near
future."
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 successfully conclude the pivotal
clinical trial. 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-completes-site-enrollment-and-conducts-initial-site-training-to-start-pivotal-cellulite-trial-300896797.html
SOURCE Soliton, Inc.