HOUSTON, July 16, 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 submitted its pivotal cellulite clinical
trial protocol for independent Institutional Review Board ("IRB")
approval.
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Dr. Chris Capelli, President, CEO
and co-founder of Soliton explained, "We have submitted our
protocol for the pivotal cellulite study to Advara for review and
approval. Based on the encouraging results we recently announced
from our proof of concept cellulite trial, we expect this larger
pivotal trial to form the basis for FDA clearance of our Rapid
Acoustic Pulse (RAP) device. We hope to receive approval from
the IRB in the very near future which will enable us to move
forward with the site initiation visits and ultimate treatment of
patients in this important study."
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
receive IRB approval of its protocol. 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.