HOUSTON, Aug. 1, 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 Sanmina, Corp., the Company's global manufacturing
partner has delivered the Company's second generation rapid
acoustic pulse ("Gen 2 RAP") device for use in the upcoming pivotal
trial targeting cellulite reduction.
We previously announced the completion of final testing of the
device by Sanmina, Corp. After completing safety testing,
they have delivered the devices to the first clinical trial site
for the pivotal trial. The Gen 2 RAP device will be used in
Company's upcoming pivotal registration clinical trial to submit to
the FDA for 510(k) clearance of the device. This new device
is designed to be capable of functioning both as the Gen 1 device
does for the acceleration of tattoo removal, and as a stand-alone
device for potential reduction of cellulite and other future
indications. In this second model, the Gen 2 RAP is capable
of delivering higher-powered acoustic pulses at greater depths,
making it a platform device with a wide range of potential future
uses. This new device has not been cleared by the FDA.
The treatment head accommodates a specific reflector design to
allow for treatment depths that are optimized for addressing the
fibrotic structures that contribute to cellulite.
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"This new device is designed with the reduction of cellulite in
mind and we are excited to begin the pivotal study with this new
technology," commented Dr. Chris
Capelli, President and CEO of Soliton. "We believe this new
design could improve on the good results that we were able to
achieve in our proof-of-concept study with the earlier
technology."
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 the Soliton RAP
technology, including the Gen 2 RAP device, to prove safe and
effective at reducing cellulite and to achieve FDA clearance for
this 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.
SOURCE Soliton, Inc.