HOUSTON, April 23, 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 its development team has completed final testing of the
Company's second generation rapid acoustic pulse ("Gen 2 RAP")
device at Sanmina, Inc., the Company's global manufacturing
partner.
The Gen 2 RAP device is intended to 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 should be
capable of delivering higher-powered acoustic pulses at greater
depths, making it a platform device with a wide range of potential
future uses. This device has not been cleared by the FDA.
The treatment head of the Gen 2 RAP device is automated to allow
continuous feeding of electrode material enabling the
electrohydraulic pulse generator to operate for longer treatment
times at higher and more consistent peak acoustic pressures.
As well, the treatment head can now accommodate varying reflector
designs to allow for treatment depths that are optimized for
addressing the fibrotic structures that contribute to
cellulite.
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"Given the excitement surrounding the proof of concept cellulite
trial results that are about to be presented to the scientific
community," commented Dr. Chris
Capelli, President and CEO of Soliton, "we needed to be
ready to launch an expanded clinical trial for the cellulite
indication. The Gen 2 RAP device is the key to being able to
start this expanded trial and seek FDA clearance."
Dr. Capelli continued: "The Gen 2 RAP device represents the kind
of multi-indication platform potential that we believe may make our
RAP system an indispensable tool for clinicians."
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 planned commercial product is designed to use rapid
pulses of designed acoustic shockwaves in conjunction with existing
lasers to accelerate the removal of unwanted tattoos (RAP device).
In addition, higher energy versions of acoustic pulse devices are
in early stages of development for potential stand-alone treatment
of cellulite and other indications. Both products are
investigational and are not available for sale in the United States.
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.
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SOURCE Soliton, Inc.