HOUSTON, April 15, 2021 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology, today
announced that the U.S. Food and Drug Administration ("FDA") has
accepted its special 510(k) application previously submitted on
March 31, 2021 for modifications to
RESONIC™ device planned for commercial launch as
complete. The company expects to hear if the FDA has cleared its
special 510(k) application in the next 15-20 days unless the
process takes slightly longer than normal given the COVID-related
workload inside the FDA.
The changes submitted in the special 510(k) application include
the development of an autoloading cartridge and an improved user
interface. These modifications are geared towards providing for a
more seamless user experience.
In addition, Soliton achieved several manufacturing milestones
in anticipation for its planned 2Q21 initial launch of RESONIC for
both cellulite and tattoo removal indications. The Company
successfully completed all required safety testing including
Quality System/Current Good Manufacturing Practice regulations for
medical devices (21 CFR Part 820) inspection from the FDA.
Additionally, the Company expanded its sales team through the
hiring of two Senior Practice Development Managers with previous
experience in the aesthetics space. This role will be focused on
in-practice execution of the introduction and support of the
RESONIC device and RAP technology.
"With the FDA's acceptance of our special 510(k) application for
improved commercial use and successful completion of all safety
testing, we believe are well positioned to successfully bring
RESONIC™ to market later this quarter," stated Brad Hauser, Soliton CEO and President. "We
believe our commitment to improving the design and safety of our
RAP technology is critical for Soliton's commercial success. We
look forward to bringing these improvements to market with the
support of our new seasoned Practice Development Managers."
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About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and
proprietary platform technology licensed from The University of Texas on behalf of MD Anderson Cancer
Center. The Company's first FDA cleared commercial product,
RESONIC™, will use rapid pulses of acoustic shockwaves for the
treatment of cellulite and as an accessory to lasers for the
removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in
bringing RESONIC 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. The Company also believes the
technology will provide the first non-invasive acoustic technology
to target the underlying causes of dimples and ridges in cellulite.
Soliton is investigating potential additional capabilities of the
RAP technology. The device is currently cleared in the United States only for use in tattoo
removal and cellulite.
For more information about the Company, please visit:
http://www.soliton.com
Forward-Looking Statements
This press release includes 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 statements involve
risks and uncertainties. These statements relate to future events,
future expectations, plans and prospects. Forward-looking
statements in this release include, but are not limited to, our
ability to receive clearance from the FDA for our special
501k and to successfully launch the
RESONIC™ technology. Although Soliton believes that
the expectations reflected in such forward-looking statements are
reasonable as of the date made, actual results or outcomes may
prove to be materially different from the expectations 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,'' "would," ''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
in our filings with the Securities and Exchange Commission ("SEC"),
including under the heading " Risk Factors" in our most recently
filed Form 10-K filed with the SEC and as updated in our Form 10-Q
filings and in our other 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.
DC:82291517.1
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SOURCE Soliton, Inc.