HOUSTON, July 15, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary aesthetic platform technology,
today announced that its 510(k) application for premarket clearance
filed with the U.S. Food and Drug Administration ("FDA") for its
second generation Rapid Acoustic Pulse ("RAP") device for cellulite
reduction has cleared the agency's acceptance review. The
application now moves to a substantive review. The device is
already indicated as an accessory to the 1064 nm Q-Switched laser
for black ink tattoo removal in Fitzpatrick Skin Type I-III
patients and this latest new application is for the temporary
improvement of the appearance of cellulite. Clinical trials have
demonstrated an average 32.5% improvement in the Cellulite Severity
Score in our subjects and strong patient satisfaction with 91.9% of
subjects agreeing or strongly agreeing that their cellulite
appeared improved. Further, there were no unexpected or serious
adverse events and the average pain scores were 2.4 on a 10-point
scale.
Dr. Christopher Capelli,
president and CEO of Soliton, said, "We are very pleased with the
progress of our premarket notification through the FDA review
process." Dr. Capelli continued, "Having found that our submission
contained all the necessary elements and information, we look
forward to the substantive review and FDA clearance of the RAP
device."
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Cellulite affects between 80% and 90% of women and over a
billion dollars per year is spent on treatment in the U.S.
The Soliton clinical trial protocol provided for a single 20 to
30-minute, non-invasive treatment in which the Rapid Acoustic Pulse
(RAP) device was applied to the surface of the subjects'
skin. The treatment required no anesthesia, caused no
unexpected or serious adverse events, and was evaluated as
relatively painless by the trial subjects, with an average pain
score of 2.4 out of 10.
The Company believes there is a reasonable expectation that the
FDA will allow it to remain on the 510(k) clearance pathway in
order to market the product. However, acceptance of our
application does not indicate that the FDA has accepted the
Company's predicate argument. Should the FDA deem our choice
of predicate device to be inadequate, we would be required to
convert our application to a De Novo request, which we estimate
would extend the filing and review process by approximately six to
nine months.
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 the MD Anderson
Cancer Center. 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 clinical and
preclinical testing, including the potential to improve the
appearance of cellulite by creating mechanical stress at the
cellular level and inducing significant collagen growth and the
potential to treat keloid and hypertrophic scars by targeting the
stiffened environment in the intracellular matrix.
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 Company to
receive clearance from the FDA to market the device for the
reduction of cellulite. 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
in our SEC filings, including under the heading "Item 1A. Risk
Factors" in the Form 10-K for year ended December 31, 2019 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.