HOUSTON, June 15, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology, today
announced that new positive data from the company's pivotal
cellulite clinical trial was presented in an oral presentation via
the American Academy of Dermatology (AAD) 2020 VMX Virtual
Conference on June 12,
2020.
![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. (PRNewsfoto/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. (PRNewsfoto/Soliton, Inc.)](https://mma.prnewswire.com/media/871205/Soliton_Logo.jpg)
"We are pleased that our pivotal cellulite study demonstrated
positive results and appreciate the opportunity to have our
findings presented through this prestigious dermatology
organization," stated Christopher
Capelli, MD, founder, President and CEO of Soliton. "In
addition to demonstrating an average 32.5% improvement in the
Cellulite Severity Score in our subjects, patient satisfaction was
strong 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."
------------------------
For a more detailed overview of the results of this pivotal study,
please view the brief presentation on the following website:
https://secure.soliton.com/cellulite
------------------------
The pivotal cellulite clinical trial enrolled and treated 67
subjects at four clinical sites, of which 62 subjects were
evaluated in the results analysis due to the exclusion of five
patients for failing to meet inclusion criteria or incomplete
follow-ups. Eighty-five percent (85%) of subjects responded to
treatment with their improvement in the Cellulite Severity Scores
ranging from 6.7% to 85.7%.
The majority of existing non-invasive cellulite treatment
options on the market today recommend four to six treatments.
The results seen in this study were generated by a single treatment
session.
Dr. Elizabeth Tanzi, Director at
Capital Laser & Skin Care, Chevy
Chase, MD, member of Soliton's Scientific Advisory Board,
and presenter of the trial results at AAD, commented "I am excited
to bring the rapid acoustic pulse technology to my patients to
improve the appearance of their cellulite, in particular given that
it is a non-invasive procedure that requires no downtime. I think
my patients will love it."
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.
Soliton is further reviewing and analyzing these results for
inclusion in a marketing application to the U.S. Food and Drug
Administration (FDA) and believes that these data are sufficient to
support its 510(k) submission to the FDA for consideration of
clearance of its RAP technology for reduction in the appearance of
cellulite. We intend to file a 510(k) notification and
believe there is a reasonable expectation that the FDA will allow
us to utilize this clearance pathway in order to market the
product. However, 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 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 has completed a clinical study using the RAP device to
improve the appearance of cellulite and 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. The device is currently
cleared in the United States only
for use in tattoo removal and is not yet cleared for use to address
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. Forward-looking statements in this press
release include, without limitation, whether the cellulite clinical
trial data is sufficient to support Soliton's application to the
FDA for consideration of clearance of its RAP technology for
reduction in the appearance of cellulite, the potential benefits of
the RAP technology, and, if cleared by the FDA, expectations with
respect to the potential acceptance and use of the RAP technology
by doctors and patients. 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, 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 the Form 10-K for
year ended December 31, 2019 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.
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SOURCE Soliton, Inc.