HOUSTON, July 15, 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
additional positive data from its proof of concept clinical trial
for the reduction of cellulite.
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Dr. Chris Capelli, President, CEO
and co-founder of Soliton, commented, "Most cellulite treatments
today generally provide only temporary improvement. In fact, the
only FDA-cleared treatment to produce long-term (6 months or
longer) cellulite improvement is an invasive procedure that
requires the injection of anesthesia and can result in bruising and
bleeding and significant post treatment discomfort and
downtime. In light of this treatment landscape, our results
that not only lasted 6 months, but actually improved 20% on the
GAIS scale from months 3 to 6 from a single non-invasive procedure
with no post-treatment discomfort or downtime are very
encouraging."
The Global Aesthetic Improvement Scale (GAIS) 5-point scale was
used to evaluate changes between the 3-month and 6-month timepoints
and patients improved, on average, a full point on this
scale. As reported earlier, the initial improvement at
3-months on the Cellulite Severity Score (CSS) ranged from 20% to
47%, with the average improvement being 29%. At the 6-month
time point, CSS continued to improve with an average improvement of
31%. As a point of reference, the only invasive procedure
approved by the FDA for long-term reduction of cellulite (Cellfina)
produced an average improvement on the same CSS scale in their own
clinical trial of about 2 points. It is important to note that
Soliton RAP was not directly compared with Cellfina in our clinical
trial.
The Soliton proof of concept trial involved a study of five
patients with moderate to severe cellulite, each treated on their
thighs, with a higher-powered version of Soliton's recently cleared
RAP device intended to assist in tattoo removal. Three blinded
reviewers, who are trained in the use of the CSS and GAIS scoring
systems, scored the before and after photos, including both a
3-month and 6-month timepoints post treatment. The average
improvement for all patients was 1.24 and 1.31 on the 0 to 5-point
CSS scale, for the 3-month and 6-month timepoints,
respectively.
"The market for cellulite treatments is about $1 billion in the U.S., so it is clear that many
women who are affected by the condition are interested in finding
ways to reduce or eliminate it," said Walter Klemp, co-founder and Executive Chairman
of Soliton. "The very encouraging results of the proof of concept
clinical trial suggest we may be able to improve the appearance of
cellulite with a single, non-invasive procedure in a long-term
manner. This will now be evaluated in a larger pivotal
trial."
Cellulite affects up to 90% of women and over a billion dollars
per year is spent on treatment in the U.S. Now, results from
this initial proof of concept clinical trial suggest the potential
for our RAP device to effectively treat cellulite. In a single
20-minute, non-invasive treatment, the Rapid Acoustic Pulse (RAP)
device was applied to the surface of the patients' skin. The
treatments required no anesthesia, caused no bruising, swelling or
infection, and were evaluated by the trial participants as a "0" on
a pain scale of 0-10 in 97% of the treatments. None of the
study participants experienced any post-treatment downtime. This
device is investigational and not yet available for sale for the
treatment of cellulite. Similar results may not be achieved in
subsequent clinical trials.
How the Soliton Device Treats Cellulite with Potential
Long-term Effects
Although cellulite has many contributing factors, a primary
cause of the deep dimples and ridges associated with cellulite is
the presence of sclerotic septa connecting the dermis to the body's
fascia through the layer of subcutaneous fat. Septa normally
provide structure and uniformity to the skin, but over time they
can lose uniformity and become stiff and less resilient with larger
pockets of subcutaneous fat in-between. As the presence of
subcutaneous fat increases, it can push up against the dermis
causing it to bulge between these septa, leaving dimples and ridges
where the septa refuse to yield.
Superficial therapies generally provide only temporary cellulite
reduction. Severing the septa may offer long-term improvement
of dimples and ridges. The Soliton technology is designed to
couple this with tightening of the skin to remove the "orange peel"
or "cottage cheese" appearance often associated with cellulite.
Soliton was recently awarded "Best in Show" by the American
Society for Laser Medicine and Surgery (ASLMS) and has shown in
animal models that its technology is capable of selective
disruption of sclerotic septa without penetrating the skin. In
clinical trials, the procedure created no bleeding or bruising and
resulted in no post-treatment discomfort or downtime.
"Many patients are looking to reduce the appearance of cellulite
with a convenient, non-invasive, long-lasting approach," explained
Dr. Chris Capelli, President, CEO,
and co-founder of Soliton. "The Soliton technology uses very fast,
compressed acoustic pulses in the form of shockwaves that may be
able to achieve these effects."
The study was conducted by Dr. Michael
Kaminer at SkinCare Physicians in Boston in collaboration with Dr. Elizabeth Tanzi of Capital Laser and Skin
Care.
Dr. Kaminer stated: "Having led the clinical development of
Cellfina, the only treatment with FDA clearance for producing
long-term reduction of cellulite, I am particularly aware of the
unmet need in the treatment of cellulite. Having a non-invasive
alternative treatment with lasting results could provide a real
benefit for patients while also expanding the breadth of services
offered by clinicians."
Drs. Kaminer and Tanzi are members of Soliton's Scientific
Advisory Board.
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 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 Soliton's
acoustic shockwave device to prove safe and effective at reducing
cellulite and the ability of this device to receive FDA clearance.
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.