HOUSTON, May 29, 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
its decision to move forward with a pivotal trial in cellulite
after positive data from its proof of concept clinical trial for
the reduction of cellulite (the "POC Trial") confirmed.
The Pivotal cellulite study is being designed to take place at
multiple clinical sites across the country with between 45 and 60
patients to be treated in the study. We hope to begin the
study within the next three months.
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 Trial suggest the potential for a totally new approach to
treating 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 bleeding, and were evaluated as
relatively painless by the trial participants, none of whom
experienced any post-treatment discomfort or downtime. The
data was originally presented at the SCALE (Symposium for Cosmetic
Advances and Laser Education) conference in Nashville, Tennessee, by Dr. Elizabeth Tanzi on May
11, 2019.
The POC Trial involved a study of five patients with moderate to
severe cellulite, each treated on their thighs, with a new
higher-powered version of Soliton's RAP device. While the Company's
RAP device intended to assist in tattoo removal was recently
cleared by the FDA, this higher-powered version will require a new
application for clearance for the cellulite indication. In
the POC Trial, approximately 97% of treatments were rated 0 on a 0
to 10-point pain scale (with 0 being no pain). At the end of the
12-week POC Trial, in a blinded review by doctors of before and
after photos, 100 percent correctly identified which photo was the
"after." The three blinded reviewers, who are trained in the
use of the cellulite severity scoring system, scored the before and
after photos using the 5-point system. 100% of the patients
showed clinical improvement. The range of improvement in
cellulite severity score was 20% to 47% and the average improvement
for all patients was nearly a 30% improvement (1.24 reduction on
the 0 to 5-point cellulite severity scale). As a point of
reference, the only FDA approved method for long-term reduction of
cellulite is an invasive treatment called Cellfina that produced an
average improvement on the same scale of about 2 points.
However, this is a procedure requiring topical anesthesia,
penetration of the skin and involves potential bleeding, bruising
and significant post-treatment discomfort and downtime. We
believe Soliton RAP involves none of these potential negatives.
"The market for non-invasive 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
POC Trial are driving our decision to launch the pivotal trial as
quickly as possible and suggest we may be able to significantly
improve the appearance of cellulite with a single completely
non-invasive procedure. The procedure requires no recovery time and
avoids the risks that go with even minimally invasive surgery."
How the Soliton Device Treats Cellulite
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 are largely ineffective at changing this
condition and severing the offending septa is the most effective
therapy. Currently, the only method cleared by the FDA for
long-term reduction of cellulite is called Cellfina and involves
the insertion of a blade or lance into the skin below the
dermis. The blade is then moved from side to side in a
sweeping motion to cut any septa in its path.
While this "invasive subcision" is immediately effective at
removing or reducing deep dimples and ridges, it is also quite
painful, requiring the subcutaneous injection of anesthesia.
It can also cause bleeding and bruising and significant patient
downtime due to ongoing soreness as the wounds from these skin
penetrations and cutting actions heal. In addition, this
method does very little to smooth or tighten the skin to remove the
"orange peel" or "cottage cheese" appearance often associated with
cellulite.
Soliton has created a new form of acoustic pulses, which was
recently awarded "Best in Show" by the American Society for Laser
Medicine and Surgery (ASLMS), that it has shown in animal models
are capable of selective disruption of sclerotic septa
without ever penetrating the skin. The procedure creates no
bleeding or bruising and results in no post-treatment discomfort or
downtime.
We believe the disrupted septa resulting from the acoustic
pulses induces increased collagen production that thickens and
tightens the skin over time. More normal and robust septa are
rebuilt with the skin in a smoother position.
"We believe this could represent a new approach to reducing
cellulite, which could represent a significant change from the
currently available invasive and non-invasive treatments, many of
which only work with surface dimpling and can't help the big
dimples in the skin that many want to eliminate," explained Dr.
Chris Capelli, President, CEO, and
co-founder of Soliton. "This new approach uses very fast,
compressed acoustic pulses in the form of shockwaves and our data
suggests that the acoustic pulses may be capable of achieving
results previously only thought possible with invasive
therapies."
The Trial 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 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 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 Soliton's
acoustic shockwave device to prove safe and effective for reducing
cellulite in larger clinical trials and the timing of the
commencement of the pivotal clinical trial. 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.
CONTACT:
|
Joe Dorame, Joe
Diaz & Robert Blum
|
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Lytham Partners,
LLC
|
|
602-889-9700
|
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soly@lythampartners.com
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SOURCE Soliton, Inc.