HOUSTON, June 4, 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
results of preclinical studies of the use of a new version of its
acoustic pulse technology which reveal its RAP device appears to be
capable of selective disruption of the fibrotic septa that
contribute to the appearance of cellulite. The new discovery,
referred to as "acoustic subcision," helps explain the recent
proof-of-concept trial results showing an improvement in the
appearance of cellulite following use of the Company's RAP
device. Together with the device's demonstrated ability to
stimulate new collagen production in animal models, this represents
what the Company believes is a potentially important new way to
treat cellulite and improve the appearance of the skin. The
RAP device for the treatment of cellulite is investigational and
not available for sale in the United
States.
"While the proof-of-concept clinical trial results we have
recently announced regarding the improvement in the appearance of
cellulite have been very encouraging," commented Dr. Chris Capelli, President and CEO of Soliton,
"Understanding the basic science and biology behind these results
is very important. We believe the discovery we are outlining
here helps explain the promising results we saw from this trial, as
well as setting the foundation for a platform technology that may
have potential in a number of aesthetic indications."
The term 'subcision' normally refers to a surgical procedure
used to sever the fibrotic septa using a special hypodermic needle,
punctured through the skin, in order to allow the dimpled skin
associated with cellulite to return to a flatter, smoother state.
This procedure is typically painful enough that anesthesia is
required. Furthermore, this surgical procedure can result in
extensive bruising, bleeding or post-treatment discomfort and
downtime. Our use of the term 'acoustic subcision' describes
the apparent ability of our RAP technology to do this without ever
breaking the skin. What's more, the procedure should require
no anesthesia and importantly, as seen in our clinical trial, there
should be no bruising, bleeding or post-treatment discomfort or
downtime.
The histology images below (figures 1 and 2) show how, in an
animal model, untreated skin (left image) contains thin, flexible,
fibrous structures (called "septa"). Some of these fibrous
septa connect the dermis to the muscle layers through the layer of
subcutaneous fat. In certain situations, these fibrous septa
become stiff ("sclerotic") and inflexible. As a result, when
subcutaneous fat pushes up, the sclerotic fibrous septa hold the
skin down causing the appearance of cellulite with deep dimples.
Severing the fibrotic septa is currently the only viable
means to remove these dimples.
The images on the right in figures 1 and 2 show a tissue
sample taken after a single 2-minute treatment with our modified
RAP device demonstrating selective mechanical disruption of the
septa. Importantly, there was little evidence of unintended
damage to surrounding tissues such as blood vessels or muscle (not
shown). And, in our recent proof of concept clinical trial,
97% of the treatments were rated as having zero pain.
Until now, the only way to have this kind of mechanical
disruption of fibrous septa has been through painful invasive
procedures. We believe Soliton's acoustic subcision could
change all that. The longer-term effect seen in our proof of
concept trial is an improvement in the overall appearance of the
skin we believe is driven through the stimulation of collagen
production.
Collagen is a key component in the extracellular matrix ("ECM")
that help keeps skin strong and smooth. We believe our
higher-powered prototype RAP device promotes collagen production
through the body's repair of the mechanically disrupted
septa. Preclinical testing indicates that new collagen is
being produced which results in the formation of new and thicker
septa throughout the subcutaneous fat layer. The Company
believes the impact of this response in humans could further
provide improvements in the appearance of cellulite.
As shown in the histology images below (figure 3), the septa
throughout the subcutaneous fat layer demonstrate increased
thickening over time as a result of the new acoustic treatments.
The histology image on the left was prior to any treatment.
The image in the middle was after a single acoustic treatment with
the prototype device and the histology image on the far right was
after multiple treatments with the device. Soliton believes the
development of new and thicker septa could lead to increased
integrity and uniformity of the skin.
"We believe the ability to promote production of new collagen is
a major finding and critical to the ability of this new technology
to potentially improve the appearance of cellulite," commented Dr.
Chris Capelli, Soliton's President,
CEO and co-founder.
Dr. Capelli concluded: "An important message here is to
understand the potential value of the combined effects – the nearly
immediate effect of acoustic subcision to mechanically disrupt
sclerotic septa leading to the improvement in the appearance of
cellulite dimples and ridges and the longer-term effect of
increased collagen production which has the potential to improve
the overall smoothness of the skin. More clinical
testing is planned to validate these early results."
The Company's device for use in tattoo removal was cleared on
May 24, 2019, however technology for
the treatment of cellulite is investigational and not available for
sale in the United States. Soliton will file an additional
510(k) application for the use of RAP technology to improve the
appearance of cellulite.
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 significant
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
prototype technology to safely and effectively reduce the
appearance of cellulite and its ability to receive regulatory
approval for the cellulite indication. 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.
Additional Information:
Figure 1
Figure 2
Figure 3
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SOURCE Soliton, Inc.