HOUSTON, Aug. 20, 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 which reveal its RAP device appears
to deliver increased disruption of the fibrotic septa that
contribute to the appearance of cellulite with increased treatment
time, implying a dose response to the therapy. The new discovery,
referred to as "acoustic subcision," helps explain the recent
proof-of-concept (POC) trial results, which demonstrated a 20-47%
improvement in the patient's Cellulite Severity Score following the
use of the Company's RAP device. The RAP device for the treatment
of cellulite is investigational and not available for sale in
the United States.
Join our more than 200K fans here
to follow the Company: https://soly-investors.com
"We are excited to have demonstrated that an increase in
treatment time does indeed appear to result in heightened acoustic
subcision," commented Dr. Chris
Capelli, President and CEO of Soliton. "Dose ranging has
long been seen in the scientific community as an indication that a
technology or drug is responsible for the effect observed. It also
increases our optimism regarding the results we will see in our
recently started pivotal clinical trial for the treatment of
cellulite."
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 invasive procedure is painful, requiring the use of injected
anesthesia and can result in bleeding, bruising and significant
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 above show how, in an animal model,
untreated skin (left image) contains 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 moving progressively to the right in the figure
above, show tissue samples taken after progressively longer
treatments (1 minute, 2 minutes and 3 minutes) with our modified
RAP device demonstrating that the mechanical disruption of the
septa (shown in red), indeed increases as the time of treatment
increases. Importantly, there was little evidence of unintended
damage to surrounding tissues such as blood vessels or muscle (not
shown). And, in our recent POC 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
this entirely. The longer-term effect seen in our POC trial is an
improvement in the overall appearance of the skin, which we believe
is driven through the stimulation of new collagen
production.
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
Accoustic Subcision Histology
Image
View original content to download
multimedia:http://www.prnewswire.com/news-releases/soliton-announces-positive-results-demonstrated-from-longer-rap-treatment-300904087.html
SOURCE Soliton, Inc.