HOUSTON, Sept. 10, 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
that it has selected Clear Dermatology & Aesthetic Center in
Scottsdale, AZ as the site for its
proof-of-concept ("POC") clinical trial for the use of its RAP
technology for the treatment of keloid and hypertrophic
scars. Dr. Brenda LaTowsky will
serve as Principal Investigator.
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"We are proud to have Clear Dermatology & Aesthetic Center
selected as the clinical site for what could be a ground-breaking
new treatment for keloid and hypertrophic scars," added Dr.
Brenda LaTowsky, Clinical
Dermatologist and Principal Investigator of the
study. "Unfortunately for many of our patients, the currently
available treatment options are unacceptable, so a new non-invasive
procedure could be quite important."
Keloid and hypertrophic scars (also called "fibrotic scars")
represent wound healing gone awry. A typical example of a keloid
scar would be a post-surgical scar that grows beyond its
boundaries. Existing published research suggests that factors
relating to the wound-healing environment (including tension at the
boundary of the scar) can cause fibroblasts to become stuck in a
hyper-productive loop, unable to stop the production of collagen
that leads to the thickened, raised and dense structures often
associated with these fibrotic scars.
The American Osteopathic College of Dermatology estimates that
keloids affect around 10 percent of people,
whereas hypertrophic scars are more common. Keloid
scars are more prevalent among populations with darker skin
pigmentation. Hypertrophic scars affect men and women from any
racial group equally, although people between the ages of
10 and 30 years old are more likely to be affected.
Grand View Research estimates the global market for keloid and
hypertrophic scars may reach $10.2
billion by 2025. There are few treatment options
available for fibrotic scars, which in addition to being
disfiguring, can also cause significant discomfort. Currently,
the most common treatment is the direct injection of steroids into
the scar, however this can require multiple injections and may not
be a permanent solution.
"The initial study design calls for a blinded evaluation of
treated scars before and 12 weeks after a single RAP treatment
session," stated Dr. Chris Capelli,
Soliton CEO and co-founder. "Our hope is to be able to demonstrate
a clinically significant reduction in the volume and height of
these scars that currently have limited treatment options. Our
preclinical studies combined with published literature on the
behavior of fibrotic tissue have suggested that our acoustic
shockwaves may be capable of disrupting stiff, sclerotic structures
created by unwanted fibrosis, of which keloids and hypertrophic
scars are just one example. The disruption of stiff structures
may help reset the targeted tissue to more normal fibroblast
activity for lasting effects."
The Company's device for use as an accessory to 1064nm
Q-switched lasers for tattoo removal was cleared on May 24, 2019, however technology for the
treatment of cellulite and fibrotic scars is investigational and
not available for sale in the United
States. Soliton will file additional 510(k) applications for
the use of RAP technology in these indications.
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
improve fibrotic conditions such as keloid or hypertrophic scars 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 the Soliton RAP
device to demonstrate safety and efficacy in the reduction keloid
and hypertrophic scars, the potential for efficacy in fibrotic
scars to extend to other fibrotic disorders, and the ability for
Soliton to receive FDA clearance for these additional
indications. 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.