HOUSTON, Aug. 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
that it is planning a proof of concept (POC) clinical trial for the
use of its RAP technology for the treatment of keloid and
hypertrophic scars.
Keloid and hypertrophic scars represent wound healing gone
awry. A typical example 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 estimate that
keloids affect around 10 percent of people,
whereas hypertrophic scars are more common. Keloid
scars a more prevalent among populations with darker
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. Current
treatment methods include surgical excision of the scar of
corticosteroid injections, laser treatment or cryotherapy.
Some patients even receive radiation to help prevent the return of
the scar. 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.
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"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. Beyond this, we may also be able
to help reset the targeted tissue to more normal fibroblast
activity for lasting effects," said Dr. Chris Capelli, CEO, President and
Co-founder.
The Company's device for use as an accessory to a 1064 Q switch
laser 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.
Additional Information
Fibrotic Scars Image
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SOURCE Soliton, Inc.