HOUSTON, Oct. 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"), discussed
multiple additional indications that may be possible targets given
the preliminary results from the keloid and hypertrophic scars
clinical trial during the Company's recent webcast.
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"We are excited about the impact our RAP technology could have
on many fibrotic disorders," stated Christopher Capelli, MD, founder, president and
CEO of Soliton. "We view our keloid and hypertrophic scar
proof-of-concept clinical trial as the starting point for
demonstrating efficacy in fibrosis. The same mechanism of
action at work to reduce keloid and hypertrophic scars may extend
to many other indications."
Discovering the nature of fibroblasts and the impact that
acoustic shockwaves may have on them is critical to understanding
why Soliton's Rapid Acoustic Pulse ("RAP") may have efficacy
against other fibrotic disorders. A fibroblast is a
type of biological cell that synthesizes the extracellular matrix
and collagen, produces the structural framework for human tissues,
and plays a critical role in wound
healing. Fibroblasts are the most common cells of
connective tissue in humans.
Considerable independent published research demonstrates that
fibroblasts respond to mechanical stress. Published research
has established that one way to restore beneficial fibroblast
activity is through the use of shockwaves like those produced by
our RAP device.
However, fibroblasts can function abnormally in the body which
leads to a multitude of issues. In the case of fibrosis, it is
believed that stiffness in the surrounding extracellular matrix, or
ECM, can cause fibroblasts to become aberrant, switching on with no
way to switch off, so they just keep producing collagen well beyond
what is needed. Paradoxically, acoustic shockwaves have been
shown to disrupt and loosen the ECM making the ECM 'less
stiff'. This results in the replacement of aberrant
fibroblasts with normally functioning fibroblasts. This then
potentially leads to resolution of fibrosis.
A large body of scientific literature supports that the basic
mechanism of action for addressing fibrotic scars could be
applicable to a wide range of fibrotic disorders. This could
include disorders such as capsular contracture, Peyronie's Disease,
and even liver fibrosis.
Capsular contracture involves the fibrotic encapsulation of
implants in the body, such as breast implants, and this can cause
pain and physical deformity. Published research has now shown
that acoustic shockwaves post-implant may actually prevent the
onset of capsular contracture. So, Soliton's RAP technology may not
only be important just for the patients who suffer from this
complication (which can be as much as 30% of women whose implants
follow resection and radiation treatment for breast cancer), but it
could become a prophylactic treatment for all implants.
Peyronie's disease is a condition in which scar tissue in the
penis causes the penis to bend. Independent research suggests
that 11% of adult males in the
United States may suffer from probable Peyronie's Disease.
Current treatment options are primarily injectable and are painful
for the patient.
Nonalcoholic steatohepatitis (NASH) is the most severe form of
non-alcoholic fatty liver disease (NAFLD), and is
characterized by the presence of an abnormal accumulation of fat in
the liver which in some individuals can progress to liver cell
injury (hepatocellular ballooning) and
inflammation. Hepatocellular ballooning and inflammation –
sometimes called necroinflammation – are commonly considered
as the drivers of disease progression, or as the underlying causes
of the disease. As NASH
evolves, over time it can result in excessive scarring in the
liver (fibrosis), a natural response to injury which can lead
to liver cirrhosis or liver cancer. The overall
NASH prevalence in the adult
population of developed countries has been estimated as high
as 12%.
We believe RAP is actually a platform technology that will have
a wide range of applications. And, we believe that continued
success with the current keloid trial could be instrumental in
unlocking that opportunity. We look forward to
reporting the longer-term results from this trial and to announcing
the beginning of a larger pivotal registration trial to follow.
Our technology is not currently cleared by the FDA for the
treatment of keloid or hypertrophic scars, capsular contracure,
Peyronie's Disease or liver fibrosis.
To access the webinar discussing our keloid and hypertrophic
scar trial results click
here: https://www.soliton.com/conference-call-10-25-19/
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 the Soliton RAP
device to demonstrate safety and efficacy in the reduction of
keloid and hypertrophic scars, the ability for Soliton to receive
FDA clearance for these additional indications and the ability of
Soliton to pursue treatment of other fibrotic disorders. 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.