HOUSTON, Jan. 27, 2020 /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
positive proof-of-concept (POC) study results out to 12 weeks using
its Rapid Acoustic Pulse (RAP) Device for the treatment of fibrotic
(keloid and hypertrophic) scars.
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"We were excited to share the 12-week follow-up results at this
key dermatology conference, amongst some of the top physicians in
this field," stated Christopher
Capelli, MD, founder, President and CEO of Soliton. "The
clinical results clearly demonstrate that an overall average
reduction in both the volume of the scars and the height of the
scars at the 12-week follow-up after the intial single 6-minute
treatment is continuing without the need for further dosing. We are
very encouraged by these positive results that further substantiate
the merit of our RAP device and look forward to continuing the
development and enhancement of its clinical program."
The data was presented in the abstract, "Volume And Height
Reduction of Fibrotic Scars Shown With 3D Imaging 12 Weeks After
Non-Invasive Treatment With a Rapid Acoustic Pulse (RAP) Device In
a Proof Of Concept Study" at the Maui Derm for Dermatologists 2020
meeting.
The objective of this single-site POC
IRB-approved human clinical study was to evaluate the
safety, tolerability, and efficacy of the RAP device for the
temporary improvement in the appearance of fibrotic scars. A single
6-minute RAP session was used to treat 11 fibrotic scars in 10
participants. Images were analyzed using proprietary software for
changes in scar volume and height from pretreatment to the 12 week
follow-up. 3D scar assessment of the pre- and post-treatment
photographs of 11 treated scars demonstrated an average reduction
in volume of 29.6% (p<0.01) and an average reduction in height
of 14.6% (p<0.005). While the 12 week data represents an
improvement in volume reduction over the 6 week volume reductions
of 27% previously announced, this was without any additional
treatment, suggesting that the scars continued to improve over
time. This continued improvement from a single treatment is
especially important as keloid scars are prone to recurrence after
treatment with existing therapies. Patients treated with steroid
injections see recurrence rates as high as 50%, while patients
treated with a chemotherapeutic agent have recurrence rates as high
as 47%.
Overall, the treatment of fibrotic scars using the RAP device
proved safe and tolerable during this POC study. Follow up results
at 12 weeks demonstrate that the RAP device provides significant
improvements in the appearance of fibrotic scars from a single
6-minute noninvasive treatment, with minimal pain, and most
patients express satisfaction with the scar improvement.
Grand View Research estimates the global market for keloid and
hypertrophic scars may reach $10.2
billion by 2025.
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 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.