HOUSTON, Jan. 26, 2021 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology, today
announced it has entered into a collaboration with the US Navy to
conduct a multi-treatment proof-of-concept clinical study to
evaluate the safety, and efficacy of multiple treatments with
Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in
the appearance of fibrotic scars. The study will be a US-based,
single-center, prospective trial, examining a maximum of 25
patients.
![Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications. (PRNewsfoto/Soliton, Inc.) Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications. (PRNewsfoto/Soliton, Inc.)](https://mma.prnewswire.com/media/871205/Soliton_Logo.jpg)
"We are extremely pleased to collaborate with the US Navy and
investigate the safety and efficacy of our RAP device in improving
the appearance of fibrotic scars," commented Brad Hauser, Soliton CEO and President. "The
results from our previous proof-of-concept Keloid and Hypertrophic
Scar trial were extremely encouraging, as the RAP device
demonstrated reductions in both the volume of the scars and the
height of the scars after a single 6-minute treatment. We look
forward to building on the tremendous promise our RAP Device has
demonstrated in this adjacent indication and exploring its ability
to improve the standard of care in this large market, which size is
expected to reach an estimated value of $10.0 billion by 2025."
Dr. Curtis L. Hardy, Dermatology
Resident at the Naval Medical Center San Diego, will serve as the
principal investigator for the trial. The trial will investigate
efficacy, measured by improvement in fibrotic scar appearance using
Global Aesthetic Improvement Scale (GAIS) as determined by the
Investigator at the 12-week follow up visit, as a primary endpoint.
Additionally, the trial will examine safety, measured by unexpected
adverse events or serious adverse events attributable to the RAP
device immediately post-treatments and at the 12-week follow-up
visit as a second primary endpoint. The trial will be conducted in
a single US-based center and examine a maximum of 25 patients. The
US Navy will be responsible for the recruitment and treatment of
the subjects, with Soliton providing equipment and contributing to
the design of the clinical protocol.
Soliton previously announced positive results from its
single-site proof-of-concept IRB-approved human clinical study to
evaluate the safety, 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. 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 demonstrated an
improvement in volume reduction over 6 weeks, this was without any
additional treatment, suggesting that the scars continued to
improve over time. Furthermore, the treatment of fibrotic scars
using the RAP device was proven safe and tolerable during this POC
study.
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About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and
proprietary platform technology licensed from The University of Texas on behalf of MD Anderson Cancer
Center. 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 has filed a 510(k) application with
the FDA for clearance of its RAP device to improve the appearance
of cellulite and is investigating potential additional capabilities
of the RAP technology. The device is currently cleared in
the United States only for use in
tattoo removal and is not yet cleared for use to address
cellulite.
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, whether the planned
collaborative trial will be commenced on a timely basis, if at all,
and the ability of the RAP device to successfully
treat fibrotic scars. 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, 2019 we filed with the SEC on
March 2, 2020 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.