HOUSTON, Feb. 1, 2021 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary aesthetic platform technology,
today announced that the U.S. Food and Drug Administration ("FDA")
has cleared its Rapid Acoustic Pulse ("RAP") technology for the
short-term improvement in the appearance of cellulite. This
innovative technology harnesses the power of sound for the
treatment of cellulite. The unique, rapid-pulsed technology safely
and comfortably breaks apart the fibrous septa bands beneath the
skin that cause cellulite to deliver efficacious results in just
one, 40–60-minute treatment.
![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're thrilled to receive this latest clearance for our RAP
technology," said Brad Hauser,
President & CEO of Soliton. "Our technology will now provide
physicians a new, innovative and non-invasive approach for patients
seeking a non-surgical option to improve the appearance of
cellulite. This latest clearance also marks the next step in
the planned commercialization of our RAP technology, and we look
forward to introducing this new approach to treating cellulite to
physicians in the months to come."
For full details on the clearance and the Company's
commercialization plans, watch this short video:
https://ir.soliton.com/soliton-leadership-discusses-fda-510k-clearance-for-cellulite
In the clinical trials submitted to the FDA as part of the
510(k) application that was cleared, patient results were generated
by a single, non-invasive treatment that required no anesthesia,
caused no unexpected or serious adverse events, received strong
patient satisfaction ratings and was well tolerated by the trial
subjects, with an average pain score of 2.4 out of 10. The
RAP device induces mechanical disruption in fibrous structures,
such as the septae contributing to dimples in cellulite, that
results in release of the dimples and general smoothing of the
skin.
"Until now, patients have had limited options to effectively
improve the appearance of cellulite other than cutting into the
skin or less invasive procedures that can have low patient
satisfaction. The clearance of this technology for cellulite fills
this gap in available treatments and is an exciting development for
healthcare professionals who are committed to providing patients
effective procedures without any downtime," said Elizabeth Tanzi, Director at Capital Laser &
Skin Care, Chevy Chase, MD and a
member of Soliton's Scientific Advisory Board. "This non-invasive
technology gives us a new cellulite reduction option to help
address this unmet need for our patients."
- Leveraging its proprietary technology, the Soliton RAP device
is designed to safely deliver rapid, high-pressure acoustic
shockwaves at a rate of up to 100 pulses per second through a
replaceable treatment cartridge. This results in physical effects
on targeted structures and tissues, such as fibrous septa.
- Importantly, the negative pressure component of each acoustic
pulse is attenuated so therapy can be provided without creating
cavitation or heating that could result in surrounding tissue
damage. As a result, the RAP technology can provide meaningful
results within a single, comfortable treatment that has minimal
side effects and no downtime.
- Soliton RAP technology also received 510(k) clearance from the
FDA for the removal of tattoos in mid 2019.
The Company plans to begin selling the device for both tattoo
removal and cellulite treatment in the first half of 2021.
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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 and the temporary improvement in
the appearance of cellulite. 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.
The Company also believes the technology will provide the first
non-invasive acoustic technology to be able to target the
underlying cause of dimples and ridges in cellulite.
For more information about the Company, please
visit: http://www.soliton.com
Forward-Looking Statements
This press release includes 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 statements involve
risks and uncertainties. Forward-looking statements in this press
release include, without limitation, our ability to successfully
treat patients for tattoo removal and cellulite and to launch our
product in the first half of 2021. 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,
actual results or outcomes may prove to be materially different
from the expectations 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,'' "would,"
''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 in our filings with the
Securities and Exchange Commission ("SEC"), including under the
heading " Risk Factors" in our most recently filed Form 10-K filed
with the SEC and as updated in our Form 10-Q filings and in our
other 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.