HOUSTON, July 1, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary aesthetic platform technology,
today announced that it filed for 510(k) premarket clearance with
the U.S. Food and Drug Administration ("FDA") of its second
generation Rapid Acoustic Pulse ("RAP") device for the reduction in
the appearance of cellulite on June 30,
2020.
![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)
The 510(k) filing is based on results from Soliton's pivotal
cellulite clinical trial, which were recently presented in an oral
presentation via the American Academy of Dermatology (AAD) 2020 VMX
Virtual Conference on June 12, 2020.
The RAP device demonstrated an average reduction of 32.5% in the
Cellulite Severity Score and strong patient satisfaction
demonstrated by 91.9% of subjects agreeing or
strongly agreeing their cellulite appeared improved. There was a
1.16 mean change in the Cellulite Severity Score for all patients
with a primary endpoint target of a 1.00 mean changes. The results
were generated by a single, 20 to 30-minute, non-invasive treatment
that required no anesthesia and caused no unexpected or
serious adverse events. The treatment was well tolerated by
the trial subjects, with an average pain score of 2.4 out of
10.
The RAP device was previously cleared by the FDA as an accessory
to a 1064 nm Q-switched laser for tattoo removal of black ink on
patients with skin tones on the Fitzpatrick scale between I and
III.
"Our 510(k) submission for the reduction in cellulite appearance
represents an exciting step forward in Soliton's U.S.
commercialization plans for the RAP device," stated Christopher Capelli, MD, founder, President and
CEO of Soliton. "Supported by our positive pivotal cellulite
results generated with only one treatment session per patient, the
RAP device has the potential to offer patients a non-invasive
treatment to reduce the appearance of cellulite. We hope to offer
an innovative aesthetic technology to our customers capable of both
tattoo removal and cellulite reduction."
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 has completed a clinical study using the 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
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, whether the cellulite clinical
trial data is sufficient to support Soliton's application to the
FDA for consideration of clearance of its RAP technology for
reduction in the appearance of cellulite, the potential for the
510(k) path to be appropriate with the FDA, the estimated timeline
for the receipt of FDA clearance, the potential benefits of the RAP
technology, and, if cleared by the FDA, expectations with respect
to the potential acceptance and use of the RAP technology by
doctors and patients. 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 the Form 10-K for
year ended December 31, 2019 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.