HOUSTON, June 12, 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"), today announced
that Dr. Omer Ibrahim of
Chicago Cosmetic Surgery and Dermatology will present 26-week
data from its completed proof-of-concept cellulite clinical trial
at The Aesthetics Show dermatology conference in Las Vegas, Nevada, to be held July 11-14, 2019.
The study, conducted by Dr. Michael
Kaminer at SkinCare Physicians in Boston, MA, in collaboration with Dr.
Elizabeth Tanzi at Capital Laser
& Skin Care in Washington DC
was designed to evaluate the safety and efficacy of Soliton's
acoustic pulse device for the reduction of cellulite.
The long-term follow-up to this proof of concept
study was conducted by Dr. Michael
Kaminer in collaboration with Dr. Ibrahim. The data
presented will reflect results from a single acoustic pulse
treatment, operating at a higher power level than the Company's RAP
device intended for tattoo removal, at the 26-week timepoint. Dr.
Ibrahim will also review preclinical data that appears to support
what the Company refers to as "acoustic subcision," which it
believes may be a new method for treating cellulite.
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"Since the announcement of our 12-week data that showed a 20 to
47% reduction in cellulite severity score from a single
non-invasive treatment using our rapid acoustic pulse ("RAP")
device, the dermatology community has been waiting to see if the
long-term data would show continued improvement," commented Dr.
Chris Capelli, President and CEO of
Soliton. "We believe the proof-of-concept data is impressive.
Since 97% of the treatments (which required no anesthesia) in this
trial were rated as creating 'zero pain,' and none of the patients
experienced any bruising or post-treatment discomfort or downtime,
if these results are demonstrated in a future larger pivotal
clinical trial, we believe our technology may represent a major
advancement in the treatment of cellulite."
Dr. Capelli continued, "We believe this new long-term
proof-of-concept data makes initiating the larger pivotal clinical
trial we intend to start within a few months for the treatment of
cellulite even more important."
The Company's RAP device received FDA clearance for the
indication of tattoo removal earlier this year, however RAP has not
yet been reviewed or cleared by the FDA for the cellulite
indication.
Drs. Kaminer and Tanzi are members of Soliton's Advisory
Board.
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 Soliton's
acoustic shockwave device to reduce cellulite in a larger clinical
trial or to receive FDA clearance for the cellulite indication, and
the ability of Soliton to commence such larger clinical trial
within the next few months. 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.