Soliton Discusses Rapid Acoustic Pulse Technology for Treatment of Cellulite
February 28 2019 - 7:00AM
Soliton, Inc., (Nasdaq: SOLY), (“Soliton” or the “Company”), a
medical technology company that has developed a new breakthrough
acoustic shockwave device, today announced that it believes that
what they have discovered in preclinical testing with their Rapid
Acoustic Pulse (“RAP”) technology may also give them the ability to
reduce cellulite.
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Cellulite is believed to be the result of multiple
factors. One of those factors is inadequate collagen
structure in the dermis leading to a weakening of the dermal
extracellular matrix (ECM). Excess subcutaneous fat can then
protrude into the weak pockets within the ECM resulting in a
mottled or lumpy appearance to the skin.
The cells in the body that are responsible for synthesizing
collagen and helping to maintain a well structured ECM are called
“fibroblasts.” Soliton believes its RAP technology is capable of
delivering a very compressed, high pressure shockwave at repetition
rates of up to 100 per second, providing the necessary mechanical
stress to induce fibroblast production of collagen without pain, or
patient downtime. In preclinical testing, the Company
demonstrated that their RAP device is capable of consistently
inducing the production of new collagen within the ECM of the
dermis, therefore creating the potential for reducing the
appearance of cellulite and skin laxity.
“The discovery that our proprietary rapid acoustic pulse
technology has the potential to treat cellulite constitutes a
potential game-changer for our company,” commented Dr. Chris
Capelli, CEO of Soliton, Inc. “Preclinical research supported
conducting a preliminary proof of concept clinical trial for the
treatment of cellulite, which we are now close to completing.”
The Company intends to conduct both a proof-of-concept and a
full FDA trial targeting the cellulite indication. To learn
more about how Soliton RAP works and its potential impact on
cellulite, please visit Soliton.com.
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 planned commercial product will use rapid pulses of
designed acoustic shockwaves to dramatically accelerate the removal
of unwanted tattoos. The Company is based in Houston, Texas, and is
actively engaged in bringing this device to the market. The Company
expects to file for premarket clearance with the U.S. Food and Drug
Administration ("FDA") for its’ first device in the first quarter
of 2019 and expects to receive clearance to market the device in
mid 2019. This initial filing is limited to the Company’s device
used in conjunction with the 1064 nm Q-switched laser to enable
effective multiple pass laser treatments in a single office session
to accelerate removal of black tattoos on the arms, legs and torso
in Fitzpatrick Skin Type I-III individuals. While the Company
believes its’ technology has many potential applications, the
Company has initially focused on the removal of tattoos, where both
animal and human studies have shown promising results. The current
standard of care for tattoo removal is to use a Q-switched (pulsed)
laser to ablate the tattoo ink particles into pieces small enough
for the body’s natural processes to remove them. Unfortunately,
this current method is highly inefficient, requiring up to 10 or
more office visits to achieve acceptable results. A clinical trial
has demonstrated that using the Company’s RAP device, in
conjunction with a Q-switched laser, has the potential to produce
similar results in just 2 to 3 office visits versus the industry
average of 10 or more with a stand-alone laser. The Company
believes this “Soliton” method can not only dramatically accelerate
tattoo removal, but also has the potential to lower removal cost
for patients, while increasing profitability to practitioners, and
to reduce the potential for unwanted side effects from current
laser removal methods.
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 RAP to
reduce cellulite in clinical trials. Clinical trials relatred
to the acceleration of existing fat removal technologies and
cellulite are in early stages and there is no guarantee that any
specific outcome will be achieved. 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 "Risk
Factors" in the Form 1-A we filed with the SEC on February 13,
2019. 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.
CONTACT:
Joe Dorame, Joe Diaz & Robert BlumLytham
Partners,
LLC602-889-9700soly@lythampartners.com
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