HOUSTON, April 1, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology, today
provided an update on its business strategy and financial position
in light of the current COVID-19 situation.
"In light of the widespread impact of COVID-19, our view of the
ideal launch window for our RAP device has naturally changed,"
commented Christopher Capelli, MD,
founder, President and CEO of Soliton. "Clearly, launching an
aesthetic device during a national crisis such as the COVID-19
pandemic would be ill-advised. Fortunately for us, though the
delay of our limited market launch costs us some time, it has also
had a valuable upside. Instead of launching our RAP device focused
solely on tattoo removal in mid-2020, we are electing to delay that
launch until the aesthetic and financial markets are demonstrating
more stability. In the meantime, we will remain highly
focused on our regulatory pathway for cellulite reduction. We
now believe our initial launch could be timed appropriately to
incorporate both tattoo and cellulite indications, subject to FDA
clearance of the latter. We are all hopeful that this strategic
shift allows sufficient time for our dermatology customers and the
market in general to return to some sense of normalcy."
Soliton recently announced that we will be sharing the results
from the 12-week follow-up of our pivotal cellulite study through
the American Academy of Dermatology's virtual meeting expected to
be held in the next 5 - 7 weeks. It is this data that will provide
the clinical basis for our planned regulatory filing. At this
time, we do not anticipate a delay in our regulatory plans for the
cellulite indication and plan to file our 510(k) in the second
quarter of 2020.
As many dermatologist offices are currently closed, we are
experiencing follow-up visit cancellations in our ongoing 26-week
cellulite assessment and increased difficulty in executing the
initiation of further clinical trials at sites around the country.
While this will not impact the regulatory pathway for the initial
cellulite indication, there is the expectation this will impact the
timing of Soliton's planned additional hypertrophic scar
proof-of-concept study and the longer-term 26-week follow-up visits
in our cellulite pivotal study. Furthermore, it is possible this
may extend the time required to file for additional, improved
cellulite reduction claims with the FDA and for initial approvals
of a hypertrophic scar indication that we may seek in the
future.
Given the modification in our timeline and the instability in
the financial markets, we have modified our spending plans and now
expect our cash on hand to finance our operations to December 2020, assuming that we do not encounter
any unforeseen costs or expenses. We will modulate our launch
timeline with early indicators of the recovery of the financial and
aesthetic markets, with the objective of identifying an appropriate
window of opportunity for a successful product debut.
Dr. Capelli concluded, "Despite the turmoil created by COVID-19,
Soliton remains focused on executing it's 2020 milestones related
to the regulatory pathway for cellulite and implementing new
initiatives to drive continued business momentum. Although our
commercialization timeline has been modified and we are facing
incremental challenges, we remain committed to our long-term goal
of providing our customers with the innovative Rapid Acoustic Pulse
technology and generating long-term shareholder value. We
appreciate for your continued interest and support in Soliton."
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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 clinical and preclinical testing, including the
potential to improve the appearance of cellulite by creating
mechanical stress at the cellular level and inducing significant
collagen growth and the potential to treat keloid and hypertrophic
scars by targeting the stiffened environment in the intracellular
matrix.
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 to execute a
commercial launch of the RAP device for tattoo removal and
cellulite, to execute on our 2020 regulatory plans, and to
successfully fund the Company's operations through December
2020. 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 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 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.