HOUSTON, March 4, 2021 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology, today
reported financial results for the fourth quarter and full year
ended December 31, 2020.
Recent Company Highlights:
- Received FDA 510(k) clearance for short-term improvement in the
appearance of cellulite;
- Selected RESONIC™ as the brand name for the Rapid Acoustic
Pulse (RAP) device;
- Appointed Sean J. Shapiro, a
seasoned sales executive in the aesthetics device industry, as Vice
President of Sales, effective January 1,
2021;
- Entered into a collaboration with the US Navy to conduct a
12-week proof-of-concept clinical study to evaluate the safety and
efficacy of RESONIC™ for the improvement in the appearance of
fibrotic scars; and
- Announced positive pre-clinical results for RESONIC™ in
treating liver fibrosis.
Brad Hauser, Soliton's President
and CEO, commented, "Despite the challenges presented by 2020, this
was a transformative year for the Company, which has positioned us
for long-term success and the upcoming initial launch of our RAP
device in cellulite reduction and tattoo removal during the second
quarter of 2021. We are extremely encouraged by the progress we
made in preparation for our upcoming initial launch, as we received
FDA 510(k) clearance for the RAP device in cellulite, bolstered our
sales team by hiring aesthetic veteran Sean
Shapiro as VP of Sales, and initiated the transition to
manufacturing with our manufacturing partner. I am very excited to
share that we have selected RESONIC™ as the brand name for our RAP
device, which we believe captures our technology's foundation in
sound and will provide a true identity for our technology with
customers and consumers. While ensuring a successful initial launch
remains our key priority, we are also encouraged by the promise our
RAP device has demonstrated in selected adjacent indications, such
as fibrotic scars and liver fibrosis. 2021 will be a pivotal year
for the Company as we transition to a commercial company. We look
forward to launching our RESONIC™ device in cellulite reduction and
tattoo removal and driving its clinical progress across adjacent
indications with our goal of delivering shareholder value."
Fourth Quarter and Full Year 2020 Financial Results:
Operating expenses for the fourth quarter ended December 31, 2020 were $4.6 million compared to $3.3 million in the fourth quarter 2019.
Operating expenses for the full year ended December 31, 2020 were $14.7 million compared to $12.9 million in the full year 2019. The
increases in the three and twelve months ended December 31, 2020 were primarily attributable to
increases is general and administrative and sales and marketing
expenses. The increase in general and administrative expense
resulted from the hiring of new employees, including executives,
and stock-based compensation and incentives tied to these new
employees, as well as overall expenses related to operating as a
public company. The increase in sales and marketing expenses
resulted as we prepared to commercialize our product, with specific
increases attributed to social media marketing development, website
demos and videos and salaries and related expenses.
Net loss for the fourth quarter ended December 31, 2020 was $4.5
million, or ($0.22) basic and
diluted per share, compared with net loss of $3.3 million, or ($0.20) basic and diluted per share, for the
fourth quarter 2019. Net loss for the full year ended December 31, 2020 was $14.5 million, or ($0.77) basic and diluted per share, compared
with net loss of $13.9 million, or
($1.00) basic and diluted per share,
for the full year 2019.
Total cash, cash equivalents and restricted cash was
$31.8 million as of December 31, 2020 compared to $12.1 million as of December 31, 2019. The Company's cash, cash
equivalents and restricted cash on hand is expected to be
sufficient to fund the Company's operations into the third quarter
of 2022 and is expected to fully support the initial phase of the
commercial launch of the RAP device.
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Conference Call Information
Soliton will host a conference call with a live presentation on
Thursday, March 4, 2021, at
4:30 p.m. ET to discuss the results.
The dial-in numbers for the conference call are (833) 423-0479 for
domestic callers and (918) 922-2373 for international callers. The
conference ID number is 7559148.
A live webcast of the call and an updated investor presentation
will be available on the Investor relations page of the Soliton,
Inc. website, https://www.soliton.com/. A replay of the webcast
will be archived on Soliton's website for 30 days following the
completion of the call.
In addition, a telephonic replay of the call will be available
until March 11, 2021. The replay
dial-in numbers are (855) 859-2056 for domestic callers and (404)
537-3406 for international callers. Please use the replay
conference ID number 7559148.
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. Soliton 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 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. These statements relate to future events,
future expectations, plans and prospects. Forward-looking
statements in this release include, but are not limited to, our
ability to successfully commercialize our technology, our ability
to complete our commercial launch in the second quarter of 2021,
our ability to make clinical progress on additional potential
indications such as liver fibrosis and fibrotic scars, and our
ability to successfully manufacture our device. 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.