HOUSTON, May 12, 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 first quarter ended March 31, 2021.
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 Company's Rapid
Acoustic Pulse (RAP) device;
- Received FDA Special 510(k) clearance for modifications to the
RESONIC device to facilitate ease of use in commercial
settings;
- Successfully completed all required safety testing including
Quality System/Current Good Manufacturing Practice regulations for
medical devices (21 CFR Part 820) inspection from the FDA;
- Expanded sales team through appointment of Sean J. Shapiro as Vice President of Sales, and
two Senior Practice Development Managers with experience in the
aesthetics space;
- 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
- Initiated second pre-clinical study in animals for treatment of
liver fibrosis to validate positive results demonstrated in initial
pre-clinical study.
First Quarter 2021 Financial Results:
Operating expenses for the first quarter ended March 31, 2021 were $5.2
million compared to $3.3 million in the first quarter of 2020.
The increase in the three months ended March
31, 2021 was primarily attributable to increases in general
and administrative ("G&A") and sales and marketing expenses.
The increase in G&A was a result of increased salary and stock
compensation expenses, as well as board-related and legal expenses.
Sales and marketing expenses increased as we continued to prepare
for our upcoming commercialization, with specific increases
attributed to social media marketing development, new brand website
development and supporting explanatory video creation.
Net loss for the quarter ended March 31,
2021 was $5.2 million, or
($0.25) basic and diluted per share,
compared with net loss of $3.3
million, or ($0.19) basic and
diluted per share, for the first quarter of 2020.
Total cash, cash equivalents and restricted cash was
$26.3 million as of March 31, 2021 compared to $31.8 million as of December 31, 2020. 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 RESONIC.
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Conference Call Information
Given the strategic announcement made earlier this week, the
Company is cancelling the conference call previously scheduled for
Thursday, May 13, 2021 at
4:30 p.m. ET.
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,
RESONIC™, will use rapid pulses of acoustic shockwaves for the
treatment of cellulite and as an accessory to lasers for the
removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in
bringing RESONIC to the market. The Company believes the technology
will provide the first non-invasive acoustic technology to target
the underlying causes of dimples and ridges in cellulite. The
Company also 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. 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
belief that our cash, cash equivalents and restricted cash on hand
will be sufficient to fund our operations into the third quarter of
2022 and to fully support the initial phase of the commercial
launch of RESONIC, our belief that RESONIC will provide the first
non-invasive acoustic technology to target the underlying causes of
dimples and ridges in cellulite, and our belief that our
"Soliton" method has the potential to lower tattoo removal
costs for patients, while increasing profitability to
practitioners, compared to current laser removal methods. Although
we believe 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. 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.