HOUSTON, May 14, 2020 /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, 2020.
Recent Company Highlights:
- Announced new strategic launch plan of next generation Rapid
Acoustic Pulse (RAP) device expected to incorporate cellulite
capability, if cleared by the FDA
- Received FDA clearance of Special 510(k) Premarket Notification
for the Generation 2 RAP device
- Granted key US patent, deepening broad IP portfolio for FDA
cleared RAP technology with over 100 patents issued or
pending.
First Quarter Company Milestones:
- Completed follow-up visits of all pivotal cellulite clinical
trial patients; results to be presented at virtual American Academy
of Dermatology 2020 Conference in mid-June
2020
- Entered into a Manufacturing Services Agreement with leading
integrated manufacturing solutions provider to manufacture RAP
device and replaceable cartridges
- Completed 12-week keloid and hypertrophic scar proof-of-concept
clinical trial with positive results
Dr. Chris Capelli, Soliton's
President, CEO and co-founder, commented, "Although the first
quarter of 2020 was largely governed by the unprecedented COVID-19
pandemic, Soliton continued to achieve a number of significant
milestones, including FDA clearance of the Special 510(k) premarket
notification for the Generation II RAP device and the completion of
both the 12-week keloid and hypertrophic scar proof-of-concept
study and the pivotal cellulite clinical trial. We plan to present
the results of the cellulite trial at the virtual AAD Conference
expected to be held in mid-June 2020. The results of this
study will support our anticipated 510(k) filing with the FDA for
the treatment of cellulite during the second quarter. Our focus
remains on executing our revised U.S. commercialization plans,
adapted as a result of the COVID-19 crisis and now strategically
incorporating both tattoo removal and cellulite treatment into a
Generation II RAP device. We remain optimistic the aesthetic and
financial markets will recover and look forward to providing
details of our future U.S. commercial launch once conditions have
stabilized for our dermatology customers."
First Quarter 2020 Financial Results:
Operating expenses for the first quarter ended March 31, 2020 were $3.3
million, as compared to $2.4
million in the first quarter 2019. The increase was
primarily attributable to higher research and development expenses
resulting from increases in spending with development partners and
costs related to clinical trials.
Net loss for the first quarter ended March 31, 2020 was $3.3
million, or $0.19 basic and
diluted net loss per share, compared with net loss of $3.4 million, or $0.43 basic and diluted net loss per share, for
the first quarter 2019.
Total cash was $7.7 million as of
March 31, 2020, compared to
$12.1 million as of December 31, 2019. The Company's cash, cash
equivalents and restricted cash on hand is sufficient to fund the
Company's operations into December
2020 but not beyond.
Conference Call Details:
Management will host a conference call and live webcast to
discuss Soliton's financial results at 8:30
a.m. ET today. A question and answer session will follow
management remarks.
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 is 8193636.
A replay of the call will be available following its completion
through May 21, 2020. To access the
replay, dial (855) 859-2056 for domestic callers and (404) 537-3406
for international callers and use the replay conference ID
8193636.
A live audio webcast of the call will be available on the
Investor Relations page of the Soliton, Inc.
website, https://ir.soliton.com/. A replay of the webcast will
be archived on Soliton's website for 30 days following the
completion of the call.
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About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and
proprietary platform technology licensed from The University of Texas 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. 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 successfully
complete the clinical trials planned for 2020 and to report data
from such trials on a timely basis, to submit our FDA filing for
the treatment of cellulite in the second quarter of 2020 and to
receive FDA clearance for such indication, to effectively
commercialize our products, and the ability of the RAP device to
successfully treat cellulite and fibrotic scars. 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, 2019
we filed with the SEC on March 2,
2020 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.