HOUSTON, March 2, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology licensed
from The University of Texas on behalf
of the MD Anderson Cancer Center ("MD Anderson"), today reported
financial results for the fourth quarter and full year ended
December 31, 2019.
Recent Company Highlights:
- Completed pivotal cellulite clinical trial with all required
patients successfully treated across four clinical sites and
initiated patient follow-up visits
- Completed 12-week keloid proof-of-concept clinical trial with
positive results
- Submitted 510(k) for the updates to the Gen 2 device for the
tattoo removal indication
- Entered into 3-year development agreement with Emphysys for
design and engineering services related to the acoustical shockwave
therapy
Significant 2019 Company Milestones:
- Completed initial public offering and listing on NASDAQ on
February 19, 2019
- Received FDA Clearance of initial device on May 24, 2019, clearing the device for use as an
accessory to a 1064 Q-switch laser for tattoo removal
- Honored with the "Best in Session" award by the American
Society for Laser Medicine & Surgery, the world's largest
scientific organization in the field of medical laser
applications
- Added to the Russell 2000 and 3000 Indexes in June 2019
- Demonstrated in proof-of-concept trial the ability of
technology to deliver "acoustic subcision," a key step for the
potential treatment using the device, if approved, of cellulite
dimples and ridges
- Initiated a full, four-site pivotal clinical trial for the
treatment of cellulite, with results expected in Q1 2020
- Increased the size of the patent portfolio with an additional
31 patents filed and 17 patents granted
- Closed two private placements for a total of $15.95 million in gross proceeds
Dr. Chris Capelli, Soliton's
President, CEO and co-founder, commented, "We achieved significant
clinical and corporate milestones in 2019 that we believe will
prove fundamental to Soliton's future success. The completion of
Company's initial public offering last February highlights the
long-term opportunity for our investors. In conjunction with an FDA
clearance of our Rapid Acoustic Pulse ("RAP") device for tattoo
removal in May, we look forward to leveraging the platform
technology for the potential treatment, if approved, of cellulite
and keloid scars. We believe the positive results from our 12-week
keloid proof-of-concept study further validate our growth
opportunity."
"Based on the solid foundation we built in 2019, we are entering
2020 with strong momentum and look forward to a number of key
milestones we believe will drive our future success. We are on
track to release the results from our cellulite pivotal study in
the first quarter and to submit our FDA filing for the treatment of
cellulite in the second quarter of 2020. Most notable is our
anticipated mid-2020 launch of our RAP device for tattoo
removal. While we expect the early revenues from this launch
to be limited, we expect the applicable market dynamic and
physician use information generated to be invaluable. 2020 will be
a turning point in Soliton's history as we seek to transition into
a commercial entity," Dr. Capelli concluded.
Fourth Quarter and Full Year 2019 Financial Results:
Operating expenses for the fourth quarter ended December 31, 2019 were $3.3 million, as compared to $2.1 million in the fourth quarter 2018. The
increase was primarily attributable to higher general and
administrative expenses resulting from hiring new employees,
including executives, and increases in costs related to operating
as a public company. Operating expenses for the full year ended
December 31, 2019 were $12.9 million, as compared to $8.2 million in the full year 2018. The increase
was primarily attributable to higher general and administrative
expenses resulting from the hiring of new employees, including
executives, and increases in the costs related to operating as a
public company.
Net loss for the fourth quarter ended December 31, 2019 was $3.3
million, or $0.20 basic and
diluted net loss per share, compared with net income of
$2.7 million, or $1.41 basic and diluted net loss per share, for
the fourth quarter 2018. Net loss for the full year ended
December 31, 2019 was $13.9 million, or $1.01 basic and diluted net loss per share,
compared with net loss of $10.6
million, or $5.64 basic and
diluted net loss per share, for the full year 2018.
Total cash was $12.1 million as of
December 31, 2019, compared to
$8.7 million as of September 30, 2019. During the fourth quarter
Soliton entered into definitive agreements with certain
institutional and accredited investors to raise aggregate gross
proceeds of approximately $6.25
million through the private placement of its equity
securities. The financing was led by Remeditex Ventures, LLC, the
Company's largest shareholder.
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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 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.