HOUSTON, July 21, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary aesthetic platform technology,
today provided an update regarding the U.S. commercialization of
its Rapid Acoustic Pulse device indicating the initial U.S.
commercial launch is now targeted for the first half of 2021.
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Anticipated Launch Timing
The Company expects to initiate its U.S. commercial launch in
the first half of 2021. In April of 2020, Soliton announced a new
launch plan for its acoustic pulse device electing to delay the
originally planned mid-2020 launch for tattoo removal in response
to the COVID-19 pandemic.
The impact of COVID-19 on the global economy continues to be
significant. As we speak with our advising physicians in the
aesthetic space, it is clear that, while slowly starting to reopen,
practices remain limited by social distancing requirements that are
constraining the number of patients that can be seen each
day. As such, the most urgent patient needs are being
prioritized. We believe that we will continue to see this
dynamic throughout 2020.
Given these conditions, we expect the most appropriate launch
window for our new technology will open in the first half of
2021. We are making plans to launch the RAP device during the
first half of 2021, which will include the tattoo removal and
cellulite reduction indications, subject to FDA clearance of the
latter. We believe the opportunity to launch both indications
simultaneously will significantly enhance both physician and
patient adoption and result in a stronger launch of our
technology.
"Soliton has taken great strides in the past months towards the
full U.S. commercialization of our RAP device," stated Walter Klemp, Executive Chairman and co-founder
of Soliton. "Bolstered by our latest financing, we will continue to
execute on our manufacturing, regulatory and marketing objectives
to progress toward our goal of initial product launch in the first
half of 2021."
Regulatory Progress
The Generation 1 RAP device received U.S. FDA clearance in May
of 2019 for use as an accessory to the 1064 Q-Switched laser for
black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
Commercial upgrades to the Generation 2.0 device to improve
usability were subsequently approved through a Special 510(k) in
March of 2020. This improved device was utilized in the Company's
recently completed pivotal cellulite trial, the data from which was
included in the 510(k) pre-market application of its Generation 2.0
device for the temporary reduction in the appearance of cellulite
filed on June 30, 2020. The 510(k)
notice was found administratively complete and is currently under
substantive review. Soliton anticipates FDA clearance for
this indication prior to the conclusion of the first quarter 2021.
This timeline is based on our belief that there is a reasonable
expectation that the FDA will allow us to remain on the 510(k)
clearance pathway in order to market the product.
Engineering and Manufacturing
Soliton completed the design and initiated manufacturing of the
Generation 2.0 RAP device with global manufacturing partner Sanmina
and that device has passed all verification and certification
testing. This technology was cleared by the FDA in the Special
510(k) which was cleared in March of 2020 and was the device used
in the cellulite pivotal study.
Further usability and manufacturability enhancements are planned
that will reduce the cost of goods and improve margins.
We have entered into a manufacturing agreement with our global
contract manufacturer signaling the initiation of the transition
from the design stage to the manufacturing stage of the final
device. Fixtures and tooling to build the prototype devices
that will be used to validate our production line have been ordered
as well as the components for the prototype and commercial devices
to be built.
Recent Financing and Cash Position
The Company recently completed a $35
million capital raise that it believes will extend the
Company's cash runway through the third quarter of 2022 allowing
the Company to support the eighteen months of the commercial launch
of the RAP device. The proceeds from the financing will fund the
initial commercialization of the product described above, including
the early manufacturing, fundamental brand development investment,
and the initiation of a sales force and practice development team
instrumental in developing relationships with key customers.
Sales and Marketing
Soliton's sales and marketing efforts to support the initial
commercial launch are led by Jim
Bucher, our previously announced Consulting Head of Sales,
and newly appointed Vice President of Marketing, Ms. Jennifer Cook. Together Mr. Bucher and Ms. Cook
will implement the strategic sales and marketing initiatives
including initial practice management and marketing launch support
materials to effectively support the commercial launch.
Ms. Jennifer Cook joined Soliton
on July 1, 2020. Most recently, she
was Director of Consumer Marketing and Marketing Communications at
Apollo Endosurgery, a global leader in less invasive medical
devices for gastrointestinal and bariatric procedures. While there,
she built and launched a successful direct-to-consumer (DTC)
marketing program that drove consumer demand and market
development. Prior to Apollo Endosurgery, Ms. Cook successfully
designed and executed multiple consumer DTC launches across health
& wellness, retail, consumer packaged goods, and
telecommunication industries. Jennifer earned a Bachelor of Science
in Business Administration and Marketing at Miami University of Ohio.
During 2020, we plan to hire members of our Practice Development
Team to support the initially placed devices through training
programs regarding both the implementation of the technology and
practice development tools designed to help doctors attract
eligible patients to their offices for Soliton RAP treatments.
Ongoing Clinical Development
Given the state of the dermatology marketplace today, we have
experienced significant follow-up visit cancellations in our
ongoing 26-week cellulite clinical trial assessment and increased
difficulty in executing the initiation of further clinical trials
at sites around the country. We expect this to impact the timing of
Soliton's planned additional fibrotic scar proof-of-concept study
and the longer-term follow-up visits in our cellulite pivotal
study.
As soon as it is feasible, we will continue our cellulite
clinical trial 26-week follow up visits and initiate the additional
fibrotic scar proof-of-concept study. We are also designing
protocols for a proof-of-concept study specifically focused on skin
laxity and will seek to initiate that trial as soon as
possible.
During this period in which it is difficult to enroll and treat
patients in human trials, we are exploring animal models that will
allow us an opportunity to demonstrate efficacy against other
specific fibrotic conditions of a medical nature.
Dr. Chris Capelli, Soliton's
President, CEO and co-founder, commented, "I am enthusiastic and
increasingly optimistic about Soliton's future potential. We
continue to explore and identify new target indications for our RAP
device. While we are steadfastly focused on our revised U.S.
commercialization plans, we believe that we can demonstrate real
value in other target indications and will work to do just
that."
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 the 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 and the potential to treat keloid and
hypertrophic scars by targeting the stiffened environment in the
intracellular matrix. The RAP device has received 510(k)
clearance for use in tattoo removal but remains investigational for
use in improving the appearance of cellulite and scar
treatment.
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 of the Company to
execute a limited launch, the potential for the cash on hand to
support operations through the third quarter of 2022, the ability
to receive FDA clearance for our cellulite indication, our ability
to remain on a 510(k) clearance path and therefore receive
clearance on our suggested timeline, our ability to successfully
transition to manufacturing and build the commercial devices, and
our ability to successfully attract and retain necessary
personnel. 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.