HOUSTON, Aug. 13, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary aesthetic platform technology,
today announced it has completed the design process for an advanced
handpiece and cartridge for its Rapid Acoustic Pulse (RAP)
device.
The new design for the handpiece and cartridge includes several
improved features providing ease of use, and a more user-friendly
experience. Upgrades to the device include modifications to five
circuit boards in the consoles, automatically inserting and
ejecting cartridges, a system to detect counterfeit cartridges, a
method of automatic adjustment of the electrode resulting in longer
cartridge life, and RFID chip detection. The Company's engineering
and design services partner has now assembled the new handpiece and
cartridge and successfully tested its functionality.
The cartridge design will be handed off to the Company's
manufacturing partner to execute appropriate design adjustments for
manufacturability and begin preparing to manufacture the cartridges
in mass for the upcoming product launch.
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"Designing the improved cartridge was a strategic decision made
to capitalize on the time afforded by the delay in our launch plan
resulting from COVID-19," commented Christopher Capelli, MD, founder, President and
CEO of Soliton. "We believe the single-use replaceable RAP
cartridges will be a main driver of future revenue, and through
this new design, we have not only improved the device's
functionality and ease of use, but positioned ourselves for
efficient manufacturing and production and the collection of
important marketing data."
Dr. Capelli continued, "As we have previously discussed, we
revised our launch plan for RAP, due to the current COVID-19
pandemic. As we give the markets an opportunity to recover from the
pandemic, we are moving forward with design improvements that
should enhance our initial launch. The extended timeline
ahead of the initial launch has allowed us the opportunity to
launch the RAP device incorporating both the tattoo removal
indication as well as the cellulite indication, pending FDA
approval of the latter."
Soliton's RAP technology has not yet been cleared by the FDA for
cellulite reduction and is not available for sale in the United States for this indication.
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 has completed a clinical study using the RAP device to
improve the appearance of cellulite and 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 is not yet cleared
for use to address 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. Forward-looking statements in this press
release include, without limitation, our ability to successfully
manufacture and receive the required safety and regulatory
approvals for the improved cartridges, to receive clearance of the
cellulite indication, and to successfully launch our product.
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, 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 the Form 10-K for
year ended December 31, 2019 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.