Soliton Receives FDA Clearance of Special 510(k)
Notification paves way for second quarter commercial launch
HOUSTON, April 29, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology, today announced the U.S. Food and Drug Administration ("FDA") clearance of the Company's special 510(k) for modifications to its RESONIC™ device.
"We were thrilled to receive this clearance as it marks the last significant hurdle to our ability to initiate our commercial launch of the improved RESONIC device in the second quarter," stated Brad Hauser, Soliton CEO and President. "Our discussions with our target dermatologists and plastic surgeons on our Rapid Acoustic Pulse (RAP) technology have been very well received and there is strong enthusiasm for an effective and efficient patient experience for tattoo removal and cellulite treatment with the RESONIC device over the coming months."
The RESONIC device utilizes the RAP technology to deliver safe and effective tattoo removal and cellulite treatment and now includes an autoloading cartridge and an improved user interface. These modifications are geared towards providing for a more seamless user experience. The special 510(k) application was submitted to the FDA on March 31, 2021.
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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 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 this "Soliton" method has the potential to lower tattoo removal costs for patients, while increasing profitability to practitioners, compared to current laser removal methods. The Company also believes the technology will provide the first non-invasive acoustic technology to target the underlying causes of dimples and ridges in cellulite. 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
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 ability to successfully launch the RESONICTM technology. 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 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.
Released April 29, 2021