Soliton Selects RESONIC™ As Brand Name for FDA-Cleared Rapid Acoustic Pulse Device

Rhea-AI Summary

Soliton, Inc. (Nasdaq: SOLY) has announced the brand name RESONIC™ for its Rapid Acoustic Pulse (RAP) Device, aimed at tattoo and cellulite treatment. The device received FDA 510(k) clearance for tattoo removal in May 2019 and cellulite treatment in February 2021, with an expected commercial launch in Q2 2021. CEO Brad Hauser expressed optimism about RESONIC being a significant advancement in aesthetic treatments, offering patients innovative solutions for unwanted tattoos and cellulite improvement.

Positive

• FDA clearance for tattoo removal in May 2019 and cellulite in February 2021.
• Projected launch of the RESONIC brand in Q2 2021.
• Potential to reduce tattoo removal costs while increasing practitioners' profitability.

Negative

• None.

HOUSTON, March 2, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology, today announced that it has selected RESONIC™ as the brand name for the Rapid Acoustic Pulse (RAP) Device.

The RAP device received FDA 510(k) clearance for its tattoo indication in May 2019 and its cellulite indication in February 2021. The initial launch of the RESONIC brand for both indications is expected in Q2 2021.

"We are excited to begin establishing Soliton's presence in the aesthetics industry with a new brand that brings to life our groundbreaking acoustic technology. We expect RESONIC to be a gamechanger in the removal of tattoos and improvement in cellulite appearance and believe the RESONIC brand captures our innovation; giving patients the opportunity to reimagine themselves without their tattoo or with greatly improved cellulite. We look forward to commercializing the FDA-cleared RESONIC device in the second quarter of 2021," said Brad Hauser, Soliton CEO and President.

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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 as an accessory to lasers for the removal of unwanted tattoos and the treatment of cellulite. 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. The Company also believe 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

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 to successfully treat patients for tattoo removal and cellulite and to launch our product during the second quarter of 2021. 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 our most recently filed Form 10-K 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.

FAQ

What is the brand name selected by Soliton for its RAP device?

Soliton has selected RESONIC™ as the brand name for its Rapid Acoustic Pulse (RAP) Device.

When did Soliton receive FDA clearance for its RAP device?

Soliton received FDA 510(k) clearance for tattoo removal in May 2019 and for cellulite treatment in February 2021.

When is the expected launch date for the RESONIC device?

The RESONIC device is expected to be launched in the second quarter of 2021.

What are the intended uses of the RESONIC device?

The RESONIC device is intended for the removal of unwanted tattoos and the treatment of cellulite.