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Soliton's RAP Device Able to Penetrate Vacuole Shielding; Targets $4 Billion Potential Tattoo Removal Market

HOUSTON, May 16, 2019 /PRNewswire/ -- Soliton, Inc., (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 discussed the use of its Rapid Acoustic Pulse Technology for the removal of tattoos using the capability of the device to clear the vacuoles that result from the use of a laser to ablate tattoo ink.

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A problem arises the moment that laser light contacts ink particles within its path. Almost instantly, a plasma event occurs that quickly results in the formation of steam vacuoles in the skin. These vacuoles appear white in color and result in "optical scattering" that immediately blocks any additional laser energy from reaching ink particles below the vacuoles. Biopsies taken shortly after laser treatment reveal that, in addition to surface vacuoles that clear within an hour or less, deeper "dermal vacuoles" have also formed and shield the remaining particles from subsequent laser passes. Our studies have shown that these deep dermal vacuoles persist for up to 48 hours. Until those vacuoles are gone, we believe subsequent laser passes will have very little effect.

"When you apply the RAP device immediately following a laser treatment, histology reveals that both surface vacuoles and the deep dermal vacuoles are dispersed, allowing lasers to again have line of sight access to pigment particles," said Dr. Christopher Capelli, President, CEO and Co-Founder of Soliton, Inc.  "Thus, using the Soliton RAP device immediately after a laser treatment allows for a subsequent laser treatment in the same office visit, and this cycle may be repeated multiple times."  The RAP device has not been cleared by the FDA.

"On average, a typical black tattoo can require 10 office visits to achieve acceptable removal. Our studies have shown this can now be reduced to just 2-3 visits, and we believe this will have a significant impact on the tattoo removal market, which is predicted to reach $4.3 billion by 2023," said Walter Klemp, Executive Chairman of Soliton, Inc.

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 planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to reduce the number of treatment visits to remove unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications. Both products are investigational and are not available for sale in the United States.

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 Soliton RAP technology, to prove safe and effective at reducing office visits required to remove a tattoo, for the Company's devices to achieve FDA clearance for the tattoo indications and the projected size of the tattoo removal market. 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, 2018 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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