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Soliton Announces Positive Results Demonstrated from Longer RAP Treatment

Dosing Effect Identified with Acoustic Subcision Treatment of Cellulite

HOUSTON, Aug. 20, 2019 /PRNewswire/ -- Soliton, Inc., (NASDAQ: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 announced results of preclinical studies which reveal its RAP device appears to deliver increased disruption of the fibrotic septa that contribute to the appearance of cellulite with increased treatment time, implying a dose response to the therapy. The new discovery, referred to as "acoustic subcision," helps explain the recent proof-of-concept (POC) trial results, which demonstrated a 20-47% improvement in the patient's Cellulite Severity Score following the use of the Company's RAP device. The RAP device for the treatment of cellulite is investigational and not available for sale in the United States.

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"We are excited to have demonstrated that an increase in treatment time does indeed appear to result in heightened acoustic subcision," commented Dr. Chris Capelli, President and CEO of Soliton. "Dose ranging has long been seen in the scientific community as an indication that a technology or drug is responsible for the effect observed. It also increases our optimism regarding the results we will see in our recently started pivotal clinical trial for the treatment of cellulite."

The term 'subcision' normally refers to a surgical procedure used to sever the fibrotic septa using a special hypodermic needle, punctured through the skin, in order to allow the dimpled skin associated with cellulite to return to a flatter, smoother state. This invasive procedure is painful, requiring the use of injected anesthesia and can result in bleeding, bruising and significant post-treatment discomfort and downtime. Our use of the term 'acoustic subcision' describes the apparent ability of our RAP technology to do this without ever breaking the skin. What's more, the procedure should require no anesthesia and importantly, as seen in our clinical trial, there should be no bruising, bleeding or post-treatment discomfort or downtime.

The histology images above show how, in an animal model, untreated skin (left image) contains fibrous structures (called "septa"). Some of these fibrous septa connect the dermis to the muscle layers through the layer of subcutaneous fat. In certain situations, these fibrous septa become stiff ("sclerotic") and inflexible. As a result, when subcutaneous fat pushes up, the sclerotic fibrous septa hold the skin down causing the appearance of cellulite with deep dimples. Severing the fibrotic septa is currently the only viable means to remove these dimples.

The images moving progressively to the right in the figure above, show tissue samples taken after progressively longer treatments (1 minute, 2 minutes and 3 minutes) with our modified RAP device demonstrating that the mechanical disruption of the septa (shown in red), indeed increases as the time of treatment increases. Importantly, there was little evidence of unintended damage to surrounding tissues such as blood vessels or muscle (not shown). And, in our recent POC clinical trial, 97% of the treatments were rated as having zero pain.

Until now, the only way to have this kind of mechanical disruption of fibrous septa has been through painful invasive procedures. We believe Soliton's acoustic subcision could change this entirely. The longer-term effect seen in our POC trial is an improvement in the overall appearance of the skin, which we believe is driven through the stimulation of new collagen production. 

The Company's device for use in tattoo removal was cleared on May 24, 2019, however technology for the treatment of cellulite is investigational and not available for sale in the United States. Soliton will file an additional 510(k) application for the use of RAP technology to improve the appearance of cellulite.

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 is investigating potential additional capabilities of the RAP technology in preclinical testing, including the potential to assist existing fat reduction technology in the reduction of fat as well as improving the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth. 

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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 Soliton's prototype technology to safely and effectively reduce the appearance of cellulite and its ability to receive regulatory approval for the cellulite indication. 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.

Additional Information Accoustic Subcision Histology Image

SOURCE Soliton, Inc.


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