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Soliton Announces Positive Interim Clinical Trial Results with 27% Average Reduction in Scar Volume

From Single Non-Invasive Treatment

Interim Results Presented at American Society for Dermatologic Surgery Annual Meeting

HOUSTON, Oct. 25, 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 released interim clinical trial results presented at the American Society for Dermatologic Surgery ("ASDS") Annual Meeting on October 24, 2019.  

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During our keloid and hypertrophic scar (also known as "fibrotic scars") proof-of-concept trial, we treated 10 people, each of whom received just a single 6-minute treatment with our Rapid Acoustic Pulse ("RAP") device.  Before treatment, we photographed each scar with a 3D imaging device that allows for precise measurement of both the volume and height of the raised scar.  6 weeks after that single treatment we took another set of 3D images, which then allowed for an objective comparison of before and after data.

The graph below provides a recap of the average for nine scars as one patient was not able to come in for this 6-week timepoint.  There was an average reduction in volume of over 27%, and a reduction in height of almost 17% for the nine patients. 

Importantly, there were no treatment-related adverse events of any kind and patients reported little pain from the treatment, so with the primary endpoint of this study being to establish safety and tolerability of RAP for this indication, we believe we are on our way to meeting that endpoint.

"We are very pleased with the interim results from this study," stated Christopher Capelli, MD, founder, President and CEO of Soliton. "We will be conducting an analysis of the 12-week follow-up visit results and providing that data in the coming months.  We view this proof-of-concept trial as the starting point for demonstrating that our technology could impact other fibrotic disorders.  The same mechanism of action at work to reduce keloid and hypertrophic scars may extend to such indications as capsular contraction, Peyronie's Disease, and even liver fibrosis."

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Fibrotic scars, such as keloid and hypertrophic scars, represent wound healing gone awry.  Existing published research suggests that factors relating to the wound-healing environment (including stiffness in the extracellular matrix and tension at the boundary of the scar) can cause fibroblasts to become stuck in a hyper-productive loop, unable to stop the production of collagen that leads to the thickened, raised and dense structures often associated with these fibrotic scars. 

The American Osteopathic College of Dermatology estimates that keloids affect around 10 percent of people, whereas hypertrophic scars are more common. Keloid scars are more prevalent among populations with darker skin pigmentation.  Hypertrophic scars affect men and women from any racial group equally, with people between the ages of 10 and 30 years old being the most likely to be affected.

Grand View Research estimates the global market for keloid and hypertrophic scars may reach $10.2 billion by 2025.  There are few treatment options available for fibrotic scars, which in addition to being disfiguring, can also cause significant discomfort.  Currently, the most common treatment is the direct injection of steroids into the scar, however this can require multiple injections and may not be a permanent solution.

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 the Soliton RAP device to demonstrate safety and efficacy in the reduction of keloid and hypertrophic scars, the ability for Soliton to receive FDA clearance for these additional indications and the ability of Soliton to pursue treatment of other fibrotic disorders. 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 Clinical Trial Results Graph

SOURCE Soliton, Inc.


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