Soliton Announces Initiation of Second Animal Study for Potential RAP Treatment of Liver Fibrosis

Rhea-AI Summary

Soliton, Inc. (Nasdaq: SOLY) announced the initiation of a second pre-clinical study for its Rapid Acoustic Pulse (RAP) device aimed at treating liver fibrosis, following positive results from an initial study. The first study showed a 42% reduction in liver fibrosis 7 days post-treatment. The RAP device is FDA-cleared for tattoo removal and cellulite treatment but not yet for liver fibrosis. Soliton aims to validate its findings, potentially offering a non-drug treatment for the estimated 6-7% of the global population affected by liver fibrosis.

Positive

• Second pre-clinical study initiated to validate first study results.
• First study showed a 42% reduction in liver fibrosis using RAP therapy.
• RAP technology positioned as a potential non-drug treatment option for liver fibrosis.

Negative

• RAP device not yet cleared for the treatment of liver fibrosis.

HOUSTON, March 9, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary aesthetic platform technology, today announced that the company initiated a second pre-clinical study in animals for potential treatment of liver fibrosis intending to validate the first animal study that demonstrated positive results for the potential treatment of liver fibrosis.

This additional pre-clinical study will seek to confirm the positive findings of Soliton's initial pre-clinical study in animals. The methods and conditions of the first study will remain the same in this second study. In the initial study, validated laboratory and histological assessments in a mouse model demonstrated that Rapid Acoustic Pulse (RAP) therapy reduced the effects of induced liver fibrosis 7-days following completion of carbon tetrachloride (CCL₄) induction by 42%.  Post treatment histology slides stained with picrosirius red (PSR) showed a lower percentage of fibrosis from a single 2-minute RAP treatment than the Control group. 

"We look forward to conducting further studies seeking to validate and build on the initial pre-clinical results our RAP device demonstrated in treating liver fibrosis. We believe our RAP device has the potential to become the first non-drug based treatment option that can treat liver fibrosis and, in turn, aid the estimated 6-7% of the world's population suffering from liver fibrosis," said Dr. Chris Capelli, Vice Chairman, CSO and Founder of Soliton. "Our RAP technology has a strong scientific background, and we are excited to continue to explore its potential in adjacent medical and aesthetic applications."

The RAP device is currently cleared by the FDA for short-term improvement in the appearance of cellulite. The RAP device is also indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The device is not yet cleared for the treatment of liver fibrosis.

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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

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. Forward-looking statements in this press release include, without limitation, our ability to successfully replicate the results of this animal study in further clinical studies in either animals or humans.  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, 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.

FAQ

What is the purpose of Soliton's second pre-clinical study for SOLY?

The second study aims to validate positive findings from an initial pre-clinical study regarding the treatment of liver fibrosis using the RAP device.

What were the results of Soliton's first pre-clinical study for liver fibrosis?

The first study demonstrated a 42% reduction in liver fibrosis effects seven days after treatment with RAP therapy.

Is the RAP device FDA-cleared for treating liver fibrosis?

No, the RAP device is currently FDA-cleared only for tattoo removal and cellulite treatment.

What is the significance of the 6-7% statistic mentioned by Soliton?

It indicates the estimated percentage of the global population suffering from liver fibrosis, highlighting the potential market for Soliton's treatment.