Soliton Initiated Clinical Trials for Treatment of Cellulite in Humans
HOUSTON, April 1, 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 summarized its efforts to conduct a proof of concept clinical trial for the treatment of cellulite based on Institutional Review Board ("IRB") approval of the study. The study was initiated after positive results in animal studies indicated the potential for a higher-energy version of its acoustic shockwave technology to affect the factors contributing to the formation of cellulite.
The study treated each thigh of five patients (n=10) with a higher-energy version of Soliton's acoustic shockwave device with the intent to evaluate safety and efficacy in the treatment of cellulite. The study is designed to evaluate results at both the 12-week and 26-week timepoints from initial treatment in order to assess both near-term and long-term effects.
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"Our preclinical data led us to believe we could have a significant impact on the reduction of cellulite," commented Dr. Chris Capelli, Soliton's President and CEO. "This is especially significant since our technology should represent a non-invasive, pain free treatment that requires no anesthesia and involves no bruising, discomfort or downtime. If we are right, we believe this could be a major breakthrough in the treatment 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 planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of 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
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 acoustic shockwave device to reduce cellulite in the proof of concept clinical trial. 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 the year ended December 31, 2018 we filed with the SEC and updated from time to time 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.
Joe Dorame, Joe Diaz & Robert Blum
Lytham Partners, LLC
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SOURCE Soliton, Inc.
Company Codes: NASDAQ-NMS:SOLY