HOUSTON, July 8, 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 announced that it will release the cumulative 26-week patient data from its cellulite proof of concept clinical trial on Monday, July 15, 2019. As the Company has previously announced, the proof-of-concept clinical trial studied the safety and efficacy of a new version of its acoustic shockwave device for the treatment of moderate to severe cellulite. The results from the 26-week assessment are being presented at The Aesthetics Show in Las Vegas on July 12, 2019.
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"We were excited and encouraged by the initial patient results we saw when the trial treatments were completed," said Chris Capelli, Soliton President, Chief Science Officer and co-founder. "Those initial results suggested that Soliton has the potential for a new approach to treating cellulite. Our excitement has continued to grow as we have tracked the patient responses to the treatment and we look forward to presenting what will be 26 weeks of data on July 15. This data forms the foundation for the protocol development for our recently announced expanded pivotal Clinical Cellulite Trial to launch later this summer."
Cellulite affects up to 90% of women and over a billion dollars per year is spent on treatment in the U.S. In the proof-of-concept trial, the Soliton Rapid Acoustic Pulse ("RAP") device was applied to the surface of the patients' skin for a single 20-minute, non-invasive treatment. The treatments required no anesthesia, caused no bruising, swelling or infection, and were evaluated by the trial participants as a "0" on a pain scale of 0-10 in 97% of the treatments. None of the patients experienced any post-treatment downtime. The proof-of-concept trial was conducted by Dr. Michael S. Kaminer at SkinCare Physicians in Boston in collaboration with Elizabeth L. Tanzi, MD FAAD of Capital Laser and Skin Care in Chevy Chase, MD. Both Drs. Kaminer and Tanzi serve on the Company's Scientific Advisory Board. The Soliton device used in this trial has not been reviewed or cleared by the FDA for marketing and, accordingly, none of the information in this press release is intended to promote the sale or use of the device. The device is investigational and is not available for sale in the United States.
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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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 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.