Soliton Announces Long-Term Cellulite Trial Results to be Presented at The Aesthetics Show on July 11-14, 2019
Dr. Omer Ibrahim to Present Data Showing Long-Term Benefit from Soliton's RAP Treatment
HOUSTON, June 12, 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 that Dr. Omer Ibrahim of Chicago Cosmetic Surgery and Dermatology will present 26-week data from its completed proof-of-concept cellulite clinical trial at The Aesthetics Show dermatology conference in Las Vegas, Nevada, to be held July 11-14, 2019.
The study, conducted by Dr. Michael Kaminer at SkinCare Physicians in Boston, MA, in collaboration with Dr. Elizabeth Tanzi at Capital Laser & Skin Care in Washington DC was designed to evaluate the safety and efficacy of Soliton's acoustic pulse device for the reduction of cellulite.
The long-term follow-up to this proof of concept study was conducted by Dr. Michael Kaminer in collaboration with Dr. Ibrahim. The data presented will reflect results from a single acoustic pulse treatment, operating at a higher power level than the Company's RAP device intended for tattoo removal, at the 26-week timepoint. Dr. Ibrahim will also review preclinical data that appears to support what the Company refers to as "acoustic subcision," which it believes may be a new method for treating cellulite.
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"Since the announcement of our 12-week data that showed a 20 to 47% reduction in cellulite severity score from a single non-invasive treatment using our rapid acoustic pulse ("RAP") device, the dermatology community has been waiting to see if the long-term data would show continued improvement," commented Dr. Chris Capelli, President and CEO of Soliton. "We believe the proof-of-concept data is impressive. Since 97% of the treatments (which required no anesthesia) in this trial were rated as creating 'zero pain,' and none of the patients experienced any bruising or post-treatment discomfort or downtime, if these results are demonstrated in a future larger pivotal clinical trial, we believe our technology may represent a major advancement in the treatment of cellulite."
Dr. Capelli continued, "We believe this new long-term proof-of-concept data makes initiating the larger pivotal clinical trial we intend to start within a few months for the treatment of cellulite even more important."
The Company's RAP device received FDA clearance for the indication of tattoo removal earlier this year, however RAP has not yet been reviewed or cleared by the FDA for the cellulite indication.
Drs. Kaminer and Tanzi are members of Soliton's Advisory Board.
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.
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 a larger clinical trial or to receive FDA clearance for the cellulite indication, and the ability of Soliton to commence such larger clinical trial within the next few months. 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.
SOURCE Soliton, Inc.
Released June 12, 2019