Cellulite Reduction for Pivotal Trial
HOUSTON, Aug. 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 announced that Sanmina, Corp., the Company's global manufacturing partner has delivered the Company's second generation rapid acoustic pulse ("Gen 2 RAP") device for use in the upcoming pivotal trial targeting cellulite reduction.
We previously announced the completion of final testing of the device by Sanmina, Corp. After completing safety testing, they have delivered the devices to the first clinical trial site for the pivotal trial. The Gen 2 RAP device will be used in Company's upcoming pivotal registration clinical trial to submit to the FDA for 510(k) clearance of the device. This new device is designed to be capable of functioning both as the Gen 1 device does for the acceleration of tattoo removal, and as a stand-alone device for potential reduction of cellulite and other future indications. In this second model, the Gen 2 RAP is capable of delivering higher-powered acoustic pulses at greater depths, making it a platform device with a wide range of potential future uses. This new device has not been cleared by the FDA.
The treatment head accommodates a specific reflector design to allow for treatment depths that are optimized for addressing the fibrotic structures that contribute to cellulite.
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"This new device is designed with the reduction of cellulite in mind and we are excited to begin the pivotal study with this new technology," commented Dr. Chris Capelli, President and CEO of Soliton. "We believe this new design could improve on the good results that we were able to achieve in our proof-of-concept study with the earlier technology."
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 the Soliton RAP technology, including the Gen 2 RAP device, to prove safe and effective at reducing cellulite and to achieve FDA clearance for this indication. 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.