HOUSTON, April 23, 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 its development team has completed final testing of the Company's second generation rapid acoustic pulse ("Gen 2 RAP") device at Sanmina, Inc., the Company's global manufacturing partner.
The Gen 2 RAP device is intended to 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 should be capable of delivering higher-powered acoustic pulses at greater depths, making it a platform device with a wide range of potential future uses. This device has not been cleared by the FDA.
The treatment head of the Gen 2 RAP device is automated to allow continuous feeding of electrode material enabling the electrohydraulic pulse generator to operate for longer treatment times at higher and more consistent peak acoustic pressures. As well, the treatment head can now accommodate varying reflector designs to allow for treatment depths that are optimized for addressing the fibrotic structures that contribute to cellulite.
"Given the excitement surrounding the proof of concept cellulite trial results that are about to be presented to the scientific community," commented Dr. Chris Capelli, President and CEO of Soliton, "we needed to be ready to launch an expanded clinical trial for the cellulite indication. The Gen 2 RAP device is the key to being able to start this expanded trial and seek FDA clearance."
Dr. Capelli continued: "The Gen 2 RAP device represents the kind of multi-indication platform potential that we believe may make our RAP system an indispensable tool for clinicians."
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.
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.