Le Lézard
Classified in: Health
Subjects: TRI, FDA

Soliton Completes Clinical Trials for Initial FDA Filing for Tattoo Indication


HOUSTON, March 19, 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"), completed the human trials of its proprietary Rapid Acoustic Pulse (RAP) Device to support the Company's FDA 510(k) submission. The Company conducted three rounds of human trials to study the use of the RAP device to accelerate tattoo fading.

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). (PRNewsfoto/Soliton, Inc.)

------------------------

Join our more than 208K fans here to follow the Company: https://soly-investors.com 

------------------------

"The human trials provided evidence of the potential for the RAP technology to accelerate tattoo fading," said Dr. Chris Capelli, Soliton's President and CEO. "The combination treatment of the RAP device and a laser outperformed a laser alone, showing an average of 80% fading after only two visits vs 44% fading for the laser alone. After 3 Soliton Multi-Pass treatments, 100% of the treated tattoos had a 'Complete' (76-100% faded) response; in comparison, only 17% of the tattoos treated with the Laser Only had a 'Complete' response." 

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

Forward-Looking Statements

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 RAP to receive FDA clearance. 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 "Risk Factors" in the Form 1-A we filed with the SEC on February 13, 2019. 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.

CONTACT:  

Joe Dorame, Joe Diaz & Robert Blum


Lytham Partners, LLC


602-889-9700


soly@lythampartners.com

 

SOURCE Soliton, Inc.


These press releases may also interest you

at 15:35
In search of treatments for human diseases, medical researchers rely on the latest technologies to gather vast amounts of information. Genomics studies, for example, collect data about millions of DNA sequences, generating huge datasets. To decipher...

at 15:30
Haemonetics Corporation , a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, today opened its new global headquarters in Boston. The new space supports Haemonetics' work to...

at 15:30
Medico of South Carolina "(Medico") is a medical billing company for covered entities. On September 16, 2019, Medico mailed letters to some individuals potentially affected by a security incident.    On June 20, 2019, a security research firm...

at 15:30
The "Fractional Flow Reserve Market Size, Share & Trends Analysis Report By Application (Multi-Vessel CAD, Single-Vessel CAD), By Product (Monitoring Systems, Guidewires), By Region, and Segment Forecasts, 2019 - 2026" report has been added to...

at 15:18
Today, the co-chairs of the federal, provincial, and territorial Special Advisory Committee on the Epidemic of Opioid Overdoses?Dr. Theresa Tam, Chief Public Health Officer of Canada, and Dr. Saqib Shahab, Saskatchewan's Chief Medical Health...

at 15:15
The "Blood Pressure Monitoring Devices Market Size, Share & Trends Analysis By Product (Sphygmomanometers, Digital BP Monitor, Ambulatory BP Monitors), By End-use, And Segment Forecasts, 2019 - 2026" report has been added to ResearchAndMarkets.com's...



News published on 19 march 2019 at 08:00 and distributed by: