Soliton Receives FDA Approval for Small Business Designation
The Company qualifies for reduced or waived fees for medical device submissions with the FDA
HOUSTON, TX / ACCESSWIRE / March 4, 2019 / 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 M.D. on behalf of the MD Anderson Cancer Center (''MD Anderson''), today announced that it has received notice from the U.S. Food and Drug Administration ("FDA") that the Company has qualified for the ''Small Business'' designation under the Medical Device User Fee Amendments (''MDUFA''). As a Small Business under the MDUFA, Soliton qualifies for a reduce or waived fee for medical device submissions made during the fiscal year 2019.
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Dr. Christopher Capelli, president and CEO of Soliton, said, ''We are pleased to have qualified for Small Business status allowing us to receive reduced or waived fees for our FDA submissions. We appreciate the opportunity to submit device applications for review and approval at more favorable rates. In certain submissions, the savings could be dramatic. This helps us to operate more efficiently. Our plan is to is to submit our Rapid Acoustic Pulse (''RAP'') device for tattoo removal for premarket clearance with the FDA under our new status in the near future.''
The MDUFA rates cover a number of submissions that are routinely made to the FDA for review and approval. The rate table assigns fees for the fiscal year - which ends on September 30, 2019 - for the application type submitted for review along with the Standard Fee and the Small Business fee for companies that qualify for the designation.
The table of 2019 MDUFA rates can be accessed at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm615142.htm
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 will use rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing this device to the market. The Company believes this ''Soliton'' method can not only dramatically accelerate tattoo removal, but also has the potential to lower removal cost for patients, while increasing profitability to practitioners, and to reduce the potential for unwanted side effects from current laser removal methods. Soliton has discovered other capabilities of the RAP technology during preclinical testing, including the potential to assist existing fat reduction technology in the reduction of fat as well as reducing 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 RAP to accelerate tattoo fading or fat removal and/or to reduce cellulite, and whether future clinical trials related to the acceleration of existing fat removal technologies and cellulite are successful. 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.
Joe Dorame, Joe Diaz & Robert Blum
Lytham Partners, LLC
SOURCE: Soliton, Inc.
Released March 4, 2019