HOUSTON, Feb. 1, 2021 /PRNewswire/ — Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Firm”), a medical gadget firm with a novel and proprietary aesthetic platform know-how, right now introduced that the U.S. Meals and Drug Administration (“FDA”) has cleared its Fast Acoustic Pulse (“RAP”) know-how for the short-term enchancment within the look of cellulite. This progressive know-how harnesses the facility of sound for the remedy of cellulite. The distinctive, rapid-pulsed know-how safely and comfortably breaks aside the fibrous septa bands beneath the pores and skin that trigger cellulite to ship efficacious ends in only one, 40–60-minute remedy.
“We’re thrilled to obtain this newest clearance for our RAP know-how,” stated Brad Hauser, President & CEO of Soliton. “Our know-how will now present physicians a brand new, progressive and non-invasive strategy for sufferers in search of a non-surgical possibility to enhance the looks of cellulite. This newest clearance additionally marks the subsequent step within the deliberate commercialization of our RAP know-how, and we look ahead to introducing this new strategy to treating cellulite to physicians within the months to come back.”
For full particulars on the clearance and the Firm’s commercialization plans, watch this brief video: https://ir.soliton.com/soliton-leadership-discusses-fda-510k-clearance-for-cellulite
Within the medical trials submitted to the FDA as a part of the 510(okay) software that was cleared, affected person outcomes had been generated by a single, non-invasive remedy that required no anesthesia, induced no sudden or severe hostile occasions, obtained sturdy affected person satisfaction rankings and was properly tolerated by the trial topics, with a median ache rating of two.4 out of 10. The RAP gadget induces mechanical disruption in fibrous buildings, such because the septae contributing to dimples in cellulite, that ends in launch of the dimples and normal smoothing of the pores and skin.
“Till now, sufferers have had restricted choices to successfully enhance the looks of cellulite apart from reducing into the pores and skin or much less invasive procedures that may have low affected person satisfaction. The clearance of this know-how for cellulite fills this hole in obtainable therapies and is an thrilling growth for healthcare professionals who’re dedicated to offering sufferers efficient procedures with none downtime,” stated Elizabeth Tanzi, Director at Capital Laser & Pores and skin Care, Chevy Chase, MD and a member of Soliton’s Scientific Advisory Board. “This non-invasive know-how offers us a brand new cellulite discount possibility to assist tackle this unmet want for our sufferers.”
- Leveraging its proprietary know-how, the Soliton RAP gadget is designed to soundly ship speedy, high-pressure acoustic shockwaves at a fee of as much as 100 pulses per second via a replaceable remedy cartridge. This ends in bodily results on focused buildings and tissues, similar to fibrous septa.
- Importantly, the destructive strain element of every acoustic pulse is attenuated so remedy may be supplied with out creating cavitation or heating that might end in surrounding tissue harm. Consequently, the RAP know-how can present significant outcomes inside a single, comfy remedy that has minimal unwanted effects and no downtime.
- Soliton RAP know-how additionally obtained 510(okay) clearance from the FDA for the elimination of tattoos in mid 2019.
The Firm plans to start promoting the gadget for each tattoo elimination and cellulite remedy within the first half of 2021.
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About Soliton, Inc.
Soliton, Inc. is a medical gadget firm with a novel and proprietary platform know-how licensed from The College of Texas on behalf of MD Anderson Most cancers Heart. The Firm’s first FDA cleared industrial product will use speedy pulses of acoustic shockwaves as an adjunct to lasers for the elimination of undesirable tattoos and the short-term enchancment within the look of cellulite. The Firm relies in Houston, Texas, and is actively engaged in bringing the Fast Acoustic Pulse (“RAP”) gadget to the market. The Firm believes this “Soliton” technique has the potential to decrease tattoo elimination prices for sufferers, whereas rising profitability to practitioners, in comparison with present laser elimination strategies. The Firm additionally believes the know-how will present the primary non-invasive acoustic know-how to have the ability to goal the underlying reason behind dimples and ridges in cellulite.
For extra details about the Firm, please go to: http://www.soliton.com
This press launch contains forward-looking statements throughout the which means of Part 27A of the Securities Act of 1933, Part 21E of the Securities Change Act of 1934 and the Personal Securities Litigation Reform Act of 1995, which statements contain dangers and uncertainties. Ahead-looking statements on this press launch embody, with out limitation, our capability to efficiently deal with sufferers for tattoo elimination and cellulite and to launch our product within the first half of 2021. These statements relate to future occasions, future expectations, plans and prospects. Though Soliton believes that the expectations mirrored in such forward-looking statements are cheap as of the date made, precise outcomes or outcomes might show to be materially totally different from the expectations expressed or implied by such forward-looking statements. Soliton has tried to determine forward-looking statements by terminology together with ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”tasks,” ”intends,” ”potential,” ”might,” ”might,” ”may,” ”will,” “would,” ”ought to,” ”roughly” or different phrases that convey uncertainty of future occasions or outcomes to determine these forward-looking statements. These statements are solely predictions and contain identified and unknown dangers, uncertainties, and different components, together with these mentioned in our filings with the Securities and Change Fee (“SEC”), together with underneath the heading ” Threat Components” in our most lately filed Type 10-Ok filed with the SEC and as up to date in our Type 10-Q filings and in our different filings with the SEC. Any forward-looking statements contained on this launch communicate solely as of its date. Soliton undertakes no obligation to replace any forward-looking statements contained on this launch to replicate occasions or circumstances occurring after its date or to replicate the prevalence of unanticipated occasions.
SOURCE Soliton, Inc.