This latest clearance also marks the next step in the planned commercialization of our RAP technology, and we look forward to introducing this new approach to treating cellulite to physicians in the months to come. The Rapid Acoustic Pulse device physically changes the septa that tether the skin down, and also helps restore smoothness to the skin. Typical techniques used for this include laser surgical procedure, surgical removals, or dermabrasion. The Company is based in Houston,. For more information about the Company, please visit:http://www.soliton.com. Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.). We found a very favorable side-effect profile, although 95% of patients had some redness to their skin, Dr. Tanzi added. 510(k) Application for Premarket Clearance filed with the FDA for Rapid Acoustic Pulse ("RAP") device in tattoo removal. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS). Treatment for the temporary improvement in the appearance of cellulite. HOUSTON, Feb. 28, 2019 -- Soliton, Inc., , a medical technology company that has developed a new breakthrough acoustic shockwave device, today announced that it believes that what they have. HOUSTON, Feb. 1, 2021 /PRNewswire/ -- Soliton, Inc., , a medical device company with a novel and proprietary aesthetic platform technology, today announced that the U.S. Food and Drug. We further hypothesize that rapid acoustic pulse's mechanical action on the dermal extracellular . See more with MDedge! Listing a study does not mean it has been evaluated by the U.S. Federal Government. The anticipated Rapid Acoustic Pulse (RAP) device is a dual-platform that is built to utilize a first-of-its-kind technology, offering a paradigm-shifting . The average time of treatment was 28 minutes. Anyone who has cellulite can attest to how unsightly it looks! Study record managers: refer to the Data Element Definitions if submitting registration or results information. Breakthrough Rapid Acoustic Pulse Technology for Cellulite and Tattoo Removal | Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from The . The pulses rupture and shear the fibrotic septa, which causes release of the septa and smoothing of the skin dimples, explained Dr. Tanzi, director of Capital Laser & Skin Care in Chevy Chase, Md. The studies, conducted by Michael Kaminer, MD, at SkinCare Physicians in Chestnut Hill, Massachusetts and Elizabeth Tanzi, MD, at Capital Laser & Skin Care in Washington D.C., were designed to evaluate the safety and efficacy of RAP for the reduction of cellulite. Epionce Skincare and founder Carl Thornfeldt, M.D., "The Father of Skin Barrier Repair," celebrate 20 years of protecting the skin barrier. Learn more about how RESONIC is changing the . Operations Coordinator. Noninvasive fat removal devices continue to gain popularity, Microneedling plus 10% TCA peels bests CO2 laser alone for infraorbital dark circles, Expert Insights in Hidradenitis Suppurativa, Treating Patients with Acne by Telemedicine in the Era of COVID-19, Nurse Practitioners / Physician Assistants. Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline 4.0 (Table 2) Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater. Ninety-seven percent of the treatments, which required no anesthesia, were rated as creating zero pain, and none of the patients experienced any bruising or post-treatment discomfort or downtime, said said Capelli. Seeking treatment of cellulite in the thigh and/or buttock areas. They had some erythema and folliculitis, but it was transient and very mild. Subjects in the study received a single treatment to one buttock and thigh area, with the contralateral side serving as a control. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed in our filings with the Securities and Exchange Commission ("SEC"), including under the heading " Risk Factors" in our most recently filed Form 10-K filed with the SEC and as updated in our Form 10-Q filings and in our other filings with the SEC. Its Rapid Acoustic Pulse technology is the only FDA-cleared device that can offer some benefits of both surgical and non-surgical cellulite treatment. Mar 02, 2021, 08:01 ET HOUSTON, March 2, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology,. But also, theres no cavitation and there are nonthermal physical effects. Health Canada Approves Two New Gynecological Indications For Candelas CO2RE Laser Platform, AAD Survey: Parents Get the Importance of Sunscreen for their Kids. The US Food and Drug Administration (FDA) has awarded 510 (k) clearance for a new rapid acoustic pulse (RAP) technology device for the treatment of cellulite. Soliton Announces FDA Clearance of Rapid Acoustic Pulse Technology for Use in Cellulite. Epionce Skincare Celebrates 20th Anniversary. Omer Ibrahim, MD, of Chicago Cosmetic Surgery and Dermatology will present 26-week data from the cellulite clinical trial at The Aesthetics Show in Las Vegas, Nevada, to be held July 11-14, 2019. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse (RAP) device to the market. RAP uses shockwaves to break apart the fibrous septa bands beneath the skin that cause cellulite. I dont think theres a ceiling or a floor to which we have to pigeonhole patients into potentially treating with this device. events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment. First, this was a single treatment. RESONIC, manufactured by Soliton Inc for tattoo removal and cellulite reduction, will be available through a select network of physicians and medically supervised spas beginning in June 2021. Talk with your doctor and family members or friends about deciding to join a study. in the treatment area. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers. Whats really happening in the tissue on a molecular level when those rapid acoustic pulses are going through the skin? I think that's important, as well as the overall subject satisfaction. Bellaire Dermatology is one of 16 offices on the globe with this novel treatment. The patented Rapid Acoustic Pulse (RAP) device by Soliton Inc, uses acoustic shockwaves that accelerated the speed of tattoo removal when used with lasers, delivering results i. The approval, awarded to Soliton, is earmarked for short-term improvement in the appearance of cellulite. Mark For: RAPID ACOUSTIC PULSE trademark registration is intended to cover the categories of medical devices and apparatuses, namely, stand-alone devices with attached treatment heads emitting energy in the form of acoustic waves for use in cosmetic procedures, aesthetic procedures, and dermatology procedures; Medical devices and apparatuses, namely, stand-alone devices with attached . Irakleio was named after a sanctuary of Heracles that was located in the area in classical antiquity. 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. Determining the Ideal Anthropometric Measurements in Asian Eyes. Clinical Trial Outcome Measures Primary Measures See our Other Publications. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse (RAP) device to the market. The skins never punctured. Houston, TX - March 21, 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 on behalf of the MD Anderson Cancer Center ("MD . While the proof-of-concept clinical trial results we have recently announced regarding the improvement in the appearance of cellulite have been very encouraging, understanding the basic science and biology behind these results is very important, said Chris Capelli, MD, president and CEO of Soliton. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. AcelRx Pharmaceuticals Presents DSUVIA Study Abstract at Plastic Surgery The Meeting. Mar. Theres a lot of unanswered questions, but this is exciting technology.. RESONIC FAQs What is Cellulite? Soliton Announces FDA Clearance of Rapid Acoustic Pulse Technology for Use in Cellulite; . Study Design Go to Arms and Interventions Go to The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. The device was well-tolerated among patients in clinical trials. The Company's first FDA cleared commercial product, RESONIC will use rapid pulses of acoustic shockwaves as an accessory to lasers for the removal of unwanted tattoos and the treatment of cellulite. The study hosted patients that underwent complex plastic surgery procedures and found many positive benefits of using sufentanil sublingual tablets. When typing in this field, a list of search results will appear and be automatically updated as you type. HOUSTON, Feb. 1, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ('Soliton' or the 'Company'), a medical device company with a novel and propri. 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. The approval, awarded to Soliton, is earmarked for short-term improvement in the appearance of cellulite. rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. The US Food and Drug Administration (FDA) has awarded 510(k) clearance for a new rapid acoustic pulse (RAP) technology device for the treatment of cellulite. The three independent evaluating physicians were able to correctly identify before and after photos about 85 percent of the time, Dr. Tanzi says. 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 and the temporary improvement in the appearance of cellulite. Introducing RESONIC. The Company . If you suffer from some form of cellulite, RESONIC could be the treatment for you. Histology performed before and after a single, two-minute treatment with the modified RAP device demonstrated selective mechanical disruption of the septa with little evidence of unintended damage to surrounding tissues, such as blood vessels or muscle. Aesthetic One App Registers Milestone 22K Breast Implants. Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.). For general information, Learn About Clinical Studies. Clear Dermatology and Aesthetics Center Investigate MD, Scottsdale, Arizona, United States, 85255, Chevy Chase, Maryland, United States, 20815, Chestnut Hill, Massachusetts, United States, 02467. A rapid acoustic pulse (RAP) device being developed by Soliton emits rapid acoustic pulses and shock waves at 50 Hz that are transmitted through the skin. What happens if we do multiple treatments to the tissue? she asked. This approach is finest if you don't like your current design but are open to another tattoo in its area. After a single treatment, it provided a roughly 1.16 point reduction in the five-point Cellulite Severity Scale at 12 weeks, which corresponds to a roughly 32.5% reduction in cellulite. Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial. All rights reserved. Watch Kimberly Butterwick, MD explain how the RESONIC is able to effectively and non-invasively treat cellulite on the buttocks and thighs! Stable weight nominally +/- 5% for at least the past 6 months. Participant is pregnant or planning to become pregnant during the duration of the study. Software only modification to change the pulse repetition rate of the acoustic waves for cellulite treatment mode from 50Hz to 100Hz . Rapid Acoustic Pulse Rapid Acoustic Pulse. 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