All rights reserved. Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) Study Design Go to Arms and Interventions Go to The announcement noted that the addition of Soliton together with its Rapid Acoustic Pulse technology used for improving appearance of cellulite will serve to expand and complement Allergan Aesthetics' Body Contouring treatment portfolio, which includes the CoolSculpting Elite line of products and services. What's more, the new device also shows potential in aesthetics market for cellulite and fat removal. The high peak pressure and fast repetition rate exploit the viscoelastic nature of the tissue. Soliton Announces FDA Clearance of Rapid Acoustic Pulse Technology for Use in Cellulite. ASDSA Names 2022 Patient Safety Hero Awardees. Juggle multiple projects and priorities simultaneously in a fast-paced environment. Results of proof-of-concept, preclinical studies on the use of a new version of the companys acoustic pulse technology reveal that, in addition to the RAP devices demonstrated ability to stimulate collagen, the technology also appears to be capable of selective disruption of the fibrotic septa that contribute to the appearance of cellulite. 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. Patients treated with Solitons investigational Rapid Acoustic Pulse (RAP) device experienced an average 32.5 percent improvement in Cellulite Severity Score, according to newly released data presented via the American Academy of Dermatology (AAD) 2020 VMX Virtual Conference. 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. Its Rapid Acoustic Pulse technology is the only FDA-cleared device that can offer some benefits of both surgical and non-surgical cellulite treatment. History of coagulopathy(ies) and/or on anticoagulant medication. Importantly, the negative pressure component of each acoustic pulse is attenuated so therapy can be provided without creating cavitation or heating that could result in surrounding tissue damage. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment. 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. We further hypothesize that rapid acoustic pulse's mechanical action on the dermal extracellular . If these results are demonstrated in a future larger pivotal clinical trial, we believe our technology may represent a major advancement in the treatment of cellulite.. They had some erythema and folliculitis, but it was transient and very mild. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse (RAP) device to the market. He performed the long-term follow-up to the proof-of-concept study in collaboration with Dr. Kaminer. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. Their award-winning muscle sculpting technology, truSculpt flex is now enhanced with flex+, a ground-breaking 15-minute, no-downtime, rapid muscle building mode. Please remove one or more studies before adding more. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers. The Company . Arms, Groups and Cohorts Experimental: RAP Treatment Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment. AcelRx Pharmaceuticals Presents DSUVIA Study Abstract at Plastic Surgery The Meeting. Unauthorized use prohibited. In cellulite, we know that the septa within the fat those fibrous bands that pull down the skin and tether lead to the traditional look of cellulite dimples and ridges, lead study author Elizabeth Tanzi, MD, said during a late-breaking abstract session at the virtual annual meeting of the American Academy of Dermatology. Its completely noninvasive and its truly an incisionless treatment, Dr. Tanzi said of the procedure. 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. RESONIC treatments to reduce the appearance of cellulite have minimal discomfort and do not require any anesthesia or downtime. I think the key is [targeting] cellulite and not necessarily skin laxity., She emphasized that much remains to be known about the RAP device for treating 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 . The next generation of non-invasive body shaping hails from Cutera. RESONIC generates high-frequency sound waves that get sent through the skin, physically affecting its structure. After being placed on the skin, the device emits high-frequency sound waves up to 50 times per second. 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. For more information about the Company, please visit:http://www.soliton.com. This technology is exciting to me for a number of reasons. Tattoo removal is a treatment done to try and also get rid of an undesirable tattoo. No anesthesia was required, and photographs were taken on all sites with QuantifiCare medical imaging software. Allergan Aesthetics is set to acquire Soliton and Resonic, its Rapid Acoustic Pulse device. share: Share on Facebook Tweet on Twitter Post to Reddit. Treatment was administered with no pain control. Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite. The average time of treatment was 28 minutes. 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. RESONIC Rapid Aco. Noninvasive fat removal devices continue to gain popularity, The mean age of patients was 43 years, 92% were white, and their mean body mass index was 24.5 kg/m2. Dr. Tanzi disclosed that she is either a consultant for or is a member of the scientific advisory board for Allergan/Coolsculpting, Beiersdorf, Cutera, Merz/Ulthera, Pulse Biosciences, Sciton, Soliton, Solta, and Syneron/Candela. from 8 AM - 9 PM ET. Any surgical procedure in the prior 3 months, or planned during the duration of the study. Leveraging its proprietary technology, the Soliton RAP device is designed to safely deliver rapid, high-pressure acoustic shockwaves at a rate of up to 100 pulses per second through a replaceable treatment cartridge. But also, theres no cavitation and there are nonthermal physical effects. for the prior 12 months. Patients have reported that it feels relaxing, like a deep tissue massage. The approval, awarded to Soliton, is earmarked for short-term improvement in the appearance of cellulite. The U.S. Food and Drug Administration (FDA) has granted marketing clearance to Soliton 's Rapid Acoustic Pulse (RAP) technology for the short-term improvement in the appearance of cellulite. Participant is willing to participate in study and adhere to follow-up schedule, Participant is able to read and comprehend English, Participant has completed the Informed Consent Form. Watch Kimberly Butterwick, MD explain how the RESONIC is able to effectively and non-invasively treat cellulite on the buttocks and thighs! Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater. We need additional research to determine what happens after multiple treatments. On subject satisfaction surveys, 92% of the patient said that they agree or strongly agree that their cellulite appeared improved. 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. 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. The Company also believes the technology will provide the first non-invasive acoustic technology to be able to target the underlying cause of dimples and ridges in cellulite. Soliton has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' "would," ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. A recent study determined the anthropometric measurements that determine attractiveness in Asian eyes, and the effect it has on how surgeons approach cosmetically enhancing eyes. Typical techniques used for this include laser surgical procedure, surgical removals, or dermabrasion. First opening its doors in 1997 in Geneva, Switzerland, the Forever Institute was the first medical aesthetics center in Switzerland. 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. 2022 Bryn Mawr Communications III, LLC. As for pain, on a 0-10 scale, with 10 being the worst, subjects rated their pain level at 2.4 during the treatment and 0.3 immediately afterward. Forever Institut Celebrates 25th Anniversary. --Soliton, Inc.,, a medical device company with a novel and proprietary aesthetic platform technology, today announced that the U.S. Food and Drug Administration has cleared its Rapid Acoustic . "Until now, patients have had limited options to effectively improve the appearance of cellulite other than cutting into the skin or less invasive procedures that can have low patient satisfaction. Cutera announced that the 12 month clinical data related to AviClear was presented at the Annual Clinical Dermatology Conference on Oct. 20-23, 2022 in Las Vegas, NV. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Also, we need to investigate the best interval between treatments because what we are seeing is that clinical results seem to improve over time, which is the exact opposite from the non-invasive treatments that are on the market today.. Detailed Description: To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. Anyone who has cellulite can attest to how unsightly it looks! The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. The information provided is for educational purposes only. When asked if their cellulite appeared improved, 92 percent of the subjects said they agreed or strongly agreed. Criteria. Before the Greek War of Independence the village was known as Arakli.. Irakleio was refounded as a military colony for the Bavarian Auxiliary Corps by King Otto.Due to the divide between the Catholic Bavarians and the Orthodox Greeks, the local Catholic pastor had to function as match-maker . Elizabeth Tanzi, MD, Director at Capital Laser & Skin Care, Chevy Chase, MD and a member of Solitons Scientific Advisory Board, presented the results at the AAD. Operations Coordinator. Its the rapid rate at which the energy is being delivered, as well as the very short times that energy is being delivered, that makes the technology an entirely different device-tissue interaction., The physical effects observed occur in the extracellular matrix and in the destruction of fibrous septa. 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