Treatment was administered with no pain control. ASDSA Names 2022 Patient Safety Hero Awardees. As a result, the RAP technology can provide meaningful results within a single, comfortable treatment that has minimal side effects and no downtime. 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. 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. Houston-based company receives FDA for use of Rapid Acoustic Pulse Solitons RAP (rapid acoustic pulse) device, initially developed for tattoo removal treatments, may be effective in reducing the appearance of cellulite. Soliton Receives FDA Clearance for Cellulite Improvement Health Canada Approves Two New Gynecological Indications For Candelas CO2RE Laser Platform, AAD Survey: Parents Get the Importance of Sunscreen for their Kids. 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. Inclusion Criteria: Female ages 18-50 years. Soliton Selects RESONIC As Brand Name for FDA-Cleared Rapid Acoustic We believe the discovery we are outlining here helps explain the promising results we saw from this trial, as well as setting the foundation for a platform technology that may have potential in a number of aesthetic indications.. See more with MDedge! HOUSTON, March 2, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology . AbbVies Allergan Aesthetics to Acquire Soliton for $550 Million 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Based on the CSS scores, the researchers found that 87% of the study subjects had some improvement of their cellulite after a single RAP treatment. Soliton Will Deliver RESONIC Dual-Platform Device June 2021 One year after a single RAP treatment, patients give the - MDedge Thats the acoustic subcision, she continued. 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. ASDS announced the 2022 Annual Membership Meeting awards for the Societys the highest honors in dermatologic surgery. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. We need additional research to determine what happens after multiple treatments. Results were assessed using the validated Simplified Cellulite Severity Scale. Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for RESONIC - Clear Dermatology He performed the long-term follow-up to the proof-of-concept study in collaboration with Dr. Kaminer. 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. Honorees are chosen based on their contribution to various advocacy efforts throughout the year and demonstrated commitment to patient safety in the field of dermatologic surgery. Houston-based company receives FDA for use of Rapid Acoustic Pulse technology to reduce cellulite appearance Briana Edwards , Digital Contributor Published: March 1, 2021, 3:02 PM Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers. For general information, Learn About Clinical Studies. The skins never punctured. The award recipients included Mathew Avram, MD, JD and Joel Cohen, MD. But also, theres no cavitation and there are nonthermal physical effects. See our Other Publications. Use of this Web site is subject to the medical disclaimer. Information provided by (Responsible Party): To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite. The next generation of non-invasive body shaping hails from Cutera. 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. Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.). Software only modification to change the pulse repetition rate of the acoustic waves for cellulite treatment mode from 50Hz to 100Hz . Anyone who has cellulite can attest to how unsightly it looks! 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. New Rapid Acoustic Pulse (RAP) Device That Speeds Up Laser Tattoo Seeking treatment of cellulite in the thigh and/or buttock areas. Efficacy was determined by photographic assessment by three blinded independent physicians who used a validated, simplified version of the Cellulite Severity Scale (CSS), a 0-5 scale based on the number of cellulite depressions, as well as the average depth of those depressions. We believe the proof-of-concept data is impressive. 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. Those same blinded assessors graded about 86% of the treated cellulite areas as appearing either improved, much improved, or very much improved on the Global Aesthetic Improvement Scale (GAIS). "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. 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 . Patients have reported that it feels relaxing, like a deep tissue massage. Soliton files 510(k) with FDA for its Rapid Acoustic Pulse Device The medical device company Soliton's Rapid Acoustic Pulse ("RAP") device has been cleared by the FDA, too. Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) EltaMD has been named in Fast Company's "Brands that Matter" list for its memorable campaign to raise skin cancer awareness and prevention. --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 . (Clinical Trial), Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite. Determining the Ideal Anthropometric Measurements in Asian Eyes. Allergan Aesthetics to Acquire Soliton, Expanding Body - AbbVie Kenny Walter. This approach is finest if you don't like your current design but are open to another tattoo in its area. Soliton Selects RESONIC As Brand Name for FDA-Cleared Rapid Acoustic The pivotal cellulite clinical trial enrolled and treated 67 subjects at four clinical sites, of which 62 subjects were evaluated in the results analysis (five patients were excluded for violation of inclusion criteria or incomplete follow-ups). These statements relate to future events, future expectations, plans and prospects. 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. Patients treated with Soliton's 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. 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. Bellaire Dermatology is one of 16 offices on the globe with this novel treatment. She noted in an interview with Practical Dermatology magazine that the new technology shows substantial promise. Learn more about how RESONIC is changing the . Image: Histology images from an animal (pig) model comparing untreated skin sample (control) and treated sample (taken after a single 2-minute treatment with the modified RAP) showing selective mechanical disruption of the septa. Coordinating volunteers while maintaining the camp and doing morning & night surveys in terms of finding sea turtle nests along the Kyparissian bay and protect them from predation and conservation threats Clear Dermatology and Aesthetics Center Investigate MD, Scottsdale, Arizona, United States, 85255, Chevy Chase, Maryland, United States, 20815, Chestnut Hill, Massachusetts, United States, 02467. Subjects in the study received a single treatment to one buttock and thigh area, with the contralateral side serving as a control. Patients with moderate cellulite seem to respond [to this treatment], too, Dr. Tanzi said. Stable weight nominally +/- 5% for at least the past 6 months. Patients have reported that it feels relaxing, like a deep tissue massage. "Our technology will now provide physicians a new, innovative and non-invasive approach for patients seeking a non-surgical option to improve the appearance of cellulite. Alpine 4 Subsidiary RCA Commercial's Revenue See's Rapid Expansion of 28% in Q3 2022. . Soliton : Announces FDA Clearance of Rapid Acoustic Pulse Technology Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment. | July 12, 2022 We further hypothesize that rapid acoustic pulse's mechanical action on the dermal extracellular . Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Acoustic Pulse Subcision May Improve Appearance of Cellulite RESONIC generates high-frequency sound waves that get sent through the skin, physically affecting its structure. Soliton RAP technology also received 510(k) clearance from the FDA for the removal of tattoos in mid 2019. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse (RAP) device to the market. 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. All rights reserved. Soliton Provides Commercialization Update for Rapid Acoustic Pulse Soliton sponsored the trial. 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. Allergan Aesthetics Celebrates Botoxs 20th Anniversary of FDA Approval. HOME | Resonic At Nuvell AZ Resonic Cellulite Treatment - Youngstown, OH & Akron, OH: Gentile 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 . Evaluated by the U.S. Federal Government JD and Joel Cohen, MD feels. 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