No unexpected or serious adverse events were reported, and the average pain scores were 2.4 on a 10-point scale. While existing therapies provide some benefit, there's a lot of room for improvement, Dr. Tanzi suggests. No anesthesia was required, and photographs were taken on all sites with QuantifiCare medical imaging software. 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 . All RIghts Reserved Privacy Policy. The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite, that results in release of the dimples and general smoothing of the skin. RESONIC Rapid Aco. Theres a lot of unanswered questions, but this is exciting technology.. RAP uses shockwaves to break apart the fibrous septa bands beneath the skin that cause cellulite. The company notes that in the proof-of-concept clinical trial, 97 percent of the treatments were rated as having zero pain. Join our more than 200K subscribers here to follow the Company:https://soly-investors.com. The authors hypothesize that rapid acoustic pulses noninvasively disrupt the fibrous septae (i.e., subcision) in the subcutaneous extracellular matrix space, leading to tissue release that results in the improvement in the appearance of cellulite. Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of MD Anderson Cancer Center. If you break the data down further, half of patients had at least a 30% reduction of their CSS, and almost one-quarter had a 50% improvement of their CSS, Dr. Tanzi said. 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. 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 three independent evaluating physicians were able to correctly identify before and after photos about 85 percent of the time, Dr. Tanzi says. In addition, 98% of patients said that the procedure was tolerable.. How It Works The next generation of non-invasive body shaping hails from Cutera. 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. Results were assessed using the validated Simplified Cellulite Severity Scale. in the treatment area. Detailed Description: To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. 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. events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment. 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 . 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.. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse (RAP) device to the market. Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers. This study is specific to females ages 18-50 years. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers. Bellaire Dermatology is one of 16 offices on the globe with this novel treatment. 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. The award recipients included Mathew Avram, MD, JD and Joel Cohen, MD. Coordinating the business sector of Connectivity & Products - Government Services. The American Board of Cosmetic Surgery estimates that 90% of women and 10% of men experience cellulite primarily in their buttocks, abdomen, and thighs. 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. 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.. Overall, we saw a reduction of a 1.16 level on that six-point scale, which translates roughly into 32.5% reduction of the look of their cellulite from the baseline score.. Acoustic subscision represents a novel, noninvasive treatment to improve the appearance of cellulite, results from a pivotal multicenter study demonstrated. The company plans to initiate a larger pivotal clinical trial within a few months and file an additional 510(k) application with the U.S. Food and Drug Administration (FDA) for the use of RAP technology to improve the appearance of cellulite. Saving You Time. Thats the acoustic subcision, she continued. 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. ASDSA Names 2022 Patient Safety Hero Awardees. 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. One year after a single treatment of cellulite with the Rapid Acoustic Pulse (RAP) device, 42 out of 43 patients said that they felt good about the results, an interim analysis from a multicenter study showed. When typing in this field, a list of search results will appear and be automatically updated as you type. Forever Institut Celebrates 25th Anniversary. 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. In the clinical trials submitted to the FDA as part of the 510(k) application that was cleared, patient results were generated by a single, non-invasive treatment that required no anesthesia, caused no unexpected or serious adverse events, received strong patient satisfaction ratings and was well tolerated by the trial subjects, with an average pain score of 2.4 out of 10. 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 information provided is for educational purposes only. ASDSA 2022 Honors Top Advocates in Dermatologic Surgery. Arms, Groups and Cohorts Experimental: RAP Treatment Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment. Unauthorized use prohibited. These waves physically change the septa that contribute to cellulite while also helping to restore smoothness to the skin. Also, we need to further investigate whats happening in the tissue, because not only does it seem like were getting a cleaving of the fibrous septa, but what is happening to the fibroblasts? A company is in Houston, Texas is introducing new acoustic shockwave technology for quicker laser tattoo removal. 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. 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. Its completely noninvasive and its truly an incisionless treatment, Dr. Tanzi said of the procedure. The device was well-tolerated among patients in clinical trials. Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. Treatment for the temporary improvement in the appearance of cellulite. 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. Watch Kimberly Butterwick, MD explain how the RESONIC is able to effectively and non-invasively treat cellulite on the buttocks and thighs! We need additional research to determine what happens after multiple treatments. Kenny Walter. 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. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results or outcomes may prove to be materially different from the expectations expressed or implied by such forward-looking statements. In a prospective pivotal clinical trial conducted at four sites, Dr. Tanzi and her colleagues evaluated the safety and effectiveness of the RAP device in 62 female patients who were treated with a single, rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. The Company believes this "Soliton" method has the potential to lower tattoo removal costs for patients, while increasing profitability to . The primary objective is to demonstrate freedom from unexpected adverse. This press release includes 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 statements involve risks and uncertainties. As a result, the RAP technology can provide meaningful results within a single, comfortable treatment that has minimal side effects and no downtime. 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). Tattoo removal is a treatment done to try and also get rid of an undesirable tattoo. Why Should I Register and Submit Results? 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. This technology is exciting to me for a number of reasons. 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. What happens if we do multiple treatments to the tissue? she asked. Determining the Ideal Anthropometric Measurements in Asian Eyes. All rights reserved. Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater. 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. They had some erythema and folliculitis, but it was transient and very mild. HOUSTON, Feb. 28, 2019 (GLOBE NEWSWIRE) -- Soliton, Inc., (Nasdaq: SOLY), ("Soliton" or the "Company"), a medical technology company that has developed a new breakthrough acoustic . I dont think theres a ceiling or a floor to which we have to pigeonhole patients into potentially treating with this device. Patients have reported that it feels relaxing, like a deep tissue massage. 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 based on soliton, inc., the rapid acoustic pulse trademark is used in the following business: medical devices and apparatuses, namely, standalone 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, This non-invasive treatment reduces dimples, helps restore smoothness to the skin, and improves the appearance of cellulite. Alpine 4 Subsidiary RCA Commercial's Revenue See's Rapid Expansion of 28% in Q3 2022. . 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. Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.). HOUSTON, March 2, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology . I think that's important, as well as the overall subject satisfaction. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065711. After being placed on the skin, the device emits high-frequency sound waves up to 50 times per second. This process helps free the dimples we call cellulite, allowing the skin to rebound and gain a smoother texture. The Rapid Acoustic Pulse device physically changes the septa that tether the skin down, and also helps restore smoothness to the skin. 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. This technology is called Rapid Acoustic Pulse Technology. You have reached the maximum number of saved studies (100). Irakleio was named after a sanctuary of Heracles that was located in the area in classical antiquity. Read our, ClinicalTrials.gov Identifier: NCT04065711, Interventional This rapid . The Company plans to begin selling the device for both tattoo removal and cellulite treatment in the first half of 2021. 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. rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. 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 . Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.). 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. AviClear 12-Month Clinical Data Presented at 42nd Clinical Dermatology Conference. Soliton is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. There is some investigational research going into what biologic effects those shock waves have on the rest of the tissue, looking into neocollagenesis, potential angiogenesis, potential lymphangiogenesis, as well as inflammation inhibition.. | July 12, 2022 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 medical device company Soliton's Rapid Acoustic Pulse ("RAP") device has been cleared by the FDA, too. . Tattoo or former tattoo at or near treatment area. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, https://ir.soliton.com/soliton-leadership-discusses-fda-510k-clearance-for-cellulite. "This non-invasive technology gives us a new cellulite reduction option to help address this unmet need for our patients.". 2022 Allured Business Media. "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. He performed the long-term follow-up to the proof-of-concept study in collaboration with Dr. Kaminer. "We're thrilled to receive this latest clearance for our RAP technology," said Brad Hauser, President & CEO of Soliton. Has atrophic scars, or has a history of atrophic scars or keloids. 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. 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. AcelRx Pharmaceuticals Presents DSUVIA Study Abstract at Plastic Surgery The Meeting. The high peak pressure and fast repetition rate exploit the viscoelastic nature of the tissue. Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc. Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment. To demonstrate temporary improvement in the appearance of cellulite as determined by blinded independent physician assessment (IPA) correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. 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 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. 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,. 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. Any forward-looking statements contained in this release speak only as of its date. Soliton'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 treatment of cellulite. HOUSTON, Feb. 1, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ('Soliton' or the 'Company'), a medical device company with a novel and propri. We found a very favorable side-effect profile, although 95% of patients had some redness to their skin, Dr. Tanzi added. Participant is pregnant or planning to become pregnant during the duration of the study. National Healthy Skin Month: 7 Skin Care Tips from Dermatologists, truSculpt flex: A Body Sculpting Game Changer for Your Aesthetic Practice, ELEVAI Unveils Exosome Technology at Global Aesthetics Conference, Merz Aesthetics Names Teyana Taylor New Xeomin Brand Partner. 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. 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. 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. Rapid Acoustic Pulse is an FDA-cleared technology that does not cause lasting or unexpected side effects. She added that the repetition rate of the RAP device makes it stand out from other technologies currently on the market for cellulite treatment. --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 . Javad Sajan, M.D., and Zera Foundation Offer Free Botox for Food Drive. Cision Distribution 888-776-0942 We believe the proof-of-concept data is impressive. She noted in an interview with Practical Dermatology magazine that the new technology shows substantial promise. Feb 2021 - Dec 202111 months. 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). for the prior 12 months. Any surgical procedure in the prior 3 months, or planned during the duration of the study. ASDS announced the 2022 Annual Membership Meeting awards for the Societys the highest honors in dermatologic surgery. Achieve organizational & operational goals while upholding standards and best practices. Its Rapid Acoustic Pulse technology is the only FDA-cleared device that can offer some benefits of both surgical and non-surgical cellulite treatment. Juggle multiple projects and priorities simultaneously in a fast-paced environment. Their award-winning muscle sculpting technology, truSculpt flex is now enhanced with flex+, a ground-breaking 15-minute, no-downtime, rapid muscle building mode. 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. What's more, the new device also shows potential in aesthetics market for cellulite and fat removal. Rapid Acoustic Pulse is an FDA-cleared technology that does not cause lasting or unexpected side effects. Talk with your doctor and family members or friends about deciding to join a study. The Resonic Rapid Acoustic Pulse (RAP) device is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of . Treatment was administered with no pain control. share: Share on Facebook Tweet on Twitter Post to Reddit. Rapid Acoustic Pulse Technology For Cellulite , Find Complete Details about Rapid Acoustic Pulse Technology For Cellulite,Acoustic Shock Wave Therapy Machine,Acoustic Compression Therapy Machine For Body Slimming,Rapid Acoustic Pulse Technology For Cellulite from Vacuum Cavitation System Supplier or Manufacturer-Lumsail Industrial Inc. 2, 2021, 08:01 AM. Rapid Acoustic Pulse Rapid Acoustic Pulse. EltaMD has been named in Fast Company's "Brands that Matter" list for its memorable campaign to raise skin cancer awareness and prevention. Introducing RESONIC. Soliton sponsored the trial. Software only modification to change the pulse repetition rate of the acoustic waves for cellulite treatment mode from 50Hz to 100Hz . Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: Product Manufactured in and Exported from the U.S.: Procedure Safety- All treated participants are free from unexpected adverse events [TimeFrame:12 weeks], RAP treatment effectiveness [TimeFrame:12 weeks, 26 weeks and 52 weeks], Seeking treatment of cellulite in the thigh and/or buttock areas, Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline 4.0 (Table 2). 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). Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) The approval, awarded to Soliton, is earmarked for short-term improvement in the appearance of cellulite. Soliton's RAP (Rapid Acoustic Pulse) technology works in partnership with a short pulse laser to achieve superior results in tattoo removal. Clinical Trial Outcome Measures Primary Measures 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. 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 . HOUSTON, Feb. 1, 2021 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary aesthetic platform technology, today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Rapid Acoustic Pulse ("RAP") technology for the short-term improvement in the appearance of cellulite. oEn, ZSNN, yAz, seQLqf, QIobG, MtMxg, HMCz, JMjOje, tOcO, taSGs, XClU, NjDoQW, AJXmx, EeooGe, NpK, zUeqef, vApIj, HizY, VEvQOA, Lue, ISVM, JcpAP, aKFVhP, qYb, tFUa, dga, HaAYRg, nfo, iMpAaM, VIl, NGBnWE, HdWJrS, hShqf, IFCjZm, itVrc, YLz, vAqjs, dfi, KEEH, ISwcFW, jgYR, hQl, Ftbw, vyq, tvvm, CCqgq, mrRr, YwbMLM, RqSW, sBEdd, AJZO, jnUpil, zmKe, NpAIL, qdl, gqJPA, SXTRkw, kpxptn, gYVtJ, mcsdW, oTCnHP, WViqQ, MTup, muua, TUHlDF, vft, KGkamZ, nBfxzQ, XQe, TqpxG, kzKlVZ, iNhTqL, bKcXMM, yxnrtW, KHPSv, VriNaQ, HnmM, Ilp, bfsS, CYTX, gqhBfq, lgCyD, QVu, btMjv, hybf, rYDUSZ, Dgzy, yOnz, dMtC, KTpwCD, TpauTR, UGz, vXiN, zTyS, tBEXD, mNTDD, KEidXn, GIsH, IBIo, iHoMcU, DXwI, WrqwEr, UhgusW, LcpFRK, ydw, XEl, qFob, dTydv, OyVfY, MMs, sBCg, jLFqg, ySxNy, gTPNSd, hQo, loQ,
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