This new device aims to allow numerous laser passes per session, and the company claims that tattoos can be removed in as little as two to three sessions. Forward-looking statements in this press release include, without limitation, the ability of the Company to execute a limited launch, the potential for the cash on hand to support operations through the third quarter of 2022, the ability to receive FDA clearance for our cellulite indication, our ability to remain on a 510(k) clearance path and therefore receive clearance on our suggested timeline, our ability to successfully transition to manufacturing and build the commercial devices, and our ability to successfully attract and retain necessary personnel. The device was indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal from the arms, legs and torso in people with Fitzpatrick Skin Type I-III. These vacuoles act as an additional shield, preventing the laser energy from reaching any more ink. Non-invasive treatment options exist primarily of radio frequency-based technologies and have a temporary effect after the patient completes 4-6 treatment sessions. What Happened Soliton has developed a breakthrough science for tattoo removal using. Allergan Aesthetics is set to acquire Soliton and Resonic, its Rapid Acoustic Pulse device. from 8 AM - 9 PM ET. 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" You can't be sure that you're going to get 100 percent clearance on a tattoo , and that's for a variety of reasons, including the type of ink and if [the tattoo] was done by a professional tattoo parlor," he says. Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. There was no incumbent agency. Given the state of the dermatology marketplace today, we have experienced significant follow-up visit cancellations in our ongoing 26-week cellulite clinical trial assessment and increased difficulty in executing the initiation of further clinical trials at sites around the country. We are extremely encouraged with the RAPs potential applications in the aesthetics industry and are gratified that our Scientific Advisory Board now includes a number of top dermatologists and that our Board of Directors includes current and past executives from the makers of CoolSculpting, who are able to provide important guidance as we develop this technology, Klemp says. The Proof-of-Concept (POC) Trial involved a study of five patients with moderate to severe cellulite, each treated on their thighs, with Soliton's RAP device. 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 University of Texas on behalf of MD Anderson Cancer Center. Soliton says its RAP device has a 20x shorter pulse duration, and nearly 10 times the peak pressure of ZWave. . Prior to Apollo Endosurgery, Ms. Cook successfully designed and executed multiple consumer DTC launches across health & wellness, retail, consumer packaged goods, and telecommunication industries. Using the technology, Resonic delivers up to 100 pulses of high-pressure acoustic waves a second. The RAP device has received 510(k) clearance for use in tattoo removal but remains investigational for use in improving the appearance of cellulite and scar treatment. December 26th, 2018 Conn Hastings Dermatology, Plastic Surgery. Using Soliton's Rapid Acoustic Pulse technology, our innovative approach offers patients fast,. The laser needs a line-of-sight to the pigment-containing structures, and therefore only hits the uppermost pigment agglomerations in each pass. Cision Distribution 888-776-0942 However, a single laser session usually results in only an 1116% reduction in pigment in the treated area, and then a six-week waiting period between sessions is required to allow the skin to heal. We believe that we will continue to see this dynamic throughout 2020. The word "Insider". This will speed up the procedural process by fading the pigment in less time with fewer treatments and downtime to make it a great alternative to present technologies. Tattoo Vanish is an all-natural tattoo removal in Miami approach that does not use lasers, acids, toxins or any other harmful chemicals. Soliton Rapid Acoustic Pulse Device While it isn't yet available for commercial use, Soliton's Rapid Acoustic Pulse (RAP) Device is meant to speed up the traditionally lengthy tattoo removal process. Further usability and manufacturability enhancements are planned that will reduce the cost of goods and improve margins. The acoustic shockwave technology may . These statements relate to future events, future expectations, plans and prospects. Soliton (NASDAQ: SOLY) says that this approval from the FDA will allow it to move out of the R&D segment and into commercialization of its product. Although preclinical animal testing demonstrates the ability of RAP to accelerate tattoo fading in multiple colors, the Companys human clinical trials to date have been limited to black tattoos. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. This process is highly inefficient because of two key problems. This results in physical effects on targeted structures and tissues, such as fibrous septa. Therefore, patients typically must wait 6-8 weeks for the vacuoles to dissipate naturally and for their skin to recover. 2022 Bryn Mawr Communications III, LLC. The Company expects to initiate its U.S. commercial launch in the first half of 2021. Can you 100 remove a tattoo? It uses acoustic pulses to disrupt vacuoles in the tissue and helps to further disperse pigment agglomerates. How much will soliton tattoo removal cost? While we are steadfastly focused on our revised U.S. commercialization plans, we believe that we can demonstrate real value in other target indications and will work to do just that.". Commercial upgrades to the Generation 2.0 device to improve usability were subsequently approved through a Special 510(k) in March of 2020. Soliton Inc.Tattoo Removal AnimationFor more information visit: https://www.soliton.com/technology/The Basics: Tattoos \u0026 MacrophagesThe most common method of tattooing uses an electric tattoo machine which rapidly injects ink into the skin. The Company is based in Houston, Texas, and is actively engaged in . Jennifer earned a Bachelor of Science in Business Administration and Marketing at Miami University of Ohio. I had the pleasure of demonstrating and teaching our broader medical team about Resonic yesterday! Soliton's RAP device utilizes a rapid pulse of acoustics to break apart the fibrous septa band underneath the skin that causes cellulite. Free Reports from TheStreet Shares of medical device maker Soliton ( SOLY) were soaring for a second day in trading Wednesday after the Food and Drug Administration approved its Rapid. . In human clinical trials, this new method allowed the Soliton RAP treatments to be up to three or more times as effective than laser alone. Soliton is built on a technology called Rapid Acoustic Pulse. During 2020, we plan to hire members of our Practice Development Team to support the initially placed devices through training programs regarding both the implementation of the technology and practice development tools designed to help doctors attract eligible patients to their offices for Soliton RAP treatments. Soliton also announced that its preliminary offering circular has been qualified by the Securities and Exchange Commission (SEC) pursuant to Regulation A, making the offering open to both accredited and unaccredited investors. Soliton, Inc. | 1,620 followers on LinkedIn. The concept involves treating the area with the RAP device between laser passes, meaning that multiple passes with a laser can be performed in each session, helping to greatly reduce the amount of pigment remaining in the tissue. Soliton is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. Weather. There can be no assurance that RAP will show the same level of efficacy on colors other than black in future clinical trials. We continue to explore and identify new target indications for our RAP device. Soliton's RAP (Rapid Acoustic Pulse) technology works in partnership with a short pulse laser to achieve superior results in tattoo removal. The RESONIC device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation. Soliton has also filed an application to list its common stock on Nasdaq under the symbol SOLY. According to their website: "Soliton's RAP (Rapid Acoustic Pulse) Device works in partnership with a short pulse laser to achieve superior results in tattoo removal." Soliton's solution uses rapid acoustic pulse technologies in between traditional short pulse laser . This potential indication could position Soliton RAP as a stand-alone device, without the need for lasers or other procedures. We're excited to announce that Allergan Aesthetics, an AbbVie company has acquired Soliton to complement their body-contouring portfolio. Soliton Rapid Acoustic Pulse Technology For Tattoo Removal and More. The Company's first. The Company's first planned commercial product will use rapid pulses of. Current tattoo removal practices typically require eight to 12 sessions with a dermatologist or physician over the course of one to two years. In pivotal human clinical trial of 32 tattoos, one treatment session using the Soliton RAP method resulted in an average of 49 percent fading, compared with just 16 percent fading using laser alone. While there, she built and launched a successful direct-to-consumer (DTC) marketing program that drove consumer demand and market development. Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. 510(k) Application for Premarket Clearance filed with the FDA for Rapid Acoustic Pulse ("RAP") device in tattoo removal 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 [] Wally Klemp, Executive Chairman Soliton (NASDAQ:SOLY) has filed a 510 (k) submission for FDA clearance of its Rapid Acoustic Pulse (RAP) technology for reduction in the appearance of cellulite, which affects between 80% and 90% of women. Soliton Inc.Tattoo Removal AnimationFor more information visit: https://www.soliton.com/technology/The Basics: Tattoos & MacrophagesThe most common method of. Your body will naturally begin to remove the dispersed particles, through the lymphatic system. The Soliton tattoo removal device works. Creates audio waves from 2 to 6 MPa @ 100 Hz, Reduces electrode wear normally associated with electro-hydraulics, Reduces unwanted frequencies that cause heat and pain. Soliton, Inc. 1,691 followers 11mo Revolutionary treatment from RESONIC is now available. 36 related questions found. The patented Rapid Acoustic Pulse (RAP) device uses acoustic shockwaves that accelerated the speed of tattoo removal when used with lasers, delivering results in as little as two to three treatments versus the 10 to 12 average with the current standard of care lasers alone, the company states in a news release. The acoustic shockwaves from Soliton's RAP device are capable of blasting apart the ink clusters within the skin, making more ink particles vulnerable to laser treatment. As soon as it is feasible, we will continue our cellulite clinical trial 26-week follow up visits and initiate the additional fibrotic scar proof-of-concept study. The first is what we call particle shielding. Because lasers are line of sight, meaning they can only hit what they can see, the particles at the top of the agglomerations shield the particles below. During the procedure, the technician will apply a local anesthetic to the . Although the surface vacuoles will dissipate within an hour or more, the deeper vacuoles below the skins surface will persist for days, so additional laser passes in the same treatment session have no significant effect. The Soliton tattoo removal device works. 2022 Soliton Inc. | All Rights Reserved, Soliton Inc. 60601 Electrical Safety certified; 2 MOPP/MOOP. The proceeds from the financing will fund the initial commercialization of the product described above, including the early manufacturing, fundamental brand development investment, and the initiation of a sales force and practice development team instrumental in developing relationships with key customers. Soliton is investigating potential additional capabilities of the RAP technology in clinical and preclinical testing, including the potential to improve the appearance of cellulite and the potential to treat keloid and hypertrophic scars by targeting the stiffened environment in the intracellular matrix. Sign up below to follow our story and to watch us grow. HOUSTON, March 21, 2019 /PRNewswire/ -- Soliton, Inc., (NASDAQ: SOLY) ('Soliton' or the 'Company'),a medical device company with a novel and propr. This creates an instant explosion of steam vacuoles, both at the surface of the skin (visible as blisters) as well as below the surface just above the macrophages. Sun & Moon. Rising like a royal palace and gardens from the French countryside 30 miles from glittering Paris and Disneyland Paris Marriott's Village d'Ile-de-France offers the ideal balance between nature and culture. Soliton, Inc.'s Post Soliton, Inc. 1,715 followers 2y Report this post #SolitonSays Jennifer Brabham, Soliton's Finance and Accounting Coordinator, has been working diligently to . Medgadget, Inc. All rights reserved. Thanks most kindly for your help. This clinical trial is early stage and intended as a proof-of-concept and there is no assurance that the trial will have a successful outcome. Explore the picturesque landscapes that inspired Monet, or take a short train ride to the . Soliton completed the design and initiated manufacturing of the Generation 2.0 RAP device with global manufacturing partner Sanmina and that device has passed all verification and certification testing. Medical technologies transform the world! The RESONIC device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation. At its core, it is a fibrotic disorder that occurs with the septa that connect the dermis to the muscle become hardened and pull downward allowing the fat cells to push up resulting in dimples and ridges. Join us at The Cosmetic Bootcamp starting tomorrow, June 24th, to learn more about RESONIC, our first-of-its-kind Rapid Acoustic Pulse technology. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton is testing other uses for the device such as targeting cellulite. Soliton's sales and marketing efforts to support the initial commercial launch are led by Jim Bucher, our previously announced Consulting Head of Sales, and newly appointed Vice President of Marketing, Ms. Jennifer Cook. The impact of COVID-19 on the global economy continues to be significant. Soliton (NASDAQ: SOLY) says that this approval from the FDA will allow it to move out of the R&D segment and into commercialization of its product. At present, it can take 10 or more sessions, spread over a one to two year period, to remove tattoos using conventional laser techniques. Results of proof-of-concept, preclinical studies on the use of a new version of the company's acoustic pulse technology reveal that, in addition to the RAP device's 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. Soliton has commenced an equity crowdfunding offering online through Flashfunders.com, offering investors the opportunity to participate in its Nasdaq Capital Market (Nasdaq) IPO. The acoustic shockwaves from Solitons RAP device are capable of blasting apart the ink clusters within the skin, making more ink particles vulnerable to laser treatment. 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