. Using the technology, Resonic delivers up to 100 pulses of high-pressure acoustic waves a second. RESONIC (Rapid Acoustic Pulse device) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. We believe that we will continue to see this dynamic throughout 2020. Soliton, Inc.is introducing new acoustic shockwave technology for quicker laser tattoo removal. 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. With content by and for clinicians, each edition offers unique perspective and insight regarding the latest developments in aestheticsfrom skincare to advanced proceduresand strategies for clinicians to successfully incorporate them into practice. One major drawback to the market is that tattoo removal is an elective, private pay procedure that can cost anything between $1,000 - $5,000 based on 10 visits to a laser removal clinic. 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. 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. The Company is based in Houston, Texas, and is actively engaged in . The Company recently completed a $35 million capital raise that it believes will extend the Company's cash runway through the third quarter of 2022 allowing the Company to support the eighteen months of the commercial launch of the RAP device. HOUSTON, July 21, 2020 /PRNewswire/ --Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary aesthetic platform technology, today provided an update regarding the U.S. commercialization of its Rapid Acoustic Pulse device indicating the initial U.S. commercial launch is now targeted for the first half of 2021. 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. We are also designing protocols for a proof-of-concept study specifically focused on skin laxity and will seek to initiate that trial as soon as possible. Tattoo Vanish is an all-natural tattoo removal in Miami approach that does not use lasers, acids, toxins or any other harmful chemicals. #SOLYUpdates Soliton Provides Special 510(k) and Commercialization Update Brad Hauser, President and CEO of the Company, commented, "With the FDA's acceptance of our special 510(k) . The new discovery helps explain our clinical trial results showing an improvement in the appearance of cellulite following use of the Companys RAP device. . Some of the statements in this release are 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 involve risks and uncertainties. Cellulite is a condition of the skin effecting between 80 90% of adult women. Also, the RAP disperses the steam vacuoles created by the lasers heat, allowing multiple effective laser passes in a single office visit. . Image Credit: Soliton Our RAP device appears to be capable of selective disruption of the fibrotic septa that contribute to the appearance of cellulite. We are honored to join the brand's legacy of cutting . This results in physical effects on targeted structures and tissues, such as fibrous septa. The Soliton Rapid Acoustic Pulse System is reported to provide 49% pigment fading in just one session compared to the 16% that is achieved using a laser only. Devices Dermatology FDA News Release - March 21, 2019 Soliton Files 510(k) with FDA for its Rapid Acoustic Pulse Device 510(k) Application for Premarket Clearance filed with the FDA for Rapid Acoustic Pulse ("RAP") device in tattoo removal To remove a single tattoo, it can take up to 12 sessions spaced out over the course of two years and each treatment can cost between $100 and $400. During the procedure, the technician will apply a local anesthetic to the . Ms. Jennifer Cook joined Soliton on July 1, 2020. Soliton is positioning its proprietary technology as a new standard of care in the multimillion-dollar tattoo-removal industry The company recently filed a 501(k) with the FDA for its Rapid Acoustic Pulse tattoo-removal device Soliton's cellulite reduction clinical trials have been featured on Yahoo Finance's First Trade live stream Medical device company Soliton Inc. (NASDAQ: SOLY) Soliton, Inc. 1,691 followers 11mo Revolutionary treatment from RESONIC is now available. However, the second problem results from the intense heat generated when the laser interacts with the ink. Emerging Technology Markets Soliton's RAP (rapid acoustic pulse) technology addressed 2 highly lucrative markets - tattoo removal and cellulite treatment. 17 related questions found. 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. Soliton has commenced an equity crowdfunding offering online through Flashfunders.com, offering investors the opportunity to participate in its Nasdaq Capital Market (Nasdaq) IPO. In April of 2020, Soliton announced a new launch plan for its acoustic pulse device electing to delay the originally planned mid-2020 launch for tattoo removal in response to the COVID-19 pandemic . from 8 AM - 9 PM ET. Soliton has conducted a clinical trial to confirm the effectiveness of the RAP device in assisting tattoo removal. Fixtures and tooling to build the prototype devices that will be used to validate our production line have been ordered as well as the components for the prototype and commercial devices to be built. All RIghts Reserved Privacy Policy. | The Medical Revolution Will Be Blogged. . Jennifer earned a Bachelor of Science in Business Administration and Marketing at Miami University of Ohio. 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. Some macrophages over-consume and become so full that they cant move, remaining where they are, and the agglomeration of ink they have consumed is visible through the skin as a tattoo. The agreement will see Aesthetic Solutions distribute Soliton's rapid acoustic pulse (RAP) device and advanced design cartridges during a U.S. commercial launch targeted for the first half of 2021. Clear. DST Changes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed in our SEC filings, including under the heading "Item 1A. 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 . The RAP device, applied as an accessory to the 1064 nm Nd:YAG QS laser, safely enables multiple QS laser treatments in a single office laser tattoo removal session by clearing the whitening caused by the previous QS laser pass. During the procedure, the technician will apply a local anesthetic . At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004. Join us at The Cosmetic Bootcamp starting tomorrow, June 24th, to learn more about RESONIC, our first-of-its-kind Rapid Acoustic Pulse technology. The most common method of tattoo removal uses a short-pulse laser to target tattoo macrophages and break down the agglomerations of ink into smaller particles that can be carried away by the bodys immune system. Soliton Rapid Acoustic Pulse Technology For Tattoo Removal and More. Existing treatment options currently available are surgical in nature and therefore invasive or require on average 4-6 treatments to reach the optimal results which then have a temporary effect. Sign up below to follow our story and to watch us grow. Prior to Apollo Endosurgery, Ms. Cook successfully designed and executed multiple consumer DTC launches across health & wellness, retail, consumer packaged goods, and telecommunication industries. Tattoo Vanish is an all-natural tattoo removal in Miami approach that does not use lasers, acids, toxins or any other harmful chemicals. Soliton says its RAP device has a 20x shorter pulse duration, and nearly 10 times the peak pressure of ZWave. When typing in this field, a list of search results will appear and be automatically updated as you type. At present, laser tattoo removal takes a significant number of sessions, with long waits between visits and a significant overall cost. inkey list q10 serum ingredients Fale conosco agora!. Join our more than 200K subscribers here to follow the Company:https://soly-investors.com. The Generation 1 RAP device received U.S. FDA clearance in May of 2019 for use as an accessory to the 1064 Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. RAP Technology for Cellulite,Fat Removal. The Soliton tattoo removal device works. This is where Solitons rapid acoustic pulse (RAP) device comes in. HOUSTON, March 21, 2019 /PRNewswire/ -- Soliton, Inc., (NASDAQ: SOLY) ('Soliton' or the 'Company'),a medical device company with a novel and propr. Medical technologies transform the world! If that were the only problem, as these upper particles are destroyed, an additional pass with the laser during the same treatment session would reach the next layer of particles and eventually, enough additional laser passes could reach most of the ink. Thanks Alda Karic, Pharm.D. We continue to explore and identify new target indications for our RAP device. . 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. 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. 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. On the right, the tattoo was removed in 3 sessions with Soliton RAP device plus laser. 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. 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. I had the pleasure of demonstrating and teaching our broader medical team about Resonic yesterday! In animal studies, Soliton also discovered that their patented shockwave technology may have the potential to blast apart fat cells which could make todays most popular fat reduction technologies more effective. 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. Imagine how much better it will be if a tattoo could be gone after just two or three office visits instead of the 10 to 12 visits over 1 to 2 years using current methods? Your physician will use a laser to treat the tattoo, then use a RESONIC Rapid Acoustic Pulse device to disperse the initial vacuoles, ink particles, and macrophages. As we speak with our advising physicians in the aesthetic space, it is clear that, while slowly starting to reopen, practices remain limited by social distancing requirements that are constraining the number of patients that can be seen each day. Soliton anticipates FDA clearance for this indication prior to the conclusion of the first quarter 2021. Here's my mini-rant: It is a dual-service device, Soliton has been cleared by the FDA for the assistance of tattoo removal and cellulite reduction. Back in May 2019, Soliton's device was cleared for use in tattoo removal, as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III. What's more, the new device also shows potential in aesthetics market for cellulite and fat removal. Is tattoo removal painful? The FDA has accepted the filing for substantive review. Because it significantly accelerates the removal process, we think tattoo owners will be much more likely to be satisfied with their results, which we believe will lead to a higher percentage of patients completing the process. Boustead Securities, LLC is the lead underwriter and Nasdaq Sponsor of the IPO. 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. Using Soliton's Rapid Acoustic Pulse technology, our innovative approach offers patients fast,. 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. Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. We believe the opportunity to launch both indications simultaneously will significantly enhance both physician and patient adoption and result in a stronger launch of our technology. 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.". The Company's first planned commercial product will use rapid pulses of. - On track to launch RAP device in 1H 2021 under COVID-19 Adjusted Commercialization Strategy -, - Present Cash Provides 2 years of runway through revenue initiation -. After achieving his PhD and completing a year of postdoctoral research, Conn pursued a career in academic publishing, before becoming a full-time science writer and editor, combining his experience within the biomedical sciences with his passion for written communication. Weather. Surgical treatments require anesthesia and usually result in significant downtime for the patient. 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. 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 bodys immune system attacks the invading ink pigment with macrophages to capture, consume and remove the ink from your system. 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 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. 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. While there, she built and launched a successful direct-to-consumer (DTC) marketing program that drove consumer demand and market development. 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. 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. 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. Eleven lines are currently operational (counting Lines 3a and 3b as separate lines), with extensions and additional lines in the planning and construction stage. For more information on the SOLY IPO and Offering Circular, visit: https://www.flashfunders.com/soliton. Join us and see the progress in real time. Trials. . 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. 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. These statements relate to future events, future expectations, plans and prospects. Dear reader, since you choose to block our ads, please click here to help support Medgadget. One of the major issues with laser tattoo removal is its limited efficacy. Explore the picturesque landscapes that inspired Monet, or take a short train ride to the . Soliton's Rapid Acoustic Pulse(RAP) device is an electrohydraulic (EH) device using Soliton's Rapid Acoustic Pulse (RAP) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts' Soliton Rapid Acoustic Pulse Technology For Tattoo Removal and More. What Happened Soliton has developed a breakthrough science for tattoo removal using. Time Zone. 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. We are making plans to launch the RAP device during the first half of 2021, which will include the tattoo removal and cellulite reduction indications, subject to FDA clearance of the latter. Time/General. 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 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. 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. Although the system mainly runs in . This timeline is based on our belief that there is a reasonable expectation that the FDA will allow us to remain on the 510(k) clearance pathway in order to market the product. We have entered into a manufacturing agreement with our global contract manufacturer signaling the initiation of the transition from the design stage to the manufacturing stage of the final device. Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. Soliton, Inc. is introducing new acoustic shockwave technology for quicker laser tattoo removal. 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. Soliton, Inc. is 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. 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. 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 reports that over 70 million people in the U.S. have tattoos, and of these, over 50% have considered tattoo removal. The Company's first FDA cleared commercial product, RESONIC, will use rapid pulses of acoustic . We expect this to impact the timing of Soliton's planned additional fibrotic scar proof-of-concept study and the longer-term follow-up visits in our cellulite pivotal study. CAPTION: In the image on the left, the tattoo is untreated. Soliton, Inc. is 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. Lippe Taylor is charged with driving awareness of Soliton's RAP (Rapid Acoustic Pulse) device, which uses acoustic wave technology to remove tattoos faster and cheaper than traditional laser removal does.
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