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Soliton, Inc. (Nasdaq: SOLY) announced the initiation of a second pre-clinical study for its Rapid Acoustic Pulse (RAP) device aimed at treating liver fibrosis, following positive results from an initial study. The first study showed a 42% reduction in liver fibrosis 7 days post-treatment. The RAP device is FDA-cleared for tattoo removal and cellulite treatment but not yet for liver fibrosis. Soliton aims to validate its findings, potentially offering a non-drug treatment for the estimated 6-7% of the global population affected by liver fibrosis.
Soliton, Inc. (Nasdaq: SOLY) reported its fourth quarter and full year 2020 financial results, revealing a net loss of $4.5 million for Q4 and $14.5 million for the year. Total cash as of December 31, 2020, was $31.8 million, anticipated to fund operations into Q3 2022. The company highlights FDA 510(k) clearance for its RAP device for cellulite treatment, with plans for its commercial launch in Q2 2021. Soliton appointed Sean J. Shapiro as VP of Sales and initiated collaborations for clinical studies on fibrotic scars and liver fibrosis, positioning for growth and shareholder value.
Soliton, Inc. (Nasdaq: SOLY) has announced the brand name RESONIC™ for its Rapid Acoustic Pulse (RAP) Device, aimed at tattoo and cellulite treatment. The device received FDA 510(k) clearance for tattoo removal in May 2019 and cellulite treatment in February 2021, with an expected commercial launch in Q2 2021. CEO Brad Hauser expressed optimism about RESONIC being a significant advancement in aesthetic treatments, offering patients innovative solutions for unwanted tattoos and cellulite improvement.
Soliton, Inc. (Nasdaq: SOLY) announced positive pre-clinical results demonstrating that its Rapid Acoustic Pulse (RAP) therapy reduced liver fibrosis by 42% in a mouse model. This study validates the RAP mechanism while exploring treatment for a significant unmet medical need, as current treatments for liver fibrosis are lacking. The global market for liver fibrosis treatment is projected to reach US$ 28.1 billion by 2026. The RAP device is cleared by the FDA for cellulite and tattoo removal, with plans for commercial launch in the first half of 2021.
Soliton, Inc. (Nasdaq: SOLY) will release its fourth quarter and full year 2020 financial results on March 4, 2021, post-market close. A conference call will follow at 4:30 p.m. ET for discussion and live presentation, with dial-in numbers provided. The company’s proprietary technology aims to reduce tattoo removal costs while increasing profitability for practitioners. With FDA clearance for the 'RAP' device, Soliton is focused on commercialization and potential expansion into additional treatments. For details, visit Soliton's website.
Soliton, Inc. (Nasdaq: SOLY) announced that Brad Hauser, President and CEO, has joined the advisory board of the Aesthetic Industry Association (AIA). Hauser expressed enthusiasm about this role, emphasizing its potential to foster a mutually beneficial relationship between Soliton and AIA as the company advances towards commercialization. The AIA, founded in 2019, aims to promote the medical aesthetic industry, which is valued at $14 billion. This collaboration could enhance Soliton's market position and provide insights into the evolving aesthetic landscape.
Soliton, Inc. (Nasdaq: SOLY) announced FDA clearance for its Rapid Acoustic Pulse (RAP) technology, aimed at enhancing the appearance of cellulite. This non-invasive treatment requires a single session lasting 40-60 minutes and utilizes sound waves to disrupt fibrous structures without causing damage or downtime. Clinical trials reported high patient satisfaction, minimal pain, and no serious side effects. The company plans to commercialize the RAP device for both cellulite treatment and tattoo removal in the first half of 2021, addressing an unmet need in aesthetic procedures.
Soliton, Inc. (Nasdaq: SOLY) has announced a collaboration with the US Navy to conduct a proof-of-concept clinical study evaluating the safety and efficacy of its Rapid Acoustic Pulse (RAP) device for treating fibrotic scars. The study will take place at a US center with a maximum of 25 patients. Previous trials showed significant improvements in scars after treatment, with a 29.6% reduction in volume and 14.6% in height. The fibrotic scar treatment market is projected to reach $10 billion by 2025, providing Soliton a notable growth opportunity.
Soliton, Inc. has appointed Sean J. Shapiro as the new Vice President of Sales, effective January 1, 2021. This strategic move comes as the company anticipates FDA clearance for its RAP device aimed at cellulite reduction within Q1 2021. Shapiro brings extensive experience from his previous roles, including generating $11 million in revenue at Viveve and leading the launch of the $15 million Cellfina device at Merz. Soliton aims to leverage Shapiro's expertise to successfully commercialize its innovative medical devices.
