A Houston-based company plans to begin selling its device on the commercial market after clearing a final hurdle from the U.S. Food and Drug Administration last month.
Soliton Inc. (Nasdaq: SOLY), a medical device company focused on the aesthetics industry, received FDA clearance for use of its rapid acoustic pulse medical device in the short-term improvement of the appearance of cellulite. The new application of Soliton's platform is in addition to the removal of tattoos, which the company received FDA clearance for in 2019.
With the newest FDA clearance, Soliton plans to begin rolling out its rapid acoustic pulse devices, branded as Resonic, to a select group of clinicians by the second quarter of 2021, said Soliton President and CEO Brad Hauser.
"All functions across the organization are driving towards making sure that we get our product out and get our customers trained up," Hauser said. "We'll go to some of the premier [plastic surgeons] and dermatologists that will then influence, talk about Resonic in trade shows, on podiums and in peer-to-peer conversations."
Hauser, who was hired as Soliton's new chief executive late last year, said the company is taking steps to prepare for a nationwide commercial launch. Soliton hired Sean Shapiro as its vice president of sales effective Jan. 1. Shapiro joined from Colorado-based women's health company Viveve Medical Inc. (Nasdaq: VIVE), where he served as vice president of commercial operations.
Soliton has also brought on a number of new employees in commercial sales and post-market functions, like product surveillance and customer support. The company's headcount has grown to more than 20, up from around a dozen employees when Hauser was hired as CEO last year.
Following the select rollout of Resonic devices in 2021, Soliton is planning for nationwide commercialization in 2022. Hauser said that as the company begins to add accounts, Soliton will need to hire additional sales representatives to acquire new accounts and practice development leaders, who make sure a practice is marketing to its patients effectively. Soliton expects many of its employees in Houston to focus on sales support, customer service and product surveillance functions.
"We'll be growing significantly over the next several years as we start to get up to scale," Hauser said.
Soliton went public on the Nasdaq Capital Market in February 2019, when the company closed an initial public offering at $10.4 million.
