Medical device company Soliton, Inc. (NASDAQ: SOLY) reacted Friday to a blog post calling the firm a "PR machine" and addressed whether it can achieve Food and Drug Administration clearance to market its new Rapid Acoustic Pulse technology.
RAP technology has the ability to reduce cellulite and aid in tattoo removal, according to Soliton.
The Seeking Alpha post by White Diamond Research said Soliton has issued 17 press releases since March with little real news following a Reg A+ IPO in Feburary. The post accuses Soliton of being "years from having an FDA approved product."
Soliton shares were trading higher by 12.31 percent at $8.11 at the time of publication Friday.
Soliton responded to the Seeking Alpha post Friday with an 18th press release.
The blog contains "numerous misstatements" of fact, and the company said it has been "compelled to comment on the most egregious of those misstatements to ensure that investors are not further misled."
The company is aware of the focus on whether and when Soliton can secure FDA clearance to market the RAP technology, Dr. Chris Capelli, the company's CEO, said in the press release.
Soliton submitted a 510(k) request for marketing clearance in March, and the targeted time period for review is 90 days, Capelli said.
"This means we should be receiving feedback from the FDA before the end of this month. Importantly, we have not been notified that our application must be converted to a 'De Novo' process, the approval of which can take considerably longer to secure," the CEO said.
"While we cannot be certain that our application will continue as a 510(k) or that our application will eventually be cleared, we are now cautiously optimistic that our RAP device could be cleared sooner than we have been estimating."
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