Pear Therapeutics announced today that it received FDA breakthrough device designation for its reSET-A prescription digital therapeutic.
Boston-based Pear Therapeutics designed its reSET-A PDT product candidate for treating alcohol use disorder (AUD), adding to the company’s portfolio of PDTs for treating substance use disorder (SUD) and opioid use disorder (OUD).
The breakthrough device designation granted by the FDA marks the second received by Pear after reSET-O received the first-ever breakthrough nod for a PDT, with an indication for treating OUD, according to a news release. The company said there are no FDA-authorized medical devices or PDTs indicated for people suffering from AUD only at present.
“We believe that PDTs can bring effective, evidence-based treatments for alcohol use disorder to many more people and in doing so help address the public health burden of AUD,” Pear CMO Yuri Maricich said in the release. “We applaud FDA for recognizing the need to bring safe, effective, and innovative treatment options to patients and clinicians, and we look forward to working closely with FDA under the Breakthrough Devices Program to gain marketing authorization of our AUD-only PDT product candidate.”
News of breakthrough device designation comes a week after Pear announced that it received additional funding worth $50 million ahead of its upcoming merger.
Pear confirmed in June that it will go public by merging Thimble Point Acquisition Corp., a special purpose acquisition company (SPAC). A special meeting will be held for Thimble Point stockholders to vote on the merger on Nov. 30, and, subject to approval, the combination is expected to close shortly thereafter.