Pear Therapeutics announced Monday it had received Breakthrough Device Designation from the FDA for its prescription digital therapeutic aimed at treating alcohol use disorder, reSET-A.

The news comes just ahead of the company’s planned merger with a special purpose acquisition company, Thimble Point Acquisition Corp., which will allow it to trade publicly. Pear already has FDA-cleared digital therapeutics for substance abuse disorder, opioid use disorder and chronic insomnia. 

The Breakthrough Device Designation isn’t a marketing approval from the FDA, but it aims to accelerate review of products that could help treat debilitating or life-threatening conditions. 

“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,” Yuri Maricich, Pear’s chief medical officer, said in a statement.

“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.”

WHY IT MATTERS

Nearly 15 million people in the U.S. ages 12 and over had alcohol use disorder in 2019, according to the National Survey on Drug Use and Health. But only 7.2% of those with AUD had received any treatment. 

Meanwhile the CDC estimates more than 95,000 people die each year from alcohol-related causes. 

THE LARGER TREND

Last week, Pear announced it had secured up to $50 million in additional capital as part of the private investment in public equity funding, or PIPE, that is raised alongside the SPAC merger. A shareholder meeting to vote on the combination is scheduled for next week. 

The company had revealed its plans to go public via a SPAC – an increasingly popular way for digital health companies to make a public exit – in June this year.

In October, Pear announced that Massachusetts' Medicaid program, MassHealth, planned to cover its prescription digital therapeutics for treating substance and opioid use disorders, reSET and reSET-O.

The company has a number of therapeutics in its pipeline. reSET for substance use disorder received FDA De Novo clearance in 2017; reSET-O for opioid use was Pear’s second therapeutic to get the FDA nod in 2018; and Somryst for insomnia won marketing authorization in 2020.