Pear therapeutics announced Monday that it has received Breakthrough Device Designation from the FDA for its prescription digital therapeutic for the treatment of alcohol use disorders, reSET-A.
The news comes just before that of the company proposed merger with a special acquisition company, Thimble Point Acquisition Corp., which will enable it to trade publicly. Pear already has FDA-cleared digital therapeutics for substance abuse disorders, opioid use disorders, and chronic insomnia.
the Breakthrough Device Designation isn’t FDA approved, but it aims to expedite the review of products that could help treat debilitating or life-threatening diseases.
“We believe PDTs can provide many more people with effective, evidence-based treatments for alcohol abuse disorder and help reduce the AUD burden on public health,” said Yuri Maricich, Pear’s chief medical officer, in a statement.
“We applaud the FDA for recognizing the need to provide safe, effective, and innovative treatment options to patients and clinicians, and we look forward to working closely with the FDA on the Breakthrough Devices program to bring our PDT to market approval. Product candidates only available for AUD. “
WHY IT IS IMPORTANT
Almost 15 million people in the United States ages 12 and over had alcohol abuse disorder in 2019. according to the National Survey on Drug Use and Health. But only 7.2% of patients with AUD had received treatment.
The CDC now appreciates more than 95,000 people die each year from alcohol-related causes.
THE BIGGER TREND
Last week, pear announced that it has raised up to $ 50 million in additional capital through the private investment in public equity finance (PIPE) raised as part of the SPAC merger. A shareholders’ meeting to vote on the merger is planned for next week.
The company announced its plans to go public SPAC – an increasingly popular way for digital health companies to make a public exit – this June.
In October, Pear announced that Massachusetts’ Medicaid program, MassHealth, planned to cover its prescription digital therapeutics for the treatment of 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 de novo approval from the FDA in 2017; reSET-O for opioid use was Pear’s second therapeutic to receive FDA recognition in 2018; and Somryst for insomnia received marketing approval in 2020.