Pear Therapeutics plans to add a new digital therapy for alcohol use disorder to its app-based treatment suite. This application-based program called reSET-A recently received a breakthrough device designation from the U.S. Food and Drug Administration.
It is estimated that alcohol use disorder affects 14 million people in the United States, but less than 10% of them receive any treatment within one year after diagnosis. According to a recent study Researchers at the University of Washington School of Medicine. Current treatment options include counseling, drug-assisted treatment to help eliminate craving or withdrawal effects, and mutual support groups.
If it can provide new or better treatments for life-threatening or debilitating diseases, the FDA will grant the device a breakthrough designation.Products that have received this designation are usually reviewed first to speed up market entry, although it no longer guarantees the medical insurance coverage of the device, because the Medical Insurance and Medicaid Service Center recently Canceled the overwrite rule This was finalized by the previous government.
Pear, based in Boston, currently has multiple app-based programs that focus on solving addiction problems, usually in combination with other treatment methods. For example, it has two FDA-approved therapies to address substance use and opioid use disorders, including modules for patients to understand their reasons for use and sober motives. It also has an FDA-approved insomnia application.
Now Pear has brought three digital therapies to the market Strive for coverage Through a health plan.This is also Committed to treating schizophrenia, Has not yet been approved by the FDA. Since the FDA has abandoned pre-market notification requirements for some software-based mental health products, Pear is able to open it to patients.
In addition, Pear also plans to go public through a merger with a special purpose acquisition company. This transaction will bring Pear’s value to $1.6 billion.
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