Pear Therapeutics Receives Expedited Access Pathway Designation from FDA for reSET-O™ Prescription Digital Therapeutic to Treat Opioid Use Disorder
BOSTON, and SAN FRANCISCO, October 18, 2017—Pear Therapeutics, the leader in prescription digital therapeutics, today announced that it has received an Expedited Access Pathway (EAP) designation from the U.S. Food and Drug Administration (FDA) for its reSET-O™ Prescription Digital Therapeutic, the first of its kind designed for treating Opioid Use Disorder (OUD).
“The opioid epidemic continues to ravage cities and towns across this country with officials estimating even higher numbers of overdoses in 2017,” said Corey McCann, M.D., Ph.D., President and Chief Executive Officer of Pear Therapeutics. “With states struggling to provide treatment resources, we firmly believe that prescription digital therapeutics will change the way we address opioid dependence. We applaud the FDA for recognizing the need to bring innovative new treatment options to patients and clinicians and we look forward to closely working with them under the EAP program to accelerate access to reSET-O.”
BOSTON and SAN FRANCISCO – September 26, 2017 – Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the company has been selected as one of nine companies to participate in the FDA’s Digital Health Software Pre-Cert Pilot Program. The goal of the pilot program is to leverage the best processes and principles from all nine participants to inform the development of a new digital health regulatory framework. This announcement follows the recent FDA clearance of the company’s lead product reSET® for Substance Use Disorder (SUD), the first prescription digital therapeutic to treat disease.
“We commend the FDA’s Digital Health Innovation Action Plan initiative and the speed with which they are moving towards building a regulatory pathway to bring these important products to patients,” commented Corey McCann, President and Chief Executive Officer of Pear Therapeutics. “We are honored to be at the table with these eight other companies and the FDA as we help write the new chapter on digital health and digital therapeutics.”
BOSTON, and SAN FRANCISCO, September 14, 2017– Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Pear’s De Novo request, allowing the company to market reSET® for the treatment of patients with substance use disorder (SUD) under a new class of treatment. This is the first time that the FDA has cleared a Prescription Digital Therapeutic with claims to improve clinical outcomes in a disease.
“This is a defining moment for digital therapeutics and for patients with substance use disorder,” said Corey McCann, President and Chief Executive Officer of Pear Therapeutics. “As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET® has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas. Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology.”
The New England Venture Capital Association on Tuesday announced nominees in more than a dozen categories of its 5th annual NEVY Awards.
The awards are sponsored this year by General Electric (NYSE: GE) and winners will be announce May 17 at an event at the House of Blues.
“New England is home to some of the world’s brightest innovators and our new headquarters,” Sue Siegel, CEO of GE Ventures, said in a statement. “From the area companies solving complex challenges, to the venture capitalists funding the ideas, it’s important to recognize all the great work happening across the ecosystem and we’re happy to support the NEVYs to do just that.”
Pear Therapeutics to Collaborate with NIDA, Columbia University Medical Center Department of Psychiatry, and CleanSlate to Develop Enhanced Digital Therapeutics for Addiction
BOSTON and SAN FRANCISCO, July 11, 2017 /PRNewswire/ — Pear Therapeutics (PEAR) announced today that it is the recipient of a Small Business Innovation Research (SBIR) Fast-Track award funded by the National Institute on Drug Abuse (NIDA). Grant #R44DA042652 will support the development of next generation digital therapeutics to treat opioid use disorder (OUD). The effort will apply enhanced engagement and gamification mechanisms to reSET® and reSET-O™, PEAR’s current products for the treatment of substance use disorder (SUD) and OUD.
Utilizing Software Modules as an Enhancement to Pharmaceuticals for Chronic Conditions Is Poised to Be Critical Component of Digital Healthcare
NEW YORK, NY–(Marketwired – Oct 6, 2016) – Psilos Group, in its seventh annual Outlook outlining major emerging healthcare trends, says digital therapeutics is a $6 billion market opportunity by 2021. Digital therapeutics — “software as a drug” — deploys software modules as an enhancement, or even a substitute, to a drug. It is poised to become a critical component of digital health and to substantially improve the efficiency of American healthcare.
Health, technology, research, human behavior and public policy intersect at Connected Health Symposium 2016. Over 1,000 visionaries, leaders, practitioners and thinkers will gather for the 13th year at this premier destination event hosted by Partners HealthCare Connected Health.
The 13th Annual Connected Health Symposium: Digital Technology that Cares: Bringing the Human Element to Life
October 20-21, 2016, at Boston’s Seaport Hotel and World Trade Center
The Largest and Longest Study of Patients with Schizophrenia Interacting with Digital Therapeutics Results Released
Pear Therapeutics to Bring to Market Digital Therapeutics Based on Clinical Research from Dr. Dror Ben-Zeev et al for Patients with Severe Mental Illness
BOSTON, MA and SAN FRANCISCO, CA – Pear Therapeutics (PEAR), the creator of prescription digital therapies called eFormulationsTM, announced today results from a real-world implementation study examining a research version of THRIVETM, PEAR’s digital therapy for treating patients with Serious Mental Illness including schizophrenia, schizoaffective disorder, and bipolar disorder.
Pear Therapeutics Advances the First Regulated Digital Therapies for Addiction
Pear Therapeutics has grown significantly over the past year and now boasts forty employees split between the Boston, MA office and the San Francisco, CA location. NeuroInsights caught up with Dr. Corey McCann, founder and CEO, to learn about Pear’s progress developing digital therapeutics.
Wandering through booths at a neurogaming conference in downtown San Francisco this week was a little like finding myself in a science fiction infomercial.
This was the the fourth annual Experiential Technology & NeuroGaming Conference and Expo, where I mingled with neuroscientists and inventors, eager to explain the technology behind their multiwired headsets or sleek brain gadgets.