Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.
Pear Therapeutics Inc. released nine-month, real-world data showing long-term reduction in costly health care utilization categories, including inpatient stays and emergency department visits, in patients with opioid use disorder (OUD) who utilize its Reset-O prescription digital therapeutic. The findings suggest that Reset-O could help to stabilize patient outcomes long-term when used in conjunction with outpatient treatment.
Pear Therapeutics Inc. has joined a growing number of med-tech startups that are merging with special purpose acquisition companies (SPACs) as a backdoor pathway to an initial public offering (IPO). On Tuesday, Pear, a company developing digital therapeutics, reported plans to combine with Thimble Point Acquisition Corp., a blank check company affiliated with the Pritzker Vlock Family Office (PVFO), in a deal valued at approximately $1.6 billion. The $400 million in gross proceeds, including roughly $276 million in cash held in Thimble’s trust account and about $125 million, at $10 per share, from an oversubscribed PIPE (private investment in public equity), will be used to further commercialize Pear’s three FDA-authorized products, advance its pipeline and scale its end-to-end platform.
Pear Therapeutics Inc. has seen its efforts in the prescription digital therapeutics (PDT) space come to fruition with two new deals reported this week. The Hartford Financial Services Group Inc. now covers two of the company's therapeutics – Reset, for substance use disorder, and Reset-O, for opioid use disorder – for its employees and their beneficiaries. Preferredone will also cover the two PDTs for all its members.
Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 to address depressive symptoms in multiple sclerosis (MS).
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 – which Pear Therapeutics is developing in collaboration with Basel, Switzerland-based Novartis AG – to address depressive symptoms in multiple sclerosis (MS).
