Pear Therapeutics was once regarded as a digital therapeutics pioneer, but its spiral into bankruptcy has the industry searching for the best path forward. While some favor going direct to consumers, others say the solution is in generating more robust clinical trial data to persuade hesitant payers.

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested […]

Pear Therapeutics’ Chapter 11 bankruptcy filing follows three corporate restructurings and the inability to secure additional financing to support commercialization of its FDA-cleared prescription digital therapeutics. An auction of Pear’s assets is expected to happen in early May.

Pear Therapeutics isn’t meeting the commercialization goals for its prescription digital therapeutics, so it’s now seeking strategic alternatives for the business. Prospective buyers can pick up Pear’s FDA-cleared products for substance use disorder, opioid use disorder, and insomnia.

Pear Therapeutics is implementing a corporate restructuring projected to save about $28 million. The goal is to extend its available cash as the company presses on with commercialization efforts for its digital therapeutics.

The company got a breakthrough device designation for its app-based program for alcohol use disorder, reset-A. Pear currently has FDA-cleared digital therapeutics to address opioid use and substance use disorders.

Digital therapeutics startup Pear Therapeutics struck a deal to go public through a blank-check acquisition that would value the company at $1.6B. But it still faces big challenges in selling its app-based treatments. 

EtectRx, which makes wireless sensors embedded in medications, struck a partner with Pear Therapeutics. The companies hope to build products together combining medication adherence data with digital therapeutics.

SoftBank’s second Vision Fund led the recent funding round. Pear plans to use it to accelerate reimbursement coverage for its three FDA-cleared products.

After receiving FDA clearance in March, Pear began marketing its prescription digital therapeutic for insomnia. It’s available by prescription only.

Lightened regulations and cancelled appointments have led to an uptick in the number of patients using digital therapeutics. But companies still face many of the same obstacles as before, including securing coverage and reimbursement from insurers.

Recent moves by the Food and Drug Administration have given digital health companies a big boost during the Covid-19 pandemic. The FDA gave Livongo an emergency use authorization to allow its blood glucose monitors to be used in hospitals, and has loosened requirements around the use of digital tools for mental health.

Pear Therapeutics received market authorization from the FDA for its insomnia digital therapeutic, Somryst. It is Pear’s third product to receive FDA clearance, and the first product to be reviewed under the FDA’s new software precertification pilot program.

Healthcare startups saw smaller amounts of investment after a record-breaking 2018, according to a report from Silicon Valley Bank. Despite the dip in funding, 2019 saw more deals overall, led by increased investment into healthcare technology companies.

Digital health companies faced bad news going into 2020, from job cuts to dissolving pharma partnerships. But these struggles are part of an industry that is finding its identity in a crowded healthcare market.

The company is adding several new products to its pipeline, including treatments for chronic pain and migraines, and voice-based biomarkers.

The companies will evaluate prescription digital therapeutics for patients with gastrointestinal diseases. Pear said it would allow the company to expand beyond its focus on neurological conditions.

Express Scripts will offer payers a curated list of technology and software-enabled applications and devices that have been vetted for safety, effectiveness and usability.

In exchange for ceding rights to develop, sell and market Akili’s two lead products in Japan and Taiwan to Shionogi, Akili will receive $20 million upfront and up to $105 million in additional payments dependent on reaching certain development and commercial milestones.

The startup previously developed the Sleepio application, which is targeted at insomnia, and is offered to around 12 million users through partnerships with payers and employers like Boston Medical Center, Comcast and the NHS.

The report also found that 56 percent of physicians have brought up the potential for a digital therapy as an option for their patients, and 26 percent have discussed the option after a patient brought it up.

A range of companies at the Digital Health showcase in San Francisco discussed how they view the changing regulatory environment within the category of software as a medical device.

The reSET-O prescription mobile application is directed at supporting patients using buprenorphine as a medicinal aid in treatment to overcome opioid addiction.

In 2018 alone, ten companies have inked mega-deals of more than $100 million including Livongo, 23andMe and American Well.

At the MedCity INVEST conference in Chicago last week, panelists shared insights on what companies need to consider for what can be a complicated pathway to reimbursement.

It’s not enough for a healthcare startup to just have cool technology. To get buy-in from investors, entrepreneurs have to showcase some healthcare economics chops, as well as a solid business model and reimbursement plan.

Pear Therapeutics Chief Medical Officer Yuri Maricich emphasized that the products Pear is developing with Novartis are intended to do more than support adherence. 

ECRI Institute has unveiled a list of 10 emerging innovations healthcare leaders should watch this year. A neonatal MRI system, direct-to-consumer genetic testing and VR for pediatric patients are among the topics that made the cut.

The picks span telecom giants to medtech companies but also include smaller companies with novel technologies such as digital therapeutics developer Pear Therapeutics and Tidepool — an open source technology developer to support diabetes management, .

The FDA’s clearance for the prescribed app, aimed at individuals as part of outpatient therapy for substance use disorders spanning alcohol, cocaine, marijuana, and stimulants, is a major milestone for digital therapeutics and suggests more companies will seek FDA approval.