After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.
The U.S. FDA has issued a draft guidance for devices intended to address opioid use disorder (OUD), a problem with a massive public health footprint that has defied the efforts of public health programs. The draft guidance highlights some of the difficulties in executing pivotal studies for these devices, but the FDA’s July 27 press omits any mention of a 2018 innovation challenge for this category of devices, a programmatic effort that seems to have yielded little in the way of tangible results.
There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.
A financial freefall left prescription digital therapeutic pioneer Pear Therapeutics Inc. cut into four pieces following a bankruptcy judge’s approval of the sale of its assets for a total of $6.05 million. Sleep-focused Nox Health Group took the biggest bite, acquiring the FDA-cleared Somryst PDT for $3.9 million. Other buyers included Harvest Bio LLC, Click Therapeutics Inc. and Welt Corp. Ltd. The total generated from the assets was woefully short of the company’s $32 million in debt.
Pear Therapeutics Inc. filed for bankruptcy protection under chapter 11 to buy time to sell its assets. The company was the first-to-market for prescription digital therapies, with three PDTs gaining regulatory nods from the FDA: Reset for substance use disorder, Reset-O for opioid use disorder and Somryst for insomnia. Reset-A received breakthrough device designation in 2021. The Reset therapies are approved for use in conjunction with medication therapy or other outpatient therapy for substance use.
March 17 brought neither good luck nor good news to Pear Therapeutics Inc. Just prior to the opening bell, the prescription digital therapeutics company reported that it had engaged MTSA Health Partners LP to explore strategic alternatives for the company. In addition, Pear filed an 8-K with the SEC withdrawing its revenue and operating guidance for fiscal 2022 and 2023 and indicating that it does not plan to hold a fourth quarter and full year 2022 earnings conference call and webcast.
Sema4 Holdings Corp., Illumina Inc. and Pear Therapeutics Inc. joined a growing list of med-tech companies responding to what Pear CEO Corey McCann called a “challenging macroenvironment” by spinning off, selling or shuttering non-core lines of business and slimming payroll.
Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone.
Pear Therapeutics Inc. partnered with Softbank Corp. to bring a digital therapy for sleep/wake disorders to the Japanese market. Pear will develop the app, while Softbank will evaluate Japanese market potential with an option to negotiate an exclusive license for Pear’s Japanese sleep/wake disorder therapeutics.
The FDA gave Pear Therapeutics Inc. a second breakthrough device designation with the company’s Reset-A prescription digital therapeutic (PDT) for alcohol use disorder getting the regulatory agency’s speed pass. The news comes a week out from the vote of stockholders of blank-check company Thimble Point Acquisition Corp. Inc. on a combination with Pear that will take the digital therapeutic company public.
