Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available.
The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
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.
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.
German regulators have unveiled their initial report covering the prescription and deployment of reimbursable health apps. The survey was carried out by Hamburg-based health insurance fund Techniker Krankenkasse (TK) in conjunction with Bielefeld University in North Rhine-Westphalia and health care economics analysis research bureau Vandage GmbH, also based in Bielefeld.
Better Therapeutics Inc. reported that the pivotal trial for its BT-001 prescription digital therapy (PDT) demonstrated significant decreases in hemoglobin A1c at 90 days that improved further at 180 days in participants with type 2 diabetes. The study showed a clear dose-response between greater use of the PDT and improvements in blood glucose levels.
Akili Interactive Labs Inc. has made grabbing and holding attention a distinguishing feature of its digital therapeutics and overall company strategy. Last month, it made news with its hire of gaming industry veteran Jon David as its chief product officer. Now, a study indicates a new product in development may help people with depression extend their attention span and possibly improve cognition, two common symptoms associated with the mood disorder that are not treated by most medications.
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.