In a significant milestone for the rapidly evolving, and at times tumultuous behavioral digital therapeutics (DTx) industry, the FDA granted 510(k) clearance to a novel therapeutic developed by Curio Digital.
Curio’s eight-week prescription-only digital therapeutic treats mild to moderate postpartum depression in patients ages 22 and older in tandem with clinician-supervised outpatient care.
Postpartum depression affects up to 15% of people who give birth, according to the Cleveland Clinic.
“This is an incredible development for women suffering from postpartum depression who are looking for non-pharmaceutical alternatives given the shortage of trained mental health professionals,” Dr. Alice Domar, a women’s health expert and scientific advisor to Curio, said in a statement.
Princeton, New Jersey-based Curio develops technological, behavioral health interventions for women. The company received a $75,000 grant from the Commission on Science, Innovation and Technology (CSIT) Board in early 2023 to accelerate the development of its technologies.
Curio partnered with the Metro Nashville Public Schools system (MNPS) in December 2023 to provide MNPS members access to its MamaLift program.
The company also offers a digital health care platform for fertility and is developing another for menopause support. The platforms deliver therapeutic lessons in a gamified, multi-media format and also offer support from a chat bot, live health coaches and therapists, according to Curio’s site.
MamaLift Plus uses principles of cognitive behavioral therapy (CBT), behavioral activation therapy (BAT), interpersonal therapy (IPT) and dialectical behavior therapy (DBT) to treat postpartum depression.
“MamaLift is a game-changer for maternal mental health,” Dr. Shailja Dixit, founder and CEO of Curio, said in a previous statement. “It empowers mothers to take charge of their mental health and wellness and provides them with the tools and support they need to thrive.”
In 2017, Pear Therapeutics, a company that developed three digital therapeutics designed to treat substance use disorders (SUDs), became the first to receive an FDA de novo clearance.
The trailblazing company then rocked the digital therapeutic industry when it filed for bankruptcy and was later sold for parts.
Since then, difficulties with reimbursement have led DTx companies to largely pivot to the employer market.
Digital therapeutics company Akili Inc. (Nasdaq: AKLI) changed trajectories in September 2023, opting away from its prescription model and relying on non-prescription user subscriptions instead. The company also laid off 40% of its workforce.
The shift reduced Akili’s reliance on payers to reimburse its products, granting the company more control over its financial success, according to Eddie Martucci, CEO and co-founder of Akili.
“A non-prescription model removes reliance on intermediaries, which we believe will give us more control over our growth and enable us to build a lasting, sustainable business,” Martucci said in a statement.
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