Curio Digital Therapeutics has achieved a significant milestone with the recent clearance of MamaLift Plus by the U.S. Food and Drug Administration (FDA). This marks a notable advancement, as MamaLift Plus becomes the first prescription digital therapeutic authorized for the treatment of Postpartum Depression (PPD).

Postpartum depression affects approximately one in seven women who have recently given birth in the U.S., equating to around 500,000 women annually. Despite its prevalence, accessing appropriate treatment can be challenging due to various factors, including shortages in mental health professionals, insurance coverage limitations, childcare responsibilities, transportation issues, and breastfeeding considerations. Hence, there exists a significant unmet need for novel treatment modalities for PPD.

MamaLift Plus is specifically designed to address this gap, offering a prescription-only digital therapeutic to provide neurobehavioral interventions for patients aged 22 and older, in conjunction with clinician-managed outpatient care. It effectively treats mild to moderate PPD by improving patients’ symptoms of depression, utilizing evidence-based approaches such as Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT).

MamaLift Plus can be used on a mobile device, such as a smartphone or tablet.

“MamaLift Plus opens a new chapter of prescribed digital therapeutics that provide women with a non-pharmaceutical alternative. I am happy to support this groundbreaking innovation,” said Jean-Pierre Lehner, MD, ex-Global CMO Sanofi, and Board of Director Curio.

The clearance of MamaLift Plus follows the successful completion of the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) study, a national, sham-controlled, pivotal randomized controlled trial (RCT). In this study, MamaLift Plus demonstrated significant efficacy in improving symptoms associated with PPD, as measured by scores on the Edinburgh Postnatal Depression Scale (EPDS).

The EPDS is a clinically validated screener recommended by the American College of Obstetricians and Gynecologists (ACOG). Results from the SuMMER study showed that participants using MamaLift Plus achieved a clinically meaningful improvement, with 86.3% experiencing a reduction in symptoms compared to only 23.9% in the sham control arm.

“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health. MamaLift Plus is the first and only digital solution that can help address the serious unmet need uniquely faced by women who have recently delivered,” said Shailja Dixit, MD, MPH, MS, CEO & Founder of Curio Digital Therapeutics.

“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,” adds Alice D. Domar, PhD, women’s health expert, Curio Scientific Advisor.

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