Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug Administration (FDA) Clearance of MamaLift Plus™, the Fir

PRINCETON, N.J. & NEW YORK , April 23 /Businesswire/ - Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift Plus^TM. MamaLift Plus is the first prescription digital therapeutic for the treatment of postpartum depression (PPD), a complex mental health disorder affecting as many as one in seven women with a recent live birth experience.¹

MamaLift Plus is a prescription‐only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of and older, as an adjunct to clinician‐managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.

MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for postpartum depression. CBT, BAT, IPT, and DBT are neurobehavioral treatments which focus on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate during postpartum depression. 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 is based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER). SuMMER is a national, sham-controlled RCT. 141 participants who had recently had a live birth and were diagnosed with PPD were enrolled in the study.

“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.

The study met its primary endpoint, improvement of four or more points on the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a clinically validated screener that is recommended by the American College of Obstetricians and Gynecologists (ACOG). In the intent-to-treat (ITT) population, 86.3% (82/95) of participants in the MamaLift Plus arm achieved a clinically meaningful improvement, versus in the sham control arm, where only 23.9% (11/46) of participants achieved a four-point improvement with a p-value <0.0001.

“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,” said Alice D. Domar, PhD, top women's health expert, Curio Scientific Advisor.

Further details of the study are available in the Instructions For Use, available here.

To learn more about MamaLift Plus and sign up for updates, click here. Healthcare providers can access additional information at https://curiodigitaltx.com/.

INDICATION FOR USE

MamaLift Plus is a prescription‐only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of and older, as an adjunct to clinician‐managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.

SAFETY INFORMATION

MamaLift Plus is not intended to be used as a stand-alone treatment. MamaLift Plus may not be appropriate for everyone. Patients with severe depression or anxiety, Serious Mental Illness (SMI), psychosis, suicidal thoughts, or who are under the age of 22 should not use MamaLift Plus. Patients should dial 911 or go to the nearest emergency room in the event of a medical emergency. MamaLift Plus is intended to be used under the supervision of a qualified health care provider.

ABOUT SUMMER

SuMMER is a national, sham-controlled, pivotal randomized controlled trial (RCT). The study enrolled 141 participants who had recently given birth and were diagnosed with PPD. Participants were randomized to the MamaLift Plus arm or the sham control arm. Participants were blinded to knowledge of their treatment arm. Participants used MamaLift Plus or sham control every day for eight weeks. Efficacy was measured using the EPDS scale.

ABOUT POSTPARTUM DEPRESSION

Postpartum depression is estimated to affect approximately one in seven women who have given birth in the U.S. or approximately 500,000 women annually.^1,2 Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy.³ Clinical guidelines for treatment of postpartum depression recommend medication and cognitive behavioral therapy. However, many women may not be able to access these medications and treatments due to national shortages in mental health providers, insurance coverage, childcare challenges, transportation issues, or breastfeeding status. Hence, there is an unmet need for novel treatment modalities.

ABOUT PRESCRIPTION DIGITAL THERAPEUTICS

Digital therapeutics are health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.⁴ A prescription digital therapeutic (PDT) is a digital therapeutic only available to patients by a prescription from a healthcare provider. PDTs can be used independently or in conjunction with medications, devices, or other therapies to optimize patient care under the guidance of their healthcare provider.⁵ As a new modality of treatment, PDTs deliver medical interventions directly to patients from their smartphones using software programs that are subject to clinical evidence requirements and regulatory oversight and are recognized as medical devices by the FDA.

ABOUT CURIO DIGITAL THERAPEUTICS, INC.

Curio Digital is a pioneer in developing digital therapeutics solutions and interventions across the behavioral health continuum for women throughout the cycle of life. Curio aims to create a world where every woman can access a behavioral health solution at her fingertips. Curio is reshaping maternal mental health care by leveraging proprietary algorithms, clinically validated screening tools, and personalized digital behavioral interventions to facilitate timely identification and care. Curio aspires to make women’s health products and solutions across their life cycle. MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. Curio’s AI-driven predictive algorithm, Curio-I, identifies and risk stratifies women who would go on to develop common behavioral health conditions. For more information, visit Curio at www.curiodigitaltx.com.

CITATIONS

1. March of Dimes. https://www.marchofdimes.org/find-support/topics/postpartum/postpartum-depression#:~:text=PPD%20is%20the%20most%20common,women%20(about%2015%20percent).
2. Bauman BL, et al. Morbidity and Mortality Weekly Report, 2020;69(19):575-581.X
3. “ACOG Committee Opinion No. 757: Screening for Perinatal Depression.” Obstetrics and gynecology vol. 132, 5 (2018): e208-e212. Doi:10.1907/AOG.0000000000002927.
4. Digital Therapeutics Alliance. www.dtxalliance.org FACT SHEET DTA’s Adoption & Interpretation of ISO’s DTx Definition. Accessed February 13, 2024. https://dtxalliance.org/wp-content/uploads/2023/06/DTA_FS_New-DTx-Definition.pdf
5. Digital Therapeutics for Management and Treatment in Behavioral Health. Accessed February 5, 2024. https://store.samhsa.gov/sites/default/files/pep23-06-00-001.pdf

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