NJ-based digital health company Curio Digital Therapeutics Inc.
announces 510(k) clearance for MamaLift PlusTM, an eight-week
prescription digital therapeutic (PDT) for symptomatic treatment
for postpartum depression (PPD). Use of MamaLift Plus should be
undertaken only under the supervised care of a healthcare
provider.
The clearance is based on results of the Supporting Maternal
Mental Health and Emotional Regulation (SuMMER) study, a national,
sham-controlled, pivotal randomized controlled trial (RCT). The
SuMMER study successfully met primary and key secondary endpoints
for efficacy, as measured by EPDS scores.
Curio Digital Therapeutics Inc. announced that the U.S. Food and
Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
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
- March of Dimes.
https://www.marchofdimes.org/find-support/topics/postpartum/postpartum-depression#:~:text=PPD%20is%20the%20most%20common,women%20(about%2015%20percent).
- Bauman BL, et al. Morbidity and Mortality Weekly Report,
2020;69(19):575-581.X
- “ACOG Committee Opinion No. 757: Screening for Perinatal
Depression.” Obstetrics and gynecology vol. 132, 5 (2018):
e208-e212. Doi:10.1907/AOG.0000000000002927.
- 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
- 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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version on businesswire.com: https://www.businesswire.com/news/home/20240423992799/en/
Director of Product & Marketing Robert Keough
RobertK@curiodigitaltx.com