Science and research

Evidence you can check.

We publish how our programs were tested, what the results were, and who paid for the work. Every number on this page links to its source or says where it comes from.

Read the trial results Publications and sources

A clinician walking a colleague through outcome charts on a tablet

At a glance

FDA clearance: MamaLift Plus, 510(k) K223515, April 2024
Pivotal trial: SuMMER, NCT05958095, 141 women
Published: Journal of Medical Internet Research, 2025
Risk model: Curio-i, validated on ~2M lives

Featured study

The SuMMER pivotal trial of MamaLift Plus.

A randomized, double-blind, sham-controlled trial in women with postpartum depression, run in the US over 8 weeks.

DesignDecentralized, double-blind, sham-controlled, United States

Participants141 women aged 18 to 50 with clinician-confirmed postpartum depression (baseline EPDS 13 to 19), randomized 2:1: 95 to MamaLift Plus, 46 to a sham app

Length8 weeks

Primary endpointImprovement of 4 or more points on the Edinburgh Postnatal Depression Scale (EPDS)

FundingFunded by Curio Digital Therapeutics. All four authors, including founder Dr. Shailja Dixit, are Curio employees.

Patients meeting the primary endpoint at 8 weeksPercentage of participants, intent-to-treat and full analysis sets

Intent-to-treat

MamaLift Plus

86.3%

Sham app

23.9%

Full analysis set

MamaLift Plus

91.1%

Sham app

27.5%

0%50%100%

Intent-to-treat: 82 of 95 vs 11 of 46, p<.0001. Response is an improvement in symptoms, not remission. Source: JMIR 2025;27:e69050.

Regulatory status

MamaLift Plus is FDA-cleared.

Cleared through the FDA’s 510(k) pathway as a prescription digital therapeutic for postpartum depression.

View the FDA 510(k) record

510(k) numberK223515

Decision dateApril 22, 2024 (substantially equivalent)

Device classClass II, product code SAP

Regulation21 CFR 882.5801, computerized behavioral therapy device

Predicate deviceSomryst (K191716)

IndicationPrescription-only, 8-week neurobehavioral program for patients 22 and older with mild to moderate postpartum depression, as an adjunct to clinician-managed outpatient care.

Predictive analytics

Curio-i finds risk earlier.

Our predictive model identifies maternal mental health risk as early as the second trimester, so outreach and screening can start before symptoms escalate.

Curio internal data. Model methodology and validation summary available to partners on request.

~2Mlives in the validation data

2ndtrimester: earliest point risk can be flagged

How we measure

Validated measures at intake, every visit and discharge.

Standard, published questionnaires track symptoms over time, so therapists, patients and referring clinicians see the same picture.

EPDSEdinburgh Postnatal Depression Scale: depression during pregnancy and after birth

PHQ-9Patient Health Questionnaire: depression severity

GAD-7Generalized Anxiety Disorder scale: anxiety severity

SCI-8Sleep Condition Indicator: sleep problems and insomnia

Therapeutic approaches in our programs

Cognitive behavioral therapy (CBT)Interpersonal therapyMindfulness-based skillsTrauma-informed careMedication managementPrescription digital therapeutics

Research and real-world results

What we’ve seen across our programs.

2,500+women included in over 3 years of Curio research

2 of 3cases of postpartum depression avoided, in Curio’s research

<4 hrsfrom referral to first outreach attempt

80%of patients with access to care within 72 hours

Curio internal research and operational data. Access figures: January to June 2026, 1,250 referred patients.

Publications and sources

Read the primary sources.

Researchers and partners can request our full evidence pack, including study protocols and the Curio-i validation summary.

Request the evidence pack

SuMMER pivotal trial results Journal of Medical Internet Research, 2025;27:e69050. Peer-reviewed.
Trial registration NCT05958095 ClinicalTrials.gov, US National Library of Medicine.
FDA 510(k) premarket notification K223515 US Food and Drug Administration database.
FDA clearance announcement, April 2024 Curio Digital Therapeutics press release, Business Wire.
Pivotal trial meets efficacy endpoints, October 2023 Curio Digital Therapeutics press release, Business Wire.

Research questions

Questions about our research?

Whether you’re looking for care, referring a patient, exploring a partnership or need help with your account, our team will point you in the right direction.

Email supportcontact@curiohealthcare.com