Women's health DTx developer Curio raises funds for PPD app

Digital therapeutics (DTx) developer Curio has raised over $10 million in first-round financing that will be used to fund the rollout of its MamaLift Plus app for postpartum depression (PPD).

The DTx, which was approved by the FDA in April under the 510(k) regulatory route used for software as a medical device (SaMD) products, is an eight-week neurobehavioral intervention that can be prescribed for women aged 22 years and older with mild to moderate PPD as an adjunct to clinician‐managed outpatient care.

The Series A was backed by UK healthcare investor RYSE Asset Management – which set up a dedicated $50 million fund for digital health projects earlier this year – alongside Otsuka subsidiary ONCE, Bridge Point Capital and Avestria.

PPD is estimated to affect approximately one in seven women who have given birth in the US – or approximately 500,000 women annually – and is recognised as one of the most common medical complications during and after pregnancy.

It is, however, under-treated, and MamaLift is the only FDA-approved prescription DTx available for PPD, and one of only six prescription DTx available that have cleared that regulatory milestone in the US. Along with cognitive behavioural therapy (CBT) exercises, it provides self-help tools, educational content, and sleep, mood, and activity trackers.

The approval is based on the SuMMER trial, which enrolled 141 women with a confirmed diagnosis of moderate PPD before enrolment – i.e. a score above 13 but not exceeding 19 on the widely used Edinburgh Postnatal Depression Scale (EPDS) scale – and compared MamaLift Plus to a placebo app.

The study met its primary endpoint, with a four-point or greater improvement in the EPDS score seen in 83% of the treatment group compared to only 22% of the control arm, which was a statistically significant difference. Almost all (82%) of responders achieved a 13-point or greater improvement, taking them out of the moderate depression category, compared to 30% of the control group.

In a statement, Curo said the new financing will be used to support the commercialisation of MamaLift Plus in its initial markets in the US, UK, and India, as well as other DTx programmes in its portfolio, including FertiLift for women trying to conceive and MenoLift for those going through the menopause.

"Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioural health," said Shailja Dixit, Curio's chief executive and founder.

"We are grateful to have the backing of RYSE and our committed new investors as we bring these products to new markets," she added.

Along with efforts to encourage health plans, insurers, and corporate employee benefit plans to cover MamaLift Plus, Curio is also working with pharma companies that want to tap into its platform for R&D purposes.

The company has also developed an artificial intelligence-driven predictive algorithm, Curio-I, designed to identify women who are at risk of developing common behavioural health conditions.