A New Alliance Aims to End the Tragedy of Stillbirth

SAN FRANCISCO, CA – January 12, 2026 – In a move aimed at tackling one of global health's most persistent and heartbreaking crises, Wellcome Leap and Medicines360 today announced a major partnership to accelerate the development of life-saving technologies that can predict and prevent stillbirths. The collaboration intends to deliver breakthrough diagnostic tools to mothers worldwide, drastically shortening a development timeline that typically spans decades into just a few years.

Globally, a baby is stillborn every 16 seconds, amounting to more than two million silent tragedies each year. In the United States alone, more than one in 150 births ends in stillbirth, a burden that falls disproportionately on families in low-income communities. The new initiative combines the scientific firepower of Wellcome Leap, a U.S. non-profit breakthrough engine, with the global access and innovation model of Medicines360, a women’s health organization.

“Before you finish this paragraph, another baby will be stillborn. Every 16 seconds, a mother, a family, grieves this loss. Women deserve clearer insights of their pregnancy health,” said Regina E. Dugan, CEO of Wellcome Leap. “By combining Wellcome Leap’s scientific breakthroughs with Medicines360’s global innovation and access model, we can deliver predictive tools to mothers around the world – before complications arise. Before it’s too late.”

A Silent Crisis Demanding Innovation

The urgent need for new predictive tools is underscored by the stark limitations of current prenatal care. For the past 50 years, the methods used to assess stillbirth risk have remained largely unchanged, relying on intermittent measures like ultrasound scans and Doppler assessments of blood flow. These tests have poor predictive power and fail to detect approximately half of all cases of fetal growth restriction, a major contributor to stillbirth.

This diagnostic gap leaves both clinicians and expectant parents in the dark. A comprehensive analysis of stillbirths in the U.S., published in an October 2025 JAMA study, found that a staggering 30% of stillbirths occur in pregnancies with no currently identifiable risk factors. This finding highlights a critical void that the new partnership aims to fill, moving beyond population-level statistics to provide precise, individualized risk assessments for every pregnancy.

The Science of Prediction: A Look Inside the 'In Utero' Program

The technological foundation for this initiative stems from Wellcome Leap's $50 million 'In Utero' program, launched in 2022 with the ambitious goal of halving the global stillbirth rate. The program has funded groundbreaking research, two key examples of which are now being fast-tracked for commercial development.

At the University of Cambridge, researchers have discovered new blood-based biomarkers capable of flagging pregnancies at high risk for common complications. By analyzing thousands of proteins in a mother's blood, scientists can identify signatures associated with preeclampsia, gestational diabetes, and fetal growth restriction—conditions linked to roughly half of all stillbirths. The goal is to create a simple blood test that could, with over 80 percent accuracy, identify at-risk women as early as 12 weeks into their pregnancy.

Complementing this is a non-invasive retinal imaging technology developed at the University of Edinburgh. Based on the principle that the blood vessels in the eye offer a clear window into a mother's overall vascular health, this tool uses advanced imaging to detect subtle changes that can indicate problems with placental function. The 'I-test 2' project, a key part of this research, is developing models to translate these retinal images into actionable risk scores for clinicians. Together, these technologies promise a multi-faceted and far more accurate picture of pregnancy health than ever before.

It is important to note that both the biomarker tests and the retinal imaging technology are still under development and have not yet been cleared by the U.S. Food and Drug Administration (FDA) or other global regulatory bodies.

From Breakthrough to Bedside: The 'Years, Not Decades' Challenge

Perhaps the most audacious aspect of the partnership is its timeline. The journey from scientific discovery to clinical use for novel medical devices can often take more than a decade. Wellcome Leap and Medicines360 are determined to compress this into a matter of years. This acceleration hinges on a strategy of parallel processing, leveraging robust clinical data to speed up validation, and working proactively with regulators.

By integrating Medicines360's commercialization and market access expertise from the earliest stages, the initiative aims to bridge the notorious 'valley of death' where promising research often languishes. The partnership will likely seek to utilize accelerated regulatory pathways, such as the FDA's 'Breakthrough Devices Program,' which is designed to expedite the review of technologies that address life-threatening conditions.

“This initiative is designed to reshape the future of maternal care,” stated Dr. Andrea Olariu, CEO of Medicines360. “Every pregnancy deserves precise, individualized risk assessment to inform life-saving interventions. Partnering with Wellcome Leap allows us to translate groundbreaking science into commercial products for use in clinical practice, and at a record pace. Together, we can change the trajectory of pregnancy outcomes for women worldwide, while prioritizing access from day one.”

An Architecture for Equity

Central to the collaboration is Medicines360's core mission of embedding equitable access into the innovation process itself. Rather than being an afterthought, a plan for reaching women in rural and under-resourced communities—who suffer the most from a lack of timely maternal care—is a foundational component of the partnership.

However, the path to global equity is fraught with challenges. Implementing advanced diagnostics in low-resource settings requires overcoming significant barriers, including the lack of reliable electricity, limited cold chain storage, and a shortage of trained healthcare personnel. Furthermore, ensuring the technologies are affordable and can be integrated into existing public health systems is critical for long-term sustainability.

The partnership is expected to employ a multi-pronged strategy to address these hurdles, potentially including tiered pricing models, partnerships for local manufacturing to reduce costs, and extensive investment in training and capacity building. To fund this ambitious global scale-up, Wellcome Leap and Medicines360 are actively seeking additional financial partners, calling on philanthropic foundations, impact investors, and government agencies to join the effort to bring these critical technologies to mothers everywhere.