BCNatal’s fetaLife project for extremely preterm infants achieves 21-day survival in an artificial womb
After more than five years of research, the scientific team behind the fetaLife project has developed a functional artificial placenta, or artificial womb, that has achieved 21 days of healthy survival in an experimental model and more than 13 months of postnatal survival after removal from the device, with positive neurodevelopmental outcomes. The aim of the project is to increase survival and, above all, reduce the severe long-term complications affecting most extremely preterm newborns, namely those born at six months of gestation or earlier.
This groundbreaking initiative, led by Dr Eduard Gratacós, Professor at the Faculty of Medicine and Health Sciences of the University of Barcelona (UB), has received €7.65 million in funding from the ”la Caixa” Foundation. The project is being carried out at BCNatal, a clinical and research centre in fetal and neonatal medicine affiliated with Hospital Sant Joan de Déu, Hospital Clínic Barcelona and the University of Barcelona.
An artificial womb is a system that allows an extremely premature baby to continue developing under conditions that closely resemble life in the uterus, providing a more natural alternative. The prototype developed by BCNatal, which has already undergone several iterations, consists of a liquid environment that enables the premature infant to continue developing while connected to an extracorporeal circulation system through the umbilical cord.
Technological improvements and major advances in medical support protocols—which include the administration of nutrition, hormones and other medications, while anticipating potential clinical scenarios and the medical interventions required to address them—have significantly improved survival within the system and enabled successful neonatal transition. This transition reproduces the steps planned for future clinical use in humans, whereby the infant is transferred from the artificial womb to a conventional neonatal incubator once the organs have reached sufficient maturity.
The project’s proprietary monitoring system also remains a key component, enabling continuous remote surveillance by the medical team and allowing intensive monitoring of the fetus’s condition and development. Another major achievement has been the optimisation of the extracorporeal circulation system, consisting of an oxygenating membrane together with specially designed tubing and cannulas that facilitate blood circulation and oxygenation by replicating the natural functions of the maternal placenta and umbilical cord during intrauterine life.
Experimental validation phase to bring the technology closer to clinical application
Using an ovine model, the research team has designed and described the surgical techniques and protocols required to achieve a successful transition from the uterus to a prototype artificial womb without complications, achieving survival within the system for up to 21 days.
A major milestone has now been reached in bringing the system closer to clinical application: demonstrating that neonatal transition is feasible. Neonatal transition is a process similar to the fetus’s “birth”, during which it moves from the artificial womb to extrauterine life and begins using its lungs like any other newborn. The project has conducted trials that have resulted in viable newborns following their stay in the artificial womb. In one particular case, that of the sheep Gaia, now more than one year old, long-term neurodevelopment has been assessed, with normal outcomes.
Since its inception in 2021, the project has had its own ethics, social and safety advisory committee, which includes representatives of families of newborns. The ethical aspects related to transferring the system for use in humans are led by the Borja Institute of Bioethics (Institut Borja de Bioètica), with which the project’s research team works closely.
The project has been reviewed and positively evaluated on two occasions by a panel of internationally renowned experts in fetal and neonatal medicine from five different countries.
This project is an example of the multiplying effect of collaboration between public institutions and philanthropy in biomedical research and innovation. BCNatal is a clinical and research centre in fetal and neonatal medicine affiliated with Hospital Clínic Barcelona and Hospital Sant Joan de Déu. Meanwhile, the ”la Caixa” Foundation, which has supported the project from the outset with €7.65 million in funding, has made the experimental phase possible and has established it as the only project of its kind in Europe.
Following these results, fetaLife Technologies was established in 2025 as a spin-off of Hospital Clínic, Hospital Sant Joan de Déu and the University of Barcelona to bring the technology closer to clinical practice. Next year, the project team will focus on introducing a technological improvement, in collaboration with industry partners, to adapt the system for human use, while also beginning the ethical and regulatory preparations required to obtain approval for a first-in-human study, planned for 2028–2029, subject to the necessary investment. Additional funders are expected to join this next stage. The ”la Caixa” Foundation has already announced that it will continue supporting the project, which has also received donations from other organisations.
Artist’s rendering of the future clinical application of the project in humans.
A groundbreaking solution to save the lives of extremely premature newborns
Although more than 90% of pregnancies reach full term without complications, fetal life remains one of the most critical stages of human development. One of the major unresolved challenges is extreme prematurity (six months of gestation or less), a condition that affects 25,000 families every year in Europe alone. Survival rates for extremely premature infants remain low—even in leading neonatal centres of excellence—ranging from 25% to 75%, and a significant proportion of survivors experience severe lifelong complications.
Before six months of pregnancy, the fetus’s lungs, intestines and brain are still underdeveloped and are not ready to function properly. An extremely premature newborn is, in reality, a fetus that must survive in a highly unnatural environment. Weighing less than 1,000 grams, these babies require respiratory support and intravenous nutrition to stay alive, but these interventions can lead to complications and have lasting consequences throughout their lives. For this reason, the artificial womb could provide a solution capable of improving the quality of life of these newborns.
The research group led by Dr Gratacós is highly interdisciplinary. More than 35 researchers from different fields—including physicians from various specialties, biologists, engineers and nursing professionals—are involved in the project, together with a further 35 collaborating professionals. During some phases of the project, as many as 150 people have been involved.
In addition to BCNatal’s fetaLife project, there are currently only four other research groups worldwide—one in Philadelphia and another in Michigan (United States), a consortium involving Australia and Japan, and another group in Toronto (Canada)—that have developed similar experimental models and achieved significant progress in recent years.