Periodic Reporting for period 2 - ArtPlac (Artificial Placenta (ArtPlac) - Miniaturized Integrated Lung and Kidney Support for Critically Ill Newborns)
Berichtszeitraum: 2024-04-01 bis 2025-09-30
ArtPlac seeks to address a significant and urgent challenge in neonatal care: the high mortality and long-term morbidity associated with severe lung and kidney failure in newborns. Each year, 2.3 million children die within the first month of life globally, with preterm birth complications accounting for approximately one million of these deaths — the leading cause of under-five mortality worldwide. Many of these fatalities are attributed to the inadequacies of current treatment technologies. These devices, often adapted from adult designs, fail to meet the specific physiological needs of newborns, leading to poor outcomes, including chronic disabilities and prolonged hospitalizations. In addition, these treatments are highly invasive, requiring mechanical ventilation and multiple surgically placed lines, which can cause severe side effects and lifelong consequences.
The global neonatal care devices market, valued at approximately USD 2.8 billion in 2024 and projected to exceed USD 6.7 billion by 2034, reflects the growing demand for innovative solutions in this field. The ArtPlac project offers a transformative solution. By designing an artificial placenta inspired by the natural organ, the project introduces a compact device that integrates lung and kidney support. This device connects via the umbilical cord, providing gentle, physiological care that enables newborns to breathe and feed naturally while recovering. A critical technological pillar of ArtPlac is its advanced approach to surface functionalization and hemocompatibility. Current extracorporeal circuits are inherently prothrombotic, with 20–60% of patients experiencing major bleeding and 10–50% suffering thrombotic events. For extremely preterm infants, the systemic anticoagulation required by existing devices carries a disproportionate risk of fatal intracranial hemorrhage. ArtPlac addresses this challenge through biomimetic surface coatings — including nitric oxide-releasing polymers, zwitterionic functionalization, and phosphorylcholine layers — that dramatically reduce platelet adhesion and thrombus formation, thereby minimizing or eliminating the need for systemic anticoagulation.
The global neonatal care devices market, valued at approximately USD 2.8 billion in 2024 and projected to exceed USD 6.7 billion by 2034, reflects the growing demand for innovative solutions in this field. The ArtPlac project offers a transformative solution. By designing an artificial placenta inspired by the natural organ, the project introduces a compact device that integrates lung and kidney support. This device connects via the umbilical cord, providing gentle, physiological care that enables newborns to breathe and feed naturally while recovering. A critical technological pillar of ArtPlac is its advanced approach to surface functionalization and hemocompatibility. Current extracorporeal circuits are inherently prothrombotic, with 20–60% of patients experiencing major bleeding and 10–50% suffering thrombotic events. For extremely preterm infants, the systemic anticoagulation required by existing devices carries a disproportionate risk of fatal intracranial hemorrhage. ArtPlac addresses this challenge through biomimetic surface coatings — including nitric oxide-releasing polymers, zwitterionic functionalization, and phosphorylcholine layers — that dramatically reduce platelet adhesion and thrombus formation, thereby minimizing or eliminating the need for systemic anticoagulation.
ArtPlac has achieved critical milestones in the development and validation of its innovative technologies, advancing the device toward clinical readiness. The ArtPlac prototype integrates lung oxygenation and kidney dialysis into a single device, and has been optimized to meet the unique requirements of neonates. Its design is distinguished by a minimal blood priming volume to reduce stress on the infant’s cardiovascular system while ensuring effective organ support. Integrated real-time monitoring capabilities enable continuous assessment of vital parameters such as blood gases, pressure, and flow, providing adaptive and personalized care tailored to each patient’s needs.
To enhance safety and efficacy, the consortium has developed advanced biomimetic coatings that improve hemocompatibility, reducing the risk of clotting without requiring systemic anticoagulation. This innovation directly addresses a major limitation of current extracorporeal systems. In parallel, new expandable umbilical catheters have been created to provide safe and minimally invasive vascular access, preserving the umbilical vessels for long-term use. These technical breakthroughs are supported by extensive in vitro testing and advanced computational simulations, which have minimized the need for animal studies. Furthermore, preclinical protocols using lamb and piglet models have been prepared to validate the device's safety and effectiveness in clinically relevant scenarios. ArtPlac’s focus on scalability and adaptability ensures that the technology can benefit a wide range of newborns, from extremely preterm infants to those weighing up to 5 kilograms.
To enhance safety and efficacy, the consortium has developed advanced biomimetic coatings that improve hemocompatibility, reducing the risk of clotting without requiring systemic anticoagulation. This innovation directly addresses a major limitation of current extracorporeal systems. In parallel, new expandable umbilical catheters have been created to provide safe and minimally invasive vascular access, preserving the umbilical vessels for long-term use. These technical breakthroughs are supported by extensive in vitro testing and advanced computational simulations, which have minimized the need for animal studies. Furthermore, preclinical protocols using lamb and piglet models have been prepared to validate the device's safety and effectiveness in clinically relevant scenarios. ArtPlac’s focus on scalability and adaptability ensures that the technology can benefit a wide range of newborns, from extremely preterm infants to those weighing up to 5 kilograms.
ArtPlac represents a significant leap forward in neonatal care, with core technologies that directly address the limitations of current systems. The integration of lung and kidney support into a single device eliminates the need for multiple invasive machines, simplifying care and reducing procedural risks. The device’s real-time monitoring capabilities allow for continuous, precise adjustments to therapy, avoiding the delays and potential inaccuracies that can result from intermittent manual measurements. By connecting to preserved umbilical vessels, ArtPlac obviates the need for painful and complex surgical procedures, enhancing both safety and comfort for patients.
The compact and scalable design of ArtPlac enables its application in diverse healthcare environments, including low-resource settings where access to advanced neonatal care is limited. Its innovative approach has implications beyond neonatal care. The underlying technologies, such as biomimetic coatings, integrated sensors, and advanced microfluidic systems, can be adapted for adult extracorporeal therapies, organ transplantation, and chronic disease management. These innovations open new possibilities for wearable devices, portable organ support systems, and improved solutions for patients with conditions like chronic obstructive pulmonary disease or acute kidney injury. By advancing the state of the art, ArtPlac establishes a platform for transformative healthcare solutions that extend across diverse patient populations and medical needs.
The compact and scalable design of ArtPlac enables its application in diverse healthcare environments, including low-resource settings where access to advanced neonatal care is limited. Its innovative approach has implications beyond neonatal care. The underlying technologies, such as biomimetic coatings, integrated sensors, and advanced microfluidic systems, can be adapted for adult extracorporeal therapies, organ transplantation, and chronic disease management. These innovations open new possibilities for wearable devices, portable organ support systems, and improved solutions for patients with conditions like chronic obstructive pulmonary disease or acute kidney injury. By advancing the state of the art, ArtPlac establishes a platform for transformative healthcare solutions that extend across diverse patient populations and medical needs.