BioPorto (BIOPOR) Status update summary

Current landscape and challenges in kidney care

• Acute kidney injury (AKI) and chronic kidney disease (CKD) are rising globally, now at epidemic levels, affecting up to 25% of hospitalized patients and putting one in three adults at risk for CKD, though most are unaware of their condition.

• Advances in critical care have improved survival rates for children and adults with kidney issues, but many survivors now live with chronic conditions, increasing the burden on healthcare systems.

• There is a severe shortage of nephrologists, especially in pediatrics, making it essential for primary care and other specialists to recognize and manage kidney disease.

• Early detection using clinical phenotyping, predictive analytics, and new biomarkers is now possible and crucial for intervention.

• Access to new therapies is limited by cost and insurance coverage, creating disparities in care.

Innovations and advances in diagnostics and treatment

• The NGAL biomarker, developed over 25 years, enables early detection of AKI and is now FDA-cleared for pediatric use, with ongoing trials in adults.

• NGAL and other biomarkers help differentiate between functional and structural kidney injury, predict dialysis needs, and are used in drug development.

• AI and machine learning models are being integrated into clinical practice to predict AKI risk and optimize care, leveraging real-world data from electronic medical records and device integration.

• Combining AI-generated risk scores with biomarkers aims to improve prediction accuracy and patient outcomes.

• Purpose-built devices like CARPEDIEM have transformed care for neonates and infants with severe kidney disease, enabling earlier and safer dialysis.

Systemic and resource challenges

• Pediatric nephrology faces a staffing crisis, with low compensation and few trainees, impacting care delivery.

• Resource limitations threaten the availability of interdisciplinary teams, especially non-physician roles like dieticians and social workers, which are vital for comprehensive care.

• Access to new medications is hindered by high costs and insurance barriers, particularly affecting underserved populations.

• Rural and Medicaid-dependent populations are at increased risk of losing access to specialized kidney care due to funding cuts.