October 10, 2024 

News Release 

BioPorto Announces Appointment of National Principal Investigator and Selection of CRO for Upcoming USA ICU Adult AKI Clinical Study 

COPENHAGEN, Denmark and BOSTON, MA, USA, October 10, 2024 – BioPorto, a pioneering company in the field of diagnostic biomarkers, today announced selection of the Clinical Research Organization (CRO) and the appointment of a national Principal Investigator (PI) for their upcoming USA clinical study of Acute Kidney Injury (AKI) in adult patients which comprises an initial cut-off and a subsequent validation study.  

The cut-off study, modeled on the successful pediatric indication for first day in the Intensive Care Unit (ICU), will enroll US patients with the goal of determining a cut-off point for risk stratification based on severe AKI.

BioPorto's ProNephro AKI™ (NGAL), currently cleared by the US Food and Drug Administration (FDA) for patients 3 months through 21 years of age, has been widely recognized for its groundbreaking potential in refining AKI diagnosis.  The biomarker NGAL is a direct real-time marker of kidney cell damage and can potentially detect AKI days earlier than previously possible.   

Leading Nephrologist from Massachusetts General Hospital Appointed Principal Investigator 

Dr. Andrew Allegretti, MD, MSC of Massachusetts General Hospital, has been appointed PI for the adult study. Dr. Andrew Allegretti is the Director of Critical Care Nephrology and an Assistant Professor of Medicine at Harvard Medical School. His research has focused on Acute Kidney Injury in the ICU including specialty populations, chronic kidney diseases and cirrhosis/hepatorenal syndrome. 

Dr. Allegretti notes, “As national PI, my role has three key components. First, to collaborate with BioPorto personnel and the CRO on the operational logistics of the study across sites. Second, to support clinical decision-making or changes within the study, should any arise. Third, to represent the study in the scientific community through presentations at congresses and in the regulatory community. I hope to be one of the first enrollment sites of the study.”  

Highly Experienced CRO to Deliver Study Logistics 

BioPorto has appointed ProPharma as its CRO based on their experience with IVDR projects and compatibility with BioPorto’s goals. Dr. Ute Feger notes, “We are pleased with the interest from clinicians to participate in this study and that with ProPharma as our partner, we can deliver excellent study logistics on the pathway to regulatory submission.”? 

BioPorto expects to enroll the first patient in the cut-off study in the fourth quarter of 2024, and to submit a clearance application on the adult indication by 2026. 

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