Prospective Multi-Center observational study
Clinical Decision Support Company NeoPrediX AG Completes Prospective Multi-Center Observational Study
– Successful external validation of NeoPrediX B.1 algorithm
– Further enhancement of the NeoPrediX B.1 algorithm
– Prospective clinical study showed precise and safe
prediction of bilirubin changes/progression
Basel, Switzerland, Regensburg, Germany, and Ft. Lauderdale, FL, USA, May 25, 2022 – NeoPrediX AG, a privately held maternal and neonatal clinical decision support company focused on the development and commercialization of smart algorithms to predict dynamic progression of disease parameters during the first 1.000 days of life, announced at a poster presentation during the recent 48th Annual Meeting of the German Society for Neonatology and Pediatric Intensive Medicine held in Aachen, Germany, that a prospective multi-center observational study was formally completed. The study was designed to validate prospectively the NeoPrediX B.1 algorithm for forecasting bilirubin progression up to 48 hours after the last measurement.
To identify infants at risk of bilirubin toxicity, bilirubin is measured several times after birth and before discharge home. Most infants are discharged home within two days after birth. However, peak bilirubin concentrations are reached a couple of days later. Thus, parents are often asked to return to hospital with their newborn baby to have bilirubin follow-up checks, in order to prevent hyperbilirubinemia requiring treatment from being missed. A precise prediction of the progression of bilirubin values based on the measurements done during the initial hospital stay after birth would be desirable to identify infants at risk of bilirubin toxicity and avoid unnecessary follow-ups.
The NeoPrediX B.1 prospective multi-center observational study has been registered at Clinicaltrials.gov ID: NCT05121311and enrolled more than 430 newborns to evaluate performance of the NeoPrediX B.1 algorithm to predict the individual course of bilirubin change and thus the risk of hyperbilirubinemia based on just one or two measured bilirubin values after birth. In general, results were consistent with those from previous retrospective studies performed by using the B.1 algorithm and the study confirmed that NeoPrediX B.1 is able to accurately predict bilirubin changes in newborns. As such this study demonstrated that the NeoPrediX B.1 tool can support caregivers in personalized, optimized and accurate decision making.
NeoPrediX is developing a cloud-based platform to allow hospitals and clinics to benefit from the algorithm and generate individual forecasts for their patients. The first version of the platform is already registered with the FDA (510k exempt) and first customers are using the system.
The technical file for CE certification (software as a medical device class 2a) has been filed with the nominated body. Launch of the platform in Europe is expected for Q4-2022. Integration in current EMR systems is in progress and will be offered to customers soon. Further enhancements of the NeoPrediX B.1 tool, additional data analysis and development of further maternal and neonatal applications are in progress.
“We are very pleased that the NeoPrediX B.1 study has been completed as planned,” said Prof. Marc Pfister, CSO of NeoPrediX. “The prospective clinical study provides essential clinical data needed for validating the clinical use of the B.1 algorithm to forecast dynamics of individual bilirubin values in newborns.”
“First of all, I would like to thank all clinical investigators for their work in executing this first study in the field of predictive algorithms for newborns,” said Mr. Thorsten Waloschek, CEO of NeoPrediX. “Apart from providing us with the data required to validate our algorithm, we can further enhance the accuracy of the forecast and provide clinicians with valuable information for decision making in newborn jaundice management.”
The NeoPrediX B.1 study was coordinated by the Center for Pediatric Clinical Studies (CPCS), an academic full-service Contract Research Organization (CRO) at the University Hospital of Tuebingen, Germany, headed by Prof. Dr. Axel Franz.
NeoPrediX AG is a privately held maternal and neonatal clinical decision support company focused on the development and commercialization of smart algorithms to predict dynamic progression of disease parameters during the first 1.000 days of life.
The vision of the company is to enhance and personalize healthcare in early life. While standard-of-care tools offer risk stratification for point in time assessment of bilirubin, the new NeoPrediX B.1 algorithm allows to forecast dynamic progression of bilirubin for up to 48 hours into the future to support clinicians in their decision-making process.
The Company is headquartered in Basel, Switzerland, with wholly owned subsidiaries in Regensburg, Germany, and in Ft. Lauderdale, FL, USA.
For further information, please contact
Mr. Thorsten Waloschek (CEO)
P: +49 941 463 962 10
NeoPrediX USA, Inc.
Mr. Thorsten Waloschek (CEO)
P: +1 (954)-315-3884
Bamberg kommunikation GmbH
P: +49 7131 72472 0