Dutch MedTech start-up Bambi Medical announced today the start of two clinical trials for the skin friendly and wireless neonatal vital signs monitoring system they have developed. The medical device, called the Bambi Belt solution, measures full cardiac and respiratory functions of premature babies. This includes the ECG, heart rate, respiration waveform and respiration rate.

The first clinical trial is a non-inferiority trial led by the Amsterdam University Medical Centers (Amsterdam UMC), and executed by both Amsterdam UMC and the Maxima Medical Center (MMC) in Veldhoven. The study will compare the monitoring performance of the wireless Bambi Belt and the standard method via wired adhesive electrodes which is currently used for cardio-respiratory monitoring. In parallel, a second clinical trial at the MMC in Veldhoven will compare the skin condition of premature babies monitored with the Bambi Belt versus the skin condition after traditional monitoring with adhesive electrodes.

During the study, 40 babies, from 26 weeks of gestation, will be monitored in the Neonatal Intensive Care Units (NICU) in a standard care environment, simultaneously wearing both the Bambi Belt and the traditional monitoring system. Monitoring data from both systems will be collected and compared to prove the non-inferiority of the Bambi Belt solution.

Conducting these clinical trials is the last phase of the product development process for Bambi Medical. The results of the study will be included in the documentation to be submitted to the Notified Body for obtaining a CE mark under the European Medical Device Regulation.

“We are very excited to start these clinical trials together with the Amsterdam UMC and MMC and to see our product show solid performance in practice,” – says CEO of the company Fabio Bambang Oetomo. “We are proud that we are making the final steps towards CE marking and market release with such a small and very dedicated team.”

Mr. Bambang Oetomo emphasizes the supportive role of their clinical partners and its doctors involved in the study. “The neonatologists of both Amsterdam UMC and MMC in Veldhoven involved in the execution of the study have spent a significant amount of time, next to their existing tasks as neonatologists during the COVID-19 lockdowns, to ensure a timely start of these clinical trials. We are very pleased with their commitment in getting these trials started and together with them we are one step closer in making the lives of babies happier from day one,” - says Mr. Bambang Oetomo.

Bambi Medical plans to release the Bambi Belt solution in the European market, after obtaining the CE marking, in the second quarter of 2022.