Bambi Medical announces the start of clinical trials for its neonatal vital sign monitoring system – the Bambi Belt solution. The trials will serve as input for the dossier for the CE MDR submission and is the final step needed for approval to obtain the CE mark.
Dutch MedTech start-up Bambi Medical in a press release on Tuesday announced the start of two clinical trials for the skin friendly and wireless neonatal vital sign monitoring system they have developed. The medical device, called the Bambi Belt solution, measures full cardiac function (ECG), heart rate and respiration rate of premature babies.
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.
Traditional monitoring system
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.”
‘Making the lives of babies happier’
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.
About Bambi Medical and the Bambi Belt solution
Founded in 2016, Bambi Medical has developed its first product – a wireless neonatal vital sign monitoring system called the Bambi Belt solution. It accomplishes the same functions as the wired adhesive electrode systems currently implemented in Neonatal Intensive Care Units (NICU). The Bambi Belt system consists of a disposable Bambi Belt, and a re-usable Bambi Bridge and Bambi Monitor. The Bambi Belt functions by being wrapped around the baby’s chest. Sensors integrated inside the belt measure the ECG and respiration of the baby in a non-intrusive way, while the Bambi Bridge sends the captured data to the Bambi Monitor. The system can work either stand-alone or in combination with existing patient monitors within the hospital infrastructure. The non-sticky and skin-friendly texture of the Bambi Belt eliminates the pain and stress experienced by the babies when using the current monitoring system. Its wireless features allow parents to take the baby out of the incubator and perform Kangaroo Mother Care which, according to WHO, is essential for babies’ development.
The original concept for the system was created by, now retired, Pediatrician-Neonatologist at the MMC and neonatologist and co-founder of Bambi Medical, Professor Sidarto Bambang Oetomo, MD PhD, at the Department of Industrial Design at the Eindhoven University of Technology (TU/e).
For product development, Bambi Medical has collaborated with Benchmark Electronics, an electronics company based in Almelo, The Netherlands. Benchmark will also be the manufacturing partner of the Bambi Bridge. The company’s manufacturing partner for the Bambi Belt is Freudenberg Medical Europe GmbH, a silicone products solution provider for molded or extruded components based in Kaiserslautern, Germany. Bambi Medical closely collaborates with Maxima Medical Center in Veldhoven and Amsterdam University Medical Centers.
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