Preterm birth and its direct consequences are the leading cause of death worldwide for children under five years of age. There are around 15 million infants born prematurely every year and about 1 million deaths associated with prematurity. Globally operating organizations such as UNICEF, the Bill & Melinda Gates Foundation, Save the Children, and many more are currently tackling this problem.
OxyPrem is the first medical device that reliably monitors the oxygen levels of preterm infants’ brains in real time. Using harmless, noninvasive near-infrared light, it continuously measures local oxygenation. Clinicians can set a target level and receive immediate notification if values move above or below that level. Several simple measures can then be taken to increase or decrease the oxygenation level, for example via the incubator atmosphere or through CPAP breathing support, a commonly used method.
OxyPrem is reusable and sturdy, and its use requires only a PC or tablet. It is therefore a feasible solution even for difficult environments. It will also be compatible with frequently used standard hospital monitors in the near future.
At Wyss Zurich, the next steps are being taken so that OxyPrem can be used in the hospital setting. The first goals are to manufacture an initial batch of OxyPrem systems and obtain CE certification. The systems are to be introduced to hospitals throughout Europe in a large-scale, pan-European study running from 2019 to 2021. At the same time, efforts are being made to gain CE mark certification under the new MDR regime. Market entry is envisioned for 2022.
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Co-Project Leader – R&D
Stefan Kleiser joined Wyss Zurich in December 2018 as OxyPrem Product Engineer. Stefan holds a master’s degree in microsystems engineering from the University of Freiburg im Breisgau, Germany, and a PhD in biomedical engineering from ETH Zurich in Switzerland. Since high school, he has enjoyed working with soldering and electrical equipment, and he continued to pursue that passion during his PhD studies. He is the driving force behind the various prototypes that have evolved over the years, and thanks to his extraordinary efforts and commitment, OxyPrem has become a viable medical device. His extensive knowledge and expertise in the field have made him a sought-after advisor, both domestically and internationally, on the application of near-infrared technology.
Co-Project Leader – Business Development
Alexander Nitsch joined Wyss Zurich in December 2018 as Project Leader of OxyPrem. Alex holds an MBA in international business administration from the University of Tübingen, Germany. Over the past ten years, he has acquired considerable experience working in startup projects and companies of various kinds. Whether the topic is hedge funds, travel e-commerce or financial IT, Alex immerses himself in the subject matter and dedicates himself to the advancement of the project. He is currently focusing on the project development side, finding new ways for OxyPrem to move into the outside world.
Fabienne Di Gennaro
Regulatory Affairs and Quality Manager
Fabienne Di Gennaro joined OxyPrem in 2020, where she is responsible for regulatory affairs and quality management. Fabienne brings several years of experience in the field of regulatory affairs, supporting the development of several medical devices in small and large companies for the main markets. Fabienne holds a PhD in Biology and is involved in several tasks at OxyPrem, such as development support, road-mapping, biologics, and PMS.
Alexander Kalyanov joined OxyPrem in 2020, where he is responsible for data analysis and system development. Alexander studied biochemical physics at Saratov State University, Russia. He obtained his PhD in Optics and Biophysics Department (OBP) of the same institution in 2011. During his PhD, Alexander focused on optical coherence methods in life sciences with a particular aim at full-field optical coherence microscopy. After defense, he continued his research activity in OBP. In 2014, Alexander joined Biomedical Optics Research Laboratory (BORL) at the University Hospital Zurich as a postdoc, applying his knowledge in optics and biophotonics to Near-Infrared Optical Tomography (NIROT). There he lead the development of the new time-domain NIROT system Pioneer.
Maximillian Murphy joined Wyss Zurich in February 2019 as a Software Engineer for OxyPrem. Max is focusing on creating a superb experience for medical staff who use OxyPrem sensors. He has a PhD in mathematics and has worked for 15 years as a cryptographer in infrastructure engineering, fraud detection, penetration testing, AI and forensics. He loves making machines do things that he is “too lazy” to do himself, as he explains, and in this context he has programmed - or reverse engineered - everything from microcontrollers and FPGAs to supercomputers.
Daniel Ostojic joined Wyss Zurich in March 2019 as a Product Engineer for the OxyPrem project. Daniel advises the physicians who are using the OxyPrem device in clinical studies. His other responsibilities include the technical implementation of and support for clinical experiments, usability engineering, and hard- and software development. Daniel holds degrees in Electrical Engineering (Bachelor of Science), Computer Science (Master of Science) and Medical Physics (Master of Advanced Studies). He has been involved in the hard- and software design of OxyPrem devices since 2010. Daniel has also provided support in the use of OxyPrem devices in clinical studies conducted at the University Hospital of Zurich.
Kristina holds a PhD in Biology from the University of Zurich. After graduation, she started working in the Medical Device industry. At Tecan Switzerland, Kristina was responsible for supporting customers all over the world in Clinical Diagnostic applications, and to contribute to the development of Life Science automation. Besides her role in Product Support, the interface to many different stakeholders, she also took up the responsibility for leading large teams. At OxyPrem, Kristina brings in her experience and also her enthusiasm to work with and support others to bring the many different aspects of Customer Relationship Management forward. She joined OxyPrem in January 2020.
Clinical Studies and Post-Market Surveillance Engineer
Hanneke Verbiest joined Wyss Zurich in January 2020 as Clinical Studies and Post-market Surveillance Engineer for OxyPrem. Hanneke holds a Master of Science in Biomedical Engineering from the Technical University of Eindhoven, the Netherlands, where she did her master’s research on modeling of blood coagulation blood in aneurysms. She also holds a CAS in Clinical Trial Management from the University of Zurich. Hanneke has experience as a technical writer for hospital software as an R&D Consultant in ophthalmology and as Post-Market Surveillance Engineer in orthopedics. In the OxyPrem team, Hanneke will focus on clinical studies and post-market surveillance.