MaTiReX

One in every 1000 unborn babies needs surgery during pregnancy to survive or prevent morbidities. This is possible with minimally invasive fetal surgery. However, this type of surgery introduces a serious risk of preterm birth through puncturing the fetal membranes using fetoscopic instruments. Fetoscopic entry points cannot be sealed and do not heal spontaneously. The surgery-induced risk of preterm birth can outweigh the benefits of the procedure, as preterm birth can lead to high rates of neonatal intensive care admissions and long-term health issues. To shift this balance, MaTiReX developed an advanced collagen plug to seal the fetoscopic entry points and solve the principal drawback of fetal surgery. The plug can be easily placed through existing fetoscopic instruments. It expands when it comes in contact with amniotic fluid to fix itself in the fetal membranes and seal the surgical entry point. Currently, there is no clinical alternative. Compared to other solutions in development, MaTiReX’s proprietary collagen plug excels by having the lowest risk of preterm birth and enhancing tissue regeneration. Additionally, it exceeds in biodegradability, ease of usage and fast procedure.

To enter the market, we will provide the plug for fetoscopic surgery of babies with congenital diaphragmatic hernia, a condition that occurs in 1 in every 3000 live births. Preclinical and clinical studies will be performed to obtain combined CE and FDA registration in the first 3 years to ensure sufficient patients. After first market entry, and in cooperation with global key opinion leaders in the field, we will expand to spina bifida, twin-twin transfusion syndrome and twin reversed arterial perfusion, with a total incidence of about 7000 children per year in Europe and the USA. Next to that, the field of fetal surgery as a whole is in development, so the number of indications is expected to increase, especially when we significantly lower the risk of preterm birth.

The MaTiReX team currently consists of three researchers, affiliated to Radboudumc, Nijmegen. Rob Meuwese focused on the development of the MaTiReX plug during his PhD. Lieke van Dommelen has experience in hybrid collagen scaffold and biomaterial optimalization. Willeke Daamen, associate professor in soft tissue regeneration, is closely involved in the plug development. To extend our team, MaTiReX is looking for an experienced regulatory affairs officer and additional clinical and commercial input in our advisory board.