Pregnolia specialises in the early diagnosis of premature birth. In modern obstetrics, premature births give rise to high annual costs for medical treatment and care. Premature birth is also responsible for the poorer health outcomes of the children. If nothing else, premature births, which mostly cannot be predicted by experienced gynaecologists, are a source of uncertainty and frustration to specialists.
The ETH biomechanical engineer and founder of Pregnolia, Sabrina Badir, and her co-founder Francisco Delgado, a Massachusetts Institute of Technology (MIT) graduate, developed the Pregnolia System to provide a reliable and user-friendly device that measures cervical stiffness with a handheld probe using negative pressure. The softer the tissue, the higher the likelihood of premature birth. Early data from clinical trials demonstrate that cervical stiffness provides a more accurate prediction of a possible premature birth than measuring cervical length. Data are currently being collected on the Pregnolia System in the large-scale clinical trial “Soft Cervix”, which will form the basis for diagnosis guidance for practical gynaecological usage.
The startup has now closed an oversubscribed series A round, raising CHF 4 million from new and existing investors. Up to a million francs may additionally be secured in the post-round. The resources from the series A funding round serve mainly to prepare for the market release of the diagnostic device. In 2019, the Pregnolia System secured the CE mark certification; the funds will enable the company to obtain new certifications and set in motion all measures for the launch. This will include creating a distribution network and negotiating test reimbursement by health insurance companies.
Clinical studies continue
In parallel, the company will continue clinical studies to gather supporting data. Over 4000 measurements have already been made using the Pregnolia System in Switzerland, the majority of which within the “SoftCervix” trial being carried out in numerous University and Cantonal Hospitals. International studies using the Pregnolia system are also ongoing in the United States.