Early detection of premature births

How biomechanist Sabrina Badir became an entrepreneur and launched a measurement device that could become the standard in preterm birth diagnostics. A conversation with the founder and CEO of the start-up Pregnolia.

«It just happened that I became an entrepreneur,» Sabrina Badir says. She is sitting opposite us in the meeting room of her company in the industrial area of the Zurich suburb of Schlieren. Railway tracks can be seen through the large windows. Every few minutes a train thunders by. Sabrina Badir is a committed personality. She comes across as self-confident, direct and empathetic, and she has clear visions on how to implement her plans. «When I finished my PhD, I was faced with the question of how to proceed with my research project. At that time, I was attending a project management course and the instructor told me, `What you have done is very interesting. Why don’t you start a company?` The spark ignited immediately. But I had no idea how to proceed. Therefore, I applied for the ETH Zurich Pioneer Fellowship, where you learn how to transfer research results into a product. I was accepted and that’s how Pregnolia came into being.» Six years later, the first Pregnolia measurement devices are in medical practices and clinics and the start-up is considered a promising player in the growing FemTech market*. But getting there has demanded a lot of Sabrina Badir and her team.

 * FemTech (Female Health Technology) provides a wide range of solutions to improve healthcare for women across a broad range of female conditions and needs.

How a doctoral thesis becomes a business

As part of her doctoral project, the ETH Zurich biomechanist developed the prototype of a device that can be used to precisely measure the stiffness of the cervical tissue in pregnant women and thus estimate the risk of a premature birth. She conducted a feasibility study with the device involving 100 women. The results were promising. Both the method and the device worked. Now she was faced with the challenge of developing the prototype into a practical, affordable measurement tool. At a start-up speed dating event at ETH Zurich, she met bioengineer Francisco Delgado, who has a PhD from MIT in Boston. She was looking for someone with his profile and he was fascinated by Sabrina Badir’s device and her business idea. The two became business partners and founded the start-up Pregnolia AG. Francisco Delgado became CTO and head of Research and Development, and he immediately set about transforming the unwieldy prototype into a high-tech, marketable medical device. Sabrina Badir took on the role of CEO, focused on building the company and became the face of the start-up. She convinced investors, acquired money for the development of the device, established a network of doctors, clinics, midwives, health insurance companies and other stakeholders from the health sector, initiated clinical trials and recruited qualified staff. «We went through a very long build-up period in which we developed the device into a medical product and fought our way through the jungle of regulatory processes. It took four years until we finally received CE certification and approval for the Swiss market and thus also for the EU. That was the starting signal to enter the market with the Pregnolia device,» Sabrina Badir describes the Pregnolia founding story.

Even before certification, she had brought Bruno Candrian, an experienced marketing and sales manager, into the team, who professionally took care of the promotion and marketing of the device. In the first year, Pregnolia concentrated on the Swiss market, where the device was well-known in the medical community thanks to Sabrina Badir’s networking. A year later, the start-up expanded to Germany. To be on the safe side, she also looked for a European authorised representative when entering the German market. «We were finally able to convince the notified body TÜV-Süd to work with us. Since then, they certify our device for the European Union,» she tells us. This decision turned out to be very prescient, because when the Swiss Federal Council broke off negotiations on the framework agreement with the EU in May 2021, the European Commission withdrew the automatic approval of Swiss manufacturers for their medical products for the EU market.

Even an excellent product does not sell itself

When Pregnolia was approved for the market in 2020, the company immediately began systematic market development. After all, the device has to be perceived by the entire professional community beyond the small circle of initial users and supporters before it can be sold. To this end, Sabrina Badir and her marketing manager rely on direct personal contacts with doctors’ practices and clinics, health insurance companies and specialist publications. Gynaecologists who use the device in their practice act as ambassadors and multipliers. In order to intensify market development, Pregnolia hired two new employees in Germany. More are to follow. In addition, the marketing team uses professional events such as the congress of the renowned German Society for Gynaecology and Obstetrics, which took place in Munich in mid-October 2022 and was attended by around 2,000 doctors. Pregnolia was present with its marketing manager and the two German members of staff. The team presented the device at a booth and established many new contacts with key people in the German obstetric community. It became clear that clinical studies play a central role in convincing doctors of the benefits of the Pregnolia device. «The stiffness of the cervix is not a new parameter in obstetrics. Now, we simply examine it quantitatively with our device and no longer by palpation with the finger, as has been done up to now,» Sabrina Badir explains. «But there was a lack of clinical data showing at what level of stiffness there is an increased risk and how this knowledge can be incorporated into the diagnosis of preterm birth. That is why it is so important for us to conduct clinical studies to prove that we can predict the risk of preterm birth well with our measurement device. We saw at the congress in Munich how great the effect is when robust clinical data are available.»

Clinical data as the key to the market

The entrepreneur has therefore spent a lot of time and energy in the years past to win over researchers and hospitals for independent clinical studies with the Pregnolia device. And with Dr. Laura Bernardi, she has brought a specialist into the team who accompanies and evaluates the data collection. Ten clinical trials are currently underway in Europe and the USA. First results are already available and more will follow.

However, these large amounts of study data, which now continuously flow into Pregnolia, are far more than just a marketing tool. They form the «raw material» with which the Pregnolia device can be expanded into a digital risk assessment tool for preterm birth. Sabrina Badir has clear ideas about this: «We are in the process of adding an app to the device so that in the future we can use all the data we collect to make a personalised risk assessment for each pregnant woman. In addition, we want to develop other applications that are useful to doctors in the various stages of pregnancy. For example, gynaecologists have asked us whether the device could also be used at the end of pregnancy, for example to find out why the cervix is not opening, how long it will be before the baby is born and whether the birth should be induced. Last but not least, a birth that drags on also leads to high costs if the delivery room with all the staff is blocked for a long time.»

Nothing works without money

Already three years ago, when the first results from the application of the Pregnolia device were available, Francisco Delgado and his team began with the further development. They optimised the probe, reducing its manufacturing costs by 60% and shortening delivery times. They introduced new packaging that is easier to open and is visually more sophisticated. Pregnolia financed this development step with a contribution from the EU’s Horizon 2020 programme. A year ago, the company received further financial support from the EU to build up a database in which the results of the clinical trials are recorded and processed for use in a future app.

And now Pregnolia is about to take another development step: In the next two years, the control unit is to be improved and its production costs reduced. At the same time, an app is being developed that will allow new services to be generated on the topic of premature birth on the basis of big data. The large amounts of data for this are provided by the clinical studies and the devices used in the doctors’ practices. Sabrina Badir hopes to receive funding for this technical development from the Swiss Accelerator programme of the Swiss government.

At the same time, Pregnolia is facing a new round of financing. The start-up again needs fresh money to push the marketing of the Pregnolia device, hire staff and expand into other countries. To do this, Sabrina Badir has to convince the investors that the Pregnolia System will establish itself on the market and that the company can be sold profitably at some point. «Our investors are institutional investors as well as private individuals who, in addition to their interest in the business case, also have an emotional component. The topic of premature births leaves no one indifferent. But at some point, our investors also want to know about profitability. I have therefore recently been working very intensively on the topic of ‘mergers and acquisitions’and have spoken to many company founders who have sold their companies in order to understand how such processes work. This is a key point to show investors in the upcoming financing round how we could sell the company.»

Women’s health has become an important topic in recent years and a new market has emerged. In the meantime, there are many companies that focus on women’s health and are looking for products like the one from Pregnolia. The chances of selling the start-up profitably are quite promising. But it is not yet time. Sabrina Badir and her team will continue to work over the next two years to establish the Pregnolia System as the standard in preterm birth diagnostics. «Everything that exists today in this field is unsatisfactory,» the entrepreneur says. «In the future, every doctor’s practice will have a Pregnolia System in addition to the ultrasound machine. This is my vision.» And how does she see her own future? She pauses briefly and answers: «When I’m sure that our product is getting into the right hands and is being distributed further, I’ll move on to something new.»

The Pregnolia System

The Pregnolia System consists of a probe and a control unit with display. The probe is placed on the anterior lip of the cervix. By pressing the start button on the control unit, the device begins to determine the stiffness of the tissue. Within a few seconds, the reading appears on the display. The comparison with the table of normal values shows the gynaecologist whether there is a risk of premature birth.

Pregnolia AG

Pregnolia AG is a spin-off of ETH Zurich that has developed a diagnostic device to assess the risk of premature birth. Pregnolia emerged from the dissertation of ETH Zurich biomechanist Dr Sabrina Badir. The company currently employs 14 people.

Interview with Sabrina Badir
Sabrina Badir

Sabrina Badir has a doctorate in Biomechanics from ETH Zurich. In the course of an interdisciplinary research project of ETH Zurich and Zurich University Hospital, she investigated how changes in the cervix can be determined earlier and more accurately. The condition of the cervix is considered an important indicator for determining the risk of preterm birth. In 2016, she founded the spin-off Pregnolia AG with bioengineer Dr Francisco Delgado, of which she is CEO.
Sabrina Badir lives in Zurich with her partner and is a mother of two children.

Horizon 2020 Project

PREGNOLIA: New diagnostics to determine premature birth risk 

  • Programme: SME Instrument
  • Duration: 1. September 2019 – 30.June 2022 (34 months)
  • Contribution for SME: 1‘283‘914 €
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