The startup has already designed its first wearable medical device able to accurately diagnose in real time the risk of preterm labor and the chances of successful induction of labor.
According to the WHO (World Health Organization), it is estimated that globally 15 million births are preterm every year, and that this is the leading cause of infant mortality in children under five years of age. That is why Innitius has developed «Fine Birth», a non-invasive device capable of diagnosing the risk of preterm labor and the chances of successful induction of labor. “The techniques currently available are very inaccurate in identifying which patient may have a preterm birth,” says Rubén Molina, CEO of the company and a civil engineer by profession.
Thus, through the use of torsion waves, Fine Birth analyzes “with great precision” the consistency of the tissue of the cervix, which makes it possible to diagnose false threats of premature labor in the emergency room; to predict in the 20th week of pregnancy the risk of premature labor in the future and to determine whether or not the drug that artificially provokes contractions is effective in the induction of labor. “There are times when the patient is dilating for up to 48 hours. What this device does is to tell the specialist two hours after applying the treatment whether the woman is going to have a vaginal delivery or whether she will have to have a cesarean section directly,” explains Molina.
It is an intravaginal probe that is inserted until it touches the cervix. The wave propagates through the tissue and by analyzing how the tissue responds, the mechanical parameter with which it works can be extracted. This parameter, together with the pregnant woman’s clinical history, is incorporated into an artificial intelligence algorithm and the diagnosis is obtained, which is what the gynecologist or obstetrician sees.
Founded at the end of 2017, Innitius was previously a spin-off of the University of Granada (Spain) and the Andalusian Health Service (SAS), and is currently based in Derio (Bizkaia) where 17 people work. Molina is one of the founders, together with Drss. Francisca Molina from Granada, who in 2009 linked the risk of premature birth to the consistency of the tissue of the cervix. “We have already produced a lot of research in relation to this. In fact, we recently published three of them in the journal Nature, the leading global scientific journal,” says Molina.
In addition, Innitius has conducted clinical evaluations using the device in ten clinical settings in Spain, such as the Basurto and Cruces (Bizkaia) and Sant Joan de Deu and Vall d’Hebron (Barcelona) university hospitals. “Until a product like ours is commercialized, a lot of clinical research has to be carried out. In the first quarter of 2025 we will begin a study at the European level that will help us to obtain approval for marketing from the European Medicines Agency. We are going to do it in 20 hospitals in Spain, Germany and the Netherlands,” says the CEO of Innitius.
Facing the future and in the short term, Molina’s great ambition is that his device will finally reach the market so that pregnant women will be diagnosed in hospitals using his product. “And in 5 to 10 years, I would like it to be integrated into all ultrasound scanners in gynecology offices to make it more accessible to all patients, and also to all professionals,” concludes Molina.
