INNITIUS, differentiating between false and true Preterm labor threats at the Point-of-Care
The Start-up focused on Providing Actionable Diagnostics for Women’s Health
Incorporated in 2017, this Spanish start-up is developing the FineBirth, a medical that combines the precise and quantitative measurement women’s cervical tissue consistency with artificial intelligence to support the specialist's decisions in pathologies such as premature labor, induction of labor, cervical cancer, or in-vitro fertilization.
The device is quite simple to use; the clinician introduces the INNITIUS probe through the patient's vaginal cavity until reaching the cervix. The probe contains the novel method of measuring cervical consistency developed by INNITIUS (the so-called TorsionalWaves); by pressing the button, the device propagates a delicate, safe (it has a power 1000 times lower than conventional ultrasound) and imperceptible vibration to the tissue, and the sensor system (also contained on the probe) register show the tissue has changed the propagated vibration; thus we get our measurement: a specific and accurate value on how soft the patient's tissue is.That itself, as they have seen in their preclinical studies, is not enough to provide the physician an accurate result, so they combine that measurement with other variables from the patient's clinical history to show the obstetrician a result in the form of a Score and, depending on the pathology, a message about what that score means (i.e. risk of preterm delivery, high/low chances of success probabilities in the labor induction process, etc.).
Their first market is the diagnosis of Threat of Preterm Labor events. They evaluate pregnant patients who come to emergencies with signs and symptoms of preterm labor (before 35 weeks of gestation) and help the physician make the decision whether it is a real preterm labor event or a false threat of preterm labor (and they can discharge the patient or keep her under observation without treatment). The main problem right now is that the diagnostic tests available on the market have relatively low accuracy, and85% of patients who are hospitalized and treated as true preterm labor events are actually false threats, and these pregnant women get administrated drugs that have serious side effects associated for both the baby and the mother (in addition to the unnecessary expense associated with hospitalization and treatment of the healthy patient).
INNITIUS is going to reduce that number of unnecessary hospitalizations, preventing healthy patients from receiving treatment that they should not, and therefore reducing exposure to potentially harmful drugs for them and their babies.
Industry challenges in the development of a medical device
· Getting funding to keep moving forward the project. In Spain there are still not too many VCs or BA focused onMedical Devices, so this point is still the main challenge. INNITIUS got pre-seed funding from a VC which certainly made the task much easier at the beginning.
· Forming a team with expertise in the sector. At the beginning they had a hard time finding profiles with experience in Medical Devices in their region. The Basque Country is a region with a long tradition in classical industry, but their sector is just now starting to grow. Most of the available Medical Device talent is located either in Barcelona orMadrid. To solve this and keep growing they took two steps: firstly, they implemented teleworking within the company's protocols, so the team could be from anywhere in the world without any problem, and secondly, they opened a small office (a co-working office shared with other start-ups) in Barcelona.The fact is, that both steps have been successful and have helped them to grow and keep the talent in INNITIUS.
· Recruitment in clinical trials, which is still an issue for them. The recruitment ratio is still well below what they projected. They are trying to implement more continuous follow-up measures, implement additional centers, etc.
Future key trends
There has been an aggressive movement towards providing the physician with multidirectional information for the decision-making process. When they started in their field, they saw how the specialist would make diagnoses based either on clinical information from the patient, or on biomarkers, or on other tests performed on the patient, but never or almost never on using several different techniques for analyzing the same problem. It was a single variable analysis.
What they see now is that there is a movement toward using different techniques to get additional information about the problem, and this, according to Ruben, is happening because of the emergence of innovations that combine all this information using artificial intelligence models. Now the clinician has all that information available, and also has support from these new technologies to interpret that information, which has a direct and positive impact on his/her workflow, the safety of the decision made, and therefore on improving the quality of life of the patients.
In addition, there is also a push towards decentralization of patient care. They see how many more home-care technologies are appearing and also how the patient has more and more weight in the performance of self-tests to provide the doctor, remotely, with information (some examples are IMMA(also a Tech4Eva start-up member), or Pulsenmore, which allow the patient to test at home - under previous prescription - and send the results to the doctor so that he/she can make the decision on what to do with the patient from the doctor's office).
Questions asked to Ruben:
What are your biggest achievements to date?
"We have managed to go from a theoretical concept(torsional waves) to a design freeze prototype that is already being tested on real patients. For me, this is the greatest achievement, to see how something that did not exist becomes a reality and is used in real patient cases, which can improve their lives.
As a company, I am very happy with the milestones achieved by the team. I started alone in the office, 5 years ago, and now we are 11 full time people. We have managed to raise more than €2.5M between public and private funding. We have achieved the ISO 13485 certification, involved clinicians from different countries (some of them KOL), the device is being used by more than 50 obstetricians in clinical trials, and we are just now starting to transfer our technology to production, to be able to serialize the product and enter the market by the end of next year.
How is a program such as Tech4Eva useful to you?
I think there are two key benefits of a program likeTech4Eva that I would like to remark: (1) the extensive network they have, which has helped us to contact VCs, medical equipment manufacturers or technology research centers and that will surely help us now and in the future and (2) the visibility that the program gives our company within the Women'sHealth sector, which puts us on the radar of Corporates and VCs, clinicians and patients.
I think that just for that, the program is worth while going through, but in addition, the training sessions provided are also interesting, access to experts via their mentoring sessions is top notch, and meeting peers from other start-ups, with whom synergies may arise in the future.
About Rubén Molina, CEO and Co-Founder of INNITIUS.
He is a Building Engineer and Master in Structural Engineering (with specialization in biomechanics) by the University of Granada by training, and he established INNITIUS at the end of 2017 - being part of the PhD Thesis he was doing at the University. Since then, he focuses his professional development in the field of medical devices, where he feels that as an engineer by training and mindset entrepreneur, he can contribute to the improvement of current healthcare systems and impact the lives of millions of patients.
· Website: https://www.innitius.com/
· Facebook: https://www.facebook.com/Innitius/
· Twitter: https://twitter.com/_INNITIUS