And based on this output, they could decide to perform angiography or not?
Iborra Egea: Our technology could be used much earlier. The first time could be just when a stent was implanted, just to see if the implantation went well and if the patient can be discharged home safely.
Patients with stents need to regularly visit their cardiologist, but these visits and the examinations are very subjective. The cardiologist asks if the symptoms have become better or worse, if the patient feels good, if they tire a lot, if they can breathe well.
Our technology could objectivize these visits and the way we monitor stents. If the cardiologist notices a progressing problem with a stent, they can act preemptively. This could be by changing a patient’s medication or lifestyle. In the end, a stent that is not working properly anymore, maybe because of blockage, could be changed before it causes problems for the patient. The technology could eliminate invasive angiography from the screening arsenal clinicians have.
In March, you received funding of one million euros for your company. What are the next steps?
Iborra Egea: First, we must finish the preclinical studies. We looked at the results of our technology in pig models and are currently analyzing the data from these studies. Next, we will build a prototype of the device and look for design improvements.
When we have incorporated all improvements and the device follows all European regulatory and safety certifications, we plan to start the human pilot trial early in 2024. This trial will take place at the Germans Trias i Pujol Research Institute (IGTP) here in Barcelona and include between 30 to 50 patients. When the pilot trial is successful, we will move into the trial to receive regulatory approval for commercialization.
If possible, you want to show the prototype at MEDICA 2023.
Iborra Egea: We are considering it, but we want to have a real good prototype for this. If we can, we will be there as exhibitors. Otherwise, we will just visit the show to get to know people in the industry and catch the feeling. And come back to MEDICA as an exhibitor in 2024!