The idea behind CC Cardio It has its roots in a known but still unresolved clinical problem: congenital heart disease which involves the absence or severe underdevelopment of the right ventricle (such as Hypoplastic Right Heart Syndrome(HRHS), but also caused by underdevelopment of the left ventricle, valve abnormalities, septal defects, or other malformations such as DORV, HLHS, etc. In all these cases, the heart is unable to properly pump blood to the lungs. Today, the most common solution is the so-called Fontan circulation, a surgical strategy developed in the 1970s that allows venous blood to be diverted directly to the lungs through a "conduit" external to the heart. An effective, but imperfect, solution.
"The problem," explains Maria Alexandra Cetățoiu, "is that this tube doesn't pulsate like a ventricle and doesn't grow with the patient. The blood flows passively, with insufficient pressure, and in the long term, this strains the body, particularly the liver, increasing the risk of serious complications and transplantation."
Hence the idea of a minimally invasive pump, designed to be inserted directly into the Fontan circulation and provide a pulsatile push to the blood, compensating for the function of the missing ventricle. It's not about reconstructing the heart's anatomy, but rather complementing it, improving its efficiency. The team intends to implant the device via a catheter, using a procedure similar to that used for coronary stents, minimizing the invasiveness of the procedure.
The project isn't just the result of theoretical or engineering considerations, but also of profound personal experience. "I too was born with HRHS," Maria Alexandra explains, "and I've had two heart surgeries, the first at seven months and the second at four years old. This is my reality. As I've grown older, I've realized that many of the available solutions allow for survival, but they don't really solve the problem in the long term. Hence my desire and will to contribute to a definitive solution to the problem."
A mission that also guided her educational path: first medicine, then the decision to focus on bioengineering, and finally research at the Polytechnic University of Milan, allowing her to work directly on the development of innovative medical devices. The research that led to CC Cardio began in 2018 and developed in a very concrete and, in some ways, unconventional way. "At first," she says with amusement, "we started building a prototype at home, with 3D printers and makeshift test benches. A sort of American-style 'garage,' even though the garage was the living room of the house."
After several attempts, the project has moved beyond the domestic sphere and into the lab, thanks to academic collaborations and a network of scientific advisors. Today, CC Cardio is still in the pre-clinical phase: computational simulations and in vitro bench tests have been conducted, while the next steps include animal testing and further technological refinement. Clinical-scale production is still a long way off, but the path is clear.
Along this journey, Boldbrain and the Agire Foundation played a crucial role. "For us," explains Cetățoiu, "Boldbrain wasn't just a competition. It was a comprehensive training and coaching program. We came from the research world and had no specific entrepreneurial, financial, or strategic skills. The program helped us structure the project and understand how to engage with investors, clinicians, and industrial partners."
The added value, she emphasizes, was also human: "Moral support is extremely important, especially when working on a complex project while still pursuing a doctorate or full-time research." In addition to the prize money, CC Cardio also received a scholarship to study at USI's Executive MBA, a further step towards strengthening the team's managerial skills.
Boldbrain's experience highlights an often overlooked aspect: the size of the Ticino ecosystem, smaller but extremely focused. "Paradoxically," Cetățoiu observes, "contexts like Ticino can be even more favorable than much more structured environments, like those in the United States. Here, there's less bureaucracy, more direct support, and a network that truly supports projects in the initial stages."
CC Cardio represents not only a technological promise in the field of congenital heart disease, but also a prime example of how research, personal experience, and institutional support can converge. A project born from a real need, developed between the laboratory and the "living room," and now ready to face the next crucial challenges facing the clinic.
