The startup has already started preclinical trials in France for an innovation that will improve the quality of life of cardiac patients.
The startup will use the funding to advance the validation of its technology a mechanical valve designed to improve the quality of life of patients with heart disease.
The Barceló Foundation, with the technical and operational support of its incubator, Incubando Salud, and CITES, a venture capital fund that drives deeptech startups, announced a new joint investment of US$900,000, which has enabled the continuation of cardiac device testing already underway at the Institut Mutualiste Montsouris in Paris, France.
The product
According to estimates, since there are no exact figures, at least half a million heart valves are implanted worldwide each year to treat cardiovascular diseases, which represent the leading cause of death globally.
However, mechanical alternatives have seen no innovation for more than four decades. “Today, a surgeon must choose between a biological valve, which has a limited lifespan, or a mechanical one, which requires lifelong anticoagulation. Our proposal changes this paradigm: a mechanical heart valve that, unlike current ones, will not require lifelong anticoagulation“, explains Dr. Diego Cheja, MBA, partner in the initiative and former CEO of Medix Medical Devices.
Native heart valves are damaged by various pathologies and tend to wear out within eight to ten years. For their replacement, “bileaflet” mechanical prostheses are primarily chosen due to their long lifespan, despite their low hemodynamic performance. The design proposed by CloverLife, which already holds five patents in the United States and Europe, aims to achieve hemodynamic flow similar to a native valve, with a three rigid-leaflet (trileaflet) design.
“Osvaldo Amerio, my partner, originally from La Plata and now living in Posadas, is a cardiovascular surgeon who experiences daily the frustration of not having an ideal valve for his patients. This was his driving force to design a completely new product that addresses the core problem. Together, we have been advancing this project for ten years”, he continues.
The demand is evident. In fact, the heart valve market was estimated at US$11.94 billion last year and is expected to reach US$20.86 billion by 2029, with an annual growth rate of 11.8%, according to a study by Mordor Intelligence.
Aiming to seize this opportunity, CloverLife had already received an investment of US$750,000 from CITES in 2020. In addition to filing the five patents, the funding allowed them to manufacture prototypes and validate them in a laboratory accredited by the United States Food and Drug Administration (FDA).
But the turning point for the initiative came on September 1, when they successfully implanted two valves in sheep, animals whose heart anatomy is very similar to that of humans.
“It was an incredible emotion to see the sheep’s heart start beating again with completely normal parameters, thanks to our valve manufactured in Argentina”, says Cheja. “To this day, both animals are doing very well in a field outside Paris. Just thinking that this could help millions of people gives us goosebumps”, he adds.
CloverLife: What’s Next
According to Cheja, “these trials aim to evaluate safety, durability, and hemodynamic performance before moving on to the clinical phase in humans”.
“There is still a long way to go, but we are taking the necessary steps to achieve it. If we can demonstrate that our valve does not require anticoagulation and has a lifespan exceeding life expectancy, we would be facing one of the most disruptive innovations in the history of cardiology”, he emphasizes.
Why? According to the doctor and entrepreneur, “it would instantly change clinical practice, radically improve the lives of millions of future patients, completely redefine the cardiac device market, and generate substantial long-term savings for healthcare systems”. In his view, “it would undoubtedly be the new Holy Grail of heart valve technology”.
Nicolás Tognalli, Founder and Managing Partner of CITES, agrees: “CloverLife has a technology that could revolutionize heart valve surgeries. Conducting in-vivo trials in a French medical clinic, under strict control and the necessary protocols, is a tremendous validation”.
However, for the next stage, the startup will need to secure a third round of funding, larger than the previous ones. Nicolás explains, “Once these trials are completed, and if they are as successful as we expect, we will have a set of very strong data to approach a new fundraising process with lower risk”.
According to the investor, this capital would allow them to “conduct similar trials, but with a larger number of animals, which is necessary to go through the regulatory process of the preclinical stage – the precursor to human trials”.