A disease of the aging heart that has remained without effective treatment for decades
Tricuspid valve regurgitation (TR) is one of the mostunderdiagnosed and undertreated cardiovascular conditions worldwide. In thisdisease, blood flows backward through a leaky tricuspid valve into the rightatrium, progressively overloading the heart, reducing cardiac efficiency, andleading to worsening systemic failure.
In advanced stages, prognosis is severe — with a two-yearmortality rate approaching 50%. Despite this, TR remains largely invisible at asystem level. According to publications indexed in PMC/NIH, it affects over 70million people globally, yet more than 99% of patients never receive anyinterventional or surgical treatment.
The primary barrier is the high risk associated withconventional open-heart surgery, which in this population — typically elderly,multimorbid, and frail — is often considered too dangerous to pursue.
The“forgotten valve”: why tricuspid regurgitation remained outside mainstreaminnovation
While interventional cardiology has made major advances intreating aortic and mitral valve disease, the tricuspid valve has long remainedoutside the main focus of innovation — both diagnostically and therapeuticallyoverlooked.
Patients with TR are typically in advanced stages of heartdisease, often presenting with heart failure, pulmonary hypertension, andatrial fibrillation. In this context, open-heart surgery carries aperioperative mortality risk estimated at 2–10%.
In clinical practice, isolated tricuspid valve surgeryremains extremely rare — with only approximately 500 procedures performedannually in the United States.
Approxima:a new approach targeting the root cause of the disease
Approxima, a spin-off from the Politecnico diMilano, is developing a transcatheter system for right ventricularremodeling. Unlike most existing technologies, Approxima’s approach does notfocus solely on correcting valve geometry. Instead, it directly targets theunderlying pathology: the dilation of the right ventricle, which displacespapillary muscles and ultimately leads to valve insufficiency.
The device is implanted via a minimally invasivepercutaneous procedure under imaging guidance, without the need to stop theheart.
The company has reported promising in vivo preclinicalresults, is building a strong intellectual property portfolio (including agranted U.S. patent), and has secured funding from leading investors such asPanakès Partners and ENEA Tech e Biomedical.
Approxima has also presented its technology at majorinternational cardiology conferences, including EuroPCR, PCR London Valves,MedTech Innovator Road Tour, and LSI Europe.
A rapidlyexpanding market driven by unmet need and demographics
Regulatory milestones in 2023–2024, including CE Mark and FDA approvals for early transcatheter tricuspid devices, have opened the doorto a rapidly emerging market segment.
According to GlobalData, the transcatheter tricuspid valverepair and replacement (TTVR) market is growing at a compound annual growthrate (CAGR) of 28.5% and is expected to reach USD 3.7 billion by 2035. Thebroader tricuspid regurgitation device market is estimated at USD 1.5 billionin 2025, with projections of approximately USD 4 billion by 2033 (CAGR ~10%).
The key driver is demography. TR is a disease of the agingheart — its prevalence increases exponentially with age, from approximately0.55% in the general population to over 4% among individuals aged 75 and older.As populations in Europe and the United States continue to age, the number ofpatients is expected to rise significantly.
At the same time, available therapeutic options remaininsufficient relative to the scale of the problem.
AegisCapital perspective: innovation addressing a major unmet clinical need
At Aegis Capital, we see Approxima as an example ofdeep technological innovation in a field with a significant and still unmetclinical need.
The technology developed by this spin-off of Politecnico diMilano addresses not only the symptoms of the disease but its mechanical rootcause. In the context of aging populations and rising healthcare costs,minimally invasive and effective treatment of tricuspid regurgitationrepresents not only a commercial opportunity, but also a clinical necessity.
