ENEA Tech and Biomedical Invests in Approxima, an Innovative MedTech Startup, for the Development of a Medical Device for Tricuspid Regurgitation Treatment

ENEA Tech and Biomedical has invested in Approxima Srl, an innovative MedTech startup focused on developing a percutaneous right ventricle remodeling technology for the treatment of tricuspid regurgitation.

This funding, part of a €7.3 million Series A round co-led by ENEA Tech and Biomedical and Panakès Partners, will allow Approxima to advance its cutting-edge solution through extensive preclinical validations and pilot clinical trials. Alongside the investment, Chiara Vieceli, an international expert in the cardiovascular sector, has joined the Board of Directors. The funds raised will be dedicated to further technological development, bringing Approxima closer to definitive clinical validation.

This innovative technology directly addresses the root cause of the pathology—right ventricle dilation—and restores tricuspid valve functionality through a minimally invasive procedure. Approxima’s solution offers a unique therapeutic option tailored to individual patient needs and compatible with other treatments, providing new hope for high-risk patients for whom existing surgical options are often inadequate.

“This investment marks a significant step in the innovation of precision medicine,” stated Maria Cristina Porta, General Manager of ENEA Tech and Biomedical. “Approxima has developed a groundbreaking technology for a complex condition with currently limited therapeutic options. Through this initiative, we strengthen our commitment to advancing personalized and cutting-edge solutions that significantly improve patients’ lives while enhancing the national healthcare system.”

“Over the past two years, our team has made significant technological advancements. We are thrilled to have closed this important funding round, supported by the continued backing of our existing shareholders who share our vision. This investment enables us to take the next crucial step toward the clinical validation of our technology,” commented Michal Jaworek, CEO and Co-founder of Approxima.

Tricuspid regurgitation:

  • >13M patients worldwide suffer from at least moderate tricuspid regurgitation (TR).
  • 50% 2-year mortality rate for patients with severe TR.
  • 99% of patients remain untreated.

Tricuspid regurgitation (TR) is a pathology of the aging society that affects over 13 million patients worldwide and represents an unmet clinical need. In more than 70% of cases, TR is related to right ventricle dilation, which causes papillary muscle dislodgement leading to tricuspid valve leaflets tethering. Patients are usually frail, often hospitalized, and have a poor quality of life. The pathology is associated with a 2-year mortality rate of 50%. Chronic volume and pressure overload progress toward right heart failure, further worsening the prognosis. Today, nearly 99% of tricuspid regurgitation patients are denied open-heart surgery due to the high mortality risk.