Triflo Cardiovascular Unveils Promising Clinical Outcomes for Tricuspid Flow Optimizer in Italy

Triflo Cardiovascular has announced that Gian Paolo Ussia from the Fondazione Policlinico Universitario Campus Bio-Medico in Rome will present the clinical outcomes of the first tricuspid valve regurgitation patients treated with the company's Tricuspid Flow Optimizer system. The presentation is set to take place at the 2024 New York Valves – The Structural Heart Summit conference, held at the Javits Convention Center in New York City. This conference is the foremost global event focused on valvular and structural heart disease, organized by the Cardiovascular Research Foundation.

The initial patients treated with the Tricuspid Flow Optimizer at the Humanitas University Hospital in Milan and the Campus Bio-Medico University in Rome were not eligible for any existing approved therapeutic procedures to address their severe regurgitation. The implant procedures were both successful and safe. Nine months of follow-up data indicate consistent and marked improvements in reducing tricuspid valve regurgitation and decreasing the size and volume of the right ventricle, alongside enhancements in exercise capacity and overall quality of life. Luca Pesce, CEO of Triflo Cardiovascular, stated, "Following years of development and exhaustive testing, we are thrilled that the Optimizer has performed as intended to benefit the patients in this first-in-human trial."

Tricuspid valve regurgitation is a condition where the valve separating the top and bottom chambers of the right side of the heart fails to close properly, causing blood to leak backward. Severe leakage can result in the heart muscle operating under increased stress with diminished output, potentially leading to heart failure, arrhythmias, physical limitations, and higher mortality. In the United States, approximately 2.4 million people are affected by significant tricuspid valve regurgitation. Current drug treatments show marginal efficacy, and surgery is rarely performed due to high risks. Although two minimally invasive transcatheter repair and replacement devices have been recently approved in the U.S., patient eligibility remains limited. Frank Ahmann, Triflo's Chief Business Officer, commented, "Wide gaps remain for technologies to address a larger population of tricuspid regurgitation patients, and we expect that the Tricuspid Flow Optimizer will play a significant role in filling those gaps."

About the Tricuspid Flow Optimizer
Designed specifically for the tricuspid valve and the right side of the heart, Triflo Cardiovascular's Tricuspid Flow Optimizer is delivered via a minimally invasive transcatheter procedure. The implant works in harmony with the right atrium, right ventricle, and native valve, irrespective of their size or shape, to significantly reduce severe regurgitation. The device is expected to offer an excellent safety and biocompatibility profile due to its minimalistic design, secure fixation, and adaptive mini-valve with polymer leaflets. It remains an investigational device and is not yet available for sale.

About Triflo Cardiovascular
Headquartered in Newport Beach, California, Triflo Cardiovascular is a clinical stage startup founded in 2017. The company is dedicated to developing safe and effective device therapies for treating tricuspid valve regurgitation and right-side heart failure. For more information, visit www.triflocv.com or Triflo on LinkedIn.