Trisail

TriSail is an innovative minimally invasive transcatheter tricuspid valve repair device that aims to improve the treatment, safety, experience, and quality of life of patients with moderate to severe Tricuspid Regurgitation (TR). A highly prevalent heart disease, TR affects an estimated 70 million people worldwide, but due to a lack of suitable therapy options, fewer than 0.5% undergo isolated tricuspid repair or replacement procedures. The TriSail system solves this problem. The system is comprised of a prosthesis, transfemorally delivered using a proprietary delivery catheter. The prosthesis is made of a self-expanding nitinol stent anchored in the Inferior Vena Cava (IVC) and a single neo-leaflet ‘Sail’ that is placed inside the tricuspid valve to provide additional surface area for the native leaflets to co-apt with and thereby reducing TR.

TriSail technology was invented by Prof. Yeo Khung Keong, who led the product design and the development of preclinical and clinical protocols. In 2017, under a collaborative effort at the National Heart Centre Singapore (NHCS), Prof. Yeo successfully transitioned the complex Class III innovation from bench to bedside. In 2018, a leadership team with Prof. Yeo as Clinical lead, James Watson as Technical lead, and Dr. Srinivas Bhyahalli as Commercial lead, was established to drive the technology’s development and commercialization. By 2019, TriSail received the National Health Innovation Centre Singapore (NHIC) i2Start and Joint Centre for Technology and Development (JCTeD) research funding, which enabled further technology development and studies, leading to the incorporation of TriSail Medical in 2020, and additional funding from the National Research Foundation (NRF) Central Gap funding in 2021 to advance its progress. By the end of 2023, TriSail officially licensed its intellectual property from SingHealth and officially spun off the technology towards commercialization. It also formed an International Advisory Board with experts from the USA and Australia and secured its first equity investment from private investors, a strategic company in the cardiac devices space, and a High Net-Worth Individual investor. Subsequently, it was successful in obtaining additional financing from Enterprise Singapore’s POC and POV schemes to support its development.

The company plans to conduct First-In-Human (FIH) studies with Series A financing in 2024, followed by Series B and C rounds to advance clinical trials in the US and seeking FDA approval. TriSail’s technology aligns with academic medicine’s goals by addressing the high mortality risks and lengthy recovery times associated with traditional surgical treatment for tricuspid regurgitation (TR). The company’s proposed percutaneous approach is less invasive, aiming to reduce mortality and morbidity while improving patient quality of life. A key feature of TriSail technology is its ability to operate without an advanced imaging system, drastically reducing procedure time by more than 90% (from the current ~200 minutes to just 7 minutes). This innovation addresses the gap in healthcare, as fewer than 1% of patients with moderate to severe TR currently undergo repair or replacement procedures.

The ease of deployment and use of the TriSail device is expected to increase its adoption by healthcare professionals, allowing more patients with tricuspid valve disease to access treatment. This will improve clinical outcomes for Singapore’s aging population, reducing the need for surgical procedures and translating into cost savings for healthcare systems. The success of TriSail development would see a world-class innovative Class 3 cardiovascular medical device product developed from the SingHealth Duke-NUS Academic Medical Centre (AMC), Cardiovascular Sciences Academic Clinical Programme (CVS ACP), and TriSail. TriSail seeks to enlarge its global footprint through partnership agreements with reputed global centres/hospitals to undertake pre-clinical and clinical studies. The new capabilities and know-how created would greatly benefit cardiovascular medicine in Singapore's healthcare space.