OrbusNeich’s Joint Venture Kicks Off TricValve Clinical Trial in Mainland China

(Hong Kong, April 24, 2024) – OrbusNeich Medical Group Holdings Limited (“OrbusNeich” or the “Group”; stock code: 6929), a major global medical device manufacturer specializing in interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures, announced today that the Group’s joint venture OrbusNeich P+F Company Limited (“ON P&F”) has commenced the clinical trial for the TricValve Transcatheter Bicaval Valve System (“TricValve”), to treat patients with hemodynamically relevant tricuspid insufficiency and caval reflux, on April 22, 2024 across Mainland China.

The CE-marked medical device was named a Breakthrough Device and Innovative Medical Device by the FDA in the United States and NMPA in China, respectively. It has effectively treated a 56-year-old patient with severe tricuspid regurgitation, marking the commencement of the clinical trial across Mainland China.

Led by principal investigator Prof. Ge Junbo, Academician Zhongshan Hospital, Fudan University, and his team, the clinical trial aims to assess the safety and efficacy of TricValve. Prof. Ge Junbo had himself performed the implantation procedure on a patient. A team of experts of Zhongshan Hospital, one of the 13 medical institutions participating in the trial, believed the groundbreaking therapy could potentially revolutionize treatment options for patients, offering them new hope and improved outcomes.

Mr. Peter Peh, General Manager of OrbusNeich P&F, said, “We are pleased to see TricValve moving into clinical trial, marking the first successful implantation of a percutaneous transcatheter bicaval device in a patient by cardiologists in Mainland China, to address severe tricuspid valve regurgitation. Before that, patients with this valvular heart disease are typically deemed unfit for open-heart surgery. They had limited treatment options, and had to endure severe symptoms and a shortened lifespan. With the advent of TricValve, patients can look forward to having better quality of life and live longer. It is our privilege to offer this life-changing therapy to patients. As our first patient has been doing exceptionally well after the procedure, we hope to extend relevant care to more patients in the future.”

Via ON P&F, the Group has ventured into the structural heart domain. In addition to TricValve, ON P&F also has a comprehensive pipeline of structural heart interventional devices, including Vienna Aortic Valve, a transcatheter aortic valve replacement (TAVR) product; Vienna Mitral Valve — Replacement, a transcatheter mitral valve replacement (TMVR) product; Vienna Pulmonary Valve — Replacement, a transcatheter pulmonary valve replacement (TPVR) product, and balloon expandable valves, which are complementary additions to the Group’s series of self-expandable heart valve devices. The strategic move has opened doors for the Group to new opportunities in the transcatheter valve replacement and repair market recording double-digit growth in recent years. The notable shift from traditional open-heart surgery to minimally invasive transcatheter therapies will present the Group with substantial growth potential in the medium and long term.

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About TricValve
TricValve, a transcatheter bicaval valve system, is comprised of two self-expanding biological valves used to treat patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the superior and inferior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy.

TricValve obtained the CE Mark in 2021, received Breakthrough Device Designation from the FDA in 2020, and was granted an Innovative Medical Device designation by the NMPA in 2022.

About OrbusNeich Medical Group Holdings Limited
OrbusNeich is a major global medical device manufacturer specializing in interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures. Headquartered in Hong Kong, China, OrbusNeich sells its products in more than 70 countries and regions worldwide. It is also actively expanding into neuro vascular intervention and structural heart disease. As at December 31, 2023, OrbusNeich has more than 240 granted patents and published patent applications worldwide. Its in-house R&D team has more than two decades of product development experience and has developed world-leading proprietary technologies.

For more information, please visit the Group’s official website: https://orbusneich.com/