DE refers to the exemption of medical devices intended for marketing from regulatory requirements, allowing clinical trials to be conducted on such devices. The announced IDE approval will allow VenusP-Valve to initiate pivotal clinical trials in the U.S. to support the Pre-Market Approval (PMA). Through the Japan-US Harmonization By Doing program, jointly established by the FDA and Japan's PMDA, this clinical trial will be conducted concurrently at 10 centers in the U.S. and 5 centers in Japan, and 60 patients are expected to be enrolled. Last year, VenusP-Valve was applied in two cases for compassionate use in the U.S.

As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. To date, VenusP-Valve has been approved in more than thirty countries including China, the United Kingdom, Italy, Spain, Denmark, Greece, France, Germany, Poland, Switzerland, etc., and its implantations enjoy continuous growth in new hospitals and centers.

As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.

According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100% in 64 patients (some patients have not been included due to the COVID-19 pandemic). All-cause mortality and surgical reintervention rate were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects.

The device is set to enroll patients in the U.S. in the second half of this year and in Japan in early 2024, with approvals expected around 2026 in both markets.

In addition to VenusP-Valve, core products in the company's pipeline, such as the Cardiovalve mitral/tricuspid valve replacement system and Venus-Vitae and Venus -PowerX next-generation TAVR systems, are expected to receive successive domestic and international marketing approvals beginning in 2026.

Eric Zi, Co-Founder, Executive Director and General Manager of Venus Medtech said "The approval of VenusP-Valve's IDE marks a significant milestone in our global strategy and showcases the team's unwavering dedication to progress and innovation. As our innovative products enter the phase of fruition one after another, we anticipate 2026 as a year of substantial growth in global expansion. We excitedly look forward to VenusP-Valve's prompt patient enrollment and the collection of clinical follow-up results, leading to its marketing approval in the U.S."