Suzhou Jiecheng Medical Technology Co., Ltd.

Suzhou Jiecheng Medical Technology Co., Ltd. Overview

Suzhou Jiecheng Medical Technology Co., Ltd. (“Jiecheng Medical”) was established on 8 September 2009 and is headquartered in BioBAY, Suzhou Industrial Park, jiangsu, China. In February 2022, the company became a wholly owned subsidiary of Jenscare Scientific (健适医疗) and was integrated into its Structural Heart Disease Division. Recognized as a national “Little Giant” enterprise, Jiecheng specializes in the R&D, manufacturing, and commercialization of minimally invasive transcatheter heart-valve systems targeting aortic valve disease.

Core Business and Key Technologies

Jiecheng Medical focuses on Class III implantable cardiovascular devices. Its proprietary technologies include:

• J-Valve® Transcatheter Aortic Valve System – the first self-positioning bioprosthesis deliverable via transapical or transfemoral approach.

• Unique “3-D positioning” technology enables implantation without rapid ventricular pacing and effectively treats pure aortic regurgitation (non-calcified annulus), a condition not addressed by other TAVR devices.

• Supporting portfolio includes delivery systems (transapical introducer kit, J-Valve loader) and a next-generation low-profile valve currently under NMPA review (submitted September 2024).

Market Position and Flagship Product

J-Valve® is the only TAVR system approved by the NMPA for both aortic stenosis and regurgitation, with more than 3,000 implants performed since 2017 across 180+ centers in china. Key milestones include:

• 2017 – First Chinese TAVR approved under NMPA “Innovative Green Channel”.

• 2018 – Health Canada Special Access approval; > 100 patients treated in Canada.

• 2019 – FDA Compassionate Use approval (IDE pending) for use in the U.S.

• 2024 – CE Mark dossier submitted for review in Europe.

Production and Regulatory Updates

In 2024, Jiecheng completed a major manufacturing expansion, adding a Class-B cleanroom, an automated leaflet-assembly line, and 100% in-process imaging-based quality control. Regulatory developments include:

• 2023 – Completion of pivotal trial for the new-generation low-profile valve (NCT05412345).

• 2024 – NMPA registration dossier submitted; CMDE review ongoing.

• 2025 – Planned FDA IDE submission for pivotal U.S. clinical study.

Contact Information

Address: Building C21, BioBAY, 218 Xinghu Street, Suzhou Industrial Park, Suzhou 215123, Jiangsu, P. R. China

Phone: +86 512 6317 9688