The king of valves, buy a Chinese innovative medical device

JianShi Medical Technology Group (hereinafter referred to as JianShi Medical) recently announced that it has sold its overseas subsidiary JC Medical, Inc. to Edwards Lifesciences, including the intellectual property and commercial rights of its J-Valve System, which is a transcatheter aortic valve replacement product used for the treatment of severe aortic regurgitation. The transaction includes an upfront payment as well as potential milestone payments based on sales.

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A Win-Win Collaboration

This transaction is a win-win collaboration. Moving forward, JianShi will continue to have exclusive rights to develop, manufacture, and sell the J-VALVE® valve in China. In July last year, JianShi completed patient enrollment for the registration clinical study of the J-VALVE® transfemoral transcatheter aortic valve system (referred to as: J-VALVE® TF valve) in China, and currently, the one-year patient follow-up has been concluded. In August 2023, the J-VALVE® TF valve received the "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA).

Furthermore, Edwards Lifesciences has completed an equity investment in JianShi Medical equivalent to approximately 180 million RMB in U.S. dollars, and the funds will be used to support the development of JianShi's products and market expansion. This strategic investment from Edwards signifies that JianShi's product development capabilities and operational model have gained recognition from an international industry giant.

Wang Xin, Chairman and CEO of JianShi Medical Technology Group, stated: "The J-VALVE® valve has unique advantages in treating aortic regurgitation. We hope to maximize the clinical application of this innovative product and expand its global influence, benefiting more patients. In the future, JianShi will focus more on developing innovative products and exploring better medical solutions to benefit patients both domestically and internationally."02

J-Valve Valve

In 2022, Jianshi Medical announced that it had completed the acquisition of Suzhou Jiecheng Medical Technology Co., Ltd. (hereinafter referred to as Jiecheng Medical). Following the acquisition, Jianshi established a Structural Heart Disease Business Division, with the founder of Jiecheng Medical, Zhang Ji, serving as the Chief Technology Officer (CTO) and President of the division. Jiecheng Medical is a leading enterprise in China's cardiac interventional valve industry, and its core product, the "J-Valve Precise Positioning Heart Valve Implantation System (referred to as the J-Valve Valve or J-Valve)," has led to technological innovation at the source of China's TAVR, breaking the international monopoly. The J-Valve Valve possesses globally leading technology and independent intellectual property rights on a worldwide scale.

The J-Valve Valve is not only the only interventional valve product currently approved by the NMPA with dual indications but also has advantages such as coronary artery protection and a low rate of pacemaker implantation.

According to a report by Cath Lab Digest, "The use of left ventricular assist devices (LVADs) in the United States is rapidly expanding for destination therapy and as a bridge to heart transplantation. However, aortic valve regurgitation can affect 52% to 1% of patients with LVAD support after 15 years, leading to poorer clinical outcomes. Although transcatheter heart valve (THV) treatments designed for aortic valve stenosis have been reported, the results are poor, and repeat surgeries are risky." The unique design of the J-Valve allows the device to be anchored on non-calcified valve leaflets and can withstand the suction pressure generated by LVADs. Therefore, the J-Valve can provide a transcatheter alternative to reoperations for these critically ill patients.

Unlike traditional biological valves that rely on the calcification of diseased heart valves to provide radial support force to fix them in the implantation position, Zhang Ji emphasized two necessary conditions for the valve during the development process, based on the needs of clinical doctors—accuracy in placement and durability in residence. On the basis of these requirements, the J-Valve Valve created the "autonomous navigation positioning system," which is also key to the J-Valve's ability to provide a transcatheter alternative to reoperations for critically ill patients.Structure and Annular Engagement Function

The J-Valve system is a newly designed porcine valve that features a unique two-piece structural design, composed of a trifurcated annular ring and a supporting frame. Specifically, it is installed within a self-expanding supporting frame that is connected to a three-pronged clip via three sutures. This distinctive connection allows the prosthetic valve to move along the long axis of the annular ring.

The structure of the annular ring is designed based on the normal anatomical structure of the aortic sinuses. The curved part of the ring accommodates the aortic sinuses during implantation. The three straight sections of the ring are spaced 120 degrees apart from each other, and they can be connected through the aorta and pulled back into the subaortic space, with the curved part located within the aortic sinuses. Placing the ring in the aortic sinuses provides tactile feedback for surgeons and facilitates the accurate deployment of the prosthesis while minimizing radiation exposure. The ring also aids in securing the prosthesis by sandwiching the native valve leaflets between the prosthesis and the supporting frame.

Advantages of the Two-Stage Implantation

The movable connection between the annular ring and the supporting frame enables a two-stage implantation process, allowing for precise anatomical positioning and secure anchoring. The first stage involves placing the annular ring in the aortic sinuses. The second stage is the positioning and deployment of the prosthetic valve. Thanks to the movable connection, the position of the prosthetic valve can be adjusted even after the annular ring has been placed in the aortic sinuses, ensuring that the prosthesis can be perfectly deployed in axial alignment with the left ventricular outflow tract, despite any abnormal structures affecting the annular ring.

Thanks to its positioning wings, the J-Valve breaks through the limitation of TAVR valves that require calcified parts of the diseased aortic valve to increase resistance. The three positioning wings of the positioning piece can firmly secure the valve onto the annulus.

In addition to treating severe aortic regurgitation, the J-Valve system can also be implanted for stenotic aortic valves with severe calcification after balloon valvuloplasty. This valve has been implanted in many patients with aortic valve stenosis, and although technical success was achieved in all cases, one patient suffered from iatrogenic aortic dissection due to excessive balloon valvuloplasty. Fortunately, the patient survived and was discharged after recovering from aortic valve and hemiarch replacement surgery.

In July 2023, Jianshi completed the patient enrollment for the J-VALVE® transfemoral transcatheter aortic valve system (TAVS) valve (referred to as: J-VALVE® TF valve) in a registered clinical study in China. Currently, the one-year patient follow-up has been concluded. In August 2023, the J-VALVE valve received the "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA). In February of this year, JC Medical completed the patient enrollment for the J-VALVE valve early feasibility study (FDA EFS) in the United States and was approved to initiate a pivotal clinical trial (FDA Pivotal Trial).

Jianshi Medical's J-VALVE® valve, through its non-traditional transfemoral implantation method, reduces the invasiveness of the surgery and accelerates the recovery process for patients. In 2023, this valve received the FDA's "Breakthrough Device Designation," marking its recognition and support in the medical market. This not only brings more treatment options to patients but also provides Jianshi Medical with opportunities to collaborate with international giants, thereby further promoting product development and clinical application.

Edwards Lifesciences' strategic investment is undoubtedly an affirmation of Jianshi Medical's product development capabilities and market positioning. So, how will this powerful collaboration bring better clinical research and promotion to the J-VALVE valve in the future?