The board of Shanghai Bio-heart Biological Technology Co., Ltd. announced that the company's Iberis® multi-electrode RDN system (RDN) product has been approved by the ethics committee of Ruijin Hainan Hospital and will soon apply to the Hainan Medical Products Administration and the Hainan Provincial Health Commission for formal access and commercialization. According to the policy of Hainan Lecheng International Medical Tourism Pilot Zone and with reference to the "Notice of the People's Government of Hainan Province on Printing and Distributing the "Regulations on the Management of Imported Medical Devices Urgently Needed for Clinical Use in the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone and the "Notice on Several Measures to Further Optimize Regulatory Services to Support the High-Quality Development of Hainan Boao Lecheng International Medical Tourism Pilot Zone, the acceptance of the RDN product into Ruijin Hainan Hospital was applied based on the urgent clinical needs of medical institutions in the pilot zone and the innovative policy for the drugs or medical devices that have been approved for marketing in the United States, the European Union, Japan and other countries or regions but have not been approved for registration in the PRC and cannot be replaced by domestic marketed products. According to Frost & Sullivan, as disclosed in the company's prospectus published on December 13, 2021, the total number of hypertension patients in China in 2019 was approximately 317.4 million.

In order to make the Company's RDN products benefit the hypertension patients in China as soon as possible, the Company responded to the policy to carry out the application. The RDN technology will bring new hope to patients who can not achieve ideal blood pressure level through drug treatment, and is expected to achieve long-lasting, stable and 24-hour uninterrupted blood pressure control, reduce drug use, and break the predicament that patients can only rely on drugs to lower blood pressure. The RDN product of Bio-heart obtained CE certification in 2016.

During this application process, the product's advantages of multielectrode circumferential ablation, being able to access renal artery branches for ablation and being able to perform the surgery through both transradial and transfemoral approaches have been unanimously recognised by the expert review committee. If the final application is successful, the product will be approved for urgent clinical use in Hainan Boao Pilot Zone. On one hand, it is expected to help the Company achieve product revenue earlier; At the same time, the company hopes to take this as an opportunity to build a RDN surgery training centre in Boao, Hainan to conduct surgery training and patient education in advance.

The application is strategically important to the company's RDN products.