Huitai Medical

Shenzhen Huitai Medical Devices Co., Ltd. (hereinafter referred to as "Huitai Medical" or "the Company") is a high-tech enterprise focusing on the research and development, production, and sales of cardiac electrophysiology and interventional medical devices. It has formed a business layout dominated by complete coronary access and cardiac electrophysiology medical devices, with peripheral vascular and neurointerventional medical devices as key development directions.
Huitai Medical is one of the domestic enterprises with a complete variety and category, leading scale, and strong market competitiveness in cardiac electrophysiology and vascular interventional medical devices, and is also one of the few enterprises capable of forming strong competition with foreign products. In the field of cardiac electrophysiology medical devices, Huitai Medical is a domestic manufacturer that has obtained market access and entered clinical application in China for electrophysiology electrode catheters, controllable radiofrequency ablation electrode catheters, and floating temporary pacing electrode catheters, filling the gap in domestic brands in the field of cardiac electrophysiology. At the same time, in 2011, it became a domestic manufacturer that obtained EU CE certification for two types of products: electrophysiology electrode catheters and controllable radiofrequency ablation electrode catheters. In the field of vascular interventional devices, Huitai Medical is a domestic manufacturer that has obtained market access in China for microcatheters (coronary application), peripheral adjustable valve catheter sheaths (catheter sheath sets), guide extension catheters, and thin-wall sheaths (vascular sheath sets). The Company's guide extension catheters and thin-wall sheaths (vascular sheath sets) are domestic products approved for marketing in China, and the anchoring balloon dilation catheter is an innovative medical device that uses balloon anchoring for catheter exchange within domestic guide catheters.
The Company's research and development investment in the past three years and the most recent period were 53.3779 million yuan, 70.4227 million yuan, 71.8994 million yuan, and 50.2897 million yuan, respectively, accounting for 22.08%, 17.43%, 15.00%, and 13.07% of operating revenue. As of June 30, 2021, the Company and its subsidiaries had obtained 41 domestic medical device registration and filing certificates, including 37 Class III medical device registration certificates, 2 Class II medical device registration certificates, and 2 Class I medical device filing certificates. In addition to the domestic market, the Company has obtained EU CE certification for 14 products and completed registration in more than ten other countries and regions.
In the first half of 2021, the Company's hospital coverage of products was further improved. In the domestic market, cardiac electrophysiology products were newly implanted in more than 60 hospitals, covering more than 500 hospitals. Vascular interventional products added 284 new agents, covering more than 1,600 hospitals. As of June 30, 2021, the Company's products had covered 88 countries and markets for sales. Huitai Medical will always be committed to independent innovation and development in the field of minimally invasive cardio-cerebrovascular intervention, and will make outstanding contributions to promoting the development of global medical undertakings.