On September 29th, 2022, RainMed Medical Co., LTD. (Stock Code: 2297.HK, hereinafter referred to as "RainMed") officially announced that its caFFR system has been successfully approved by Australian Government Department of Health Therapeutic Goods Administration(TGA), unlocking a new area in overseas market. Having got TGA’s recognition means RainMed has taken a solid step in accelerating its layout of international marketing system!

As a Chinese independent innovative enterprise, RainMed expands its global business on the basis of clinical practice, aiming to create world's leading innovative medical products, and has also made remarkable achievements. In addition to EU CE marking and China NMPA certification obtained in 2019, RainMed has three authoritative medical device registration certificates at present and successfully completed its registration in the Republic of Serbia and the Republic of South Africa, laying a solid market foundation for the continuous expansion of its commercial territory. RainMed Medical’s caFFR system is the first innovative medical device product in China to obtain both CE marking and NMPA which puts forward the concept of coronary functional diagnosis and treatment based on angiograms without pressure guide wire, hyperemic agents and additional surgical operation. Based on only two angiograms, real-time aortic pressure, and an optimized CFD algorithm, caFFR could be measured in an average of 5 minutes, with an accuracy of 95.7%. Compared with traditional guide wire-based FFR, it has unique advantages of high efficiency, precision, simplicity and innovation, contributing Chinese wisdom to promote the clinical application of coronary function assessment. Its advanced diagnosis and treatment concept and excellent clinical value have been widely recognized by official institutions, experts and scholars, and passed the test of the capital market.

As early as 2018, caFFR system entered NMPA's special approval channel for innovative medical devices. As a "Mount Everest" in the field of innovative medical devices, the approval rate of this channel is only 20%. Products entering the special approval channel of innovative medical devices will enjoy the priority of NMPA certification and faster approval speed. caFFR system has broken through many tests and successfully been approved to enter the green channel of innovative medical devices, which means that caFFR system has been officially recognized by authorities in the medical device industry for its clinical superiority and global innovation.

The caFFR system has also attracted the attention of the world's top experts and scholars due to its ultra-high clinical practicability and innovation. Experts continue to promote the progress of clinical research and publish a number of influential scientific research articles in top SCI journals. Among them, the scientific research articles published in Cardiovascular Research that showed the consistency of caFFR and guide wire-based FFR were highly recognized by Academician Junbo Ge and Professor Yong Huo. Experts believe that the wide application of caFFR system will help further improve the quality of PCI therapy in China and make the country become a powerful interventional country from a big interventional country. In the future, caFFR system will largely replace guidewire-based FFR and open a new era of functional assessment of stable coronary heart disease.

Since the commercial implementation of caFFR system, the sales volume of the product has increased against the trend, leading the similar domestic innovative FFR products. In just three years, caFFR system has covered more than 1000 hospitals in 30 provinces and autonomous regions, and the sales volume in 2021 has increased by 12 times compared with that in 2020. It is worth mentioning that in the reply of the National Healthcare Security Administration to the Suggestion No. 4955 of the Fifth Session of the 13th National People's Congress issued by the National Healthcare Security Administration, it is clear that it will not implement the purchase of innovative medical devices in quantity for the time being. In addition to centralized procurement, this leaves space for the market of high-tech medical enterprises and also leaves space for price, market development and profit recovery for caFFR system.

Data show that from 2020 to 2025, FFR penetration rates in the United States, Japan and the European Union are 22.5%, 17.2% and 6.9% respectively, while the penetration rate in China is less than 0.4%. However, during the same period, the compound annual growth rate of FFR products was as high as 97.9%. This means that China's caFFR system market still has a very high potential to be explored. At the same time, the global promotion of caFFR system is expected to promote the products to meet a broader market space.

caFFR system is one of the core products of RainMed’s FlashBot vascular interventional surgery robot. In the future, it will be integrated into FlashBot together with caIMR system, which will be commercialized by the end of the year, to enable the robot to "observe" and "think".

FlashBot is the first vascular interventional surgery robot covering the whole process of diagnosis and treatment in China. Its clinical application will help surgeons make better clinical diagnosis and develop scientific integrated diagnosis and treatment strategy for vascular diseases in the cathlab, so as to better benefit clinical surgeons and patients. Currently, FlashBot has been successfully developed and completed several animal experiments, and the product is expected to be commercialized in 2024.