About RAINMED-B Company

Established in 2014, we are committed to becoming the world's leading interventional vascular surgery robotics company. Currently, we focus on the design, development and commercialization of coronary angiography-based blood flow reserve score systems (“CAFFr systems”) and coronary angiography-based microvascular resistance index systems (“caIMR systems”). Our core products (namely the CAFFR system and the CAIMR system) are innovative medical devices for evaluating the severity of myocardial ischemia caused by coronary artery stenosis and microvascular dysfunction (CAD-related causes). They are designed to replace the use of pressure guides, greatly reduce technical errors and operating time, thereby improving physiological assessment. Both systems are currently used separately for accurate CAD diagnosis. Since FFR measures macrocirculation in arteries (5% of all arteries), while IMR measures microcirculation in arteries (95% of all arteries), the combined use of IMR and FFR can provide a comprehensive assessment of coronary blood flow in CAD patients. These two systems are expected to be the core and key modules of our future vascular interventional surgery robots. Our CAFFR system is both European CE certified and approved by the National Drug Administration. It was also successfully registered in the Commonwealth of Australia (“Australia”) in 2022 and approved by the Government Drug Administration (“TGA”). Our CAFFR system has a high accuracy rate of over 95% and a convenient operation process that takes less than five minutes. It has become the leading FFR measurement product in China, and is fiercely competing with leading international medical device companies for the leading position in China's FFR measurement market. We plan to further cover patients with acute STEMI, acute NSTEMI, and HFpEF from the current scope of indications for the CAFFR system (that is, patients with stable angina, unstable angina, and patients after the acute phase of myocardial infarction). Furthermore, we are also developing the caIMR system, which is the only minimally invasive IMR measurement product in the world that has completed confirmatory clinical trials, and is expected to become the world's first minimally invasive IMR system approved for commercialization within 2023. Currently, we expect to obtain approval from the National Drug Administration to commercialize our CAIMR system in the second quarter of 2023. In December 2022, our CAFFR system and CAIMR system were incorporated into the “China Expert Consensus on Computational Coronary Physiological Testing Technology” (“Expert Consensus”). The expert consensus filled the gap where clinical application of calculated physiological indicators in interventional treatment of coronary heart disease in China lacked guidelines and regulations, and provided a basis for regulating application and expanding the scope of application. Based on our CAFFR system and CAIMR system, we aim to launch our vascular interventional surgery robot by 2024, a one-stop hybrid procedure that automates the entire PCI process by connecting and integrating all clinical application areas for diagnosis and treatment.