With the popularization of the concept of precision medicine at home and abroad, as well as the continuous deepening of scientific research, the diagnostic indicators of coronary function continue to be accepted by the majority of clinicians. Among many functional diagnostic devices, caFFR system and caIMR system launched by RainMed Medical have emerged on the international stage and been highly concerned and recognized by international top experts and scholars.

As a domestic independent innovation company, RainMed Medical attaches great importance to product innovation and scientific research, and constantly promotes scientific research cooperation with top medical institutions at home and abroad. In cooperation with top medical centers at home and abroad, such as Peking University First Hospital, Fudan University Zhongshan Hospital, Shanghai Tenth People's Hospital, Peking University People's Hospital, Beijing Hospital, Samsung Medical Center, National University of Ireland and so on, the company has published nearly 30 articles in top journals, which has laid a solid academic foundation for the large-scale clinical application of the product. The academic achievements of RainMed’s scientific research have promoted the development of coronary physiology to a higher level, and also made the company gain a broad market space.

Diversified Clinical Application Value Has Been Explored, and the Indication Range of caFFR System Has Been Continuously Expanded

caFFR system is the first coronary functional diagnostic product in China to obtain both China NMPA and EU CE certification. The Flash I study, led by Peking University First Hospital, has demonstrated that caFFR system has achieved an accuracy of 95.7% compared to conventional guide wire-derived FFR, leading other innovative FFR devices in the industry. From then on, caFFR system has gained wide attention from overseas experts and scholars, and a number of important landmark researches have been published. Previous studies have demonstrated that caFFR system can replace guide wire-derived FFR for preoperative blood flow assessment, intraoperative diagnostic strategy making and postoperative evaluation of an intervention. caFFR system is also regarded as a reference standard for coronary function, assisting in determining the diagnostic accuracy of IVUS parameters, promoting the development of clinical coronary function diagnosis.

Last year, two studies led by Peking University First Hospital and Nanfang Hospital demonstrated that caFFR can be used to assess immediate prognosis after PCI and as a potential diagnostic indicator of nonculprit vessels in patients with acute myocardial infarction. Studies have shown that the measurement of caFFR immediately after surgery can accurately reflect the outcome of intervention, and assist doctors to make reasonable intervention strategies to strive for the optimal diagnosis and treatment for patients. Meanwhile, studies have shown that functional syntax score guided by caFFR system is better than simple syntax score in differentiating tachycardia/ventricular fibrillation occurrence, which provides potential functional diagnostic indicators for improving the prognosis of patients with acute myocardial infarction.

The clinical application of caFFR is expanding, and has received a positive response from the market. In 2022, RainMed Medical expanded its commercial territory and achieved a breakthrough in obtaining the TGA certificate, unlocking Australian medical device market. Up to now, caFFR system has covered more than 1000 hospitals in 30 provinces, municipalities and autonomous regions in China, as well as 8 foreign countries and regions. The sales volume has increased by 12 times against the downtrend, which has fully opened the way for marketing landscape at home and abroad, and accumulated a solid market foundation for subsequent products.

As the First Non-interventional Diagnosis Product, caIMR System Completed First Confirmatory Clinical Study

The caIMR system, originally developed by RainMed Medical, has innovationally challenged the traditional microcirculation diagnosis, provided a new diagnostic tool for clinical practice, and provided new perspectives for the diagnosis and treatment of complex coronary artery diseases. As the world's first non-interventional coronary microcirculation diagnostic product, caIMR system has received continuous attention from scholars around the world since its launch. In 2022, the caIMR system has also achieved fruitful results in clinical studies, and the number of publications in SCI journals has increased multiple times.

Previous studies have demonstrated that the caIMR system can provide an effective way for prognostic evaluation of patients with stable angina pectoris, unstable angina pectoris, INOCA, MINOCA, STEMI, and coronary heart disease after PCI. It can help surgeons to better overcome the diagnosis and treatment difficulties of microcirculation dysfunction, and offers a very good evaluation way for the diagnosis and drug intervention of patients with microcirculation dysfunction.

The diagnostic accuracy of the caIMR system continues to be demonstrated, and Flash III clinical trials, supported by RainMed, have been successfully completed with promising scientific results. According to the study, the accuracy rate of RainMed’s caIMR system is 93.81%, which has high consistency, sensitivity and specificity compared with guide wire-derived IMR. This means that caIMR system can replace guide wire-derived IMR for large-scale clinical applications. In this study, Academician Junbo Ge from Fudan University Zhongshan Hospital served as the principal PI and Prof. Yong Huo from Peking University First Hospital served as the joint PI. The results soon aroused wide discussion among experts and scholars at home and abroad.

In addition, researchers from Samsung Medical Center, Shanghai Tenth People's Hospital, Peking University People's Hospital, Beijing Hospital and The Affiliated Hospital of Xuzhou Medical University continue to compare caIMR system with traditional cardiac MRI, CZT SPECT, ultrasound, MRI and other traditional microcirculation diagnostic methods to verify that caIMR system has better clinical diagnostic performance. In addition, the caIMR system has been demonstrated to be able to independently predict outcomes in overweight with chronic coronary syndrome patients, diabetic patients with chronic coronary syndrome and coronary slow flow .

It is worth mentioning that caIMR system provides new clinical evidence for the diagnosis and treatment concept of "intervention without implantation", and contributes important value to promoting the development of precision medicine in coronary artery disease. Researchers from The Affiliated Hospital of Xuzhou Medical University compared the caIMR value and the incidence rate of major adverse cardiovascular events after implantation of drug-eluting stents and drug-coated balloon, and found that the long-term prognostic effect of drug-eluting stents or drug-coated balloon in STEMI patients was similar, and the long-term prognostic effect of drug-coated balloon was no worse than that of drug-eluting stents, which verified that the drug-coated balloon can be used as one of the first choices for STEMI patients.

Based on the important role of caFFR system and caIMR system in promoting precision medicine in coronary artery disease, academician Junbo Ge from Fudan University Zhongshan Hospital, and Prof. Yong Huo from Peking University First Hospital, led more than 50 authoritative experts in the industry, drafted the first Chinese Expert Consensus on Clinical Pathways of Coronary Artery Computational Physiology Detection Indicators. The consensus defines the operation and application scope of caFFR system and caIMR system in a pioneering way, and provides practical guidelines for the clinical use of coronary function assessment.

Experts at the launching ceremony of Chinese Expert Consensus on Clinical Pathways of Coronary Artery Computational Physiology Detection Indicators

In fact, caFFR system and caIMR system are not only mature products that can be sold independently, but also the core parts of the digital functional diagnosis module of RainMed Medical's FlashBot vascular interventional surgical robot.

RainMed Medical is one of the few robot companies in the industry with integrated hardware and software capabilities. The company has a far-reaching layout. Since its establishment, it has determined the strategic goal of launching vascular interventional surgical robots in a differentiated way, and is committed to building world's leading vascular interventional surgical robots.

At present, FlashBot has been developed and completed many animal experiments. FlashBot integrates caFFR system and caIMR system to realize automate diagnosis, treatment, and evaluation. In the future, the robot will expand the indications of FlashBot to coronary artery, cerebrovascular, renal vascular, pulmonary vascular, and integrate a variety of diagnosis and treatment ways to adapt to different scenarios, provide an integrated diagnosis and treatment plan for the vascular surgery operating room, better empower clinicians and benefit patients!