Recently, RainMed Medical Coronary Function Measurement System (hereinafter referred to as "RainMed caIMR") has successfully entered the special approval channel for innovative medical devices of NMPA, and has obtained the priority of NMPA certification. As the world's leading non-interventional microcirculation diagnosis system, the approval of caIMR fully reflects the international leadership of its technology and its superior clinical value.   The approval of the innovative application of caIMR will accelerate its commercialization, accelerate the opening of tens of billions of blue ocean market for microcirculation diagnosis, and lead the cardiovascular field into a new era of comprehensive assessment of myocardial functional ischemia. It also lays a key foundation for RainMed Medical to build a vascular interventional surgery robot covering the whole process of comprehensive diagnosis and treatment. Announcement of the review results of the special application for innovative medical devices   As a green channel for medical device approval, the special approval channel for innovative medical devices has a high approval threshold and a very low approval rate. Since the implementation of the approval process in 2014, only 170 products have been approved in China and the approval rate is only 20%. Among them, the caIMR and caFFR of RainMed and their supporting supplies have been successfully approved to enter the green channel of innovative medical devices, demonstrating RainMed Medical's excellent innovative R&D capabilities.   Preferential policy support and excellent clinical results jointly help RainMed to accelerate the commercialization of caIMR In the process of coronary heart disease diagnosis and treatment, IMR evaluation has important clinical significance and has been widely recommended by domestic and foreign guidelines. Data show that 40% of patients with coronary artery disease still suffer from recurrent angina after PCI, partly due to microcirculatory dysfunction. Therefore, guidelines such as "Guidelines for Diagnosis and Management of Chronic Coronary Syndrome", "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Microvascular Diseases (2017)", "Chinese Multidisciplinary Expert Consensus on Diagnosis and Treatment of Microvascular Diseases (2020)" and other guidelines all recommend IMR assessment in patients with coronary heart disease. caIMR of RainMed caIMR of RainMed has made up for the deficiencies of traditional guide wire-derived IMR detection, and offered more practical clinical detection methods to coronary microcirculation. In the past, guide wire-derived IMR measurement requires the use of hyperemic agents and repeated injection of normal saline, which takes a long time to measure IMR and has a high risk and therefore it is only suitable for clinical research. caIMR does not require the pressure guide wire and hyperemic agents. It does not need to change the surgeon's surgical habits. It only takes an average of 5 minutes to measure IMR based on angiograms, blood flow velocity by TIMI frame count, real-time aortic pressure and a specially-designed CFD model. It is safe, efficient and simple, and offers a new opportunity to promote the large-scale clinical application of coronary microcirculation assessment.   As the world's first diagnostic method for coronary microcirculation function in the confirmatory clinical trial stage, RainMed caIMR was successfully approved to enter the green channel of innovative medical devices, bringing sufficient confidence to accelerate the large-scale clinical application of the product.   As of December 2021, RainMed caIMR has successfully completed the clinical enrollment of the confirmatory trial. The study is led by Zhongshan Hospital Affiliated to Fudan University with the top cardiology experts academician Ge Junbo and Professor Huo Yong of Peking University First Hospital as PI. At present, caIMR has achieved excellent clinical research results and has successfully entered the registration clinical stage. caIMR confirmatory clinical research launch ceremony The preferential policies and assistance to high-innovation medical devices given by the state and the confirmatory clinical results that exceeded expectations have brought more confidence to accelerate the commercialization of caIMR. It is believed that the large-scale clinical application of caIMR will surely improve the level of diagnosis and treatment of coronary artery disease and lead coronary artery disease into a new era of precision medicine.    Top SCI journals confirm that caIMR of RainMed has a wide range of clinical indications and excellent clinical application value The global initiative of RainMed caIMR has attracted extensive attention from well-known experts at home and abroad, and has become a hot topic of international clinical research. A number of blockbuster research papers published in SCI journals have made detailed demonstra

OCC 2023 | RainMed Medical • "Recent Progress in Medical Innovations" Coronary Physiology Forum Was Successfully Held

From May 16 to 19, 2023, RainMed Medical, an innovative medical device listed company from China, joined forces with its strategic partner SINOMED, a leading enterprise in the field of cardiovascular disease treatment, to showcase their original "Redefine PCI" collaborative concept at EuroPCR2023, a global academic conference for interventional cardiovascular medicine. The concept aims to provide tailored solutions for PCI procedures to optimize daily practice and bring optimized diagnostic and therapeutic solutions for coronary artery PCI.

On April 22, 2023, RainMed Medical successfully held the "Medicine Progresses with Innovation" Coronary Physiology Symposium at the 26th China Cardiology Intervention Forum (CCIF 2023). In order to promote the diagnostic concepts of coronary physiology evaluation and the clinical application of computed coronary physiology indicators, RainMed invited well-known experts in cardiovascular field to the symposium to discuss the latest advancements in the evaluation of coronary physiology and to explore the application prospects of innovative computed coronary physiology indicators, caFFR and caIMR systems.

RainMed Medical Was Selected as "One of the First Demonstration Units of Trade Secret Protection in Suzhou"

Paper Summary of RainMed's caFFR and caIMR (2)

Paper Summary of RainMed's caFFR & caIMR (1)

Suzhou RainMed Medical Technology Co., Ltd.(hereinafter referred to as "RainMed") has officially completed the acquisition of Tianjin Your Health Biotechnology Co., Ltd. (hereinafter referred to as "Your Health"). Recently, Yunfei Huo, Chairman of the Board of Directors, Executive Director and CEO of RainMed, Yonghui Lv, Executive Director and co-CEO of RainMed, and Zhibo He, General Manager of Your Health, have made business connections and integration on behalf of both sides. In the future, the two sides will make full use of their technological resources to develop cutting-edge in vitro diagnostic products, and jointly start a new journey of precision medicine.

At the end of March 2023, the China-Uzbekistan Medical Cooperation and Development Forum, co-sponsored by China Chamber of Commerce for Import & Export of Medicines & Health Products and the Pharmaceutical Development Bureau of Investment, Industry and Trade of Uzbekistan, and co-hosted by China-Central Asia Health Industry Alliance and China Meheco Group Co., LTD., was successfully held in Beijing. More than 50 representatives from well-known enterprises from China and Uzbekistan attended the conference. RainMed Medical was also invited to participate. At the conference, the participating enterprises had a lively discussion on the medical and health cooperation between the two countries, making new contributions to the new development of medical industry.

On March 9th, 2023, RainMed Medical donated dozens of sets of coronary angiography-derived fractional flow reserve measurement systems to Chinese Primary Health Care Foundation. Hui Wang, Deputy Secretary-General of the Foundation, and Yonghui Lv, Executive Director and co-CEO of RainMed Medical, signed the donation cooperation agreement on behalf of both sides. Professor Zheng Zhang from Beijing well-known Class A hospital attended and witnessed the signing ceremony. This donation will help bring high-quality medical resources to the grassroots, promote the development of coronary artery precision diagnosis and treatment, and implement the hierarchical diagnosis and treatment system.

RainMed Medical-B (02297.HK) announced that on March 1st, 2023, Suzhou RainMed Medical Technology Co., Ltd. (hereinafter referred to as "RainMed") will acquire a 68.32% stake in Tianjin Your Health Biotechnology Co., Ltd. (hereinafter referred to as "Your Health") at a total cost of RMB 25.96 million. This strategic merger and acquisition has extended RainMed’s precision diagnosis product pipeline from "covering the whole procedure of PCI" to "inspection on admission" and "inspection at the bedside", providing new momentum for its long-term development.

In February 2023, RainMed's caFFR was commercially launched in the Republic of Serbia and successfully completed its first charging case in Serbia’s national institute of cardiovascular diseases, KBC Dr Dragisa Misovic-Dedinje.

On February 28, 2023, RainMed Medical (stock code: 2297.HK) and SINOMED (stock code: 688108.SH) held a strategic collaboration agreement signing ceremony in Beijing. Mr. Yunfei Huo, chairman of the board, executive director and CEO of RainMed Medical, and Mr. Jianhua Sun, chairman and CEO of SINOMED, signed the agreement on behalf of both parties. Professor Yong Huo from Peking University First Hospital, and Professor Yunlong Huo, Co-founding shareholder of RainMed Medical and professor of School of Life Science and Biotechnology of Shanghai Jiao Tong University, also attended the meeting.

Recently, RainMed Medical is applying for MDSAP (Medical Device Single Audit Program). It is expected that the MDSAP certification issued by international authoritative certification body will further lay the foundation for RainMed's global development strategy.

Recently, Qiao Zhang, deputy mayor of Suzhou Government, deputy chairman of Jiangsu Committee of Chinese Peasants’ and Workers’ Democratic Party，chairman of Suzhou Committee of Chinese Peasants’ and Workers’ Democratic Party, made a field investigation of RainMed. He had a discussion on the independent innovation of domestic medical devices with Yunfei Huo, chairman of the board of directors, executive director and CEO of RainMed Medical. Kangjian Liu, vice president and secretary of the board of directors of RainMed, introduced RainMed's development strategy and core products. Yang Gu, vice president of RainMed and Chang Zhou accompanied them during the investigation. Hong Sun, deputy director of Suzhou Bureau of Industry and Information Technology; Jianhong Zhang, secondary researcher and full-time deputy chairwoman of Suzhou Committee of Chinese Peasants’ and Workers’ Democratic Party; Hongmei Lin, deputy minister of Suzhou Industrial Park Publicity and United Front Work Department and director of the Municipal Bureau of Ethnic and Religious Affairs participated in the investigation and exchange activity.

From February 1st to 3rd, 2023, the offline exhibition of High Tech Cardio Conference was grandly held at Palais du Pharo in Marseille, France. As one of the most prestigious exhibitions in Europe for sharing and exchanging cutting-edge technology and clinical treatment research of interventional cardiology, the exhibition has attracted many high-tech medical device companies and top European experts from all over the world. Exhibitors included medical device giants such as Abbott, Boston Scientific, Edwards LifeSciences, Medtronic and Philips. As a Chinese innovative company, RainMed was invited, showing the unique technical charm of its product caFFR.

RainMed, an innovative medical device company from China, will collaborate with CORRIB Research Centre for Advanced Imaging and Core laboratory at University of Galway, Ireland, to carry out a coronary clinical trial. In the clinical trial, researchers will test caFFR, a coronary angiography-derived fractional flow reserve measurement system.

A summary of RainMed in 2022.

RainMed’s caFFR will be exhibited at the offline exhibition of High Tech Cardio in Palais du Pharo, Marseille, France From February 1st to 3rd , 2023. High Tech is a professional congress gathering top interventional cardiology experts from France and the European Society of Cardiology to share cutting-edge technologies and clinical treatment research of interventional cardiology. It attracts top European experts and scholars, as well as major medical device enterprises on interventional cardiology treatment every year.

Recently, led by Academician Junbo Ge from Fudan University Zhongshan Hospital, Professor Yong Huo from Peking University First Hospital and supported by domestic independent innovation enterprise RainMed Medical, Chinese Expert Consensus on Clinical Pathways of Coronary Artery Computational Physiology Detection Indicators (hereinafter referred to as "Consensus") was officially released on the bank of Huangpu River. It took more than 7 months from the drafting to the release, innovatively included RainMed’s caFFR and caIMR into studies, and made detailed descriptions of their operating norms and application scopes, which provides practical guidelines for clinical use of coronary function evaluation, and creates an open market space for RainMed Medical’s coronary functional series products.

Recently, Suzhou RainMed Medical Technology Co., Ltd. frequently obtained the recognition of industry authority , showing its excellent comprehensive strength and leading advantage in research and development level and innovation as well as business layout.

Recently, a team from Tenth People’s Hospital of Tongji University published a clinical research paper -- "Prognostic impact of coronary microvascular dysfunction assessed by caIMR in overweight with chronic coronary syndrome patients" in an internationally renowned SCI journal. It is a groundbreaking study on the impact of coronary microvascular dysfunction in patients with overweight and chronic coronary syndrome (CCS). Results show that as the world's first non-interventional microcirculatory function diagnostic product, RainMed’s caIMR is an independent predictor of MACE in overweight patients with CCS which offers objective risk stratification for obese patients. This conclusion broadens the clinical application scenario of caIMR system, helps promote the process of epidemic management in China, and creates a new opportunity for large-scale clinical application of caIMR.

Recently, the 11-month fourth "Chip Award" of China Health Care Innovation Platform 2022 was officially held in Shanghai. After rigorous screening by more than 80 authoritative experts, RainMed Medical passed the test and stood out in nearly 300 innovative projects. Together with Innovent, RemeGen, Hutchison Pharmaceuticals and other leading enterprises in the industry, RainMed Medical won the "Medical Device Innovation Chip Award Nomination Award". This award highlights the superb product innovation ability and marketing of RainMed Medical, which is highly competitive in the industry.

On November 19th, 2022, RainMed Medical successfully held a forum on coronary function in the 17th academic conference on Cardiovascular Disease Diagnosis and Treatment Guidelines and Standardized Diagnosis and Treatment Training (Zunyi Cardiovascular Conference)-- Coronary Innovation Forum. In order to popularize the concept of functional diagnosis and promote the clinical application of the calculation of coronary physiological indicators, the forum invited famous experts in the field of cardiovascular disease in China, introduced the latest progress of coronary function, shared the clinical application of innovative computational coronary physiological indicators caFFR and caIMR, and imparted the application skills.

Recently, Dr. Chandan Deepak Bhavnani from Pusat Jantung Sarawak and president of National Heart Association of Malaysia Dr. Alan Yean Yip Dr Fong's team published results of a clinical trial using coronary angiography-derived fractional flow reserve measurement system caFFR. The paper was published in Journal of Asian Pacific Society of Cardiology (JAPSC). This was the first study of its kind in Southeast Asia. Based on previous trials, this trial advances the clinical significance of caFFR value for intermediate coronary artery stenosis. The results showed that caFFR had a good agreement with wire-based FFR. The 12-month outcomes showed that caFFR-guided deferral of PCI was safe and comparable to wired-based FFR guidance.

Recently, there is a bunch of good news in the field of medical device. A few days ago, the State Council executive meeting decided to use special re-loans and financial discount interest to support the renovation of equipment in some areas, increase market demand, and increase the development momentum. At the same time, the National Health Commission also issued a notice of upgrading medical device with financial discount loans. This policy will surely stimulate the vitality of hospital procurement and promote domestic innovative medical devices to grow with vigorous market vitality

On October 29th, 2022, during the 33rd Great Wall International Congress of Cardiology, Asia Heart Society Congress 2022, in order to popularize the concept of coronary functional evaluation and promote the clinical application of computational coronary physiological indicators, RainMed Medical successfully held a satellite symposium of computational coronary physiology. The well-known experts in the field of cardiovascular were invited, and they discussed and prospected the latest progress of coronary functional evaluation technology, and shared the clinical experience of innovative computational physiology indicators caFFR and caIMR. It is worth noting that it is the first time that RainMed shared clinical cases of caIMR in satellite symposiums in such a national academic congress, which has attracted widespread attention and aroused heated discussion among participants.

RainMed's caFFR Unveiled for the First Time at the 18th Malaysian Cardiovascular Intervention Symposium

Recently, Mr. Wenpu Ma, former vice minister of the International Department of Central Committee of CPC, Former Vice Director of the 11th NPC Foreign Affairs Committee, and Professor Yan Shen, former vice chairman of China Association for Science and Technology (CAST), former deputy of National Natural Science Foundation of China and member of Chinese Academy of Sciences and the other two people visited Beijing office of RainMed Medical and fully affirmed the achievements of RainMed Medical in scientific and technological innovation. Mr. Kangjian Liu, Vice President and Secretary of the Board of Directors of RainMed and Mr. Liang Wan, Director of Government Affairs Department, accompanied them during the visit.

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!

RainMed Medical, an innovative medical device enterprise from China, was invited to deliver a speech at TCT to announce its latest clinical trial data because of the original breakthrough technology of caIMR in coronary microcirculation function assessment, which showed the world China's local innovation strength.

In September 2022, RainMed Medical was invited to participate in the 2022 China Medical Device Outbound Conference hosted by the International Health Exchange and Cooperation Center NHC PRC (IHECC) and VBDATA.CN.

On September 1st, 2022, the "2022CHC·Citic Securities Healthcare Conference and the 11th China MedTec CEO Summit" jointly hosted by CHC Healthcare Consulting and Citic Securities, was held in Hefei, Anhui Province. The conference focused on cutting-edge research and held a special forum on surgical robots. As the strategic partner of the conference and the leader of the vascular interventional surgery robot field, RainMed Medical was invited to attend the forum. Mr. Kangjian Liu, Vice president and Secretary of the Board announced that RainMed Medical will build a platform-level vascular interventional surgery robot to promote the realization of an unmanned operating room with automated diagnosis and treatment.

On August 27, 2022, during the 21st Cardiovascular Disease Academic Conference of Shanxi Medical Association, RainMed Medical successfully held a satellite symposium in order to popularize the clinical application of calculating coronary physiological indicators and promote precise interventional treatment of coronary heart disease. Renowned experts in the field of cardiovascular diseases were invited to discuss the latest progress of coronary functional evaluation technology and the clinical application of innovative functional indicators caFFR and caIMR.

On August 20, 2022, during the fourth Confucianism and Taoism International Congress of Cardiology (CTCC), the kick-off meeting of "Expert Consensus on Clinical Pathways of Coronary Artery Computational Physiology Testing Indicators in China", led by Academician Junbo Ge from Fudan University Zhongshan Hospital and supported by RainMed Medical, was held in Anhui province.

On August 16, 2022, RainMed Medical Co., LTD. (hereinafter referred to as "RainMed", stock code: 2297.HK) and Angiotec （Tianjin）Technology Co., Ltd. (hereinafter referred to as "Angiotec”) held a signing ceremony for strategic cooperation in Tianjin. Mr. Yunfei Huo, Chairman of the Board, Executive Director and Chief Executive Officer of RainMed and Mr. Da Zhuo, General Manager of Angiotec signed the agreement on behalf of both companies. Mr. Yonghui Lv, Executive Director and co-Chief Executive Officer of RainMed also attended the meeting.

Recently, Professor Zhirong Wang's team from The Affiliated Hospital of Xuzhou Medical University published a paper in SCI journal titled "Computational Pressure-Fluid Dynamics Applied to Index of Microcirculatory Resistance, Predicting the Prognosis of Drug-Coated Balloons Compared With Drug-Coated Balloons Compared With Drug-Eluting Stents in STEMI Patients". The paper indicates that RainMed’s caIMR can independently predict the likelihood of cardiac death or readmission due to heart failure in STEMI patients. At the same time, caIMR confirmed that the effect of drug-coated balloon (DCB) therapy is not inferior to drug-eluting stent (DES) in the diagnosis and treatment of STEMI by accurately diagnosing the damage of coronary microcirculation. It has added strong clinical evidence for the advanced diagnosis and treatment concept of "intervention without implantation" in STEMI patients and assisted clinical development of better interventional diagnosis and treatment strategy.

On July 22nd, 2022, during the 18th Yellow River International Cardiology Conference (YRICC 2022), RainMed Medical successfully held a satellite symposium. Renowned cardiovascular experts from all over the country had a heated discussion on research progress, clinical significance and application scenarios of caFFR and caIMR.

On July 8, 2022, Suzhou RainMed Medical Technology Co., LTD. (02297.HK, hereinafter referred to as "RainMed Medical") was officially listed on the main board of Hong Kong Stock Exchange and held a bell ringing ceremony at 9:30 am.

On July 3rd, 2022, during the 17th Ice City Conference of Cardiology (ICC 2022), RainMed Medical successfully held the Physiological Function Forum. Renowned cardiovascular experts from all over the country had a heated discussion on research progress, clinical significance and application scenarios of caFFR and caIMR.

In the sixth 2022 Future Healthcare VB100 Conference, RainMed Medical was identified as one of the "TOP100 Medical Device Companies” in China. This list is the most concerned annual list launched by VBDATA.CN and VCBeat Research (VBR) in the field of life and health among industry and capital circles. Meanwhile, it is also the first innovative medical list of unlisted enterprises in China. RainMed Medical has brought new solutions to world's problems with China's local innovation.

At present, there is no clinical quantitative measurement product that can easily and effectively diagnose coronary microcirculation. The large-scale clinical application of caIMR--the global pioneering technology--will surely bring epoch-making significance to precise diagnosis and treatment in cardiovascular field, and provide diagnostic basis and research direction for the development of microcirculation drugs and devices. To conclude, why is caIMR so promising? We can refer to the following five reasons.

Recently, the 16th Oriental Congress of Cardiology was grandly held. Meanwhile, RainMed’s Satellite Meeting was also held at noon. During the conference, Junbo Ge, president of OCC Conference, chief of cardiology department of Zhongshan Hospital, Fudan University and academician of Chinese Academy of Sciences announced the results of Flash III trial. Compared with guidewire-based IMR, the online measurement accuracy of caIMR is up to 93.81%, and the offline accuracy is up to 94.69%. This exciting research result has aroused enormous experts and scholars' attention and heated discussion. In addition, the role of functional evaluation was discussed in the research progress of diagnosis and treatment of coronary heart disease and the coronary microvascular disease. Cases guided by caFFR and caIMR were shared.

On June 7th, 2022, RainMed's transducer compatible with both caFFR and caIMR got a new English name after voting—CadiFlash, which means RainMed has made a new progress in the internationalization of caFFR and caIMR.

Recently, at EuroPCR2022, the official annual meeting of the World-Leading Course in Interventional Cardiovascular Medicine and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), chief of cardiology department of Zhongshan Hospital, Fudan University and academician of Chinese Academy of Sciences Junbo Ge announced the excellent results of the clinical trial of Flash III supported by RainMed Medical. Data shows that compared with wire-based IMR, caIMR has high accuracy, sensitivity and specificity. This means that large-scale clinical application of caIMR will surely improve the level of diagnosis and treatment of coronary artery disease and lead precision medicine into a new era.

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The 7th Annual Meeting of Medical Scientists (2022), the theme event of the Chinese Medical Doctor Association’s only newspaper "MD weekly", was held in Beijing on March 18th. At the meeting, the "Power to drive the industry forward" and the annual "Top 10 Pharmaceutical Innovation Enterprises" were voted and Suzhou RainMed Medical Technology Co., Ltd., Pfizer, AbbVie, ZedLab, etc. won the award. As an innovative medical technology company, RainMed Medical has always been committed to pushing the industry forward. Together with the world's top pharmaceutical companies, we won the annual award issued by the authoritative organization, which is a high recognition and commendation of the achievements of RainMed Medical and has attracted wide attention from all sides.  

Recently, the first animal experiment of a vascular interventional surgery Robot of RainMed Medical- Flash Robot was successfully conducted in Suzhou. In this experiment, Flash Robot of RainMed Medical realized automatic optical positioning puncture, angiography-guided push, rapid functional diagnosis, interventional channel construction, surgical navigation guidance, postoperative evaluation and management, etc. There were no surgical complications such as vasospasm during the whole experiment, and the experiment verified the clinical operability, safety and effectiveness of the vascular interventional surgical robot system. The success of this animal experiment marks a big step forward for RainMed Medical to become the world's leading vascular interventional surgical robot company.