The worldwide first product caIMR of RainMed entered the green channel of innovative medical devices and accelerated the commercialization
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
The First Clinical Study Results of RainMed's caFFR at Heart Centre in Southeast Asia were published! caFFR-guided Deferral of PCI was Safe and Comparable to Wired-based FFR Guidance!
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.
RainMed Actively Responds to Financial Discount Interest Policy! Its Integrated Diagnosis and Treatment Plan of Vascular Diseases Promotes the Homogenization of the Diagnosis and Treatment Level Among Regions
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
GW-ICC 2022 | RainMed Medical Successfully Held a Satellite Symposium on Computational Coronary Physiology
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.
Exhibition is Underway! RainMed's caFFR Unveiled for the First Time at the 18th Malaysian Cardiovascular Intervention Symposium
RainMed's caFFR Unveiled for the First Time at the 18th Malaysian Cardiovascular Intervention Symposium
The Vice Minister Wenpu Ma and Academician Yan Shen Visited RainMed Medical for Inspection and Guide the Development of Domestic Innovative Medical Devices
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.
Good News! RainMed's caFFR System Has Been Successfully Certified by Australian TGA, Unlocking a New Area in Overseas Market!
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!
TCT 2022丨RainMed caIMR Presented at the Transcatheter Cardiovascular Therapeutics Conference, Providing a New Solution for Global Coronary Microcirculation Function Assessment
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.
2022 China Medical Device Outbound Conference | RainMed’s caIMR Series Won the Award of "2022 Most Innovative Outbound Medical Devices", Which Will Further Demonstrate the Infinite Charm of China’s Smart Manufacturing on the Global Stage
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.
2022CHC·Surgical Robot Forum: RainMed Medical Announced to Build Its Own Vascular Interventional Surgery Robot to Promote the Realization of Unmanned Operating Room
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.
RainMed Medical Satellite Symposium Has been Successfully Held During the 21st Cardiovascular Disease Academic Conference of Shanxi Medical Association
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.
The Kick-off Meeting of "Expert Consensus on Clinical Pathways of Coronary Artery Computational Physiology Testing Indicators in China" Led by Academician Junbo Ge and Supported by RainMed Medical Was Held in Anhui Province
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.
Strategic Cooperation | RainMed Medical and Angiotec Signed a Strategic Cooperation Agreement to Accelerate the Development of Integrated Solutions for Cardiovascular Operating Rooms
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.
Initial Release of caIMR's Clinical Application Potential! RainMed’s caIMR Empowered the development of clinical treatment strategies, adding strong evidence for the concept of "intervention without implantation" for STEMI patients
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.
18th YRICC | RainMed Medical Satellite Symposium Has Been Successfully Held
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.
Warmly Celebrate the Successful Listing of RainMed on the Hong Kong Stock Exchange
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.
ICC 2022 | RainMed Medical Successfully Held the Physiological Function Forum
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.
RainMed Medical Entered "TOP100 MEDICAL DEVICE COMPANIES"
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.
FIVE Amazing Features of caIMR | RainMed's Satellite Symposium at CIT was Successfully Held
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.
OCC 2022 | Chairman of OCC Announced the Results of Flash III Clinical Research, Confirming that caIMR Has High Diagnostic Accuracy
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.
New Progress! RainMed's Transducer Compatible with both caFFR and caIMR Got a New English Name
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.
New Era of Precision Medicine! EuroPCR Announced Exciting Results of caIMR’s Clinical Experiments on the Coronary Microcirculation Diagnosis
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.
RainMed Medical won the "Top 10 Pharmaceutical Innovation Enterprises" award at the 7th Annual Meeting of Medical Scientists
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.
Global pioneer! The vascular interventional surgery robot of RainMed Medical has successfully entered the animal experiment stage
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.
Recently, the FlashAngio caFFR System of RainMed is on display at High Tech 2022
Compared with the traditional guide wire-derived FFR, RainMed’s coronary angiography-derived fractional flow reserve (caFFR) has a high consistency of 95.7%, which is the highest consistency of FFR products in China.
The breakthrough of caIMR will bring the next revolution in coronary functional diagnosis
Previously, International top journal in cardiovascular field, Journal of the American College of Cardiology (JACC: Cardiovascular Interventions) published a study by Samsung Medical Center in South Korea and Zhongshan Hospital of Fudan University titled "Functional Coronary Angiography- Derived Index of Microcirculatory Resistance in Patients With ST- Segment Elevation Myocardial Infarction". The article points out that caIMR has significant predictive value for survival status in patients with acute myocardial infarction after PCI, which marks caIMR of RainMed, the world's first epoch-making technology, has solved the shortcomings of traditional microcirculation measurement methods and achieved a leap forward in the diagnosis of microcirculation disorders.
RainMed Medical builds a high-end circle of friends in the field of accurate diagnosis and treatment
At present, RainMed Medical has successively established strategic cooperative relations with top enterprises such as Ping An Capital, GE Medical China, China Resources Medical Devices, Jointown Medical Devices, Hanxiputai and so on. Through a series of strategic cooperation, RainMed Medical builds a high-end circle of friends in the field of accurate diagnosis and treatment, jointly promotes the capital operation, technology innovation, marketing, channel building, and accelerates the ecological building and strategic implementation of vascular interventional surgery robots to better empower clinicians and benefit the patients with cardiovascular disease at home and abroad.
RainMed set off a new upsurge of clinical research
In recent years, RainMed Medical has continued to establish close scientific research cooperation with dozens of domestic and foreign top medical centers, such as Zhongshan Hospital affiliated to Fudan University, Peking University First Hospital, Peking Hospital, Sungkyunkwan University Samsung Medical Center in South Korea, and continue to publish more than 20 articles in famous SCI journals. Four of the articles were included in top journals such as
and , leading the upsurge of clinical research on coronary function.
During the China Cardiovascular Health Conference 2021, RainMed Coronary Physiology Forum was successfully held
On December 18th, 2021, RainMed Coronary Physiology Forum was successfully held during the China Cardiovascular Health Conference 2021. Renowned cardiovascular experts from all over the country held a heated discussion on the research progress, clinical significance and application scenarios of caFFR and caIMR, angiography-derived coronary function assessment indicators.
RainMed Medical and Ping An Capital has held a strategic cooperation ceremony recently
Recently, Ping An Capital and RainMed Medical held a strategic cooperation launch ceremony in Suzhou. Dong Liu, Chairman of Ping An Capital, Yunfei Huo, Chairman of RainMed Medical and Yunlong Huo, co-founder of RainMed Medical participated in the signing ceremony. Lin Wang, senior investment director of Ping An Capital, and Kangjian Liu, vice president and secretary of the board of Directors of RainMed Medical signed a strategic cooperation agreement on behalf of both sides.
RainMed completed nearly $100 million series D financing
Suzhou RainMed Medical Technology Co., Ltd. (hereinafter referred to as "RainMed"), a vascular interventional surgery robot company, announced the completion of nearly $100 million series D financing led by Ping An Capital, the core private equity platform of China Ping An Group. Seresia Asset Management, Lighthouse Canton and other internationally renowned capital followed. This is after the completion of the series C financing of hundreds of millions of yuan led by the well-known institution Jinglin Asset, co-create Weiye and other shareholders, and the company has once again won the support and favor of top institutions.
RainMed products have obtained the national sales license issued by the local medical device regulatory authority in Serbia
On October 21st, 2021, Suzhou RainMed Medical Technology Co., Ltd. (hereinafter referred to as "RainMed") announced that its products Coronary Analysis System caFFR (model ASC15) and Disposable Blood Pressure Transducer (model CPT-1500) have obtained the national sales license issued by the local medical device regulatory authority in Serbia, which marks the launch of caFFR in Serbia.
RainMed Medical and GE Healthcare have reached a strategic cooperation
Recently, GE Healthcare China and RainMed Medical successfully signed a strategic cooperation agreement. The two sides will work together to innovate coronary interventional diagnosis and treatment models and procedures, and strive to create more accurate and high-quality integrated precision interventional diagnosis and treatment, and jointly improve the efficiency and level of coronary disease diagnosis and treatment.
Guangming Online interviewed Professor Huo, the co-founder of RainMed
Guangming Online invited Prof. Yunlong Huo, co-founder of RainMed Medical, professor and doctoral supervisor of Institute of Mechanobiology, Shanghai Jiao Tong University, to accept an exclusive interview. In the interview, Prof. Huo talked about his original intention and perseverance of returning to China to start his own business. He said, "From the laboratory to the clinic, this is my poem and beyond", "If I believe that what I am doing is right, then I will continue to take root in it and make it to the extreme".
RainMed Satellite Meeting at noon was successfully held
On October 30th, 2021, during the 32nd Great Wall International Congress of Cardiology and Ansian Heart Society Congress 2021, RainMed Satellite Meeting at noon was successfully held. At the meeting, experts and scholars discussed the development of caFFR and caIMR coronary artery detection technology and the clinical application of caFFR. Participants pointed out the importance of coronary microcirculation diagnosis and noted that the effective combination of caFFR and caIMR can significantly improve the macro and micro functional diagnosis of myocardial ischemia.
New partnership with Jointown
On October 25th, 2021, Suzhou RainMed Medical Technology Co., Ltd. and Jointown Medical Devices Group Co., Ltd. held the signing ceremony of strategic cooperation agreement in Beijing.
RainMed Medical and Hanxiputai has signed a strategic cooperation agreement
On August 31, 2021, Suzhou RainMed Medical Technology Co., Ltd. signed a strategic cooperation agreement with Hanxiputai (Beijing) Hospital Investment Management Co., Ltd.
RainMed attended the QICC meeting on September 25, 2021
The 15th Qianjiang International Cardiovascular Conference was successfully held in Hangzhou, Zhejiang province on September 25th, 2021.
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Recently, some new technical engineers joined RainMed Medical and received systematic training on medical knowledge and products of the company, which injected vitality into RainMed.
Sharing of two cases
In coronary artery disease, for patients with moderate stenosis, the diagnosis of coronary vessels only based on angiographic images will be ignored in 1/3 of patients with ischemia, which is easy to
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