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Dec 20, 2024 17:45 CST Updated 17:46

MitrAssist Lifesciences

Cardiovascular Innovative Medical Device R&D Manufacturer

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December 18,MitrAssist Lifesciences' Cardiovascular Products and High-Value Consumables R&D Industrialization Project Officially Launched in HefeiThe project is located in Hefei Economic and Technological Development Zone, with a total investment of about 2 billion yuan, mainly for construction.Non-invasive monitoring of heart failure and pulmonary edema, drug-coated balloons, structural heart (biological and polymer material valve series products)and other products' R&D, production, and commercialization base.

As a global leading provider of cardiovascular intervention product solutions, MitrAssist Lifesciences has independently developed the world's first non-invasive heart failure monitoring and management device, ushering in a new era of non-invasive monitoring for heart failure disease management and injecting new momentum into the biopharmaceutical industry.

For most patients who have not progressed to the late stage, the pain point of heart failure is not the initial diagnosis but the management of heart failure after confirmation, including the lungs.Monitoring and evaluating water is key to halting the progression of this cardiovascular disease. MitrAssist Lifesciences' non-invasive lung water measurement device only requires external wearing by the patient, with no invasion required, and the entire measurement process takes approximately 45 seconds.Ushering in a New Era of Non-Invasive Monitoring for Heart Failure Disease Management.

As a global leading provider of cardiovascular intervention product solutions, MitrAssist Lifesciences is establishing Hefei as an important base for development."In the future, we will continue to be based in Hefei, with the mission of achieving the universal accessibility of cardiovascular medical diagnosis and treatment. We will keep innovating our products and strive to benefit more Chinese cardiovascular patients," said Wang Li, Chairman of MitrAssist Lifesciences.

A Globally Leading Innovative Cardiovascular Enterprise

Data shows that MitrAssist Lifesciences, established in 2017, is a globally leading innovative platform-based medical device enterprise in the cardiovascular field. The group's productsCovering multiple major fields such as structural heart, heart failure, and coronary artery, with a rich product line, MitrAssist Lifesciences owns 156 authorized PCT patents globally.

Currently,MitrAssist Lifesciences has research and development centers in China, Israel, and Germany.At the same time, independent sales teams have been established in China and the United States, and a mature dealer network has been built in more than 20 countries and regions worldwide, including Europe, Asia, and the Americas.

2022 became a key milestone in the development history of MitrAssist Lifesciences. On July 6 of that year,The world's first polymer valve product, Sikelia™, independently developed by MitrAssist Lifesciences, was successfully implanted in the world's first clinical case at Zhongshan Hospital Affiliated to Fudan University in Shanghai by a team led by Academician Ge Junbo., this milestone event heralds the entry of interventional treatment for valvular heart disease into a new polymer era.

As of now, the product has completed the FIM clinical trial, with multiple patients having post-operative follow-ups exceeding one year, the longest reaching 21 months, fully confirming the product's feasibility, safety, and effectiveness. This project also won the highest award, the "Outstanding Award," in the 2022 National Disruptive Technology Innovation Competition.

Similarly, in 2022,Mitrafix®, a transcatheter mitral valve replacement product via transapical approach, enters the special review phase for innovative medical devices by the National Medical Products Administration (NMPA).The fully ultrasound-guided surgical approach has greatly enhanced the convenience and safety of the procedure.

Transcatheter Mitral Valve Replacement Product mitrafix®

Non-invasive heart failure management device reds™pro successfully approved in China after receiving approval in the U.S., Europe, India, Japan and other countries.As the world's only non-invasive heart failure management device based on the 5A principle, it brings a new model for managing heart failure patients;In addition,MitrAssist Lifesciences Coronary Product "Paclitaxel-Coated Coronary Balloon Dilatation Catheter"”MitrAssist Lifesciences' XunNiao® has been approved for marketing in China, being the first domestically produced product of its kind to utilize 4th generation paclitaxel drug coating technology.

InnoMed® Paclitaxel-Coated Coronary Balloon Dilatation Catheter

The World's FirstPolymer valves gain attention overseas

Notably, at the recently concluded 36th TCT conference, "the biggest cardiovascular tech stories from TCT 2024" were selected. Among them,MitrAssist Lifesciences' SIKELIA™ Transcatheter Polymeric Aortic Valve Replacement System has been shortlisted for this list, and it is also the only Chinese medical device brand to be shortlisted.

According to reports,As the first transcatheter valve to adopt polymeric leaflets, SIKELIA™ demonstrates significant advantages such as zero calcification, low thrombogenicity, and high biocompatibility.The service life is more than twice that of existing bioprosthetic valves. Its automated production process will significantly reduce manufacturing costs and improve product quality consistency, offering new possibilities for the innovation of TAVI technology. Initial FIM study results show that SIKELIA™ excels in both safety and performance, with the potential to significantly improve outcomes for patients with severe symptoms.

The ease of use, safety, originality, and economic accessibility of SIKELIA™ Polymer TAVR make it not only suitable for developing countries like China but also fully meet the needs of developed countries and regions such as the US and Europe.Will become a groundbreaking achievement for China-produced high-end medical consumables to enter the ranks of international leaders. MitrAssist Lifesciences will continue to bring more beneficial disease treatment options to doctors and patients worldwide with its consistently strong passion for research, development, and innovation.

SIKELIA™ The transfemoral aortic valve replacement system uses polymeric leaflets independently developed by MitrAssist Lifesciences, offering advantages of zero calcification, low thrombogenicity, and high biocompatibility compared to traditional animal pericardial leaflet materials.The theoretical lifespan of the SIKELIAᵀᴹ product after implantation can reach 20-25 years, making it suitable for younger patients and significantly expanding the range of applicable patients for similar products. In terms of production technology, full automation of industrial production can be achieved, greatly reducing product costs and significantly improving the pass rate. Its stent design features a unique riveted structure made from memory alloy wire, does not rely on radial support force for fixation, and includes a large mesh design. Additionally, the valve has the characteristics of being pre-assembled at the factory and fully recoverable, with its 100% recoverable feature greatly ensuring patient safety during surgery.

SIKELIAᵀᴹ Transcatheter Aortic Valve System Deployment Process

At that time during the conference, numerous industry leaders and medical professionals believed that SIKELIA™ was ahead of its time,The originality, safety, and economic accessibility are not only suitable for developing regions but also fully meet the standards of developed regions in Europe and America, demonstrating the innovative strength of China's medical device enterprises.Multiple overseas media reports believe that,This research achievement is one of the most cutting-edge scientific results presented at the TCT 2024 conference.

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Data shows that the global cardiovascular device market size was $61.39 billion in 2023. The market is expected to grow from $65.53 billion in 2024 to $117.68 billion by 2032, with a compound annual growth rate (CAGR) of 7.6% during the forecast period.

In 2021, the market size of China's cardiovascular interventional devices reached 37.204 billion yuan. It is expected that by 2025, the market for cardiovascular interventional devices in China will reach 25-30 billion yuan, with an annual growth rate of 7%-9%. By 2030, the market size will reach 140.179 billion yuan, with a compound annual growth rate of 15.88% from 2021 to 2030.

In terms of the competitive landscape in the global market, there is a wide variety of companies in the market, ranging from emerging players to established ones. Among them, Medtronic, Abbott, Boston Scientific, and other enterprises occupy a dominant position in the market. It should be emphasized that,In recent years, several companies, including Lepu Medical, MicroPort, Huitai Medical, Boma Medical, Venus Medtech, and Xinmai Medical, have gathered in the field of cardiovascular interventional medical devices in China.These companies have successively launched a series of independently developed products,Involving fields such as coronary stents, heart valves, congenital heart disease occluders, and cardiac rhythm management, some of the products have reached leading levels both in China and internationally.

MitrAssist Lifesciences, as a globally leading provider of cardiovascular interventional product solutions, has also emerged in the field of cardiovascular medical devices through continuous innovation, research and development, and industrialization progress.On September 26, 2023, the company also successfully completed a nearly US$100 million Series C financing round, which has injected strong momentum into the research and development and industrialization of its innovative cardiovascular products in the structural heart field.

The cardiovascular product and high-value consumables R&D industrialization project by MitrAssist Lifesciences has officially landed and been inaugurated in Hefei.Marks a new stage of development for MitrAssist Lifesciences' global supply chain system for lung water monitoring products.In the future, the development of this company is worth the industry's anticipation.

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