Shanghai, China, 25 March 2025 — Recently, 4C Medical Technologies, Inc. (4C Medical), a strategic partner of MicroPort^® CardioFlow, announced the closing of its Series D financing round, resulting in gross proceeds of up to $175 million, led by Boston Scientific Corporation, with participation from both new and existing shareholders. The financing will be utilized to accelerate the clinical development and commercialization of the AltaValve™ System, the company's next generation transcatheter mitral valve replacement (TMVR) technology.

4C Medical is a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, particularly in the areas of mitral and tricuspid valve regurgitation. Previously, MicroPort^® CardioFlow made several rounds of investments in 4C Medical and holds exclusive commercial rights for AltaValve™ System in Mainland China, Hong Kong, Macau, and Taiwan. 

Mitral regurgitation (MR) is the most common valvular heart disease, and if untreated,  can lead to heart failure, arrhythmias, and even death. Current treatments include drug management, open surgical repair or replacement, and transcatheter edge-to-edge repair (TEER). However, for patients at high surgical risk, with severe mitral annular calcification, or complex heart anatomy, traditional treatments may not provide an effective or long-term solution.

The AltaValve™ System is the only fully retrievable transcatheter mitral valve system with a low outer diameter that passes through the atrial septum. Once launched, it is expected to be the first MR treatment that requires only atrial fixation. The innovative design overcomes the anchoring challenges of current TMVR technologies, protects the patient’s heart structure during the procedure, minimizes the risk of left ventricular outflow tract obstruction or injury, and improves clinical outcomes.

4C Medical is currently conducting a global pivotal trial ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) in the U.S. and Europe. The ATLAS pivotal trial is designed to assess the safety and effectiveness of the AltaValve™ System in treating patients with moderate-to-severe or severe MR who are unsuitable for surgery or TEER.The trial includes two separate non-randomized cohorts: moderate/severe mitral annular calcification (MAC) cohort and primary cohort that will include patients with no or mild MAC. The success of this trial is crucial for AltaValve™ System’s approval and market launch and will influence the broader field of TMVR technology. 

Guoming Chen, Chairman of MicroPort^® CardioFlow, stated, "As the largest shareholder before this round, we have witnessed 4C Medical’s growth from a concept to a leader in the global cardiovascular market. This financing is an important milestone, not only bringing hope to global MR patients but also validating MicroPort® CardioFlow’s long-term investment strategy in 4C Medical — supporting disruptive innovative enterprises and driving continuous advancements in structural heart disease treatments. With the growing demand for safe, effective, and minimally invasive treatments, TMVR is set to become a major treatment option. 4C Medical is well-positioned to lead in this field, and we will continue to support its growth, helping to improve patient lives worldwide." 

Shanghai, China — MicroPort CardioFlow Medtech Corporation (02160.HK, "CardioFlow") recently announced that its VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty^®") and Alwide^® Plus Valvuloplasty Balloon Catheter ("Alwide^® Plus") have received registration approval from the Ministry of Healthcare of the Republic of Kazakhstan (Registration No.: ҚР-МБ (ММБ)-0№029027/ҚР-МБ (ММБ)-0№028972).

VitaFlow Liberty^®, the world’s first electric-retrievable TAVI (Transcatheter Aortic Valve Implantation) product, was approved by China’s National Medical Products Administration (NMPA) in 2021 and has since entered multiple overseas markets. In 2024, it became the first China-made TAVI system to obtain EU CE MDR certification. Building on the strengths of the VitaFlow^® system, it features a hybrid-density self-expanding nitinol stent, bovine pericardial leaflets, and a double-layer PET skirt, delivering high radial force, superior coaxial deployment, and reduced paravalvular leakage (PVL). Its breakthrough dual-helix retrieval mechanism ensures precise, stable deployment and retrieval, while enabling 360° flexural maneuverability.

Alwide^® Plus, a companion product for TAVI procedures, received NMPA approval in 2021 and is currently progressing toward EU CE MDR certification. Its ultra-low compliance enables precise balloon expansion while minimizing vascular injury. The high burst pressure effectively treats severely calcified lesions—a critical feature for Chinese patients. Additionally, its rapid inflation/deflation reduces pacing time and procedural risks, while enhanced puncture resistance improves intraoperative safety.

With proven clinical performance, CardioFlow’s global expansion has achieved remarkable success. To date, its VitaFlow^® TAVI series and Alwide^® balloon products have been adopted in 700+ leading hospitals across 20+ countries/regions, treating over 10,000 aortic valve disease patients worldwide.

Kazakhstan, the largest and most economically advanced country in Central Asia, is experiencing robust growth in its medical device market due to healthcare reforms and infrastructure upgrades. The approval of VitaFlow Liberty^® and Alwide^® Plus marks a strategic milestone in CardioFlow’s Asia-Pacific expansion, further solidifying its global footprint to benefit more structural heart disease patients.

Shanghai, China, 03 March 2025 – MicroPort^® CardioAdvent, a subsidiary of MicroPort^® CardioFlow, has received EU Medical Device Regulation (MDR) certification for its AnchorMan^® Left Atrial Appendage Closure System (AnchorMan^® LAAC system), securing market approval in just 14 months from registration (Registration Number: MDR 795462) . Its companion device, the AnchorMan^® Left Atrial Appendage Access System, also received approval.

Compared to open and closed left atrial appendage occluders, the AnchorMan^® LAAC system integrates the advantages of both. Its semi-closed structure, featuring 12 “3D folding” units and an advanced frame design, addresses key challenges associated with deep sheath placement in conventional plug-in closure systems while ensuring stable anchoring. The device’s rounded, soft distal end minimizes trauma to LAA tissue, while its dense NiTi alloy frame design ensures tight conformity to the LAA anatomy, providing superior sealing performance. Additionally, its two deployment options - advancement and unsheathing - offer physicians more flexibility during procedures.

In May 2023, the results of the pre-market clinical study SAFE PROTECT – a prospective, multicenter, head-to-head randomized controlled trial - were unveiled for the first time at the European Congress of Percutaneous Cardiovascular Interventions (Euro-PCR). The study successfully reached its primary endpoint and secondary efficacy endpoints within one year, with results showing low incidences of stroke, systemic embolism, major bleeding, transient ischemic attack (TIA), device-related complications, and device-related thrombus (DRT) among patients. This notably high clinical success rate and low adverse events at one year are attributed to its innovative design.

The successful EU certification of both the AnchorMan^® LAAC system and its access device paves the way for MicroPort^® CardioFlow’s expansion into the European market, reinforcing its commitments to stroke prevention in patients with atrial fibrillation. 

Jeff Lindstrom, President of MicroPort^® CardioFlow, stated, “This certification is a major milestone in our global journey. We remain dedicated to driving innovation, overcoming technological barriers, and expanding our interventional therapy portfolio to provide more comprehensive solutions for patients worldwide.”

Guoming Chen, Chairman of MicroPort^® CardioFlow, commented, “Following the success of VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System, AnchorMan^® LAAC system and its access system represent our second major entry into the EU market. As these products gain traction across Europe, they will create strong synergies, further enhancing brand recognition and market share, and jointly elevating our international presence.”

Shanghai, China, 07 January 2025 — MicroPort^® CardioFlow recently announced that its VitaFlow Liberty^® Flex Transcatheter Aortic Valve Implantation System (“VitaFlow Liberty^® Flex”) has received market approval from the National Medical Products Administration (NMPA) of the People’s Republic of China (Approval No. 20243032595). As the third generation transcatheter aortic valve implantation (TAVI) product from MicroPort^® CardioFlow, VitaFlow Liberty^® Flex delivers advanced medical solutions for the treatment of structural heart diseases, further benefiting physicians and patients in China.

VitaFlow Liberty^® Flex is the world’s only coaxial steering, self-expanding TAVI delivery system, and the first retrievable motorized TAVI delivery system. It features the innovative X³ Flexis™ 3D steering function for smoother and safer navigation over the aortic arch and valve, ensuring better coaxial alignment results. A shorter steering segment, positioned closer to the stent, enhances adaptability to the patient’s aortic anatomy. The inner tube steering technology maintains precise coaxial alignment during valve deployment, ensuring more stable and precise implantation. The system also includes a commissural alignment feature that preserves coronary access and leaves room for future coronary intervention. The delivery system is made of composite flexible materials to provide smoother navigation and reduce vascular complications. Additionally, the smart limit switch design incorporates intelligent braking during deployment, with audible and visual alarms to improve safety and enhance physician confidence during the procedure.

Mr. Jeff Lindstrom, President of MicroPort^® CardioFlow, commented: "The VitaFlow Liberty^® Flex will further enhance procedural efficiency and safety while significantly reducing surgical complications. It empowers physicians with enhanced usability while delivering higher-quality care to patients."

Mr. Guoming Chen, Chairman of MicroPort^® CardioFlow, remarked: "With over 15 years of commitment to the TAVI field, our VitaFlow^® series TAVI product has treated more than 10,000 patients with aortic valve disease and earned high praise from international experts. The launch of VitaFlow Liberty^® Flex brings cutting-edge innovative technologies to address more complex procedural scenarios and achieve superior clinical outcomes."

Shanghai, China, 14 February 2025 – MicroPort^® CardioFlow is proud to announce that its second-generation transcatheter aortic valve implantation (TAVI) solution, VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^®), has received marketing approval from the Central Drugs Standard Control Organization (CDSCO) of India (License No.: IMP/MD/2024/000964).

VitaFlow Liberty^® inherits the advantages of its predecessor, VitaFlow^®, in terms of valve design, featuring a hybrid density self-expanding stent, bovine pericardial leaflets, and an advanced double-layer PET skirt. These design elements offer strong radial support, improved coaxial deployment, and reduced perivalvular leakage post-procedure. Moreover, its breakthrough next-generation delivery system incorporates a unique and innovative double-reinforced spiral structure that ensures rapid, stable, and precise release and retrieval. This system also provides flexibility, allowing for 360-degree bending of the valve segment.

As the world’s first electric retrievable TAVI (Transcatheter Aortic Valve Implantation）system, VitaFlow Liberty®, along with its accessory, the Alwide® series Balloon Catheter, has been successfully adopted in over 700 leading hospitals across 20 countries and regions, benefiting over 10,000 patients with aortic valve diseases worldwide.

India’s TAVI market reached 3,000 units in 2024 and is expected to grow significantly. The approval of VitaFlow Liberty^® is set to enhance the surgical experience for Indian physicians through its innovative technology, potentially reshaping the competitive landscape of the country’s TAVI market. This milestone also marks a significant step in MicroPort^® CardioFlow’s expansion into the Asian market, bringing new hope to patients with structural heart diseases.

Baku, Azerbaijan — December 4, 2024. VitaFlow Liberty^®, the transcatheter aortic valve and retrievable delivery system independently developed by MicroPort CardioFlow Medical Technology Co., Ltd. (hereinafter referred to as "MicroPort CardioFlow", 02160.HK), successfully completed its first commercial application in Western Asia at Universal Hospital in Azerbaijan. The procedure was led by Dr. Uzeyir Rahimove, the hospital's director, with online guidance from Professor Jianfang Luo's team at Guangdong Provincial People's Hospital. The patient experienced no significant paravalvular leakage or other complications postoperatively, marking a complete success for the surgery.

Preoperative Assessment

A 69-year-old male patient presented with a stenotic tricuspid aortic valve exhibiting mild to moderate calcification. Computed tomography (CT) analysis revealed the following anatomical dimensions:

Aortic annulus: Circumference of 78.1 mm, mean diameter of 24.9 mm.

Left ventricular outflow tract (LVOT): Circumference of 76.3 mm, mean diameter of 24.6 mm.

Sinuses of Valsalva: Widths of 31.1 mm, 33.2 mm, and 33.3 mm, respectively.

Sinotubular junction (STJ): Mean diameter of 31.3 mm.

Ascending aorta: Mean diameter of 40.8 mm.

Surgical Procedure and Outcome

A standard tricuspid valve case was successfully treated with a TAV 27 VitaFlow Liberty^® valve, selected based on annular measurements. Due to the patient’s mild calcification, an 18mm balloon was used for pre-dilation. The effective inner diameter of the right-sided access is adequate, but the bifurcation is high. The phisician decided to perform a high puncture and still selected the right-sided access as the primary approach.

Surgical Outcomes

The postoperative pressure gradient measured 3 mmHg, with no significant paravalvular leakage observed. The valve was implanted at a depth of 5 to 6 mm below the annulus, and no additional complications were noted. Overall, the surgery was a complete success.

Summary 

Azerbaijan, situated at the core of the Eurasian continent, functions as a crucial link between Eastern and Western regions. In recent years, the nation has witnessed consistent and robust economic growth, rendering its medical device market particularly promising. The inaugural commercial deployment of the VitaFlow Liberty^® in this strategically significant market is expected to enhance its influence throughout Europe. Furthermore, this event signifies the official introduction of the world's sole electrically retrievable transcatheter aortic valve implantation (TAVI) system into the Western Asian market. This achievement is anticipated to expedite the company's expansion within Asia, ultimately benefiting a greater number of patients. 
 

Looking forward, MicroPort CardioFlow aims to accelerate its globalization efforts, thereby demonstrating the innovative capabilities associated with "Intelligent Manufacturing of China" on a global scale. The company is dedicated to contributing to the advancement of global treatments for structural heart diseases, embodying the concept of "Chinese power."

Shanghai, China — MicroPort CardioFlow's second-generation transcatheter aortic valve implantation (TAVI) device, the VitaFlow Liberty® Transcatheter Aortic Valve and Retrievable Delivery System (referred to as "VitaFlow Liberty®"), has recently been granted market approval by the Turkish Medicines and Medical Devices Agency (TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU). This product was developed independently by MicroPort CardioFlow Medical Technology Co., Ltd. (02160.HK, referred to as " MicroPort CardioFlow").

 

Shanghai, China, 12 December 2024 –The VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^®), the second-generation transcatheter aortic valve implantation (TAVI) solution from MicroPort^® CardioFlow, has recently received marketing approval from the Korean Ministry of Food and Drug Safety (MFDS) (Registration No.: 수허 24-268 호).

VitaFlow Liberty^® is the world’s only electric retrievable TAVI system. Building on the design strengths of its predecessor VitaFlow^®, it incorporates a hybrid-density self-expanding stent, bovine pericardial leaflets, and an advanced double-layer PET skirt. These features provide high radial support, enhance coaxial release, and significantly reduce the incidence of post-procedural paravalvular leaks. 

Furthermore, its groundbreaking upgraded delivery system features a unique double-reinforced spiral structure, enabling rapid, stable, and precise release and retrieval. This system also achieves flexibility, with the ability to bend the valve segment 360°, further enhancing surgical precision and adaptability.

The VitaFlow^® series TAVI solution, along with its accessory, the Alwide^® series Balloon Catheter (Alwide^® Plus), has been adopted by more than 700 hospitals across 20 countries and regions, benefiting over 10,000 patients with aortic valve diseases worldwide.

Minnesota, USA, 23 October 2024 - Recently, the AltaValve™ system, a transcatheter mitral valve replacement (TMVR) device developed by MicroPort^® CardioFlow’s strategic partner 4C Medical, initiated a pivotal clinical trial in Europe and the United States. The trial, named ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation), aims to evaluate the safety and efficacy of the AltaValve™ system in treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair (NCT06465745). The result will support its CE marking and FDA approval.

The AltaValve™ system is currently the world's only fully retrievable and low-profile TMVR system, poised to offer the world's first atrial-only fixation MR treatment solution upon its market release. Its innovative design effectively addresses the mitral annular anchoring challenges present in current TMVR technologies, protecting the patient’s heart structures during the procedure and minimizing the risk of left ventricular outflow tract obstruction or damage, resulting in safer and more superior clinical outcomes. In addition, the system employs a one-step release and positioning mechanism, simplifying the procedure and significantly shortening the learning curve for clinicians. Earlier this year, the AltaValve™ system was granted two Breakthrough Device designations by FDA, covering the indications for “moderate to severe or severe MR” and “moderate to severe or severe MR with moderate/severe mitral annular calcification.”

The ATLAS trial includes two independent, non-randomized cohorts: a) Cohort with moderate/severe mitral annular calcification (MAC) ; b) Primary cohort that includes patients with no MAC or mild MAC. 

"The AltaValve™ system is the first atrial fixation TMVR device that is designed to minimize challenges of the sub-valvular TMVRs, especially screen failures associated with the risk of left ventricular outflow tract obstruction, damage to the left ventricle and MAC," said Ron Waksman, M.D., interventional cardiologist at Medstar Washington Hospital Center (Washington, DC) and the Steering Committee Chair for the ATLAS trial. 

"We are excited to have successfully enrolled the first US patients in the ATLAS trial. I am particularly excited as the AltaValve™ System is designed to offer the broadest applicability for wide range of pathologies," said Paul Sorajja, M.D., interventional cardiologist at Minneapolis Heart Institute (Minneapolis, MN) and Co-Principal Investigator (PI) of the trial. "It is an intuitive and predictable procedure with a repositionable implant that is very much needed for the treatment of patients worldwide." 

Dr. Yoshi Kaneko, cardiothoracic surgeon at Barnes-Jewish Hospital (St. Louis, MO), shares Co-PIs responsibilities with Dr. Sorajja in US, while Dr. Vlasis Ninios, an interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece), and Dr. Lenard Conradi, cardiothoracic surgeon at University Hospital Cologne (Cologne, Germany), share Co-PIs responsibilities in Europe.

Shanghai, China - Recently, the second-generation valve balloon catheter independently developed by MicroPort CardioFlow Medtech Corporation (02160.HK, hereinafter referred to as "MicroPort CardioFlow"), the Alwide^® Plus Valve Balloon Catheter (hereinafter referred to as "Alwide^® Plus"), has obtained market approval from the Mexican National Health Supervision Bureau (COFEPRIS, full name Comisión Federal para la Protección contra Riesgos Sanitarios) (SANITARY REGISTRY NO. 2556C2024 SSA).

 

Shanghai, China, September 05, 2024 – MicroPort^® CardioFlow Medtech Corporation (02160.HK, hereinafter referred to as " MicroPort^® CardioFlow ") recently announced that its subsidiary, MicroPort^® CardioAdvent, has expedited the initial clinical applications of its independently developed AnchorMan^® Left Atrial Appendage（the “LAA”) Closure System（the “AnchorMan^® LAAC System”) following its market launch.

Approved for market release by the National Medical Products Administration (NMPA) in January 2024, AnchorMan^® is currently the only semi-closed LAAC device available in China. To date, it has been successfully implanted in 41 cases across 12 provinces, demonstrating its growing adoption in clinical practice. Initial clinical applications have shown outstanding outcomes, with postoperative imaging for all patients indicating complete occlusion and remarkable effectiveness.

The AnchorMan^™ LAAC System offers a unique combination of the benefits of both traditional open and closed LAAC devices. Its semi-closed structure, formed by the 12 “3D folding” units and the frame, combines the strengths of open and closed closure device, addressing the clinical challenge of deep sheath placement in traditional plug-in closure devices while achieving stable anchoring. The rounded, soft distal end could minimize damage to LAA tissue, while the dense NiTi alloy frame design ensures tight conformity to the LAA anatomy, providing superior sealing performance. Additionally, two deployment models of advancement and unsheathe are available, offering physicians more flexibility during procedures.

Since its launch, the AnchorMan^™ LAAC System has received significant recognition at various authoritative academic conferences in the cardiovascular field，garnering high praise for its robust performance, exceptional clinical data, and positive feedback from both physicians and patients. The rapid adoption of the first batch of implants highlights the system’s accelerated domestic commercialization, which will further contribute to increasing the MicroPort^® CardioFlow’s revenue and boosting its profitability. Concurrently, the global strategy for the AnchorMan^™ LAAC System is progressing steadily. The CE registration application was officially submitted in December 2023, with EU CE certification anticipated by 2025.

Looking ahead, with a focus on product development and technological innovation, MicroPort^® CardioFlow will continue to expand its portfolio of interventional therapy products for structural heart disease, providing high-quality, accessible, and comprehensive solutions to patients worldwide.

Shanghai, China — Recently, the VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (referred to as "VitaFlow Liberty^®"), a new generation transcatheter aortic valve implantation (TAVI) product self-developed by MicroPort CardioFlow Medtech Corporation (02160.HK, hereinafter referred to as " MicroPort^® CardioFlow "), has received market approval from the MEDICAL DEVICE AUTHORITY Malaysia (Authorization Number: GD5322224-178777).

Shanghai, China - MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK) recently announced that following Alwide^® Plus Balloon Catheter, the second generation of balloon catheter, Its self-developed new generation Transcatheter Aortic Valve Implantation (" TAVI ") product VitaFlow Liberty^® Transcatheter Aortic Valve and Retrivable Delivery System (" VitaFlow Liberty^® ") has received marketing approval  from the Saudi Food and Drug Administration (SFDA).

Santiago, Chile – On May 17, 2024, MicroPort^® CardioFlow Medtech Corporation(" MicroPort^® CardioFlow ", 02160.HK ) completed the first implantation with its self-developed VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^® ) at the Sótero del Río Hospital in Chile. Dr. Martín Valdebenito, the director of cardiology at the hospital, and Dr. Juan Pablo De Brahi, a renowned Argentine cardiologist, performed the procedure and successfully treated a patient with severe aortic valve stenosis, with no conduction blocks or paravalvular leaks occurring and the transvalvular pressure gradient dropped to 4mmHg postoperatively. The patient was discharged within three days after the successful implantation.

Shanghai, China，03 June , 2024 — Recently, AltaValve™, a transcatheter mitral valve replacement (TMVR) system developed by 4C Medical, has been granted two Breakthrough Device designations by the Food and Drug Administration (FDA). These designations specifically target treatment indications for moderate to severe or severe mitral regurgitation (MR) and moderate/severe MR with moderate/severe mitral annular calcification.

SHANGHAI, June 17, 2024 /PRNewswire/ -- MicroPort^® CardioFlow Medtech Corporation (CardioFlow) (Stock Code: 02160.HK) recently announced that its self-developed second-generation transcatheter aortic valve implantation (TAVI) device, the VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^®), has received EU CE-MDR certification. This certification highlights VitaFlow Liberty^® as a pioneering TAVI solution, that sets a new benchmark in transcatheter heart valve treatments.

Shanghai, China, 02 February 2024 - AnchorMan^® Left Atrial Appendage Closure System (AnchorMan^® LAAC System), developed by CardioAdvent^®, an associated company of MicroPort^® CardioFlow, recently obtained approval in China. Its companion product, the AnchorMan^® LAA Access System, had previously been approved in October 2023.

AnchorMan^® LAAC System comprises of a left atrial appendage (LAA) closure device and a delivery system. It is intended for patients with non-valvular atrial fibrillation who have a high risk of stroke (as indicated by a CHA2DS2-VASC score ≥2) and either have contraindications to long-term oral anticoagulation therapy, or still face a risk of stroke despite anticoagulant treatment.

AnchorMan^® LAAC System’s innovative design includes:

• A semi-closed structure (formed by the 12 “3D folding” units and the frame) facilitates the merits of an open and closed closure device. This helps achieve stable anchoring and solves the clinical pain point by minimizing LAA depth compared to the traditional plug-in closure device access sheath;
• A rounded and soft distal end that helps reduce damage to the LAA tissue;
• A dense NiTi alloy frame, facilitating tight conformity to the anatomy of the LAA and achieving better sealing performance;
• Two deployment models of advancement and unsheathe which provide more options for physicians.

Additionally, AnchorMan® LAAC System is available in six closure device diameters ranging from 20 mm to 35 mm, catering to a larger patient population.

AnchorMan® LAAC System completed its clinical enrollment for the pre-market trial in September 2021. The study demonstrated that AnchorMan® LAAC System's 12-month clinical outcomes achieved non-inferiority compared to its control group products in primary and secondary endpoints. In terms of occlusion effectiveness, the complete occlusion and minimal residual leakage rates (residual shunt < 3mm) at 12 months post-operation were superior to those of the control group products.

On 1 January 2024, MicroPort® CardioFlow strategically acquired Shanghai CardioAdvent, further expanding its expertise in the structural heart disease treatment field. The approval of AnchorMan® LAAC System marks MicroPort® CardioFlow's official entry into the stroke prevention field. Additionally, a registration application for CE certification for the product was submitted at the end of 2023.

Mr. Jeff Lindstrom, President of MicroPort® CardioFlow, stated: "The innovative design of the AnchorMan® LAAC System, with its rounded distal end and semi-closed structure, combines the advantages of both open and closed occluders. Its impressive clinical results are promising. The recent approval will enable the company to grow its business to the rapidly expanding and large patient-base segment of non-valve related structural heart disease. This expansion is anticipated to contribute to an increase in revenue scale and an optimization of operational efficiency".

Mr. Guoming Chen, Chairman of MicroPort® CardioFlow, stated: "This acquisition further deepens and expands MicroPort® CardioFlow’s pipeline layout, which contributes to enhancing our global competitiveness. In the future, MicroPort® CardioFlow will strive to provide total solutions for structural heart diseases and is dedicated to providing high quality therapeutic solutions to patients and physicians across the globe”.

Lille, France - Recently, the Transcatheter Mitral Valve Replacement System ("TMVR System") of MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as " MicroPort^® CardioFlow ") has successfully completed its first overseas clinical application under compassionate use at Lille University Center Hospital in France. The procedure, led by Prof. Thomas Modine's team at the hospital, resulted in a stable recovery for the patient, with good hemodynamic improvement, and the patient was discharged after recovery. The 30-day follow-up results showed complete disappearance of mitral regurgitation, no perivalvular leakage, and the valve was in good working order and stable position.

Moscow, Russia- On December 18, 2023, MicroPort^® CardioFlow completed the first implantation of its VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^®) in Russia, marking the completion of a highly complex Type 0 bicuspid aortic valve implantation with an extremely horizontally positioned heart via Transcatheter Aortic Valve Implantation (TAVI). Led by Professor Imaev Timur of the Russian National Medical Research Center for Cardiovascular Surgery, with guidance from Chinese experts, the team achieved precise deploy and successful release of the valve without the need for post-dilation. Post-operative echocardiography showed good valve shape and position, with no paravalvular leakage or conduction abnormalities, confirming the success of the procedure.

Shanghai, China-Recently, the second-generation balloon catheter-Alwide Plus Balloon Catheter (hereinafter referred to as "Alwide Plus") self-developed by MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK) was approved for marketing by Saudi Food & Drug Authority.

London, UK - November 19th - November 21st, 2023, evidence-based data from the VitaFlow^® Transcatheter Aortic Valve (VitaFlow^®), developed by MicroPort^® CardioFlow (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK), were revealed on PCR London Valves, a leading global event on structural heart diseases. The data showed that the long-term and excellent clinical outcomes of VitaFlow^® have reached the international mainstream level, and this is also the first time for the domestically-developed transcatheter aortic valve system to publish 7-year long-term follow-up data in the international authoritative academic arena in the field of interventional treatment of heart valve disease.

Shanghai, China, MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK) has recently received marketing approval for its VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (hereinafter referred to as "VitaFlow Liberty^®" ) and Alwide^® Plus balloon catheter (hereinafter referred to as "Alwide^® Plus") from the Indonesian Ministry of Health (MOH).

Copenhagen, Denmark - MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK) announced that its self-developed VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty^®") has completed five pre-market implantations at Rigshospitalet (Copenhagen University Hospital) in Denmark. The surgery was conducted by cardiologist Dr. Ole De Backer and his team from Rigshospitalet, with Dr. Darren Mylotte, an Irish cardiology expert, serving as a special invited consultant. During the surgery, The valves of all five patients were released to the ideal position, and immediate postoperative imaging showed good valve morphology and position, with no perivalvular leakage or regurgitation, indicating the successful completion of the surgery. All patients recovered well and were discharged the following day.

Shanghai, China - MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK) recently announced that following Alwide^® Plus Balloon Catheter, the second generation of balloon catheter, Its self-developed new generation Transcatheter Aortic Valve Implantation (" TAVI ") product VitaFlow Liberty^® Transcatheter Aortic Valve and Retrivable Delivery System (" VitaFlow Liberty^® ") has received marketing approval from the Russian State Food and Drug Regulatory Agency (RZN)

Shanghai, China — Recently, MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK) has received marketing approval for its second-generation balloon catheter , Alwide^® Plus Balloon Catheter (hereinafter referred to as "Alwide^® Plus") from Russian State Food and Drug Administration(RZN).

On September 4, 2023, at 15:00 local time, the VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty^®"), self-developed by MicroPort^® CardioFlow, VitaFlow Liberty^® was presented at the Police General Hospital in Thailand. Under the leadership of Prof. Luo Jianfang from Guangdong Provincial People's Hospital, Prof. Anuruck Jeamanukoolkit, an expert from the hospital, together with his team, successfully performed the first implantation of VitaFlow Liberty^® in Thailand. Postoperative imaging showed that the patient's valve was in good shape and position, with no perivalvular leakage or coronary occlusion, and the surgery was a complete success.

Shanghai, China - As a new generation of TAVI product developed by MicroPort^® CardioFlow Medtech Corpration, VitaFlow Liberty^® is the first and only motorized retrievable transcatheter aortic valve system in the world. Recently, MicroPort^® CardioFlow team accompanied the expert team from four renowned hospitals in Thailand to Xiamen Cardiovascular Hospital Xiamen University to observe the successful implantation of a patient with moderate aortic stenosis combined with severe regurgitation by the local physician team using the product, which has been reprinted and reported by a number of media outlets.

VitaFlow Liberty^®'s groundbreaking breakthrough upgraded delivery system, adding the retrievable function combined with the world’s first double reinforced spiral design on the basis of the electric handle, which achieves the flexibility and 360°range of motion, while ensuring fast, stable and precise release and recapture.

MicroPort^® CardioFlow Medtech Corporation (MicroPort^® CardioFlow, stock code: 02160.HK) announced that its self-developed VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty^®") completed the first implantation in Colombia at the Organizacion Clinica General del Norte Hospital.

As the only TAVI product with motorized retrievable delivery system in the Latin American market, VitaFlow Liberty^® combines the advantages of VitaFlow^® ’s valve design with groundbreaking improvements to the delivery system.

VitaFlow Liberty^® stood out from tens of thousands of projects and won the silver award in the 2021-2022 Italian A’Design Award Design Grand Prix . This is another international design award won by VitaFlow Liberty^® after the German Red Dot Design Award in 2022.

Recently, MicroPort^® CardioFlow’s VitaFlow Liberty^® Transcatheter Aortic Valve and Rretrievable Delivery System (hereinafter referred to as "VitaFlow Liberty^®"),stood out from numerous works around the world with its innovative design concept and excellent product performance, and successfully won the 2022 German Red Dot Design Award (product design).

Shanghai, China - MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to MicroPort^® CardioFlow ,02160.HK) announced that its self-developed Alwide^® Plus balloon catheter (hereinafter referred to as "Alwide^® Plus") has been approved by the Argentine National Administration of Drugs, Foods, and Medical Devices (ANMAT).

Shanghai, China - MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow", stock code: 02160.HK) announced that its self-developed VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (hereinafter referred to as "VitaFlow Liberty^®"), a new generation product for Transcatheter Aortic Valve Implantation (TAVI), has been approved by the Argentine National Administration of Drugs, Foods, and Medical Devices (ANMAT).

Shanghai, China, 28 December 2021 — MicroPort^® CardioFlow Medtech Corporation (MicroPort^® CardioFlow) recently announced that its latest transcatheter aortic valve implantation (TAVI) solution, the new-generation VitaFlow Liberty™ Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty™) has completed the submission of applications materials for the EU CE certification.

Shanghai, China, 5 November 2021 — MicroPort^® CardioFlow Medtech Corporation (CardioFlow Medtech) hosted a symposium for its next-generation transcatheter aortic valve implantation (TAVI) product, the VitaFlow Liberty™ Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty™), during the 32nd Great Wall International Congress of Cardiology (GW-ICC) and Asia Heart Society Congress. The event brought together experts in the field of structural heart disease to share their experience on the clinical application of VitaFlow Liberty™.

Shanghai, China, 5 November 2021 — MicroPort^® CardioFlow Medtech Corporation (02160.HK, MicroPort^® CardioFlow) is set to become the largest shareholder of 4C Medical Technologies, Inc. (4C Medical) following the recent completion of a series C preferred shares subscription agreement. As the lead investor of the round, MicroPort^® CardioFlow will make a strategic investment up to USD 25 million in 4C Medical, and will be granted the exclusive commercial rights to the investigational tricuspid products in China.

Shanghai, China, 30 October 2021 — MicroPort^® CardioFlow Medtech Corporation (MicroPort^® CardioFlow) recently hosted a launch event for the VitaFlow Liberty™ Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty™), a next-generation product for transcatheter aortic valve implantation (“TAVI”). The product, presented at China Structural Week 2021 and the 5th China International Structural Heart Disease Conference held in Beijing, Shanghai, Guangzhou, and Xi'an, drew the attention of experts in the field of structural heart disease and triggered discussions on the development of the TAVI procedure.

Shanghai, China—MicroPort^® CardioFlow Medtech Corporation (MicroPort^® CardioFlow) is pleased to announce the results of the Company and its subsidiaries for the year ended December 31st, 2020.

February 4, 2021, Shanghai, China— MicroPort^® CardioFlow Medtech Corporation (“MicroPort^® CardioFlow”, stock code: 2160), is successfully listed on the Main Board of the Stock Exchange of Hong Kong Limited (SEHK).

On April 15, 2020, MicroPort^® Scientific Corporation (Stock code: 00853) ("MicroPort^®"), announced that MicroPort^® CardioFlow ("MicroPort^® CardioFlow"), which is a subsidiary of MicroPort^®, had completed raising a new round of funds on the basis of a pre-money valuation of US$1.1 billion. The introduction of seven prominent strategic investors, who are CPE, Hillhouse Capital Management, Ltd., Lake Bleu Capital, Gamnat, China Reform Conson Soochow Overseas Fund I L.P., Gortune Artemis Limited, and 3H Health Investment Fund I, L.P., raised approximately US$130 million. After this round of fundraising, the investors will have an aggregate shareholding of 10.83% in MicroPort^® CardioFlow. J.P. Morgan Securities (Asia Pacific) Limited and Citigroup Global Markets Asia Limited acted as co-placement agents in the transaction.

On September 19, 2019, the first post-marketing implantation of the VitaFlow^® Valve System and Alwide^® Balloon in Lingnan Region was successfully performed by the team of Prof. Luo Jianfang at Guangdong General Hospital.

Shanghai, China - on August 28, 2019, the first implantation of the self-developed VitaFlow^® Transcatheter Aortic Valve System of MicroPort^® Cardioflow was performed at Zhongshan Hospital affiliated to Fudan University. Prof. Ge Junbo, Academician of Chinese Academy of Sciences, Director of the Cardiology Department of Zhongshan Hospital, performed the surgery and successfully implanted the VitaFlow^® aortic valve into a 70-year-old male patient.

In Shanghai, China on December 12, 2018, the self-developed VitaFlow^® II Transcatheter Aortic Valve and Recyclable Delivery System of MicroPort^® Cardioflow has been admitted into the “Green Path”from National Medical Products Administration (NMPA) for the special approval procedure for innovative medical devices. 

In Galway, Ireland on December 11, 2018, Shanghai MicroPort^® CardioFlow Medtech Co., Ltd. (hereinafter referred to as “MicroPort^® CardioFlow”) announced that the first patient enrollment was completed in Europe for the project of pre-market clinical research on its self-developed VitaFlow^® II Transcatheter Aortic Valve and Recyclable Delivery System (hereinafter referred to as “VitaFlow™ II System”) (“VITALE” project for short).

Shanghai, China - VitaFlow^® Transcatheter Aortic Valve and Delivery System ("VitaFlow^®"), in-house developed by MicroPort CardioFlow has been admitted into the "Green Path" by the China Food and Drug Administration ("CFDA"), a special fast-track procedure for innovative medical devices to gain CFDA approval.

Suzhou, China – From March 22 to March 25, MicroPort^® Shanghai CardioFlow Medtech Co., Ltd. ("MicroPort^® CardioFlow"), a wholly owned subsidiary of Shanghai MicroPort^® Medical (Group) Co., Ltd. ("MicroPort^®"), attended CIT 2018 and released the one-year clinical outcome of VitaFlow^® Transcatheter Aortic Valve and Delivery System ("VitaFlow^®").

Shanghai, China – On August 22, MicroPort Shanghai CardioFlow Medtech Co., Ltd. ("MicroPort^®CardioFlow"), a wholly owned subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort^®"), entered into financing agreements at a consideration of RMB430million and achieved a valuation of RMB2.1 billion after this round of financing.

Shanghai, China - MicroPort^® CardioFlow has recently completed the patient enrollment of the pre-market clinical trial of its self-developed VitaFlow^® Transcatheter Aortic Valve and Delivery System ("VitaFlow^®"), which is three months prior to the scheduled completion date. The clinical trial is a prospective, multi-center trial, aiming at assessing the safety and efficacyof VitaFlow^® in the treatment of severe aortic stenosis. The clinical trial was organized by Professor Junbo Ge, an academician of Chinese Society of Sciences and a renowned cardiologist. Zhongshan Hospital of Fudan University, led eleven domestic hospitals to complete the clinical trial.