Home BioTrack April Monthly Report: Acumen Medical Secures Third Flow Diverter Registration; Huihe Medical Completes First Commercial Implants of K-Clip, Ushering in a New Era for Transcatheter Tricuspid Valve Repair in China

BioTrack April Monthly Report: Acumen Medical Secures Third Flow Diverter Registration; Huihe Medical Completes First Commercial Implants of K-Clip, Ushering in a New Era for Transcatheter Tricuspid Valve Repair in China

May 13, 2025 09:28 CST Updated 09:28
AccuMedical

Innovative Neurointerventional Devices and Related Access Devices Developer

HuiHe Healthcare

R&D and Producer of Interventional Medical Devices for Heart Disease

NewMed

Artificial Heart Valve System Developer

Valgen Medtech

Minimally Invasive Interventional Device Developer

Union Strong

Developer of Artificial Intelligence-Assisted Diagnosis and Treatment Systems

Edge Medical

Developer of Robot-Assisted Minimally Invasive Surgical Systems

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Business Progress

1

"AccuMedical Receives Third Mesh Registration Certificate"

Recently, AccuMedical's new flow diverter stent system "Lattice COUPLE" has successfully obtained approval for registration from the National Medical Products Administration. [Registration Certificate Number: NMPA Approval 20253130668]. Thus, AccuMedical has become the first company in the neurointervention industry to possess three flow diverter registrations.

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2

NewMed's Chengdu NewMed Bio Adjustable Bend Sheath Kit Approved for Marketing

On April 10, 2025, the deflectable sheath kit independently developed by Chengdu NewMed Biotechnology Co., Ltd. ("NewMed Biotech") has been approved for marketing by the Sichuan Provincial Drug Administration.

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3

"Valgen Medtech EU MDR Certification | China's First Domestically Produced Transfemoral Mitral Valve Edge-to-Edge Repair Product — DragonFly™ Transcatheter Mitral Valve Clip System Initiates a Global Revolution"

On April 7, 2025, the DragonFly™ Transcatheter Mitral Valve Clip System, independently developed by Valgen Medtech Co., Ltd. (Hangzhou), successfully passed the EU MDR (Medical Device Regulation) certification, becoming the first product in China's transvenous mitral valve edge-to-edge repair field to receive this authoritative certification.

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4

"Union Strong" Global First, China-Originated AI "Catheter Shaping Robot" Unveiled at 2025 CMEF: Ushering in a New Era of Intelligent Neurointerventional Healthcare

On April 9, 2025, at the China International Medical Equipment Fair (CMEF) held in Shanghai, Union Strong® officially launched its AI-driven innovative product, the "self-navigating catheter" shaping robot, marking the entry of the neurointerventional surgery field into a new era of intelligence. At the event, the new generation of catheter shaping robot products was jointly released by Ms. Qin Lan, founder, chairwoman, and general manager of Union Strong®, Professor Zhang Hongqi from Xuanwu Hospital, Capital Medical University, and Professor Ni Wei from Huashan Hospital, Fudan University.

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5

"Edge Medical's MP2000 officially enters Peking University Third Hospital and the First Affiliated Hospital of Zhejiang University School of Medicine — Edge Medical fully deploys in China's top hospital market!"

Recently, the latest generation of multi-port endoscopic surgical robot MP2000, independently developed by Edge Medical®, has successively completed commercial installation at Peking University Third Hospital (hereinafter referred to as "PUH3") and the First Affiliated Hospital of Zhejiang University School of Medicine (hereinafter referred to as "FAHZU"), officially beginning its service. This marks the first time that domestically produced surgical robots have entered the "top tier" of China's top 100 hospitals in such density, indicating that Chinese-made surgical robots now possess the solid capability to compete head-to-head with internationally leading products.

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6

HuiHe Healthcare's K-Clip First Implantation After Market Launch | 3 Locations, 4 Procedures, Successfully Opens a New Chapter in China's Transcatheter Tricuspid Valve Repair

On April 22, 2025, HuiHe Healthcare's K-Clip® Transcatheter Tricuspid Annuloplasty System officially commenced its first commercial implantation post-market launch. Teams led by Academician Ge Junbo from Zhongshan Hospital Affiliated to Fudan University, Academician Wang Jian'an from the Second Affiliated Hospital of Zhejiang University School of Medicine, and Professor Song Guangyuan alongside Professor Lin Yixian from Beijing Anzhen Hospital Affiliated to Capital Medical University successfully performed the first post-market implantation of K-Clip® on the same day across three locations. This marked the official beginning of the commercialization of transcatheter tricuspid valve treatment in China.

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7

"Tendvia Medical" Director Chen Sipan's team from the Minimally Invasive Intervention Department of Shaanxi Provincial People's Hospital successfully treated one case of acute pulmonary embolism using the Tendvia® Pulmonary Artery Thrombectomy Stent System.

Recently, the team led by Director Chen Sipan of the Minimally Invasive Intervention Department at Shaanxi Provincial People's Hospital successfully performed a mechanical thrombectomy on a patient with acute pulmonary embolism using Tendvia® Pulmonary Artery Thrombectomy Stent System, the first domestically produced system in China developed by Tengfu Medical. The clinical application of this innovative technology marks a new step forward for Shaanxi Provincial People's Hospital in the field of pulmonary vascular interventional treatment. More importantly, patients with pulmonary thrombosis now have a wider and safer range of treatment options.

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8

"Ease Medical" easyScopy™ Electronic Ureteroscope System and Electronic Cystoscope System Receive EU MDR Certification, Officially Entering the European Market

On April 24, 2025, Ease Medical announced that its self-developed electronic ureteroscope system and electronic cystoscope system (domestic trademark: easyScopy™; international trademark: enScope™) successfully passed the EU Medical Device Regulation (EU MDR 2017/745) certification. This milestone not only marks the company's strategic expansion in the urology sector but also highlights Ease Medical’s continued commitment to deepening its presence in the European market, driven by innovation to enhance clinical value.

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9

"Huayi Lejian's Class 1 New Drug GS1191-0445 Injection Included in CDE Breakthrough Therapy Designation"

On April 24, 2025, the breakthrough therapy designation announced on the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration revealed that GS1191-0445 Injection, a Class 1 innovative drug independently developed by Suzhou Huayi Lejian Biotechnology Co., Ltd., has been included as a breakthrough therapy variety. The public comment period for this designation is from April 16 to April 23, 2025. This marks high recognition of the company's continuous innovation capabilities in the field of gene therapy and signifies that China’s research and development in the field of hemophilia gene therapy has reached an advanced global level.

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Research Progress

1

"AccuMedical" Published the Latest Research Results on Ziresovir for the Treatment of Respiratory Syncytial Virus Infection in Hospitalized Infants Under 6 Months Old in The Lancet Child & Adolescent Health

On April 16, 2025, The Lancet Child & Adolescent Health, the top journal in the field of international child and adolescent health, published online the Phase III clinical research results of the first RSV-specific antiviral drug Ziresovir, titled "Efficacy and safety of ziresovir in hospitalised infants aged 6 months or younger with respiratory syncytial virus infection in China: findings from a phase 3 randomised trial with 24-month follow-up". This follows the publication of the Phase III clinical study results in The New England Journal of Medicine in September 2024, marking its appearance once again in a globally renowned medical journal.

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2

"NewMed's Self-Developed Prizvalve Transcatheter Aortic Valve System Selected for 'China's Important Medical Advances of 2024'"

On April 20, 2025, the Chinese Academy of Medical Sciences released "China's Important Medical Advances in 2024" at the China Medical Development Conference, totaling 13 items. NewMed's balloon-expandable transcatheter aortic valve system was selected.

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3

"Ruijing Bio" Participates in the Declaration of the National Science and Technology Major Project for "Four Major Chronic Diseases" Approved for Project Establishment

Recently, the Medical and Health Science and Technology Development Research Center of the National Health Commission announced the results of the major special project "Research on the Prevention and Treatment of Cancer, Cardio-cerebrovascular, Respiratory, and Metabolic Diseases." The project "Research on New Technologies for Precise Diagnosis of Thyroid Nodules and Stratified Treatment of Differentiated Thyroid Cancer (Project No.: 2024ZD0525600)," led by the First Affiliated Hospital of Sun Yat-sen University in collaboration with Tianjin People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Fudan University Shanghai Cancer Center, and Shanghai Ruijing Biotechnology Co., Ltd., has been successfully approved for funding.

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Enterprise Honors

Xinyi Technology | Awarded the Title of "Technology Little Giant Cultivation Enterprise"





TopChem Technologies | Selected for the "Zhejiang Province Future Unicorn Enterprise List"





LiXin Pharmaceuticals | Awarded "Top 15 in China Innovative Drug Business Development · 2024 PharmaCube TOP15 List"





SeekGene, Ligentec, LannerMed, Meridian Medical|Included in "KPMG China's 3rd Biotech Innovation Pioneer 50 List"


Haisi Gaidai | Selected for "Top 100 China Future Unicorns 2025"





Homologous Health | Selected as "Top 5 Best Exit Cases in China's Medical and Health Service Industry by CVSource 2024"





ShenNuo Medical, HaiJieYa | Selected as "Top 10 Best Medical Device Field Investment Cases in China's Healthcare and Health Service Industry by CVSource 2024"






Bo Yuan Honor


Invested In | Boyuan CapitalAwarded "Top 100 Best Venture Capital Institutions in China for 2024" and other awards





First New Voice |Boyu Capital Honored as "Top 20 Most Active Investment Institutions in Healthcare 2024" & Boyu Capital Founding Partner Penghui Chen Honored as "Top 30 Best Industry Investors in China 2024"





China Fund of Funds Research Center |Boyu Capital and Its Team Members Awarded "Top 20 Most Popular Direct Investment Fund Institutions Among Young Investors in 2025" and Other Honors




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