In 2025, the company's flagship DragonFly™ transcatheter mitral valve clip system ACHieved 2,043 implants in China, capturing 47.14% of the national TEER market and ranking first domestically. In April 2025, DragonFly™ obtained EU CE MDR certification, becoming the third TEER product worldwide and the first Chinese product to gain international market approval. In December 2025, Venus Medtech (02500.HK) sold its approximately 1.05% stake in Valgen Holding Corporation to Konfoong Biotech (02216.HK) for USD 15 million. In March 2026, Konfoong invested an additional USD 55.12 million to acquire approximately 3.85% equity, bringing total Konfoong investment to USD 70.12 million for approximately 4.9%. In March 2026, the company received NMPA Class III approval for its steerAble guiding sheath (可调弯导引鞘). In April 2026, DragonFly™ completed its first implantation in Vietnam and obtained Philippines marketing authorization, while the company hosted 9 live TEER demonstrations at china VALVE (Hangzhou) 2026.
Company Profile (Updated April 2026)
Hangzhou Valgen Medical Technology Co., Ltd.（杭州德晋医疗科技有限公司） is a leADINg Chinese medical device company dedicated to developing minimally invasive interventional therapies for structural heart diseases, with a Primary focus on mitral and tricuspid valve repair. Founded on August 28, 2015 and headquartered in Hangzhou National Hi-Tech Development Zone (Binjiang District), the company operates internationally through its parent entity Valgen Holding Corporation. Valgen Medical has established itself as a pioneer in China's structural heart intervention field, repeatedly recognized as a "Unicorn Enterprise" by Zhejiang Province and Hangzhou City since 2021.
Development History:
- 2015: Company founded on August 28 in Hangzhou Binjiang District with registered capital of RMB 750 million; established Shenzhen Innovation R＆D Center
- 2018: MitralStitch®, China's first transapical mitral valve repair device, successfully applied in first-in-human clinical research
- 2020: In July, completed the first-in-human implantation of DragonFly™ at the Second Affiliated Hospital of Zhejiang University School of Medicine, led by Academician Wang Jianan's team; in September, completed 10 clinical implants; in October, presented at the 2020 CSI webinar
- 2021: In March, DragonFly™ passed the Innovative Medical Device Special Review Procedure (NMPA "green channel"); in April, ranked first on the China Unicorn Enterprise List; in May, entered the pivotal multi-center registration clinical trial phase
- 2022: In October, successfully performed the first-in-human implantation of DragonRing™ transcatheter valve annuloplasty system at West China Hospital, Sichuan University, led by Professor Chen Mao's team; in November, received support from the Ministry of Science and Technology's "14th Five-Year" National Key R＆D Program
- 2023: In May, DragonFly-DMR trial follow-up results met primary efficacy and safety endpoints; in September, Magpie™ balloon dilatation catheter received NMPA approval; in November, DragonFly™ received NMPA approval for formal market launch, becoming the first Chinese domestically developed transcatheter mitral valve clip product via femoral vein approach; in December, Pu Jiejie™ medical radiation protection screen approved
- 2024: In January, completed the first commercial implantation of DragonFly™; in February, completed the first European confirmatory clinical enrollment; in April, DragonFire® transcatheter myocardial RF ablation system entered the innovative channel; in June, 2-year follow-up results of the DRAGONFLY-DMR trial published in EuroIntervention; in September, completed the first enrollment in China's first randomized controlled clinical trial for transcatheter tricuspid regurgitation treatment; in December, recognized as a National High-Tech Enterprise
- 2025: In February, DragonFly™ obtained registration certificates in Indonesia and Hong Kong; passed Brazil ANVISA-BGMP audit with zero deficiencies; in April, obtained EU CE MDR certification; achieved annual revenue of RMB 100.6 million with net loss nArrowing to RMB 40.35 million; in Q1-Q3, achieved after-tax profit of RMB 45.11 million with operating cash flow turning positive at RMB 102.8 million; captured 47.14% of China's TEER market (2,043 implants); in December, Venus Medtech sold 1.05% equity to Konfoong Biotech for USD 15 million
- 2026: In March, Konfoong Biotech invested an additional USD 55.12 million to acquire approximately 3.85% equity; on March 11, received NMPA Class III approval for the steerable guiding sheath (可调弯导引鞘); in April, completed first implantation in Vietnam; obtained Philippines marketing authorization; hosted 9 live TEER demonstrations at CHINA VALVE (HANGZHOU) 2026; on April 23, recognized again as Zhejiang Province and Hangzhou City Unicorn Enterprise at the 10th "All Things Grow" Conference; on April 25, announced the first DragonFly-T® FIM study 12-month follow-up data at CHINA VALVE 2026
Core Mission: To provide safer and more effective solutions for heart disease patients through continuous innovation in structural heart disease interventional therapy, making advanced mitral and tricuspid valve repair technologies accessible to patients worldwide.
Product Portfolio ＆ Technology Platform
DragonFly™ Transcatheter Mitral Valve Clip System
DragonFly™ is the company's flagship product and the first NMPA-approved Chinese domestically developed transcatheter mitral valve clip system via femoral vein approach. It is designed for transcatheter edge-to-edge repair (TEER) of mitral regurgitation.
Key Innovations:
- Expandable Central Occluder Mesh: Paired with arm-length self-locking mechanism to ensure stable leaflet capture while reducing leaflet tension and central residual regurgitation
- Four Clip Sizes: Multiple specifications to match different leaflet anatomical structures, providing options for various lesions and anatomies
- Independent Grasping: Enables unilateral capture to improve surgical success rates and efficiency in complex cases
- Precise Delivery System: Visualized, articulated, and scaled operating system with unique three-stage adjustable shaft design for precise and convenient operation
Clinical Performance (DragonFly-DMR Trial):
- 120 patients enrolled across 27 centers in China
- Immediate procedural success rate: 99.2%
- 12-month treatment success rate: 87.5% (95% CI: 80.1%, 92.2%)
- Mean mitral transvalvular pressure gradient (TMPG) at 12 months: 3.19±1.38 mmHg
- NYHA Class I/II proportion increased from 32.4% at baseline to 93.6% at 12 months (P＜0.001)
- KCCQ score improvement: 30.64±18.35 points (P＜0.001)
- 3-year follow-up results from large-scale registry studies validate long-term safety and efficacy
Commercial Performance:
- 2024: 650 implants (first commercial year)
- 2025: 2,043 implants, 47.14% market share in China
- Global Cumulative Implants: Over 3,000 cases
- Global Reach: Entered 12 key countries and regions including EU, Hong Kong, Indonesia, Colombia, Turkey, Peru, Vietnam, and Philippines
DragonFly-T™ Transcatheter Tricuspid Valve Clip System
DragonFly-T™ is China's first transcatheter tricuspid valve repair device via femoral vein approach. It completed 10 exploratory clinical implants in 2020, with safety and efficacy demonstrated. In September 2024, the company completed the first enrollment in China's first randomized controlled clinical trial for transcatheter tricuspid regurgitation treatment. In April 2026, the FIM study 12-month follow-up data was disclosed at CHINA VALVE (HANGZHOU) 2026, demonstrating stability and feasibility.
MitralStitch® Transapical Mitral Valve Repair System
MitralStitch® is China's first transapical mitral valve repair product. It was successfully applied in first-in-human clinical research in 2018 and is currently in the pre-market registration clinical trial stage. It is the world's first and only product capable of performing both edge-to-edge repair and artificial chordae implantation simultaneously.
DragonRing™ Transcatheter Valve Annuloplasty System
DragonRing™ is China's first transcatheter valve annuloplasty system via femoral vein, simulating contemporary cardiac surgical annuloplasty techniques. It was successfully implanted in the first human case globally in October 2022 at West China Hospital, Sichuan University. It is designed for functional mitral and tricuspid regurgitation caused by annular dilation.
DragonFire® Transcatheter Myocardial RF Ablation System
DragonFire® is the company's transcatheter myocardial radiofrequency ablation system. In April 2024, it entered the Innovative Medical Device Special Review Procedure (NMPA "green channel"), targeting novel treatment approaches in structural heart disease.
DragonPath™ Transseptal Puncture System
- Registration No.: 国械注准20233030070
- Applicable for transseptal puncture from the right atrium to the left atrium via femoral vein access to establish interatrial communication
Magpie™ Balloon Dilatation Catheter
- Registration No.: Approved September 2023 (NMPA Class III)
- Cardiovascular interventional consumable for balloon dilatation procedures
Firework™ Hard Guidewire Series
- Registration No.: 国械注准20223030843
- Applicable for cardiovascular (excluding coronary) interventional diagnostic and therapeutic procedures, primarily for guiding device insertion and positioning or establishing vascular access
Steerable Guiding Sheath (可调弯导引鞘)
- Registration No.: NMPA Class III (approved March 11, 2026)
- Cardiovascular interventional consumable with adjustable curvature to facilitate navigation in complex anatomies; debuted clinically in 2025
Pu Jiejie™ Medical Radiation Protection Screen
- Approved for market launch in November 2023
- Medical radiation protection accessory for interventional procedures
Regulatory Status ＆ Certifications
China (NMPA)
- DragonFly™ Transcatheter Mitral Valve Clip System: Approved November 2023 (国械注准20233130528) via Innovative Medical Device Special Review Procedure
- Magpie™ Balloon Dilatation Catheter: Approved September 2023
- DragonPath™ Transseptal Puncture System: Approved 2023 (国械注准20233030070)
- Firework™ Hard Guidewire Series: Approved 2022 (国械注准20223030843)
- Steerable Guiding Sheath: Approved March 11, 2026 (NMPA Class III)
- Pu Jiejie™ Medical Radiation Protection Screen: Approved November 2023
- Total Marketed Products: 5 products formally approved for sale
- Innovative Medical Device Special Review: 4 products have passed the special review procedure (DragonFly™, DragonFly-T™, DragonRing™, DragonFire®)
International Certifications
- EU CE MDR: DragonFly™ obtained CE MDR certification in April 2025, becoming the third TEER product worldwide and the first Chinese product to receive international market approval
- Hong Kong: Registration certificate obtained February 2025
- Indonesia: Registration certificate obtained February 2025
- Colombia, Turkey, Peru: Registration approved
- Vietnam: First implantation completed April 2026
- Philippines: Marketing authorization obtained April 2026
- Brazil ANVISA-BGMP: On-site audit conducted February 2025 with zero deficiencies passed
Enterprise Qualifications
- National High-Tech Enterprise (国家高新技术企业) — recognized in 2024
- Zhejiang Province "Specialized, Refinement, Differential, Innovation" SME (浙江省专精特新中小企业)
- Hangzhou High-Tech R＆D Center (杭州市高新技术研发中心)
- Hangzhou Engineering Research Center (杭州市工程研究中心)
- Zhejiang Province Unicorn Enterprise (浙江独角兽企业) — consecutive years since 2021
- Hangzhou City Unicorn Enterprise (杭州市独角兽企业) — consecutive years
Financial Performance
Revenue ＆ Profitability (Unaudited, per Konfoong Biotech Acquisition Disclosure)
- 2021: Revenue RMB 0; operating cash flow loss of RMB 118 million
- 2022: Revenue RMB 200,000; still in R＆D investment phase
- 2023: Revenue RMB 15.4 million; net loss of RMB 133 million
- 2024: Revenue RMB 100.6 million; net loss narrowed to RMB 40.35 million
- 2025 (Q1–Q3): After-tax profit of RMB 45.11 million; operating cash flow turned positive to RMB 102.8 million
- Valuation Reference: Independent valuer assessed 1.05% equity at approximately USD 14.568 million using EV/Sales methodology (implying total equity value of approximately USD 1.39 billion)
Funding ＆ Investment History
- Seed / Early Rounds: Received multiple rounds of investment including from Qiming Venture Capital (2 separate investments)
- Strategic Investors: Diamond Capital and Sequoia China participated in earlier rounds
- Venus Medtech (02500.HK) Divestment (Dec 2025): Sold approximately 1.05% stake to Konfoong Biotech for USD 15 million to streamline portfolio and strengthen cash flow
- Konfoong Biotech (02216.HK) Additional Investment (Mar 2026): USD 55.12 million for approximately 3.85% equity
- Total Konfoong Investment: USD 70.12 million for approximately 4.9% equity
Company Overview
Corporate Information
Company Name: Hangzhou Valgen Medical Technology Co., Ltd.（杭州德晋医疗科技有限公司）
International Parent: Valgen Holding Corporation
Founded: August 28, 2015
Registered Capital: RMB 750 million (75,000万人民币)
Legal Representative: Dr. Zhang Tingchao（张庭超博士）
Headquarters: 1st Floor, Building C, Kailan Science Park, No. 58 Qiuyi Road, Changhe Street, Binjiang District, Hangzhou, Zhejiang Province, China
R＆D Center: Shenzhen Innovation R＆D Center
Company Type: Limited Liability Company (Wholly Foreign-Owned Enterprise / 港澳台法人独资)
Industry: Medical Devices / Structural Heart Disease / Interventional Cardiology
Employees: Over 250 (including R＆D, medical, technical, and production staff); masters and doctoral talent accounts for nearly 20%
Production ＆ Office Space: Nearly 10,000 square meters
Website: www.valgenmed.com
Leadership Team
General Manager ＆ Legal Representative: Dr. Zhang Tingchao（张庭超博士）
- Co-founder; leads the company's overall operations and technology development; PhD candidate at Sichuan University Biomedical Engineering program under Academician Zhang Xingdong; quoted in multiple communications on DragonFly™ clinical performance and strategic direction
Chairman: Zhao Yiwei（赵亦伟）
- Also serves as CEO of Denovo Medical Group (德诺医疗集团) and related portfolio companies
Supervisor: Zhang Weiwei（张伟伟）
Financial Officer: Tang Bin（汤斌）
Key Strategic Investor: Zi Zhenjun（訾振军）— Co-founder of Venus Medtech and Denovo Medical founding investor
Key Clinical ＆ Research Partners
- Second Affiliated Hospital, Zhejiang University School of Medicine (Wang Jianan Academician Team): Completed first-in-human DragonFly™ implantation in July 2020; led the DragonFly-DMR pivotal clinical trial
- West China Hospital, Sichuan University (Chen Mao Professor Team): Completed first-in-human DragonRing™ implantation in October 2022
- National Engineering Research Center for Biomaterials, Sichuan University (Zhang Xingdong Academician Team): Collaborated on DragonFly™ system development
- Ministry of Science and Technology "14th Five-Year" National Key R＆D Program: Led the project "Transcatheter Mitral Valve Clip System R＆D" under the Diagnostic and Treatment Equipment and Biomedical Materials special program
Strategic Partnerships ＆ Collaborations
Commercial Partnerships
- Venus Medtech (02500.HK): In November 2023, Venus Medtech and Valgen Medical announced an exclusive strategic marketing cooperation for DragonFly™ to accelerate commercialization and build a comprehensive structural heart disease diagnosis and treatment platform; in December 2025, Venus Medtech sold its 1.05% stake to Konfoong Biotech for USD 15 million to focus on core business
- Konfoong Biotech (02216.HK): Strategic equity investment of USD 70.12 million between December 2025 and March 2026, forming a "heart-lung synergy" capital alliance between pulmonary intervention and cardiac valve sectors
Global Market ＆ Competitive Landscape
Target Markets
China: Core market with 47.14% TEER market share in 2025; products distributed to major tertiary hospitals and cardiovascular centers nationwide; deep collaboration with top academic medical centers
International: EU market opened via CE MDR certification (April 2025); registered in Hong Kong, Indonesia, Colombia, Turkey, and Peru; first implantation in Vietnam (April 2026); Philippines marketing authorization (April 2026); Brazil ANVISA-BGMP audit passed with zero deficiencies; targeting global expansion into 12+ key countries and regions
Primary Competitors
- Abbott (USA): MitraClip — the global TEER market leader with FDA and CE approval
- Edwards Lifesciences (USA): PASCAL — second major TEER competitor globally
- Venus Medtech (China): Domestic competitor in structural heart disease; former strategic partner for DragonFly™ commercialization
- Huanqing Medical（焕擎医疗）: Domestic competitor in mitral valve repair
- Xinrui Medical（心锐医疗）: Domestic competitor in mitral valve repair
- Aikemai Medical（艾科脉医疗）: Domestic competitor in cardiac electrophysiology and valve repair
Competitive Advantages
- First-Mover in Domestic TEER: First NMPA-approved Chinese domestically developed transcatheter mitral valve clip via femoral vein approach, breaking foreign monopoly
- Market Leadership: 47.14% Chinese TEER market share in 2025 (2,043 implants), ranking first nationally
- Comprehensive Product Matrix: Full toolbox covering edge-to-edge repair (DragonFly), annuloplasty (DragonRing), artificial chordae (MitralStitch), tricuspid repair (DragonFly-T), and RF ablation (DragonFire)
- International Regulatory Breakthrough: First Chinese TEER product to obtain CE MDR certification, enabling global commercial expansion
- Strong IP Portfolio: Over 600 patent applications globally with 200+ granted, including 150+ applications and 43+ grants specifically for DragonFly™
- Clinical Validation: Robust clinical evidence from DragonFly-DMR trial with 99.2% procedural success rate and 87.5% 12-month treatment success rate
- Unicorn Status ＆ Capital Support: Repeatedly recognized as provincial and municipal unicorn enterprise; backed by Qiming Venture Capital, Sequoia China, and strategic investor Konfoong Biotech
2026 Outlook ＆ Strategic Priorities
Near-Term Objectives
- Global Commercial Expansion: Leverage CE MDR certification to accelerate entry into European, Southeast Asian, Latin American, and Middle Eastern markets; build on Vietnam and Philippines launches
- Tricuspid Valve Program: Advance DragonFly-T™ through randomized controlled clinical trials and pursue regulatory approval for tricuspid regurgitation treatment
- Product Line Enrichment: Continue developing the steerable guiding sheath, transseptal puncture systems, and accessory devices to build a comprehensive structural heart intervention ecosystem
- Clinical Evidence Generation: Publish long-term follow-up data from DragonFly-DMR and real-world studies to support guideline inclusion and market expansion
- Strategic Capital Deployment: Utilize Konfoong Biotech investment and operating cash flow to fund R＆D, clinical trials, and international regulatory submissions
Contact Information
Corporate Headquarters
Address: 1st Floor, Building C, Kailan Science Park, No. 58 Qiuyi Road, Changhe Street, Binjiang District, Hangzhou, Zhejiang Province, China
Website: www.valgenmed.com
Shenzhen R＆D Center
Location: Shenzhen, China
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