About
Pulnovo Medical
Pulnovo Medical Limited, is a globally recognized device
pioneer in the
treatment for pulmonary hypertension and heart failure. Established in 2013 and rooted in
innovation, Pulnovo Medical is committed to leveraging our deep expertise in the science of
breakthrough technologie with the goal to market our innovative therapeutic solutions and
benefit patients around the world.
Patients it may cover
70150900
A Globally Recognized Device Pioneer
Take the innovative technologies as the engine, explore the huge unmet clinical market
of pulmonary hypertension and heart failure.
Forward-looking Business Strategy
Achieving Global Layout by Relying on Differentiated Resources in Different Regions
USA
Clinical Landscape
Regulatory Pathway
Europe
Clinical Landscape
Regulatory Pathway
Asia
R & D Resources
Production Management
Clinical Landscape
Regulatory Pathway
Middle East
Regulatory Pathway
Key Milestones & Endorsements
2025.09
PADN system received FDA Investigational Device Exemption (IDE) approval to conduct a clinical investigation in patients with Group II Pulmonary Hypertension to support a future Premarket Approval (PMA) submission and was also granted full coverage by the Centers for Medicare & Medicaid Services (CMS) during the clinical trial phase and after market approval.
2025.08
Chinese Circulation Journal included PADN in the “Chinese Expert Consensus on the Diagnosis and Treatment of Right Heart Failure Caused by Pulmonary Arterial Hypertension”.
2025.06
Pulnovo Medical Completes First Three Commercial PADN Procedures at Al Qassimi Hospital, Sharjah
2025.05
Pulnovo Medical Successfully Closes Tens of Millions of USD in Series C+ Financing
2025.05
PADN Catheter Receives EU CE Clearance Under MDR and received CE mark for European market access.
2025.04
PADN system received FDA Investigational Device Exemption (IDE) approval to initiate a clinical investigation in patients with Group I Pulmonary Hypertension to support a future Humanitarian Device Exemption (HDE) submission.
2025.03
PHD360 Pulmonary Artery RF Ablation System Receives NMPA Approval for Market Launch
2025.03
Enhancor system was accepted into China’s National Innovative Medical Device Special Review Program.
2025.03
Pulnovo Medical Successfully Closes Nearly $100 Million in Series C Financing
2025.01
PFlexi Introducer Sheath obtained China’s National Medical Products Administration (NMPA) approval.
2024.11
Pulnovo Medical Achieves FDA 510(k) Clearance for Introducer Sheath.
2024.06
The global clinical study of PADN technology in treating Pulmonary Hypertension Associated with Left Heart Disease was successfully conducted in Portugal, with the first enrollment.
2024.06
"Chinese Expert Consensus on Percutaneous Pulmonary Artery Denervation for Pulmonary Arterial Hypertension (PADN)" was officially released.
2024.03
The world's first post-market PADN procedure was successfully performed at the Xiamen Cardiovascular Hospital Xiamen University.
2023.12
PADN system obtained China’s National Medical Products Administration (NMPA) approval.
2023.12
PADN received the FDA Humanitarian Use Device (HUD) designation.
2023.03
Pulnovo Medical announced the 3-year results of the PADN-5 clinical trial at THT 2023.
2023.08
PADN-PH-HF NMPA registration trial was launched across multiple clinical centers in China, with the first patient successfully enrolled.
2022.10
Pulnovo Medical completed its Series B financing round, raising multiple millions of dollars.
2022.09
Pulnovo Medical announced results of PADN-CFDA Trial at TCT 2022.
2022.08
European Society of Cardiology（ESC）and the European Respiratory Society(ERS) included PADN in the guideline.
2021.08
Pulnovo Medical completed its Series A financing round, raising millions of dollars.
2021.02
PADN catheter received FDA Breakthrough Device Designation within 16 days, covering Group I, II, and IV pulmonary hypertension.
2019.02
PADN-5 Clinical Trial Results were published in JACC: Cardiovascular Interventions.
2018.12
PADN was first included in the Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension (2018)
2018.01
PADN-CFDA clinical trial completed the first patient enrollment.
2017.12
PADN Catheter was accepted into China’s National Innovative Medical Device Special Review Program.
2014.08
PADN-5 Clinical Trial officially launched.
2013.09
Pulnovo Medical established.
Cookie Policy
·
Legal Statement
·
Privacy Policy
Copyright © 2025 PULNOVO MEDICAL
