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
2025.05
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.
2025.03
PHD360 Pulmonary Artery RF Ablation System Receives NMPA Approval for Market Launch
2025.03
Pulnovo Medical Successfully Closes Nearly $100 Million in Series C Financing
2025.02
PADN-PH-HF clinical study completed full patient enrollment.
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.
2024.01
PADN obtained the U.S. Medicare coverage code by Center for Medicare&Medicaid Services(CMS) approval.
2023.12
PADN was obtained as the FDA Humanitarian Use Device (HUD) designation.
2023.12
PADN system obtained China’s National Medical Products Administration(NMPA) approval.
2023.08
PADN-PH-HF clinical trial launched in domestic multiple clinical center and complete the first patient enrollment.
2022.10
Pulnovo Medical completed a multi-million dollar equity financing round through Yuanbio Venture Capital, OrbiMed Healthcare Fund Management, Cenova Capital, Lilly Asia Ventures(LAV), GaoRong Capital，HuiHe Capital and GC&H Investments.
2022.09
Pulnovo Medical announced results from PADN-CFDA pivotal trial for the treatment of Pulmonary Arterial Hypertension (PAH).
2022.08
European Society of Cardiology（ESC）and the European Respiratory Society(ERS) included PADN in the guideline.
2022.05
Pulnovo Medical formed the first domestic PH Patient Care Alliance.
2021.08
Pulnovo Medical raised millions of dollars through OrbiMed Healthcare Fund Management, Cenova Capital, Lilly Asia Ventures(LAV), and GaoRong Capital.
2021.06
PADN-CFDA clinical trial completed all patients enrollment.
2021.02
PADN catheter received FDA Breakthrough Device Designation within 16 days, covering Group I, II, and IV pulmonary hypertension.
2018.01
PADN-CFDA clinical trial completed the first patient enrollment.
2017.12
PADN received China's national innovative medical devices approval.
2013.09
Pulnovo Medical established.
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