Since its inception in 2013, Pulnovo Medical has insisted on the importance of clinical value and has been committed to creating a global OTM innovation platform with its globally leading original technology. With more than 45 Chinese and international invention patents, we have developed a range of world-first products, entered the Green Channel of CFDA for innovative medical devices, and obtained CE quality system certification. In February 2021, we were granted the FDA breakthrough device designation for our original product — a radiofrequency ablation catheter. Insisting on innovation and aiming to improve patient recovery, we have, in a short time, become a leader in the interventional therapy of pulmonary arterial hypertension and will walk together with patients toward a better future with the support of our strong research and development capabilities.

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About PADN

Pulmonary hypertension (PH) is a group of pathophysiological syndromes characterized by increased pulmonary artery pressure (≥25mmHg at rest) and pulmonary vascular resistance (≥2.5Woodunits at rest) caused by different etiologies, which eventually lead to the right heart Increased load, right heart failure and sudden death. According to the World Health Organization, PH is divided into 5 categories. Pulmonary arterial hypertension (PAH) is currently classified as the first category of PH. The initial manifestations including dyspnea, fatigue, chest pain, dizziness, fainting, hemoptysis, palpitations, and progressive decline in activity endurance, which eventually leads to complications such as right heart failure, lung infection, pulmonary embolism, sudden death, and syncope.

The pathological changes of PH include pulmonary vasoconstriction, intimal hyperplasia and remodeling, and thrombosis in the body. The pathogenesis is extremely complex, and many linkages are still unclear. Global scientists have never stopped researches on the treatment of PH, but in view of the ambiguity and complexity of the pathogenesis, there is still no breakthrough in the treatment of PH.

At present, drug treatment is extremely expensive and the prognosis is comparatively poor. The cost of single-drug treatment is as high as 50,000to 70,000 dollars/year, brings a weighing burden to patients and society. Other non-pharmacological methods include transatrial septal fistula or lung transplantation, etc., which also have unsolvable problems such as high mortality and lack of donors.

Products and Solutions
Pulmonary hypertension is a group of pathophysiological syndromes characterized by increased pulmonary artery pressure and pulmonary vascular resistance caused by different etiologies, which eventually lead to increased right heart load, right heart failure and sudden death. Domestic and international scientists have never stopped research on the treatment of PH, but in view of the ambiguity and complexity of the pathogenesis, there is still no breakthrough in the treatment of PH. The current drug treatment is way too expensive and the prognosis is compartively poor. Other non-pharmacological methods include transatrial septal fistula or lung transplantation, etc., which also have unsolvable problems such as high mortality and lack of donors.
  • PADN Series
    Multipolar Synchronous Pulmonary Artery Radiofrequency Ablation Catheter
Milestones
2022
May
Establish Pulmonary Hypertension Care Alliance with CDQI
June
Rated as "Top100 Medical Device Companies "
Rated as “TOP10 Best-Performing Companies in Value field for Minimally Invasive Intervention”
Rated as “Top 50 Innovative Biotech Companies”
Dr. Krishna Sudhir Joins Scientific Advisory Board
2021
Feb
PADN ® has been granted designation as a FDA Breakthrough Device
June
PADN-CFDA clinical trial, the world’s first pulmonary hypertension treatment device RCT study, has completed all patients enrollment
Aug
Succesfully raised millions of dollars through OrbiMed Healthcare Fund Management, Cenova Capital, Lilly Asia Ventures(LAV), and GaoRong
Sep
Shanghai office opened
Expanded wuxi office
Passed MDR CE Certification
Nov
In TCT, Prof. Gregg W. Stone announced that he will lead the global PADN multicenter clinical trial
dec
PADN-CFDA clinical trial carried out all patients' follow-ups
2020
May
Started research and development of the cold salt water instrument system for the control circle
2019
Nov
Obtained the Japanese Invention Patent
Jun
Obtained the Russian Invention Patent
Mar
Obtained the European Invention Patent
2018
Jun
Became the Key Medical Device Project in Wuxi City
Jan
Carried out multi-center, randomized, blinded, sham operation clinical trials and completed the first case enrollment
2017
Dec
Pulmonary hypertension interventional products obtained the National Innovative Medical Device approval
Sept
Obtained TÜV SÜD South Germany ISO13485 system certification
Mar
Obtained the PADN ® series product registration inspection report
2016
Dec
Obtained the Japanese Invention Patent
Jul
Obtained the Korean Invention Patent
Jun
Obtained the Russian Invention Patent
2015
Dec
Obtained the China National Invention Patent
Oct
Completed the detailed design of special interventions for pulmonary hypertension and achieved the ground-breaking breakthrough
Jan
Established and operated a quality management system in accordance with YY 0287/ISO 13485
2014
Jul
Reconstruction and expansion of Wuxi 10,000-grade clean production base complete
2013
Sept
Founded
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