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About Pulnovo About Pulnovo

ABOUT
PULNOVO

Pulnovo Medical
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.

A Globally Recognized Device Pioneer
Take the innovative technologies as the engine, explore the huge unmet clinical market ofpulmonary hypertension and heart failure.
Clinical&Medical
Clinical&Medical
Pursue original innovation from the perspetive of front-line physicians
Engineering
Engineering
Comprehensive engineering and process capabilities of composite materials, structure and energy
Research & Development
Research & Development
Global clinical and registration leadership team
Manufacturing
Manufacturing
Efficient manufacturing capabilities that benchmark international quality standards
Commercialization
Commercialization
Team with international vision and local experience to lead global business expansion
A Globally Recognized Device Pioneer
Forward-looking Business Strategy
Achieving Global Layout by Relying on Differentiated Resources in Different Regions
Forward-looking Business Strategy
USA
USA

USA

Clinical Landscape
Regulatory Pathway
Europe
Europe

Europe

Clinical Landscape
Regulatory Pathway
Asia
Asia

Asia

R & D resources
Production Management
Clinical Landscape
Regulatory Pathway
Key Milestones & Endorsements
2013

Company establishment

Seed round financing completed

First-in-Human trial for PADN initiated

2014

Expansion of the 10,000-level clean production base in Wuxi completed

2015

PADN1 phaseⅡ demonstrated that in a high-risk patient population, PADN was safe and effective in reducing PAP and improving 6MWD and was associated with favorable clinical outcomes throughout the 1-year follow-up.

2016

Obtained the Invention Patents in Japan, South Korea, China and other countries

2017

PADN received national innovative medical devices approval

CE ISO 13485 system certification obtained by Wuxi entity

2018

PADN carried out multi-center, randomized, double-blind, and sham procedure clinical trials

2019

Obtained the Invention Patents in Japan, Europe and other countries

2020

PADN Won the Science and Technology Award of Jiangsu Province

2021

PADN achieved FDA Breakthrough Device Designation

Completed first round of financing

2022

Enrollment and follow-up visit of the registered clinical study completed, with PADN recognized as the world's first pulmonary hypertension device

Diversified pipelines for cardiac, pulmonary and chronic diseases built, centering on sympathetic nerve regulation

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