Pulnovo Medical, a Shanghai-based company developing therapies for pulmonary hypertension and heart failure, has raised $100 million in a strategic financing round led by Medtronic, which has also entered into a separate commercial agreement with the company exploring future commercialisation opportunities.
Pulnovo’s flagship product is the Pulmonary Artery Denervation (PADN) System, a minimally invasive device designed to reduce overactivated sympathetic nerve activity involved in pulmonary vascular remodelling. Around 1,500 procedures have been performed to date across seven countries, and the therapy is referenced in seven international clinical guidelines including the 2022 European Society of Cardiology (ESC) and European Respiratory Society (ERS) pulmonary hypertension guidelines.
In the United States, the device holds Food and Drug Administration (FDA) Breakthrough Device designation and two approved clinical trials are underway, both led by Professor Gregg Stone at Mount Sinai. The second of these is the PULSE-LHD IDE trial — a randomised, placebo-controlled study evaluating the safety and efficacy of the PADN system in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease (Group 2 of the World Health Organisation, WHO, classification). Further studies are ongoing in Europe and Asia.
Proceeds from the financing will fund clinical development, regulatory submissions and international commercialisation.
Read more at this link on Pulse 2-0
