Dive Brief:
- Medtronic has led a $100 million investment in Pulnovo Medical to support development and commercialization of a denervation device to treat a form of high blood pressure.
- The financing, which China’s Pulnovo disclosed Sunday, provides money for a pulmonary artery denervation, or PADN, system that is authorized in seven markets to treat pulmonary hypertension.
- Pulnovo and its collaborators have evaluated PADN across a series of trials. SoniVie, which Boston Scientific acquired last year, is among the other companies to test PADN in humans.
Dive Insight:
Pulmonary hypertension is defined by high blood pressure in vessels supplying the lungs. Researchers showed increased sympathetic nerve activity in people with the condition more than 20 years ago. The finding informed research at Nanjing Medical University, where physicians initiated a first-in-human trial of PADN in 2012. The data, which were published in 2013, supported a series of clinical trials.
Founded in 2013, Pulnovo has worked with the Nanjing physicians to validate PADN, leading to a study that linked its device to improvements in exercise capacity and clinical outcomes. Pulnovo has received a CE mark for its PADN catheter and ablation generator for the European market.
Working with a physician at the Icahn School of Medicine at Mount Sinai, Pulnovo recently filed to enroll about 750 pulmonary hypertension patients in a placebo-procedure controlled trial of its PADN system. The company received regulatory clearance to run two clinical trials in the U.S. last year.
Pulnovo plans to use the $100 million to support clinical development and global regulatory strategies. The money will also support commercialization in markets including China and Europe, where the PADN device is already available.
Medtronic formed a commercial agreement with Pulnovo alongside its investment. The pact envisages future commercialization opportunities using Medtronic’s global sales and marketing assets. Medtronic’s SynchroMed II system is approved by the Food and Drug Administration for delivering a pulmonary hypertension drug, and the medtech company sells the Symplicity Spyral renal denervation device for treating high blood pressure.
Boston Scientific entered the renal denervation space, where Medtronic competes with Otsuka’s Recor Medical, by acquiring SoniVie last year. While renal denervation was the focus of the $540 million deal, SoniVie funded a clinical trial of its TIVUS System in pulmonary hypertension that reported data in 2020.
European medical bodies cited the SoniVie study and Nanjing research in 2022 pulmonary hypertension guidelines, concluding that PADN is potentially promising but should be considered experimental. While the guidelines predated evidence such as one-year data from the PADN-CFDA trial of Pulnovo’s device, a meta-analysis published last year noted the limitations of existing studies and need for more evidence.
