Pulnovo Raises Millions to Develop Its PAH Device and Trials

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by Forest Ray PhD |

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Pulnovo Medical recently raised an undisclosed amount totaling millions of dollars in investment funding to support clinical trials and product development related to pulmonary arterial hypertension (PAH).

“The road of global medical innovation has never been an easy journey,” Cynthia Chen, Pulnovo’s executive president, said in a press release.

“Today we are honored for the recognition and support from OrbiMed, Cenova Capital, Lilly Asia Ventures (LAV), and GaoRong Capital,” Chen said. “We are confident and excited for the next chapter of Pulnovo Medical.”

Pulnovo develops medical devices for use in the treatment of PAH. Its lead product is a pulmonary artery denervation (PADN) device, which is being tested in the PADN-CFDA clinical trial (NCT03282266).

The device consists of a special looped catheter that is inserted into a patient’s femoral vein during the PADN procedure. PADN involves the targeted removal of nerves — in this case by focused radio waves — a procedure that has reduced blood pressure in some studies by easing the overactivation of nerves involved in vasoconstriction.

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The procedure can be used to treat PAH cases that prove resistant to medication. Pulnovo’s device is designed to better fit against the inner wall of the pulmonary artery, providing safer and more efficient radiofrequency ablation, while significantly reducing surgery time.

The PADN-CFDA trial is comparing the safety and efficacy of performing PADN using Pulnovo’s device to that of a sham operation. The study involved 128 adult participants and primarily measured changes in the six-minute walk distance (6MWD) test six months after treatment. The test measures exercise capacity.

In a prior press release, the company stated that PADN with its device “significantly improved” 6MWD results, reduced the mean pulmonary artery pressure and pulmonary vascular resistance, and had a therapeutic effect on pulmonary hypertension secondary to left heart failure.

The PADN-CFDA clinical trial is the world’s first randomized, controlled study to evaluate a pulmonary hypertension treatment device, according to Pulnovo.

“Pulmonary hypertension is known as the cancer of the heart and lung vascular system, which is a huge unmet medical need,” said Fei Chen, PhD, managing partner at Lilly Asia Ventures, which participated in this round of financing.

David Wang, MD, PhD, partner at OrbiMed Asia, another investor, added: “We are impressed by Pulnovo’s innovation and progress in PADN and willing to support the company to become a global leader in pulmonary hypertension by bringing more effective treatment solutions to this area.”

According to the company, Pulnovo’s PADN device received breakthrough designation from the U.S. Food and Drug Administration in February, being the first Chinese medical device company to receive the designation.