Pulnovo Medical Takes a Major Step Forward in Treating Pulmonary Hypertension with Initial Patient Enrollment

Pulnovo Medical's Clinical Trial Launches in the U.S.

Pulnovo Medical continues to forge a path in the field of cardiology, particularly in addressing pulmonary hypertension (PH) and heart failure (HF). Recently, the company announced a significant milestone: the first two patients have been enrolled in the PULSE-LHD clinical trial, following the FDA’s Investigational Device Exemption (IDE). The trial is taking place at Henry Ford Hospital in Detroit, under the expert guidance of Dr. Waleed Al-Darzi, alongside Dr. Vikas Aggarwal and Dr. Brian O'Neill.

This trial, referenced under NCT07214376, is a multi-center, randomized, placebo-controlled study aimed at testing the safety and efficacy of Pulmonary Artery Denervation (PADN) in patients suffering from combined pre- and post-capillary pulmonary hypertension associated with left heart disease (CpcPH-LHD). As the most prevalent subtype of pulmonary hypertension, accounting for 65% to 80% of cases, there’s an urgent need for effective therapies. Despite advancements in heart failure management, these patients still endure significant morbidity, underlining the demand for innovative treatment options.

The PULSE-LHD study also gained CMS Category B coverage approval on March 24, 2026, which aids in facilitating patient enrollment and coverage for study participants. Dr. Al-Darzi expressed enthusiasm about the trial, noting, "The enrollment of the first patients in the PULSE-LHD trial is an exciting step toward evaluating a novel treatment strategy for pulmonary hypertension associated with left heart disease. This condition represents a large yet underserved group of patients, and we are proud to contribute to this essential research for future treatment options."

Pulnovo Medical's Executive Director and CEO, Jessie Lian, highlighted that achieving this milestone reflects their dedication to international clinical practices and overcoming implementation challenges. By collaborating with premier institutions like Henry Ford Hospital, Pulnovo aims to set high-quality standards for the trial. Lian emphasized their commitment, stating, "We will continue to accelerate the advancement of the PADN procedure, aiming to provide hope to a wider population suffering from heart failure and pulmonary hypertension."

Cynthia Chen, Chairlady and President of Pulnovo Medical, stated that the PULSE-LHD trial is a crucial component of their global strategy. They are not only focused on a single trial; their mission encompasses building a worldwide clinical foundation necessary for determining if PADN can be established as a standard of care for cardiopulmonary ailments.

The clinical landscape for PADN is rapidly evolving, particularly this year. For example, the PADN-Columbus pilot study presented at EuroPCR 2026 showcased initial safety results and signs of beneficial impacts on pulmonary hemodynamics and functional capacity. Capitalizing on this momentum, Pulnovo Medical is also set to share data from the PADN-HF-PH registration trial conducted in China at the upcoming ESC Congress 2026, further highlighting their global expansion efforts.

About Pulmonary Artery Denervation (PADN)

Pulnovo's PADN is a minimally invasive approach aimed at curtailing the overactive sympathetic nerve activity that leads to pulmonary vascular changes and the progression of cardiopulmonary diseases. Early studies outside the U.S., particularly focusing on WHO Group 1 PH, have shown this technique to enhance functional capacity and reduce the rate of clinical deterioration. However, these encouraging results have yet to be confirmed in PH-LHD, which makes the ongoing trials even more critical.

Given the lack of approved therapies for PH-LHD, Pulnovo Medical is stepping up to fill this significant gap. The ongoing investigation into PADN across different types of pulmonary hypertension heralds hope for a wider array of patients needing innovative treatment solutions. With successful regulatory approvals in 12 regions and approximately 1,500 procedures already performed in WHO Group 1 PH, the company is now turning its attention to addressing the pressing clinical needs in PH-LHD, potentially transforming how these patients are treated.

About Pulnovo Medical

Founded with the mission to advance interventional therapies for pulmonary hypertension and heart failure, Pulnovo Medical stands out for its commitment to innovation. By developing groundbreaking solutions and actively participating in the global clinical scene, they aim to enhance patient outcomes significantly. For more detailed information on their ongoing efforts and clinical trials, visit Pulnovo Medical's website.