NEW YORK, Aug. 23, 2026 /PRNewswire/ — Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), today announced the enrollment of the first two patients in its PULSE-LHD clinical trial, conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), at Henry Ford Hospital in Detroit. Working in close collaboration with Site Principal Investigator Dr. Waleed Al-Darzi, Dr. Vikas Aggarwal and Dr. Brian O’Neill successfully performed the procedures for these initial patients. The milestone marks the initiation of the IDE study, representing a major step forward in the clinical advancement of the PADN procedure. By specifically targeting World Health Organization (WHO) Group 2 Pulmonary Hypertension, this IDE trial is designed to generate broader clinical data and expand the potential reach of this innovative therapy to a significantly larger patient population.
The study (NCT07214376) is a multi-center, randomized, placebo-procedure controlled trial designed to evaluate the safety and efficacy of Pulmonary Artery Denervation (PADN) in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease (CpcPH-LHD). As the most prevalent subtype of pulmonary hypertension, PH-LHD accounts for 65% to 80% of all cases[1]. Despite advances in heart failure management, patients with PH-LHD continue to experience substantial morbidity. There is currently no therapy approved for the treatment of PH-LHD[2], creating an urgent demand for innovative therapeutic strategies. Furthermore, the PULSE-LHD IDE study (G250159) received CMS Category B coverage approval on March 24, 2026.
“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,” said Dr. Waleed Al-Darzi, a Henry Ford Health cardiologist and the site principal investigator at Henry Ford Hospital. “This condition affects a large number of patients and remains an area of significant unmet clinical need. We are proud to help lead this important research and look forward to generating evidence that may inform future treatment options for patients.”
Jessie Lian, Executive Director and CEO of Pulnovo Medical said: “Bringing innovative technologies to the global stage requires a deep understanding of local clinical practices and a commitment to tackling implementation challenges head-on. Achieving this milestone alongside our frontline teams perfectly exemplifies our exceptional execution in multi-center collaboration. Advancing the PULSE-LHD trial to the highest quality standards in partnership with top-tier institutions like Henry Ford Hospital is key to building our robust clinical evidence base. We will continue to accelerate the advancement of the PADN procedure, dedicated not only to addressing the immense unmet clinical needs in Group 2 pulmonary hypertension, but also to bringing renewed hope for health to a broader population of heart failure and pulmonary hypertension patients worldwide.”
“The initiation of the PULSE-LHD trial is a pivotal moment in our overarching global strategy,” said Cynthia Chen, Chairlady and President of Pulnovo Medical. “Our focus extends far beyond a single clinical trial; we are building a worldwide clinical foundation focused on generating the evidence needed to determine whether PADN can become a standard of care for cardiopulmonary diseases. By expanding our footprint into the United States, alongside our robust clinical progress in Asia and Europe, we are translating our vision into reality, walking with patients globally to deliver innovative therapies that restore vitality and build long-term resilience.”
The clinical evidence base for PADN in treating PH-LHD has been building rapidly this year. In May, data from the PADN-Columbus pilot study presented at EuroPCR 2026 demonstrated the procedure’s initial safety and preliminary signals of benefit in pulmonary hemodynamics and functional capacity. Building on these promising early results, Pulnovo Medical will officially present data from the parallel PADN-HF-PH registration trial in China at the upcoming ESC Congress 2026. Propelled by this strong global momentum, the initiation of the PULSE-LHD trial in the United States marks the next critical phase in the company’s strategy to deliver minimally invasive PADN therapy to patients worldwide.
About Pulmonary Artery Denervation
Pulnovo’s proprietary Pulmonary Artery Denervation (PADN) is a minimally invasive therapy designed to modulate overactivated sympathetic nerve activity that contributes to pulmonary vascular remodeling and cardiopulmonary disease progression. In studies conducted outside the United States, primarily in WHO Group 1 PH, PADN has been associated with improvements in functional capacity and lower rates of clinical worsening. These results have not been established in PH-LHD and are not predictive of PULSE-LHD outcomes.
The therapy is included as an investigational interventional therapy in the 2022 ESC/ERS guidelines, which identify its clinical benefit as a gap in evidence.
Clinical investigation of the PADN procedure is ongoing across multiple subtypes of pulmonary hypertension. Building upon its regulatory approvals in 12 countries/regions and clinical experience of approximately 1,500 procedures in WHO Group 1 PH Pulnovo Medical is expanding its clinical investigation of the therapy into WHO Group 2 PH associated with Left Heart Disease (PH-LHD) to address the significant unmet clinical needs of this broader patient population.
About Pulnovo Medical
Pulnovo Medical is an innovative medical technology company dedicated to advancing interventional therapies for pulmonary hypertension and heart failure. Driven by clinical value, the company is developing breakthrough solutions based on its proprietary technology platform, with a focus on global clinical development and commercialization to improve patient outcomes worldwide. For more information, please visit www.pulnovomed.com.
Important Information Regarding Investigational Use
CAUTION – Investigational Device. Limited by United States law to investigational use. The Pulnovo Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor™ System is an investigational device that has not been approved or cleared by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary hypertension associated with left heart disease (PH-LHD). Its safety and effectiveness for this use have not been established, and it is not available for commercial sale in the United States. FDA acceptance of an Investigational Device Exemption (IDE) application permits a clinical investigation to proceed; it does not constitute an FDA determination or endorsement of the safety, effectiveness, or clinical benefit of the device. Regulatory approvals obtained, and clinical guideline references made, in other jurisdictions or for other indications do not extend to the investigational use described in this release. Results from prior or ongoing studies, including pilot, registry, and non-U.S. studies, may not be predictive of the results of the PULSE-LHD trial.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements that are based on our current expectations, beliefs, and assumptions regarding future events and clinical outcomes. Forward-looking statements may be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” and similar expressions. These statements include, but are not limited to, expectations regarding the PULSE-LHD clinical trial, the anticipated design, timing, enrollment, conduct, and results of the PULSE-LHD trial and other clinical studies; the potential performance, safety profile, and clinical utility of the Pulnovo Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor™ System; the potential benefits or adoption of PADN therapy; and the timing or likelihood of any regulatory submissions, approval, clearance, reimbursement, or commercialization. Actual results may differ materially from those projected in these forward-looking statements due to risks and uncertainties, including: the risk that interim, pilot, registry, or non-U.S. results are not replicated or are not predictive of later or U.S. results; failure to achieve trial endpoints; patient enrollment, retention, or site-activation delays; the occurrence of serious adverse events, safety findings, protocol deviations, clinical holds, or study suspension or termination; changes in study design or IDE requirements; the extent and timing of FDA and other regulatory review, which may require additional data or may not result in approval; and general economic, geopolitical, and regulatory conditions. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation, and disclaim any obligation, to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by applicable law.
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[1] Rosenkranz S, Gibbs JS, Wachter R, De Marco T, Vonk-Noordegraaf A, Vachiery JL. Left ventricular heart failure and pulmonary hypertension. European heart journal. 2016 Mar 21;37(12):942-54. [2] Khan MS, Borlaug BA, Butler J, Gomberg-Maitland M, Humbert M, Lam CS, Reddy YN, Stone GW, Zannad F, Tedford RJ. Pulmonary hypertension associated with left heart disease: challenges, emerging strategies, and future directions. JACC. 2026 Mar 11. |
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