Pulnovo Medical has announced a significant milestone in its global expansion strategy, securing two FDA investigational device exemption (IDE) approvals for its pulmonary artery denervation (PADN) system. The green light enables the Shanghai-based company to conduct pivotal studies in the United States, focusing on two distinct groups of patients living with pulmonary hypertension (PH)—a progressive and often life-threatening cardiovascular condition.

The IDE approvals cover both Pulnovo’s PADN catheter and generator, two core components of the system. With these clearances, the company can now initiate clinical trials for Group I pulmonary arterial hypertension (PAH) and Group II PH due to left heart disease. This dual approval broadens Pulnovo’s clinical footprint, positioning the company to demonstrate PADN’s potential in different subgroups of PH patients.

Equally significant is the Centers for Medicare & Medicaid Services (CMS) coverage approval, which Pulnovo has already secured. This ensures a clear reimbursement pathway for its upcoming U.S. studies, reducing financial barriers to enrollment and accelerating trial execution. For a company pursuing rapid entry into the U.S. market, the combination of FDA IDE and CMS support is a powerful enabler.

A $100 million push into U.S. trials

Pulnovo’s regulatory momentum builds on a strong financial foundation. Earlier this year, the company raised $100 million in funding to support its U.S. clinical evaluation strategy. The capital injection underscored investor confidence in PADN’s potential to address an underserved therapeutic area. Unlike renal denervation (RDN), which has recently captured industry headlines, pulmonary artery denervation remains an emerging frontier. Pulnovo’s progress signals its determination to be the global leader in this space.

How PADN works

Pulnovo designed its PADN system to deliver radiofrequency ablation to the pulmonary vascular endothelial sympathetic nerves. By targeting these nerves, PADN can reduce pulmonary artery pressure, alleviate symptoms, and slow disease progression in PH patients.

The PADN system builds on extensive preclinical and international clinical data. Its mechanism is designed to directly address the overactivation of sympathetic nerves, which is believed to play a role in the pathophysiology of PH. Importantly, the technology has already been recognized by the FDA with a breakthrough device designation, which provides priority review and accelerated pathways for novel therapies that could significantly improve patient outcomes.

Global approvals and strategic timing

Pulnovo’s PADN system is already approved in China and Europe, giving the company a valuable head start. Bringing the technology to the United States is not just about expanding regulatory reach; it’s about competing head-to-head in one of the world’s largest and most advanced MedTech markets.

The timing is notable. In the adjacent space of renal denervation, the U.S. market saw a breakthrough in late 2023 when Recor Medical received FDA approval for its RDN system, followed shortly by Medtronic. Earlier this year, Boston Scientific announced plans to acquire SoniVie, further heating up competition. While these technologies address hypertension through renal nerves, Pulnovo’s PADN addresses pulmonary vascular nerves, carving out a differentiated but complementary niche.

This convergence suggests that the U.S. cardiovascular device market is opening up to nerve modulation technologiesas viable therapeutic approaches. Pulnovo now has the opportunity to shape the conversation in pulmonary hypertension, just as its peers have in systemic hypertension.

Company outlook

In its announcement, Pulnovo emphasized the strategic importance of this milestone.

“The IDE approval marks a critical step in Pulnovo Medical’s commitment to delivering innovative, high-quality solutions for patients with pulmonary hypertension and accelerating the global expansion of PADN technology,” the company said in a statement. “The results of these studies will generate valuable data to further validate the potential of PADN. Progress in these clinical trials is expected to bring meaningful benefits to patients, including improved exercise tolerance in daily life and a better overall quality of life.”

For patients with pulmonary hypertension, those benefits could be life-changing. Current treatment options often involve chronic pharmacological therapy with limited ability to alter disease progression. If PADN can demonstrate sustained improvements in pulmonary pressures and exercise tolerance, it could redefine treatment paradigms in this complex disease area.

What’s next

With the IDE approvals in hand, Pulnovo is expected to initiate U.S. clinical trials across multiple sites later this year. These studies will focus on safety, efficacy, and long-term outcomes, generating the evidence required for future FDA premarket submissions. If successful, the company will be well-positioned to commercialize PADN in the U.S., potentially challenging larger MedTech players and reshaping the pulmonary hypertension treatment landscape.

Competitive dynamics: PADN vs. RDN and Pulnovo’s U.S. positioning

Pulnovo Medical’s dual FDA IDE approvals arrive at a pivotal time in the evolution of nerve ablation technologies for cardiovascular disease. While much of the global spotlight has centered on renal denervation (RDN) as a breakthrough for treatment-resistant hypertension, Pulnovo’s pulmonary artery denervation (PADN) aims to tackle a distinct yet equally critical unmet need: pulmonary hypertension (PH).

The strategic move into the U.S. market reflects not only Pulnovo’s ambition but also a recognition of how rapidly the cardiovascular device sector is embracing neuromodulation-based therapies. With players like Recor Medical, Medtronic, and Boston Scientific cementing their positions in systemic hypertension, Pulnovo is positioning itself as the front-runner in pulmonary hypertension interventions.

The rise of nerve ablation in cardiovascular care

Nerve ablation as a therapeutic strategy has gained momentum over the past decade, largely driven by RDN. The science rests on modulating the autonomic nervous system’s role in cardiovascular disease. In systemic hypertension, overactive renal sympathetic nerves contribute to elevated blood pressure; in pulmonary hypertension, sympathetic overactivity in the pulmonary vasculature exacerbates vascular remodeling and pressure overload.

By directly ablating these nerve pathways, both RDN and PADN target disease mechanisms at their source, rather than simply addressing symptoms with pharmacological agents. This paradigm shift explains why regulators, payors, and providers are paying close attention to these modalities.

Pulnovo’s differentiated focus on pulmonary hypertension

While RDN companies compete for dominance in systemic hypertension, Pulnovo has carved out a unique market position:

• 1. Pulmonary hypertension as a high-burden disease: PH affects hundreds of thousands of patients worldwide, with many experiencing progressive decline despite optimal drug therapy. Mortality remains high, and existing interventions primarily focus on symptom management rather than disease modification.

• 2. First mover in PADN: By advancing PADN into U.S. trials with IDE and CMS coverage, Pulnovo is setting the stage to be the first company with a validated interventional option for PH patients.

• 3. Established global validation: With regulatory approval already achieved in China and Europe, Pulnovo has a stronger clinical foundation than most MedTech startups entering the U.S.

These advantages not only differentiate Pulnovo from RDN players but also underscore its potential to own an entirely new therapeutic category.

The U.S. cardiovascular device landscape

Pulnovo’s entrance into the U.S. aligns with a broader trend: the FDA’s increasing openness to novel cardiovascular technologies. In November 2023, Recor Medical received the first U.S. approval for an RDN system, followed weeks later by Medtronic. In early 2024, Boston Scientific announced plans to acquire SoniVie, underscoring the intensity of consolidation in the space.

This activity signals that neuromodulation-based interventions are no longer fringe experiments but emerging standards of care. By aligning with this momentum, Pulnovo benefits from heightened physician awareness and growing institutional interest in nerve ablation therapies. Hospitals and cardiovascular centers that are already evaluating RDN systems may be more receptive to PADN once compelling data are available.

Challenges ahead

Despite its momentum, Pulnovo faces challenges that will test its execution:

• 1. Clinical validation: PH is a more complex condition than systemic hypertension, with diverse etiologies and patient populations. Demonstrating reproducible outcomes across Group I (PAH) and Group II (PH due to left heart disease) will require robust trial design and long-term follow-up.

• 2. Competitive distraction: While RDN companies are not direct competitors, they dominate attention and capital flows in the U.S. market. Pulnovo must work to ensure PADN does not get overshadowed by the RDN success story.

• 3. Market education: Surgeons, interventionalists, and payors will need extensive education to understand PADN’s mechanism, benefits, and role alongside pharmacotherapy.

Strategic opportunities

At the same time, Pulnovo’s trajectory presents several opportunities:

• 1. First-to-market advantage in PADN: If successful, Pulnovo could establish itself as the leader in interventional PH therapy before competitors emerge.

• 2. Synergy with RDN adoption: As physicians gain experience with nerve ablation systems, the learning curve for PADN may shorten, accelerating adoption.

• 3. Acquisition potential: Given the wave of consolidation in cardiovascular MedTech, Pulnovo’s U.S. progress could make it an attractive target for large strategics seeking to expand into PH.

A potential market inflection point

Should Pulnovo’s PADN trials succeed, the company could spark a market inflection in pulmonary hypertension care, similar to the one seen with RDN in systemic hypertension. Instead of relying solely on drug therapy, physicians could have a minimally invasive, device-based option to alter disease trajectory. For patients, that could mean improved exercise capacity, reduced hospitalizations, and enhanced quality of life.

In the broader context, Pulnovo’s IDE approvals are not just regulatory milestones—they are signals of a shifting paradigm in cardiovascular disease management, one where nerve modulation therapies could become mainstream across multiple disease states.

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