Pulnovo Medical Limited（帕母医疗） - Global Pioneer in Pulmonary Artery Denervation for Pulmonary Hyperte

📢 Key Milestones (2025–2026):
   In April 2026, Pulnovo completed an oversubscribed $100 million strategic financing round (D轮) with a leADINg investment by Medtronic, alongside existing investors EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed, Lilly Asia Ventures, and new investor HSG. Pulnovo and Medtronic also entered into a commercial agreement for future global commercialization. In January 2026, PADN was approved in Saudi Arabia and recommended in international guidelines for adult congenital heart disease-associated PAH. In September 2025, the PADN system received two FDA IDE approvals (HDE for Group I PH, PMA for Group II PH) with CMS coverage approval. In May 2025, the PADN catheter received EU MDR CE clearance.

Company Profile (Updated April 2026)

Pulnovo Medical Limited (Chinese: 帕母医疗) is a privately held medical device company headquartered in Wuxi, China. Founded in 2013, the company is dedicated to developing and commercializing breakthrough therapies for pulmonary hypertension (PH) and heart failure (HF). Pulnovo's proprietary Pulmonary Artery Denervation (PADN) System is a first-in-class, minimally invasive therapy that uses radiofrequency (RF) ablation to modulate overactivated sympathetic nerve activity in the pulmonary artery, reducing pulmonary artery pressure and inhibiting patHologic vascular remodeling.

The company has established a global presence with clinical and commercial activities across the European Union, Middle East, Asia, and the United States. To date, Pulnovo has performed approximately 1,500 PADN procedures globally and secured regulatory approvals in seven countries. PADN has been recognized in seven international clinical guidelines, including the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.

Development History:

- 2013: Founded in Wuxi, china

- 2018: PADN recognized as an NMPA innovative medical device in China

- 2021: Granted FDA Breakthrough Device designation for Groups I, II, and IV pulmonary hypertension

- 2022: Positive one-year results from the PADN-CFDA pivotal study presented at CRT 2023; published in JACC: Cardiovascular Interventions

- 2023: PADN RF catheter and RF generator received NMPA market approval in China

- 2024.07: Appointed Wu Xiaolin (吴晓琳), former Morgan Stanley investment banker, as Chief Financial Officer

- 2024.12: FDA 510(k) clearance obtained for the introducer sheath accessory product

- 2024: Initiated global multicenter clinical studies in Portugal, Serbia, Georgia, and Southeast Asia; first enrollment in Portugal and Singapore for PH associated with left heart disease

- 2025.01: Successfully completed first PADN procedure in Hong Kong

- 2025.02: Successfully completed first two PADN procedures in Macau

- 2025.03: Closed approximately $100 million Series C financing co-led by Qiming Venture Partners and Lilly Asia Ventures, with OrbiMed and Gaorong Capital participating on a super pro-rata basis

- 2025.03: PHD360 Pulmonary Artery RF Ablation System received NMPA approval for market launch; PFlexi received dual FDA and NMPA clearance; Enhancor system accepted into China's National Innovative Medical Device Special Review Program

- 2025.04: PADN system received first FDA IDE approval for Group I PH (HDE study)

- 2025.05: Closed tens of millions of USD in Series C+ financing; PADN catheter received EU MDR CE clearance; EQT welcomed as new investor

- 2025.06: Completed first three commercial PADN procedures at Al Qassimi Hospital, Sharjah, UAE

- 2025.08: PADN Included in the Chinese Circulation Journal expert consensus on right heart failure caused by pulmonary arterial hypertension

- 2025.09: PADN system received two FDA IDE approvals (HDE for Group I PH, PMA/Pulse-LHD for Group II PH) with CMS coverage approval; both trials led by Dr. Gregg Stone at Mount Sinai

- 2026.01: PADN recommended in international guidelines for adult congenital heart disease-associated PAH; approved in Saudi Arabia

- 2026.03: Completed first commercial PADN procedure in Italy with Prof. Tarantini

- 2026.04: Completed $100 million strategic financing (D轮) led by Medtronic; entered into commercial agreement with Medtronic; appointed Andre Xiao as Chief Strategy Officer

Core Mission: To leverage deep expertise in breakthrough technologies to develop innovative therapeutic solutions for pulmonary hypertension and heart failure, benefiting patients around the world through clinically driven, evidence-based innovation.

Core Product: PADN System

Pulmonary Artery Denervation (PADN)

- Mechanism: Percutaneous intervention delivering radiofrequency energy to the sympathetic nerves in the outer membrane of the pulmonary artery, resulting in myelin sheath disappearance and axon fusion, thereby inhibiting sympathetic activity

- Clinical Effects: Increases cardiac output, reduces pulmonary artery pressure, inhibits pathologic remodeling of pulmonary arteries, improves exercise endurance and cardiac function

- Procedure: Single minimally invasive procedure via femoral vein puncture; special looped catheter positioned at the proximal pulmonary artery bifurcation

- Longevity: ACHieves long-term benefits from a single procedure

PADN System Components

- PADN RF Catheter: Proprietary looped catheter designed for pulmonary artery sympathetic nerve ablation

- PADN RF Generator: Radiofrequency ablation instrument with high-precision algorithm control for stAble energy output

- PHD360 Pulmonary Artery RF Ablation System: NMPA-approved system for market launch in China (March 2025)

- PFlexi: Dual FDA and NMPA cleared product (March 2025)

- Enhancor System: Accepted into China's National Innovative Medical Device Special Review Program (March 2025)

Regulatory Milestones

- China (NMPA): PADN RF catheter and RF generator approved for market launch (late 2023); PHD360 system approved (March 2025); PFlexi approved (March 2025)

- United States (FDA): Breakthrough Device designation (2021, Groups I, II, IV); Humanitarian Use Device (HUD) designation; IDE approval for Group I PH HDE study (April 2025); IDE approval for Group II PH PULSE-LHD study (September 2025)

- United States (CMS): Coverage approval for both IDE trials (announced September 2025; CMS formal record March 2026)

- European Union: CE clearance under EU MDR (May 2025)

- Saudi Arabia: PADN approved (January 2026)

- Clinical Guidelines: Referenced in seven international clinical guidelines, including 2022 ESC/ERS Guidelines for Pulmonary Hypertension; Chinese Expert Consensus on PADN for PAH (2024); Chinese Expert Consensus on Right Heart Failure caused by PAH (2025); International guidelines for adult congenital heart disease-associated PAH (January 2026)

Clinical Trials & Evidence

- PADN-CFDA Pivotal Study: Multi-center randomized trial demonstrating significant improvements in exercise capacity, hemodynamic parameters, and clinical outcomes in PAH patients; one-year follow-up published in JACC: Cardiovascular Interventions

- PULSE-LHD IDE Trial (USA): Ongoing U.S. trial for PH associated with left heart disease (Group II PH), led by Dr. Gregg Stone at Mount Sinai

- Global Multicenter Studies: Active trials in Europe (Portugal), Southeast Asia (Singapore, Malaysia), and other regions for PH associated with left heart disease

- Real-World Evidence: Over 1,000 clinical applications across Portugal, Georgia, Singapore, Malaysia, Hong Kong, Macau, and China with demonstrated safety and efficacy

Financial Performance & Funding

Funding History

- Seed Round (2013): Initial funding

- Series A (2021): Later stage VC

- Series B (2022): Later stage VC

- Series C (March 2025): Approximately $100 million; co-led by Qiming Venture Partners and Lilly Asia Ventures; OrbiMed and Gaorong Capital participated on super pro-rata basis

- Series C+ (May 2025): Tens of millions of USD

- Series D / Strategic Round (April 2026): $100 million; oversubscribed; led by Medtronic; existing investors EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed, Lilly Asia Ventures continued support; new investor HSG (formerly Sequoia China) joined

- Total Funding Raised: Over $200 million

Key Investors

- Medtronic: Strategic investor and commercial partner (April 2026)

- EQT: Private equity investor

- Qiming Venture Partners (启明创投): Co-lead investor in Series C

- Lilly Asia Ventures (礼来亚洲基金): Co-lead investor in Series C

- OrbiMed (奥博资本): Healthcare-focused investment firm

- Gaorong Ventures / Gaorong Capital (高榕创投): Existing investor since 2021

- HSG (formerly Sequoia China / 红杉中国): New investor (April 2026)

Company Overview

Corporate Information

Legal Name: Pulnovo Medical Limited (帕母医疗)

Founded: 2013

Headquarters: Wuxi, China

Company Type: Privately held

Industry: Therapeutic Devices / Interventional Cardiology / Pulmonary Hypertension

Employees: ~100 (as of 2022)

Website: www.pulnovomed.us

Leadership Team

Chairlady, President & Executive Director: Cynthia Chen (陈艳)

- Leads global strategy, clinical development, and investor relations; spokesperson for the company's vision and mission

Chief Executive Officer: Jessie Lian

- Oversees global operations and business expansion

Chief Financial Officer: Wu Xiaolin (吴晓琳) (appointed July 2024)

- Former Morgan Stanley investment banker

Chief Strategy Officer: Andre Xiao (appointed April 2026)

- Extensive experience in healthcare investment and global capital markets; previously at Citadel and Millennium Management specializing in global MedTech investments

Global Market Presence

Commercial Operations

- China: NMPA-approved products commercially available in Chinese Mainland, Hong Kong, and Macau

- Europe: CE MDR-certified; first commercial procedures in Italy (March 2026); clinical studies in Portugal

- Middle East: Commercial procedures in UAE (Sharjah); regulatory approval in Saudi Arabia (January 2026)

- Southeast Asia: Clinical studies in Singapore and Malaysia

- United States: Two FDA IDE trials underway with CMS coverage; targeting future PMA and HDE submissions

Key Competitors

- Aria CV: Venture capital-backed company based in Saint Paul, MN; developing therapies for pulmonary hypertension

Competitive Advantages

- First-in-Class Technology: PADN is the first and only pulmonary artery denervation system with global regulatory approvals

- Strong Clinical Evidence: Published data in JACC; recognized in seven international clinical guidelines

- Global Regulatory Progress: FDA Breakthrough Device, IDE approvals with CMS coverage, NMPA approval, and EU MDR CE mark

- Strategic Partnerships: Commercial agreement with Medtronic providing access to global commercialization infrastructure

- Large Addressable Market: Targets pulmonary hypertension and heart failure patients with limited treatment options, particularly Group II PH patients with no specifically approved device therapy

2026 Strategic Outlook

- U.S. Clinical Development: Advance PULSE-LHD IDE trial and Group I/II PH studies under Dr. Gregg Stone's leadership toward FDA approval

- Global Commercialization: Leverage Medtronic partnership to scale commercial operations in Europe, Middle East, and Asia

- Technology Platform Expansion: Continue investment in core RF ablation technology and next-generation catheter designs (PHD360, PFlexi, Enhancor)

- Market Access: Secure additional national reimbursements and expand into new geographic markets including Saudi Arabia

- Clinical Evidence Generation: Complete ongoing global multicenter trials and publish long-term follow-up data to support guideline inclusion and market adoption

Contact Information

Global Headquarters

Address: Wuxi, China

Website: www.pulnovomed.us

U.S. Operations

Clinical Trials: Led by Dr. Gregg Stone, Mount Sinai, New York

Keywords: Pulnovo Medical, 帕母医疗, PADN, Pulmonary Artery Denervation, pulmonary hypertension, PH, heart failure, HF, RF ablation, radiofrequency ablation, Cynthia Chen, Jessie Lian, Andre Xiao, Wu Xiaolin, Medtronic, Qiming Venture Partners, Lilly Asia Ventures, OrbiMed, Gaorong Ventures, EQT, HSG, FDA Breakthrough Device, FDA IDE, NMPA, CE MDR, CMS, Wuxi, China, JACC, ESC/ERS Guidelines, Group I PH, Group II PH, PAH, PULSE-LHD, PHD360, PFlexi, Enhancor, Saudi Arabia, interventional cardiology