Broncus Medical (HKG: 2216) announced that China’s National Medical Products Administration (NMPA) has granted fast‑track designation for its BroncTarget lung targeted denervation (TLD) radiofrequency ablation system, a first‑in‑class bronchoscopic intervention for moderate‑to‑severe chronic obstructive pulmonary disease (COPD).
Regulatory Milestone
Item
Detail
Agency
NMPA (China)
Designation
Fast‑track
Product
BroncTarget TLD System
Indication
Moderate‑to‑severe COPD (adjunct to standard therapy)
Mechanism of Action: Delivers radiofrequency energy via bronchoscopy to ablate parasympathetic nerves supplying the airways, suppressing abnormal bronchoconstriction and mucus hypersecretion at the source
Clinical Rationale: Addresses drug‑refractory symptoms (cough, sputum, dyspnea) in patients inadequately controlled by LAMA/LABA/ICS therapy alone
Key Innovations:
Circular multi‑electrode array with adjustable loop diameter (18‑25 mm) for anatomical customization
Differentiated RF energy output with real‑time temperature/impedance monitoring to prevent airway injury
Intelligent cold saline perfusion for active cooling, ensuring precise lesion formation while preserving mucosal integrity
Procedure Time: ~45 minutes under moderate sedation; day‑case discharge
Clinical Development & Evidence
Parameter
Status/Result
Trial Design
Prospective, multicenter, single‑arm confirmatory study (n = 180)
Primary Endpoint
Change in FEV₁ (forced expiratory volume) at 12 months
Secondary Endpoints
CAT score, SGRQ, 6‑minute walk distance, exacerbation rate
Competitive Edge vs. Nuvaira’s TLD (US investigational)
BroncTarget offers smaller catheter profile (6 mm vs. 8 mm) and shorter procedure time
Market Opportunity & Revenue Forecast
Parameter
2026E
2027E
2028E
China COPD Prevalence
100 million
102 million
104 million
Moderate‑to‑Severe Cases
30 million
30.6 million
31.2 million
Drug‑Refractory (Eligible)
9 million
9.2 million
9.4 million
BroncTarget Market Penetration
0 %
0.02 %
0.15 %
Annual Procedure Volume
–
1,840
14,100
Device Price (¥)
–
¥68,000
¥65,000
China Revenue Forecast
–
¥125 million
¥917 million
Health Economics: TLD procedure reduces annual COPD‑related hospitalizations by 1.8 days/patient, saving ~¥24,000 in direct costs; ROI < 18 months for hospitals
Reimbursement Pathway: NMPA fast‑track enables priority NRDL negotiation in 2028; expected reimbursement at ¥45,000‑50,000 (65 % coverage)
Global Expansion: Broncus plans FDA IDE filing in 2028, targeting US COPD market (15 million eligible patients)
Competitive Landscape
Company/Product
Stage
Differentiation
Broncus/BroncTarget
Phase III (China)
Only system with adjustable loop and saline perfusion
Nuvaira/Nuvaira System
Phase III (US)
Larger catheter, longer procedure
Boston Scientific
Preclinical
RF balloon technology, earlier stage
Standard of Care
Marketed
LAMA/LABA/ICS triple therapy; no interventional option
Strategic Positioning
Manufacturing: Dual‑site production in Shanghai and San Jose; capacity scaled to 5,000 units/year by 2027
Intellectual Property: 28 granted patents covering electrode geometry, RF algorithms, and saline cooling; freedom‑to‑operate in US and EU confirmed
Commercial Partnership: Negotiations underway with Mindray for distribution in 300 tier‑2/3 hospitals
Pipeline Extension: Broncus developing TLD+ with integrated drug‑eluting capability for asthma (Phase I 2027)
Forward‑Looking Statements This brief contains forward‑looking statements regarding BroncTarget’s clinical trial outcomes, NMPA approval timeline, and revenue projections. Actual results may differ due to competitive dynamics, reimbursement negotiations, and unforeseen safety signals.-Fineline Info & Tech
By Fineline Cube 