New Year's Good News |堃博医疗's Self-developed Targeted Pulmonary Radiofrequency Ablation System (BroncTarget®) Enters the Special Review Channel for Innovative Medical Devices

BRONCUS wrote a column · Jan 12 19:55

Clinical Breakthrough, Accelerating Through the 'Green Channel'

Recently, the National Medical Products Administration (NMPA) released the results of the review for the 'Special Review Procedure for Innovative Medical Devices' (Announcement No. 13 of 2025). The pulmonary radiofrequency ablation system independently developed by堃博医疗—BroncTarget® Targeted Pulmonary Denervation Radiofrequency Ablation System*—has officially entered the special review procedure for innovative medical devices ('Green Channel'). This signifies that the product has received national regulatory recognition for its core technology originality and significant clinical value, and its market launch process is expected to accelerate fully.

New Year's Good News |堃博医疗's Self-developed Targeted Pulmonary Radiofrequency Ablation System (BroncTarget®) Enters the Special Review Channel for Innovative Me...

Precise intervention reshapes the management landscape of chronic obstructive pulmonary disease (COPD).

TLD (Targeted Lung Denervation) is a breakthrough interventional technology for moderate to severe chronic obstructive pulmonary disease (COPD). It delivers radiofrequency energy precisely to nerve targets via bronchoscopy, aiming to inhibit abnormal airway constriction and excessive mucus secretion at the source, thereby alleviating symptoms such as coughing, phlegm, and shortness of breath.

This technology does not replace conventional drug treatments but forms a synergistic and complementary "intervention + medication" comprehensive management approach. Its “1+1>2” model offers new treatment options, especially for patients whose symptoms remain poorly controlled after standard drug therapy. The technology shows significant potential for promotion and adoption, with some county-level hospitals already capable of conducting related trials.

Currently, the confirmatory clinical trial of the BroncTarget® Targeted Lung Denervation Radiofrequency Ablation System is proceeding in an orderly manner. Sichuan University's West China Hospital, as the leading institution, along with 27 other collaborating hospitals nationwide, is simultaneously advancing participant recruitment. This trial provides an innovative treatment option for COPD patients with FEV1 pred% between 20-60%, who continue to experience significant shortness of breath, coughing, and phlegm despite receiving standard treatment.

Backed by core technologies, building a closed-loop system for lung disease diagnosis and treatment.

The successful development and expedited approval of the BroncTarget® Targeted Lung Denervation Radiofrequency Ablation System into the 'green channel' are strongly supported by the solid technical foundation and comprehensive ecosystem that堃博医疗has built over the years in the field of precise lung interventions.

The product innovatively incorporates designs such as annular multi-electrodes, adjustable openings, differentiated radiofrequency energy output, real-time temperature and impedance monitoring, and intelligent saline infusion, ensuring the efficiency and safety of the ablation procedure.

This system does not exist in isolation. This selection marks another innovation review green channel success for 堃博医疗after its widely applied InterVapor® Thermal Vapor Therapy System (BTVA). Together, they form a comprehensive interventional diagnostic and treatment solution covering different mechanisms of action for lung diseases and meeting various clinical needs. Combined with the company’s leading lung surgery navigation and radiofrequency ablation systems, it establishes a complete diagnosis-treatment loop of 'early diagnosis - precise navigation - interventional therapy,' showcasing strong platform-based innovation capabilities and systematic advantages of the 'Chinese solution.'

Green channel acceleration reduces patient waiting time.

The inclusion of the BroncTarget® Targeted Lung Denervation Radiofrequency Ablation System into the National Innovative Medical Device Special Review Program is expected to further accelerate the process of bringing innovative products to benefit patients.

As the country increases its support for the research and innovation of medical devices, the BroncTarget® Pulmonary Targeted Denervation Radiofrequency Ablation System will follow the National Medical Products Administration's (NMPA) guidelines for 'early intervention, tailored strategies for each company, full-process guidance, and simultaneous review and approval,' gaining more resources for evaluation and approval. Throughout clinical trials, registration applications, inspections, testing, and evaluation processes, the company will strengthen communication with the NMPA and receive personalized guidance.

Empowering the ecosystem, injecting Chinese strength into 'free breathing'

This is not only a milestone for a single product but also a vivid demonstration of B&B Medical’s commitment to implementing an integrated 'diagnosis and treatment' ecosystem strategy and driving industrial innovation. The company consistently emphasizes close collaboration among industry, academia, research, and medicine, as well as in-depth cooperation with leading domestic and international clinical research centers, ensuring that its innovative products address critical clinical pain points while validating their application value under a rigorous scientific framework.

In the future, B&B Medical will continue to focus on building and strengthening an interventional diagnosis and treatment ecosystem for pulmonary diseases that is 'independently controllable and innovation-driven' through continuous technological iteration and product innovation. It aims to provide global patients with respiratory diseases more diverse and optimized solutions, leading the industry to deliver more 'Made in China' innovations and 'Chinese solutions.'

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