Broncus Pioneers Global Precision Pulmonary Interventional Solutions with Unique Full-Lung Navigation Platform

In 2012, Denovo introduced the world’s only real-time image fusion navigation technology and incubated Kunbo Medical. At that time, neither AI applications in healthcare nor respiratory interventions or pulmonary navigation had garnered significant attention. With remarkable foresight, Denovo placed its bet on a sector that was not yet mainstream at the time.

The global market for lung cancer diagnosis and treatment is substantial, with Zion Market Research estimating it will reach approximately $42.2 billion by 2025, while the global population of patients with chronic obstructive pulmonary disease (COPD) stands at 328 million. Compared to surgical resection of diseased lung lobes and the lack of effective options for moderate-to-severe emphysema, minimally invasive interventional therapies can precisely address pulmonary diseases, reduce impairment of lung function, and provide greater benefits to patients.

Targeting severe pulmonary diseases, the navigation system with a globally unique patented transbronchial airway navigation technology can reach any region of the entire lung; it is the world’s exclusive product capable of performing segmented repeat ablation therapy for emphysema; an integrated solution for pulmonary diseases from diagnosis to treatment……Kunbo Medical’s domestic product development has also entered the fast track. Its second-generation radiofrequency ablation device for lung cancer treatment has officially initiated clinical trials, with the first patient successfully enrolled in January 2021. The H-Marker, a single-use pulmonary surgical marker for surgical resection of lung tumors, has entered the Special Examination and Approval Procedure for Innovative Medical Devices and completed enrollment of all cases in December 2020.

Over eight years, Kunbo Medical has become the world’s sole provider of a real-time image fusion-based “whole-lung navigation + diagnosis + treatment” integrated platform for precise pulmonary disease management, and has established itself as a strategic partner of the da Vinci Surgical System, achieving dual success in industrial collaboration and capital growth.

After eight years of dedication and accumulation, how has Kunbo Medical become a leading enterprise in the field of precise interventional diagnosis and treatment for lung diseases? What strategic layout has Kunbo Medical adopted in its mission to establish interventional therapy as the gold standard for treating respiratory diseases? Recently, VCBeat conducted an exclusive interview with Zhan Guowei, CEO of Kunbo Medical, to explore this rising star in the field of pulmonary interventional diagnosis and treatment.

Amid the raging COVID-19 pandemic, global attention to lung health has reached an unprecedented level, with terms such as pulmonary nodules, lung cancer, and emphysema increasingly entering the public consciousness. Lung cancer, known as the “king of cancers,” accounted for 20.03% of all malignant tumor cases in 2015, ranking first among all cancers in both incidence and mortality rates.

Over the past decade, although molecular targeted therapy and immunotherapy for lung cancer have made significant progress, the overall 5-year survival rate remains unsatisfactory. Data from the United States show that the overall 5-year survival rate for lung cancer is only 19.5%. The survival rate for early-stage lung cancer is nearly six to seven times higher than that for late-stage disease. Early diagnosis and treatment may be the most effective approach to improving the current landscape of lung cancer management. However, due to the complex morphology of pulmonary nodules, diagnosis based solely on imaging is challenging. How can we achieve early diagnosis and treatment of lung cancer through effective means? This remains a formidable challenge facing the field of lung cancer therapy.

Lung cancer is not the only formidable obstacle. Chronic obstructive pulmonary disease (COPD), another major pulmonary malignancy, is the third most common chronic disease in China, following hypertension and diabetes. Due to the large number of smokers, the prevalence of COPD in China is alarmingly high. According to the “China Adult Pulmonary Health Study” published by Academician Wang Chen in the prestigious international journal The Lancet, the number of COPD patients in China has exceeded 100 million, with the country ranking first globally in COPD-related deaths, nearing one million annually. Patients with COPD characterized primarily by emphysema, especially those with severe or very severe emphysema, are facing a therapeutic dilemma where “there are no effective surgical treatments, and pharmacological interventions offer very limited benefits.” However, this high incidence rate is accompanied by low public awareness. In response, at the Third Session of the 13th National Committee of the Chinese People’s Political Consultative Conference in 2019, Academician Wang Chen, an expert in respiratory and critical care medicine, specifically submitted a proposal to include chronic obstructive pulmonary disease in the National Basic Public Health Services Program.

“There is an urgent clinical need for precise minimally invasive interventional procedures to diagnose and treat pulmonary diseases. However, due to factors such as pulmonary anatomy and lesion location, accurate localization and precise access to lesions remain challenging, hindering the widespread application of interventional surgery in the diagnosis and treatment of lung diseases. The launch of Kunbo Medical’s Whole-Lung Access Navigation Platform represents a critical technological breakthrough enabling minimally invasive interventional diagnosis and treatment of pulmonary diseases,” stated Zhan Guowei. “Leveraging the world’s only real-time image fusion whole-lung navigation technology, Kunbo Medical provides novel, precise interventional treatment solutions for these two types of malignant lung diseases, as well as for a broader range of pulmonary conditions.”

The clinical demands posed by lung cancer and chronic obstructive pulmonary disease (COPD) also signify substantial clinical value, attracting significant attention from major industry players to the field of pulmonary disease treatment. Kunbo Medical’s proprietary patented technology is the key to achieving true whole-lung navigation.

Left: LungPro^®Whole-Lung Diagnosis and Treatment Navigation System; Right: Synchronization of Real-Time Endoscopic Images with Virtual Images

Kunbo Medical possesses the world’s only real-time image fusion whole-lung navigation technology, with its flagship navigation platform, LungPoint^®Augmented Reality (AR) Navigation System and LungPro^®The whole-lung diagnosis and treatment navigation system has obtained approvals from the U.S. FDA, CE, and NMPA, and can be sold in all major markets worldwide.

BTPNA Procedure Demonstration

LungPro^®LungPro is currently the world’s only navigation platform capable of overcoming bronchial limitations to achieve whole-lung navigation and diagnosis and treatment.^®Kunbo Medical’s proprietary BTPNA technology establishes a direct tunnel to lesions located outside the airways, enabling precise localization, diagnosis, and treatment of such extraluminal lesions. This innovation addresses the limitations of existing bronchoscopic techniques, which can only access a subset of endobronchial lesions, resulting in suboptimal diagnostic yields and therapeutic efficacy.

The value of whole-lung navigation technology in clinical diagnosis and treatment has been significantly enhanced. Professor Long Fa from the Shenzhen Hospital of University of Chinese Academy of Sciences (Guangming) published diagnostic and therapeutic results in “Application of LungPoint Virtual Navigation-Assisted Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules,” showing that the overall positive diagnostic rate among 264 patients reached 85.61%. In 2020, the positive rate for transbronchial biopsies outside the airways (under BTPNA guidance) at this hospital further increased to 88.8%, whereas the diagnostic rate for conventional transbronchial biopsy was only 30%. The tangible clinical benefits have driven the rapid expansion of LungPro®’s adoption in hospitals worldwide. Currently, it is utilized in more than 30 renowned Grade A tertiary hospitals across multiple provincial capital cities in China, becoming standard equipment for the diagnosis and treatment of pulmonary diseases in these institutions.

Over the past decade, cardiac intervention has evolved through years of exploration and development to become one of the mainstream treatment modalities for heart diseases, with digital subtraction angiography (DSA) systems providing the foundational infrastructure for these procedures. Zhan Guowei believes that Kunbo Medical’s advanced navigation platform, which reconstructs the entire pulmonary anatomy and provides real-time navigation, has created significant market opportunities for precise interventional treatments of lung diseases.

In earlier media reports, Professor Felix JF Herth of the Thoraxklinik at Heidelberg University Hospital, a leading authority in respiratory medicine, stated: “The LungPro whole-lung diagnostic and therapeutic navigation technology can penetrate the airway wall to directly establish a tunnel to the lesion, not only enabling the diagnosis of small lesions but also providing a platform for treatment.” This minimally invasive diagnostic and therapeutic approach, achieved through whole-lung navigation, mitigates the high intraoperative and postoperative risks associated with traditional thoracotomy or transthoracic needle biopsy—such as pneumothorax and hemorrhage—thereby significantly alleviating patient suffering.

“Kunbo Medical’s product portfolio is centered around its globally unique navigation system. Focusing on disease areas such as lung cancer, emphysema, and pulmonary nodules, it covers the entire spectrum of diagnosis and treatment, breaks through the limitations of existing therapeutic approaches, and provides a comprehensive suite of interventional treatment solutions for clinical practice,” said Zhan Guowei.

Currently, in the field of precision interventional therapy for pulmonary diseases, Kunbo Medical has developed a series of non-implantable diagnostic and therapeutic devices and consumables. For instance, the InterVapor Thermal Vapor Ablation System enables precise targeted treatment for patients with emphysema. These solutions offer advantages such as minimal tissue damage, fewer side effects, high diagnostic accuracy, and thorough treatment efficacy. The already implemented solutions are significantly superior to existing diagnostic and therapeutic pathways, positioning interventional therapy as a potential gold standard for the treatment of pulmonary and even broader respiratory diseases.

The Global “2019 GOLD Clinical Guidelines for the Treatment of Severe Emphysema” indicate that thermal vapor ablation therapy provides a solution for patients with limited treatment options. As the only emphysema treatment platform on the market capable of segmental, repeatable ablation, Kunbo Medical’s InterVapor Thermal Vapor Ablation System delivers thermal vapor to the airways and lung parenchyma at targeted pulmonary sites, enabling focused treatment of severely affected lung segments while preserving those with milder disease. By controlling the extent of whole-lung injury, the system effectively safeguards patients’ quality of life. This is corroborated by follow-up results at 6 and 12 months, which demonstrate not only improved lung function but also significant enhancements in quality of life.

RF Radiofrequency Ablation Procedure

Kunbo Medical’s RF radiofrequency ablation product for lung cancer treatment, the first-generation EMPOWER system, was developed by a U.S. team, received FDA approval in 2019, and is currently undergoing post-marketing clinical studies. Since 2018, Kunbo’s Chinese team has been developing the second-generation product, which is about to begin patient enrollment for clinical trials. The second-generation radiofrequency energy ablation system is the only lung cancer treatment platform capable of continuously delivering radiofrequency energy within the lungs. It achieves complete coverage of the lesion with safe, low-dose ablation energy, enabling precise ablation of targeted lung cancer lesions. Clinical trials for the second-generation product have officially commenced to verify its safety and efficacy in lung cancer treatment, with the first patient successfully enrolled in January 2021. This marks the world’s first pre-market clinical trial for complete ablation of lung cancer via natural airways under navigation guidance.

Leveraging its navigation platform, Kunbo Medical is steadily advancing the global clinical trials and regulatory registrations for its remaining therapeutic products. The H-Marker, a single-use pulmonary surgical marker designed for surgical resection of lung tumors, has entered Zhejiang Province’s Special Approval Procedure for Innovative Medical Devices and successfully completed patient enrollment for all cases in December 2020. Additionally, various interventional consumables—including the FleXNeedle® biopsy needle, BioStar® single-use endoscopic aspiration biopsy needle, and DiaoKeDa™ steerable sheath—have already received marketing approval in multiple countries and regions for use in navigation platform-based interventional diagnosis and treatment. The successive market launches of these products will facilitate the medical community’s efforts to address precise interventional therapies for two major diseases: lung cancer and emphysema.

No great product can exist without the “people” behind it. At Kunbo Medical, these “people” refer to the company’s outstanding R&D teams in China and the United States, as well as its deep collaborations with top physicians worldwide.

Within Kunbo Medical’s core leadership team, CEO Zhan Guowei brings 20 years of management experience in both multinational and domestic medical device companies. During his tenure at Johnson & Johnson Medical, he spearheaded the launch and rapid growth of atrial fibrillation ablation therapy in China. Later, while serving at the domestic brand Lifetech Scientific, he successfully elevated its large stent product from an ordinary domestically produced item to the number-one domestic brand in the large stent market, and helped Lifetech Scientific complete its initial public offering.

Kunbo Medical operates dual R&D centers in China and the United States, with a team of over 50 R&D professionals and more than 200 patents applied for or granted worldwide. Zhan Guowei stated that the R&D team is expected to expand to over 100 members within the next year, accelerating the development of additional projects through talent aggregation.

Furthermore, Kunbo Medical maintains close communication with top global experts in the field of pulmonary diagnosis and treatment to accurately capture clinical needs, with more than half of its product ideas originating from clinicians. Leveraging insights derived from frontline clinical practice and extensive experience in developing mature pulmonary interventional technologies, and supported by China’s efficient R&D and clinical research capabilities, Kunbo Medical has built a diverse product portfolio that delivers innovative disease solutions.

The sole basis and source for the safety, efficacy, and iterative updates of medical devices is their evidence-based medical data. Kunbo Medical collaborates with clinical research centers worldwide to continuously generate rigorous and comprehensive clinical data, thereby accelerating product iteration and providing tangible support for market promotion.

At the conclusion of our conversation, Zhan Guowei shared with us the grand vision of a healthcare entrepreneur: “Our continuous efforts to expand and strengthen the company are ultimately aimed at accelerating the development and commercial application of minimally invasive, precision respiratory interventional diagnostic and therapeutic technologies, thereby consistently providing innovative diagnosis and treatment solutions for various severe pulmonary diseases to physicians and patients. As a medical device manufacturer, we must fulfill our corporate responsibilities in humanity’s long journey to overcome disease, keeping physicians and patients at heart, and serving as disseminators of innovative medical technologies and solutions. Step by step, we strive to reach far, leading technological innovation in respiratory intervention!”