New Study Shows Archimedes Virtual Bronchoscopy Navigation System Facilitates Dramatic Improvement to Diagnostic Yield of Lung Cancer Nodules Located Outside Airways

Broncus Medical, Inc., developer of diagnostic and therapeutic technologies for lung disease, today announced new data unveiled at the European Respiratory Society (ERS) International Congress that demonstrated that the Archimedes™ Virtual Bronchoscopy Navigation System significantly improves access to solitary pulmonary nodules (SPNs), providing an effective aid to increase the diagnostic yield for nodules without a bronchus sign or an airway leading to the nodule. The Archimedes System is the only system of its kind offering real-time virtual bronchoscopic navigation with embedded intraprocedure fused-fluoroscopic guidance, providing a three-dimensional view and access to nodules anywhere in the lung.

“It has been historically challenging to accurately diagnose solitary lung tumors located outside of the main airways, especially when they are small, with diagnosis rates only in the 30 percent range,” said Professor Felix Herth, lead author of the study and chairman of the Department of Pneumology and Critical Care Medicine at Thoraxklinik University of Heidelberg, Germany. “By pre-plotting a path to the nodule that avoids the vasculature and navigating through the lung anatomy with three-dimensional, real-time, fluoroscopic guidance, the Archimedes System demonstrated in this study that it aided in more than doubling the diagnostic yield of these challenging tumors to 77.8 percent, thereby significantly improving existing guided transbronchial biopsy.”

The multi-center study was conducted at five clinical sites and encompassed 18 SPNs lacking an airway path for biopsy. The Archimedes System was used for Bronchoscopic Transparenchymal Nodule Access (BTPNA) to select an avascular path to a point of entry on the airway wall, and to provide real-time navigation for hole creation, dilation and biopsy.

Using the Archimedes System, overall diagnostic yield was 77.8 percent on SPNs with a mean major axis of 18.1±6.8mm, without major complications or pneumothorax. Lesions <20.0mm had a diagnostic yield of 77.8 percent, with a mean major axis of 12.3 ± 4.2mm and were a mean distance to the pleura of 21.3 ± 13.2mm, while lesions ≥20.0mm also had a diagnostic yield of 77.8 percent, with a mean major axis of 23.8 ± 2.5mm and a mean distance to the pleura of 19.0 ± 18.7mm.

These results demonstrate that combining Virtual Bronchoscopic Navigation with Fused Fluoroscopy in the Archimedes System with bronchoscopy allows the bronchoscopist access to nodules located anywhere in the lungs. Prior to the Archimedes System, small nodules without a bronchus sign would have most commonly required a more invasive trans-thoracic approach, requiring a puncture through the chest wall to access the nodule.

Professor Herth will also be presenting footage from a live case using the Archimedes System tomorrow at 09:00 in an ERS session titled “Pulmonary Endoscopy: Lung Cancer and the Pleural Disease.” His presentation will cover transparenchymal nodule access (TPNA) for a single pulmonary nodule (SPN).

The company is currently enrolling at least 100 patients in a larger study of the Archimedes System, which is expected to be completed by the end of the year.

“The evidence is building that BTPNA under guidance of our Archimedes System can navigate to and access nodules anywhere in the lung without major complications,” said Broncus President Henky Wibowo. “We are demonstrating that we can address a critical need in lung cancer by enabling accurate diagnosis of nodules, regardless of the presence of a CT bronchus sign, improving overall lung cancer diagnosis and treatment.”

About Broncus Medical, Inc.

Broncus Medical, Inc. is dedicated to the development of diagnostic and therapeutic technology for lung disease. Founded in 2012, the company’s primary technology platforms focus on the diagnosis of lung cancer and the treatment of emphysema. Its lung cancer portfolio includes the Archimedes™ System, Archimedes™ Planner, LungPoint® Virtual Bronchoscopic Navigation (VBN) System, LungPoint® Planner and FleXNeedle®.

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