Data came from the bronchoscopic visualization and access platform’s first-in-human trial. Noah presented it at the American Association of Bronchology and Interventional Pulmonology conference (AABIP 2023) in Chicago.
According to a news release, the presentation marked the public debut of data from the clinical trial conducted in Australia. Results from the FRONTIER study established Galaxy’s ability to successfully navigate to peripheral pulmonary nodules. Galaxy accomplished this while ensuring safety during the bronchoscopy procedure and up to seven days post-procedure.
In the study, Galaxy targeted 19 nodules, with data showing 100% successful navigation and 100% tool-in-lesion confirmation. Galaxy produced a diagnostic yield between 89.5% and 94.7%, Noah Medical said, though it requires patient follow-up to determine final yield data.
Galaxy features advanced imaging technologies that provide real-time location updates for potentially cancerous lesions. Noah Medical designed the technology to improve tool-in-lesion and diagnostic yield.
The surgical robot offers Noah’s TiLT Technology with integrated tomosynthesis and augmented fluoroscopy. Its single-use, disposable bronchoscope improves efficiency and workflow while reducing the risk of cross-contamination. The small-footprint system’s always-on-camera bronchoscope also enables direct visualization for navigation to the lesion.
Noah Medical received FDA clearance for the Galaxy system in March. Shortly after that, the company raised $150 million, then confirmed the first U.S. procedures following Galaxy’s commercial release.
“The ability to accurately and safely navigate to and biopsy lung nodules with complete confidence is a gamechanger for pulmonologists in the fight against cancer,” said Dr. Tajalli Saghaie, co-principal investigator of the FRONTIER study. “The Galaxy System’s proprietary TiLT+ Technology exceeded our expectations in the trial, forming the basis for successful commercialization of this transformational technology.”
Noah Medical is competing in a space that also includes Intuitive’s Ion system, which the FDA cleared in 2019 as a robotic-assisted, catheter-based platform meant to enable minimally invasive biopsy deep within the lung. Ablation could be the next step for the Ion system.
