Most potentially cancerous lesions are typically situated in the outer third of the lung, which poses a challenge for doctors to access for accurate biopsy. Current technologies have limitations in both accessing these distant lesions and precisely targeting them. Now, the first in-human trial of a state-of-the-art robotic navigated bronchoscopy system has demonstrated its capability to effectively navigate to peripheral pulmonary nodules while ensuring patient safety during the bronchoscopy procedure and up to seven days after the procedure.

Noah Medical (San Carlos, CA, USA) has presented new data demonstrating the navigational success and safety of its Galaxy System from the platform’s first in-human trial. The Galaxy System's TiLT Technology offers real-time updates on lesions during biopsy procedures, designed to overcome CT-to-body divergence. The system is equipped with a single-use, disposable bronchoscope that enhances efficiency, workflow, and reduces the risk of cross-contamination. The always-on-camera bronchoscope allows direct visualization as physicians navigate to the lesion. Alongside its distinctive onboard navigation capabilities, the Galaxy System boasts a compact physical design suitable for most bronchoscopy suites.

The FRONTIER study by leading interventional pulmonologists at Macquarie University Hospital (Sydney, Australia) is the first clinical trial conducted with the Galaxy System. Nineteen nodules were targeted in the study which revealed that the Galaxy System achieved a 100% navigation success rate, 100% confirmation of tools within the lesion, and a diagnostic yield ranging from 89.5% to 94.7%. Patient follow-up is essential for final yield data. In March 2023, Noah Medical secured FDA clearance for the Galaxy System.

“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 Tajalli Saghaie, M.D., 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.”

“We continue to be encouraged by the data and the physician feedback the Galaxy System is receiving within the clinical community and from our growing roster of customers,” said Jian Zhang, PhD, Noah Medical founder and CEO. “Noah Medical was founded with a patient and physician focus to solve the most complex and challenging gaps in early diagnosis and treatment. Evidence shows the Galaxy System fulfills this goal, and we are excited to bring this innovative new robotic, navigated-bronchoscopy platform to the broader market.” 

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