Noah Medical announced that it received FDA clearance for its Galaxy System for robotic-navigated bronchoscopy.
San Carlos, California-based Noah Medical designed Galaxy and its accessories to provide bronchoscopic visualization and access. These capabilities provide diagnostic and therapeutic procedures in patient airways.
The system features advanced imaging technologies that provide real-time location updates for potentially cancerous lesions. Noah said in a news release that it designed the technology to improve tool-in-lesion and diagnostic yield.
“While various technologies to diagnose lung cancer have been utilized over time, the diagnostic yield has remained relatively low,” said Jian Zhang, Noah Medical founder and CEO. “The Galaxy System is designed to close this gap in the market, giving clinicians a safe and easy-to-use platform to potentially improve diagnostic yield and produce better clinical outcomes. With this FDA clearance, we are excited to move into the commercial phase of our journey.”
Zhang founded Noah Medical in 2018, having departed Johnson & Johnson’s Auris in 2015. He and Noah Medical are currently subject to litigation from Auris, which alleges the misappropriation of trade secrets. Noah Medical has filed a motion to have the lawsuit dismissed.
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More about the Noah Medical Galaxy System
The company announced a 10,000-square-foot facility in Sunnyvale, California and a 15,000-square-foot R&D facility in San Carlos. Noah said it aimed to pursue new medical robotics indications with these new facilities. That included the Galaxy System, Noah Medical’s first commercial robot surgery offering.
Galaxy features TiLT Technology with integrated tomosynthesis and augmented fluoroscopy. It includes an always-on-camera bronchoscope for direct visualization during the entire procedure, including at the time of biopsy.
The system’s purpose-built four-way bronchoscope articulation enables navigation to “even the most peripheral lesions,” Noah said. It marks the only robotic navigated bronchoscopy system on the market with a single-use, disposable bronchoscope, the company added. Noah designed this intentionally to improve efficiency and workflow while potentially reducing cross-contamination risks.
About the ongoing litigation with Johnson & Johnson’s Auris
At the end of 2022, Auris filed a complaint in the U.S. District Court in Northern California. Auris alleged “shameless, systematic and ongoing misappropriation of trade secrets” by Noah. It named former Auris employees Enrique Romo, Diana Cardona Ujueta, and Kenneth Nip.
The company alleges that the three former employees collectively misappropriated at least 26,000 Auris, Verb and Cilag documents. Those documents feature 81 gigabytes of data. According to the complaint, that data includes “significant trade secret material.”
Auris said in the complaint that Zhang was its second employee. The company alleges that, following his 2015 departure, he retained documents that have yet to be returned.
Lawyers for Noah Medical and the former Auris employees filed a motion to dismiss on Feb. 3. On top of a list of legal arguments against the Auris case, it said: “Auris Health filed suit even though it knew that those files had long been returned, even though it had never claimed any were still missing, and even though it had zero evidence that any such files had ever been shared with Noah Medical — versus sitting passively in personal accounts. Auris Health also makes dubious claims that basic notions like a flexible catheter and a well-known form factor for a medical device are ‘trade secrets’ and purports to attack a Noah Medical patent filing on that basis.”
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