Navigation-enhanced instruments improve surgical precision
The NaviSci System is designed to provide a ‘GPS’ for the surgeon to enable the physician to know precisely where the tumor and surrounding tissue are in relationship to the surgical instrumentation. The system is the first to provide in-vivo measurement in real-time, enabling significantly enhanced precision in tissue resection.
Specifically, the system consists of:
- An active fiducial marker (called a J-Bar) is placed next to the tumor to localize and track its position as well as identify the shortest route of entry to the tumor nodule
- A tissue marking device with a second position sensor
- Proprietary software that links the sensors on the J-Bar and instruments and provides visual as well as quantitative information to measure in real-time.
In addition, the company is developing a bronchoscope-based tissue marker (NaviSci EndoMarker™), which would be used prior to surgery and would simplify clinical workflow. The bronchoscope-based system is minimally invasive and places the J-Bar marker adjacent to the tumor based on navigation and diagnostic CT images. The development of the NaviSci EndoMarker™ has been supported by a $400,000 STTR/SBIR grant from the U.S. National Cancer Institute. In September 2025, the company was awarded a second, $400,000 STTR/SBIR grant to support the development of a software system to guide accurate J-Bar deployment close to the nodules using diagnostic CT images.
GPS Navigation for Precise Margin Control
The NaviSci technology’s proof of concept was demonstrated in a clinical trial in early-stage lung cancer patients with an active fiducial for tumor localization that was published in the peer-reviewed Journal of Surgical Oncology. In the 25-patient. Phase I-II trial, there were no significant complications, and all nodules were fully resected with negative margins.
Development and Market Access
The company has completed a pilot clinical study with NaviSci System under an Investigational Device Exemption (IDE) approved by the FDA in patients with early-stage lung cancer. The 25-patient trial, which was conducted at Brigham & Women’s Hospital will support a filing with the U.S. FDA for regulatory clearance for marketing. The results confirmed that the NaviSci™ navigation system is useful in providing real-time margin assessment for surgical resection of lung nodules, that it is safe and effective, and the system’s distance measurements strongly correlate with the pathology lab. The study was presented during a poster session in May 2023 at the annual meeting of the American Thoracic Society and published in September 2025 in the peer-reviewed, American Society for Thoracic Surgery journal, JVCVS Techniques.
