Navigation-enhanced instruments significantly 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 and recommend where to excise the tumor. The system is the first to measure surgical margins 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 from the lung surface to the tumor nodule
- A surgical cutting instrument with a second position sensor
- Proprietary software that links the sensors on the J-Bar and cutting instruments and provides visual as well as quantitative information to measure tumor margins in real-time. The real-time measurements permit resection with a sufficient margin of lung tissue surrounding the tumor.
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 minimal minimally invasive and places the J-Bar marker adjacent to the tumor through the working channel of the endoscope based on navigation and diagnostic CT images. The development of the EndoMarker is supported by a $400,000 STTR/SBIR grant from the U.S. National Cancer Institute.
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 a passive 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
In Spring 2022, the company completed a clinical feasibility 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. An abstract has been submitted to present the data at a major medical conference in January 2023.
The system is regulated as a Class II device; predicates have been defined both for the surgical navigation and active fiducial marker components of the NaviSci System. The company has also defined a U.S. reimbursement pathway for the system within existing CPT and DRG ICD-10 codes.
