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.
GPS Navigation for Precise Margin Control
In the initial system, placement of the J-Bar is done intraoperatively. The company is also developing a fiducial marker (NaviSci-EndoMarker™) that will be deployed with a bronchoscope and positioned adjacent to the tumor based on navigation and diagnostic CT images. The EndoMarker will further simplify the clinical workflow.
The 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 2021, the company began 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 is being conducted at Brigham & Women’s hospital, is evaluating the system’s safety, and ability to identify and remove tumors minimally invasively with appropriate margins. The trial is also designed to provide an initial opportunity to test the technology’s economic value proposition of improved surgical workflow and reduced hospital length of stay.
The feasibility study, if successful will support a 510(k) submission to the U.S. FDA for market clearance. 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.