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Bronchoscopic lung navigation system for accurately excising lung nodules

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA261420-01A1
Agency Tracking Number: R41CA261420
Amount: $399,975.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA20-265
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-02
Award End Date (Contract End Date): 2023-08-31
Small Business Information
Brookline, MA 02445-4167
United States
DUNS: 081109960
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (617) 525-6240
Business Contact
Phone: (617) 525-6240
Research Institution
BOSTON, MA 02115-6110
United States

 Domestic Nonprofit Research Organization

The long-term goal of this project is to develop and commercialize a navigation system that can accurately
determine margins in real-time during surgery for lung cancer. Surgery is currently the standard of care for early
stage lung cancer. A critical challenge is to reliably identify small, early-stage tumors and resect them with
sufficient margins (distance between the edge of tumor and the line of resection). Too close a margin is
associated with a higher incidence of recurrence and death. To address this challenge, this team developed a
new surgical procedure called image-guided video thoracoscopic surgery (iVATS), in which the surgeon localizes
and resects small lung nodules by marking them percutaneously using a fiducial marker, a small passive metal
tag called T-bar, placed under C-arm CT image-guidance. A novel navigation technology, NaviSci™, was
developed to aid in identifying and removing lung tumors by using an active sensing nodule marker, called J-
Bar, that is placed in the lung just next to the tumor and can track the tumor position in real-time and help assess
margins. However, use of the J-Bar requires either intraoperative imaging or approximate visual positioning of
very small tumors that may not be visible during surgery from the lung surface.
Navigation Sciences is now developing a tumor marker that can be positioned with a bronchoscope and does
not require CT imaging during surgery. The objective of this Phase I STTR project is to develop and validate the
NaviSci-EndoMarkerTM (called EndoMarker hereafter) to accurately localize small lung tumors. The
EndoMarker will be positioned adjacent to the tumor with a bronchoscope based on navigation planned using
diagnostic CT images. This will simplify the clinical workflow and make this procedure accessible to hospitals
that do not have advanced intra-operative imaging technologies. Aim 1 is to design and develop the
bronchoscopic EndoMarker. Aim 2 is to validate the workflow for deploying the EndoMarker, mechanical stability,
and electrical isolation of the EndoMarker in a 3D printed lung phantom, ex vivo porcine lungs and 2 live pigs.
This STTR project is a collaboration between Navigation Sciences and ongoing collaborators at the Brigham and
Women’s Hospital (Boston, MA). The proposed Randamp;D project is significant since it addresses an important
problem of accurately localizing and resecting lung nodules while preserving healthy lung function, which could
benefit thousands of patients each year. The novelty lies in the design of the EndoMarker, which will allow the
J-Bar marker to be placed accurately via a bronchoscope so that it can readily localize small tumors and define
their margins during surgery. Successful completion of this project will result in an innovative disruptive product
that will provide surgical guidance to ensure sufficient resection of early-stage lung cancer with acceptable
margins without any additional imaging equipment at the medical center.NARRATIVE
This project will develop a novel surgical marking device to localize small lung tumors so they can be found and
removed, with safe margins, in surgical procedures that preserve healthy lung tissue and function. The marking
device can be positioned before surgery and will not require the use of advanced imaging technologies during
surgery. Because modern screening methods identify lung cancer at an early stage when the tumors are very
small and easier to remove, this tool will benefit thousands of patients each year.

* Information listed above is at the time of submission. *

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