Navigation Sciences™ is developing the NaviSci™ System for tissue conserving removal of lung cancer and other soft tissue tumors.
NaviSci is capitalizing on the emergence of low dose CT scanning to detect early-stage lung tumors and clinical studies demonstrating that surgical removal of less tissue in early-stage lung cancer, with appropriate margins, can be curative. The system integrates Augmented Reality (AR) and advanced software with surgical hardware to guide precise surgical resection by enabling for the first time, real-time in-vivo margin measurement.
The system is designed to improve surgical outcomes – reduce recurrence risk, conserve lung function – reduce the length of stay, and enhance surgical workflow. The NaviSci System recently completed a 25-patient prospective clinical feasibility study inearly-stage lung cancer patients. The study was designed to support a submission to the FDA for U.S. market clearance. The results confirmed that the NaviSci™ 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 underlying technology for the NaviSci System was developed at Brigham & Women’s Hospital (BWH) by the company’s scientific founders, Raphael Bueno, M.D. Chief, Thoracic Surgery, and Jayender Jagadeesan, Ph.D., Associate Professor of Radiology at the hospital and Harvard Medical School. The company has the exclusive worldwide license to the patents and intellectual property from the hospital covering the technology and has filed additional patent applications. To date, three U.S. patents have issued, including the parent patent covering the NaviSci System for tissue resection with real-time margin measurement; a continuation in part of the parent patent that covers technology for determining margin measurement while compensating for soft tissue deformation during procedures such as lung, liver, thyroid, brain, and head and neck surgeries; and a patent covering bronchoscopic delivery of the fiducial marker.
In its first application, early-stage lung cancer, NaviSci has the potential to transform surgical treatment the way early-stage breast cancer surgery has evolved from mastectomy to lumpectomy – to the benefit of patients, physicians, providers, and payors.
“Margins have always been important in cancer surgery. In lung cancer, now that we are removing smaller portions of the lung with wedge resections and segmentectomies, margins become critical to reducing the risks of recurrence and thus improving patient survival. We are developing the first system to measure margins in real-time during surgery.” — Raphael Bueno, M.D. Co-founder and Chief of Thoracic Surgery, Brigham and Women’s Hospital
The emergence of low-dose CT scanning in high-risk lung cancer populations as the standard of care is increasing the detection of small, early-stage lesions, creating the opportunity for potentially curative surgery. Detection of small tumors is also enabling the use of surgical approaches, such as wedge resection and segmentectomy, that remove less normal lung tissue and conserve lung function, than complete lobar resection. Obviously, the choice of surgical approach depends on a lot of factors, but as the tumors identified become smaller, the methods of therapy change. For these procedures, the appropriate tumor margin is critical to preventing recurrence. Multiple studies have demonstrated that appropriate margins are important determinants of cancer recurrence. Navigation Sciences’ co-founder, Dr. Bueno and his group at Brigham and Women’s Hospital have been leaders in defining optimal surgical margins and resections in lung cancer. For example, in a study published in the Journal of Thoracic and Cardiovascular Surgery, Dr. Bueno and colleagues found that for non-small cell lung cancer tumors less than or equal to 2 cm local recurrence risk during wedge resection was decreased with margins of less than or equal to 15 mm.
Determination of the appropriate margins during lung cancer surgery, as well as in other soft tissue procedures, presents a significant challenge to surgeons. Currently, the tumor is imaged prior to surgery with CT while the lung is inflated; however, during surgery, there is significant tissue deformation, as the lung is deflated and tissue is often moved.
“We are providing a GPS locator for the surgeon to see beyond the tissue surface, to provide in real-time the location of the lesion and other relevant structures, determine the margin and identify precisely where to make the resection.” — Jayender Jagadeesan, Ph.D., Co-founder and Associate Professor of Research, Harvard Medical School and Brigham and Women’s Hospital