BROOKLINE, Mass.–(BUSINESS WIRE)–Navigation Sciences™ will provide an update at the annual Medtech Strategist Innovation Summit San Francisco 2019 Conference on its Image Guided, Video Assisted Surgery (iVATS™) technology for the minimally invasive identification and removal of early stage lung cancer, the company announced today. The conference will take place in Burlingame, California on November 19, 2019.
“iVATS™ is a revolutionary approach to minimally invasive soft tissue surgery that combines surgical instruments with augmented reality software to provide real-time, GPS navigation to precisely remove small tumors with optimal margins while preserving lung function,” said Alan Lucas, Navigation Sciences’ co-founder and CEO. “We have made significant progress in product development and pre-clinical testing that puts us on a course to begin a clinical trial in mid-2020. We expect the trial to provide the basis for a 510(k) submission to the FDA for marketing clearance.”
The emergence of CT chest scanning as an effective tool in high risk populations to detect lung cancer at an early stage and lower cancer deaths is creating new opportunities to improve lung surgery. Removal of small tumors deep inside the lung with appropriate margins remains a significant challenge, as insufficient distance between the tumor and resection margin is associated with recurrence and death. Current surgical approaches either remove excess tissue via lobectomy, which lowers recurrence risk but results in more impaired lung function, or smaller, wedge resections, which reduces lung impairment but may increase recurrence risk.
The Navigation Sciences™ solution integrates with multi-modal (imaging and surgery) technology and includes an active, GPS enabled marker (fiducial), proprietary, real-time navigation algorithms, and tumor cutting devices that allow for surgical precision specific to the patient’s anatomy. Radiology images are synchronized with real-time information to enable the clinician to perform surgery with precision guidance. The technology’s proof-of-concept was demonstrated in a Phase I-II clinical trial published in the Journal of Surgical Oncology. In the study, involving 25 patients (23 with early stage lung cancer), there were no significant complications, all nodules were fully resected with negative margins, and the technology was shown to integrate with surgical workflow.
There are an estimated 87,000 patients in the U.S. diagnosed each year with early stage lung cancer and that number is expected to grow with growing recognition of CT X-ray screening’s value in early detection and favorable reimbursement coverage. Beyond lung cancer, the technology has significant potential in other soft tissue cancer surgeries including breast cancer, where an estimated 250,000 lumpectomies are performed annually, as well as liver, thyroid and brain tumors.
The iVATS technology was pioneered by Raphael Bueno, MD Chief, Thoracic Surgery, at Brigham and Women’s Hospital and Professor of Surgery at Harvard Medical School, and Jayender Jagadeesan, PhD, research assistant at BWH and Assistant Professor of Radiology at Harvard Medical School. Drs. Bueno and Jagadeesan are co-founders and shareholders of the company.
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About Navigation Sciences™
Navigation Sciences is developing novel, image-guided video assisted technology (iVATS™) for minimally invasive localization and removal of early stage lung tumors and other soft tissue lesions. The technology, which combines real-time imaging with augmented reality (AR) promises to dramatically improve surgical outcomes, increase operational efficiency and surgical precision. iVATS™ clinical proof-of-concept has been demonstrated in a published clinical trial. Learn more at: www.navigationsci.com.
Alan Lucas, CEO