Data Shows Increased Dysplasia Detection Using Volumetric Laser Endomicroscopy With Laser Marking

NinePoint Medical Inc., a medical device company pioneering the use of Optical Coherence Tomography (OCT) for gastrointestinal applications, announced new clinical data highlighting clinical results achieved using the NvisionVLE Imaging System with Real-time Targeting. NinePoint Medical’s technology enables Volumetric Laser Endomicroscopy (VLE) scanning of the esophagus and subsequent laser marking of concerning regions for pathological examination.
 
Dr. Arvind Trindade and his colleagues from the Northwell Health System studied 369 consecutive patients that received endoscopic surveillance for Barrett’s Esophagus, from 2011-2017. These patients fell into three categories: one group that received Seattle Protocol random biopsies; one that received VLE scanning without laser marking; and the final group which received VLE with laser marking. Patients with raised lesions on high-definition white light endoscopy and lesions seen on electronic chromoendoscopy were excluded from analysis. The surveillance strategy was dictated by available technology at the time. The esophageal dysplasia (pre-cancer) detection rates for the three groups, respectively, were 19.6 percent, 24.8 percent, and 33.7 percent. The differences were statistically significant. Both VLE with laser marking and VLE without laser marking had statistically significant differences in neoplasia (high-grade dysplasia and intramucosal cancer) detection compared to the Seattle protocol groups (14 percent vs. 1 percent and 11 percent vs. 1 percent).
 
“When compared to a standard random biopsy protocol, VLE with laser marking yielded a statistically significant increase in the detection of dysplasia,” stated Arvind Trindade, M.D., director of Endoscopy at Long Island Jewish Medical Center, Northwell Health. “In addition, VLE with laser marking may enable more accurate targeting for biopsies and endoscopic resection, which should allow pathologists to detect more dysplasia. These promising results support the use of VLE with laser marking for the surveillance of Barrett’s esophagus in academic centers, and should be further studied prospectively for validation, as well as in the community hospital setting.”
 
“We are very encouraged by the data presented by Dr. Trindade and his colleagues, and appreciate their commitment to improving the care of patients with esophageal disease,” commented Christopher R. von Jako, Ph.D., president and CEO of NinePoint Medical. “As the fastest growing cancer in the western world, Esophageal Adenocarcinoma needs to be identified in its early, dysplastic state to allow for non-surgical treatment and improved outcomes.”
 
The NvisionVLE Imaging System provides a clinically valuable new perspective of esophageal disease: the ability to image within the wall of the esophagus. By providing a high-resolution, real-time scan of the esophagus using Optical Coherence Tomography (OCT)—a technology similar to ultrasound but using infrared light rather than sound waves—the system enables physicians to view structures not evident with conventional imaging, and potentially identify disease that would have otherwise been missed. With the recent addition of a Real-time Targeting feature, physicians can not only locate, but now mark areas of interest. This marking feature, in combination with an improved workflow, enables more accurate targeting, potentially leading to improved diagnosis and more effective therapeutic decisions for patients.
 
The NvisionVLE Imaging System has been cleared by the U.S. Food and Drug Administration and is commercially available in the United States. It is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, but providing two-dimensional, cross-sectional, real-time depth visualization and may be used to mark areas of tissue. The safety and efficacy of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
 
NinePoint Medical is a privately-held medical device company that designs, manufactures, and sells an OCT imaging platform for clinical use in gastroenterology, pulmonology, urology, gynecology, and ENT, for the evaluation of human tissue microstructure. Using proprietary imaging and software technology, the company is committed to enabling quicker diagnosis of disease and more effective treatments, while reducing the overall cost of healthcare. NinePoint Medical is located in suburban Boston, Mass.