NinePoint Medical has announced the publication of its 1000 patient Volumetric Laser Endomicroscopy (VLE) Registry study focused on Barrett’s Esophagus.
The 18 site study, published in Diseases of the Esophagus, enrolled 1000 patients between 2014 and 2016 for imaging using the Nvision VLE Imaging System.
The study was designed to determine usage patterns of VLE in clinical practice and to estimate quantitative and qualitative performance metrics, with this publication focused on Barrett’s Esophagus. All enrolled patients were examined with standard upper endoscopy, followed by the use of VLE to identify focal areas of concern for targeted biopsy. Across the Barrett’s Esophagus patient population, inclusion of VLE imaging to the endoscopy procedure increased neoplasia (high grade dysplasia and cancer) detection by 55% beyond the standard of care. In a treatment naïve cohort of patients with no concerning findings on endoscopy, biopsies based only on VLE findings identified 700% more neoplasia than random biopsies of the Barrett’s Esophagus segment, the current standard of care. Overall, study investigators reported that VLE improved the Barrett’s Esophagus management process when used as a tool for targeting biopsies and guiding treatment.
“I personally have seen VLE improve neoplasia detection in my own Barrett’s Esophagus patients, but it is great to see that impact demonstrated in this large prospective multi-center study,” stated Michael S. Smith, MD, MBA, Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Luke’s Hospitals in New York City, and National Principal Investigator of the study. “Esophageal adenocarcinoma incidence continues to grow, and unfortunately continues to inflict poor outcomes on our patients. The ability to identify and treat precursors to this terrible cancer is so important, as it gives us an opportunity to prevent it from even appearing in the first place. Conventional imaging modalities and random biopsies fail to identify neoplasia in many patients. VLE’s ability to improve detection of these lesions allows us to have a very tangible positive impact on these patients’ lives.”
“We are very pleased with the outcomes of this study, which are the culmination of hard work by 47 physicians across 18 collaborating hospitals,” commented Eman Namati, Ph.D., President and CEO of NinePoint Medical. “What is further encouraging is that this study was undertaken without key technological improvements that have since been launched commercially. We anticipate that future studies using the Real-time Targeting laser marking feature and our newly launched artificial intelligence software, Intelligent Real-time Image Segmentation, will improve upon these already very positive results. Working together with our commercial partner, Merit Medical, and many of the leading hospitals in the United States, we are ecstatic that this technology continues to have an important and beneficial impact for patients.”
Source: Company Press Release