<0> Data from Ongoing Trial in Barrett’s Esophagus Presented at ISDE, UEGW and ACG; Company on Track for 2013 Commercial Launch of Next-Generation Imaging Technology in the U.S. and Europe </0>
<0> NinePoint Medical Announces Data from Clinical Trial of NvisionVLE Imaging System Presented at Key Medical Meetings </0>
<0> Pure Communications, Inc.Susan Heins, 864-286-9597 </0>
, an emerging leader in the development of medical devices for in vivo imaging, today announced that positive data from the company’s ongoing clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using its proprietary NvisionVLE Imaging System will be presented at three key medical meetings in the U.S. and Europe. In the two studies conducted at the Mayo Clinic in Jacksonville, Fla. and Rochester, Minn., the NvisionVLE Imaging System’s high resolution and wide-field imaging enabled the detection of dysplasia that was missed with the standard biopsy protocol.
“We are excited to see these initial data from the clinical trials, which show the potential benefit of being able to image deeper into the tissue than has been possible with endoscopy alone,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “We are excited about these data presentations at ISDE, UEGW and ACG and we look forward to announcing the complete results of our clinical trial in Barrett’s esophagus soon.”
In February, NinePoint Medical a single-arm, open-label observational trial designed to evaluate the performance of the NvisionVLE Imaging System to visualize subsurface tissue in patients undergoing esophagogastroduoenoscopy (EGD) for suspected or confirmed Barrett’s esophagus, a condition that is one of the most common precursors to esophageal cancer. Study enrollment continues, with a target total population of approximately 100 patients from five leading centers worldwide, including the Mayo Clinic in Jacksonville, Fla. and Rochester, Minn.; Kansas University Medical Center in Kansas City, Mo.; Academic Medical Center in Amsterdam and University College London.
A case series of nine patients who underwent NvisionVLE imaging for the detection of dysplasia after endoscopic treatment conducted at the Mayo Clinic in Rochester, Minn., was selected as a 2012 ACG Presidential Poster Award Recipient. The poster (abstract # P1057), was presented today at the in Las Vegas by Emmanuel C. Gorospe, M.D., M.P.H. In the study, all nine patients had a history of biopsy-proven Barrett’s esophagus high-grade dysplasia (HGD) with prior endoscopic mucosal resection and/or ablation. Four patients were found to have persistent HGD at the gastroesophageal junction (GEJ) on histology. NvisionVLE images were read as HGD for all four patients with biopsy-confirmed HGD in the cohort and NvisionVLE image interpretation suggested the presence of HGD in three cases where dysplasia was not found on biopsy. NvisionVLE imaging also identified a case with image features consistent with buried intestinal metaplasia that was not detected by biopsies. No adverse events were reported in all nine cases.
Further supportive data from a study conducted at the Mayo Clinic in Jacksonville, Fla. were selected for oral and poster presentations at the (ISDE) in Venice and the (UEGW 2012) in Amsterdam. Results from imaging with the NvisionVLE Imaging System in nine patients were presented at ISDE (abstract # 317) last week, and results from 16 patients will be presented at UEGW (abstract #OP339) this week by Herbert C. Wolfsen, M.D. In the study, patients underwent EGD with patient monitoring conducted per institutional guidelines, followed by NvisionVLE imaging and routine endoscopic visualization. No adverse events were reported in the study.
NinePoint Medical, Inc. is a transformational medical device company developing innovative, real-time, in vivo imaging devices focused on dramatically improving patient care. Through its proprietary NvisionVLEImaging System, NinePoint intends to bridge the gap between the time of initial imaging to diagnosis and treatment of disease. The NvisionVLE Imaging System will enable physicians and pathologists, for the first time, to view real-time, high-resolution, volumetric images of organs and tissues up to 3mm deep at better than 10 micron resolution. NinePoint is preparing for a commercial launch of the NvisionVLE Imaging System in the U.S. and Europe in 2013. Headquartered in Cambridge, Mass., NinePoint is backed by Third Rock Ventures and Prospect Venture Partners. For more information, please visit .