CAMBRIDGE, Mass.--(BUSINESS WIRE)--NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, today announced that the company has initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using its proprietary Nvision VLE Imaging System, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this year. NinePoint Medical also announced the expansion of its executive leadership team with the appointment of Patrick MacCarthy to vice president of marketing.
The single-arm, open-label observational trial is designed to evaluate the performance of the Nvision VLE 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. The trial is expected to enroll approximately 100 patients at 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; University College London; and University Hospital in Nantes, France.
In January, NinePoint Medical announced 510(k) clearance from the FDA to market its Nvision VLE Imaging System for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. The Nvision VLE Imaging System is a next-generation optical imaging technology designed to enable physicians and pathologists, for the first time, to view high-resolution, volumetric images of organs and tissues in real time. The Nvision VLE Imaging System is the first volumetric optical coherence tomography (OCT) device cleared by the FDA for endoscopic imaging that uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real time.
“The Nvision VLE Imaging System has the potential to improve and accelerate the diagnosis and treatment of patients with potentially diseased tissues, including gastrointestinal conditions like Barrett’s esophagus, by providing physicians with high-resolution, volumetric images in real time,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “We have made rapid and significant progress in advancing the development of this technology, including 510(k) clearance from the FDA for a general indication and the initiation of this clinical trial for use in patients with Barrett’s esophagus as planned. We also are pleased to welcome Patrick to our team at this pivotal time. His broad medical device expertise will be invaluable as we continue to strengthen our management team and prepare for the commercial launch of the Nvision VLE Imaging System next year.”
Mr. MacCarthy brings to NinePoint Medical more than 10 years of marketing and sales expertise within the medical device and technology sectors. Mr. MacCarthy joins NinePoint Medical from Olympus America, Inc., where he was an integral member of the leadership team for Olympus’ flagship medical device and equipment business. Most recently, Mr. MacCarthy was vice president of marketing, responsible for marketing and strategic planning in the endoscopy division. Prior to that, he held positions of increasing responsibility at Olympus, including vice president / business unit leader and executive director of marketing, both in the endotherapy division. Mr. MacCarthy holds a Bachelor of Science in mechanical engineering from Colorado School of Mines.
For more information on NinePoint Medical’s clinical trial, please visit www.clinicaltrials.gov.
About NinePoint Medical, Inc.
NinePoint Medical, Inc. is a transformational medical device company developing innovative, real-time, in vivo pathology devices focused on dramatically improving patient care. Through its proprietary Nvision VLE Imaging System, NinePoint intends to bridge the gap between the diagnosis and treatment of disease. The Nvision VLE 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 less than 10 micron resolution. Initially, NinePoint is focusing on devices that enable real-time, endoscopic screening and surveillance of diseases of the mucosa of various tissues that are often precancerous. Eventually, the company intends to develop medical devices that provide physicians with immediately actionable information, which will allow them to diagnose and treat patients during the same procedure. This convergence of access, diagnosis and treatment during one procedure is expected to improve patient experiences and outcomes, improve the efficiency of care and provide important savings to the health care system. Headquartered in Cambridge, Mass., NinePoint is backed by Third Rock Ventures and Prospect Venture Partners. For more information, please visit www.ninepointmedical.com.
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