NinePoint Medical Receives European CE Mark Approval and ISO for NvisionVLE Imaging System
Key Milestones Achieved as Company Prepares for 2013 Commercial Launch of Next-Generation Imaging Technology in U.S. and Europe
NinePoint Medical, Inc. , an emerging leader in the development of medical devices for in vivo pathology, today announced that it has received European CE mark approval for the NvisionVLE ™ Imaging System. The CE Mark is for the company’s “optical endomicroscopy imaging devices for diagnosis of mucosa and submucosa diseases.” The company has also received ISO 13485:2003 certification, an international standard governing the requirements of a quality management system for medical devices and related services, for the company’s Cambridge facility. The CE marking – or “Conformite Europeene” – certifies that a product has met European Union (EU) requirements for marketing in Europe.
“The ISO certification and CE mark approval are important milestones for NinePoint Medical and, along with our recently announced 510(k) clearance from the FDA, strongly position the NvisionVLE Imaging System for a commercial launch in 2013,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical.
NinePoint Medical recently initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using the NvisionVLE Imaging System. Barrett’s esophagus is one of the most common precursors to esophageal adenocarcinoma, the fastest growing cancer in the Western world. With the CE Mark, the company will now add two sites in Europe to the clinical trial. In addition, in January 2012 the company announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its NvisionVLE 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 NvisionVLE Imaging System is the first volumetric, optical coherence tomography (OCT) device cleared by the FDA for endoscopic imaging that generates cross sectional and longitudinal images simultaneously, in real time.
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 NvisionVLE ™ Imaging System, NinePoint intends to bridge the gap between the 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. 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 .