Epithelial cancers account for substantial mortality and are an important public health concern. With the need for earlier detection and treatment of these malignancies, the ability to accurately detect precancerous lesions has an increasingly important role in controlling cancer incidence and mortality. New optical technologies are capable of identifying early pathology in tissues or organs in which cancer is known to develop through stages of dysplasia, including the esophagus, colon, pancreas, liver, bladder, and cervix. These diagnostic imaging advances, together as a field known as optical endomicroscopy, are based on confocal microscopy, spectroscopy-based imaging, and optical coherence tomography (OCT), and ...
Charles Carignan brings more than 20 years of experience in medical device development to his role as founding president and CEO of NinePoint Medical. Previously, Charles was executive vice president and chief medical officer of Novasys Medical, Inc., where he was responsible for the successful launch of a women’s health medical device. Prior to that, he was chief medical officer at Boston Scientific, leading medical and clinical affairs for its endosurgery group, and vice president of clinical research and medical affairs at Conceptus, overseeing the clinical development of the Essure device for female sterilization. He has conducted physician training worldwide and participated on committees of the U.S. Food and Drug Administration, Centers for Medicare & Medicaid Services, the World Health Organization, the United Nations, and the U.S. Agency for International Development. Charles earned his undergraduate degree from Yale University and his MD degree from the College of Physicians and Surgeons of Columbia University. He trained in general surgery at Columbia-Presbyterian Medical Center.
For NinePoint, the launch of our NvisionVLE Imaging System is the culmination of many major milestones over the past few years, and a great testament to the hard work of our team...It is always a great feeling to release a new medical device and make it available for improving patient care. As the only volumetric, optical coherence tomography (OCT) device for endoscopic and esophageal tissue imaging commercially available in the U.S., the introduction of the NvisionVLE Imaging System represents a significant addition to the current imaging landscape. We are pleased to offer clinicians across the country a new approach to evaluate esophageal tissue microstructure with faster imaging speed and improved image resolution, potentially leading to better biopsy targeting, reduced costs and improved patient outcomes.In NinePoint Medical Announces U.S. Commercial Availability of the NvisionVLE™ Imaging System
The NvisionVLE Imaging System is the first and only volumetric, optical coherence tomography device cleared by the FDA for endoscopic imaging, and now imaging of esophageal tissue microstructure...Expanded FDA 510(k) clearance for imaging of the esophagus represents an important milestone as we progress toward commercializing the NvisionVLE Imaging System this year. We believe that the NvisionVLE Imaging System will allow physicians to see more esophageal tissue for biopsy and treatment procedures, providing them with valuable imaging information.In NinePoint Medical Receives Additional FDA 510(k) Clearance for NvisionVLE Imaging System
It is very exciting to see research that expands our understanding of the potential for advanced OCT, the technology underlying our NvisionVLE Imaging System, in pulmonary imaging and demonstrates the value of imaging tissue microstructure...“MGH continues to be a leader in research efforts to advance the field and is a tremendous collaborator for NinePoint. We look forward to continuing our partnership with MGH in the research and development of advanced imaging techniques to improve clinical outcomes and efficiencies.In NinePoint Medical Imaging Technology Profiled in Three Recent Publications
We are excited to see the publication of this data from our collaborators at Massachusetts General Hospital that clearly demonstrate the imaging technology can produce valuable images of esophageal tissue...We look forward to moving ahead with continued development of this exciting new technology.In NinePoint Medical Imaging Technology Highlighted in Nature Medicine
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...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 NinePoint Medical Announces Data from Clinical Trial of NvisionVLE Imaging System Presented at Key Medical Meetings
It is an honor to be among the innovative companies selected for FierceMedicalDevices’ first Fierce 15 list. This designation is a testament to the great work of the NinePoint Medical team and our potential to make a significant impact in both the lives of patients and the medical devices market...We are also pleased to welcome Judy and Kurt to our leadership team. Their extensive financial and sales expertise will be invaluable as we prepare for the launch and commercialization of the NvisionVLE ™ Imaging System in the U.S. and Europe next year.In NinePoint Medical Continues to Strengthen Leadership Team with Two New Members; Also Selected to 2012 “Fierce 15” List of Innovative Companies by Fierce Medical Devices
It is an honor to be among the innovative companies selected for FierceMedicalDevices' first Fierce 15 list. This designation is a testament to the great work of the NinePoint Medical team and our potential to make a significant impact in both the lives of patients and the medical devices market.In NinePoint Medical Continues to Strengthen Leadership Team with Two New Members; Also Selected to 2012 “Fierce 15” List of Innovative Companies by Fierce Medical Devices
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.In NinePoint Medical Receives European CE Mark Approval and ISO for NvisionVLE Imaging System
We are looking forward to providing DDW 2012 attendees with informative and interactive demonstrations of our proprietary NvisionVLE Imaging System...The NvisionVLE Imaging System is designed to provide real-time images that will enable physicians to visually assess diseased tissues deeper than is possible with endoscopy, the current standard of care. We’re continuing to make important progress and this has been an exciting year for us, with 510(k) clearance from the FDA and the initiation of our multi-center clinical trial for the evaluation of Barrett’s esophagus.In NinePoint Medical to Unveil NvisionVLE Imaging System at DDW 2012
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...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.”In NinePoint Medical Initiates Clinical Trial of Nvision VLE Imaging System; Program On Track for Commercial Launch in 2013