Data Highlights First Image-Guided Biopsy of the Esophagus by Optical Frequency Domain Imaging in Patients
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, today announced that data from a Massachusetts General Hospital (MGH) study using next-generation optical frequency domain imaging (OFDI) technology in patients was presented at The 19th United European Gastroenterology Week (UEGW 2011) in Stockholm. In the study, OFDI technology with laser marking was utilized for the first time to conduct guided biopsies of the distal esophagi in seven patients. The authors conducting the study concluded that with its endomicroscopic imaging and laser marking capabilities, OFDI-guided biopsy may potentially enable more targeted biopsies and change the current treatment paradigm for precancerous areas in the esophagus. The OFDI technology was licensed to NinePoint Medical in 2010.
OFDI is a high-speed second-generation optical coherence tomography (OCT) technology that enables volumetric laser endomicroscopy (VLE) of the entire distal esophagus. Utilizing OFDI, the NinePoint Medical Nvision VLE Imaging System, currently in development, is designed to provide treating physicians and pathologists with comprehensive, volumetric images of a patient’s tissue in less than 60 seconds. Clinicians can then analyze and immediately act on these images, thus providing patients with streamlined care and significantly shortening the time between detection, diagnosis and treatment of disease.
“OFDI imaging with laser marking has the potential to improve the diagnostic paradigm for patients suspected of having Barrett’s esophagus, one of the most common precursors to esophageal cancer,” said study co-author Gary Tearney, M.D., Ph.D., professor of pathology, Harvard Medical School and associate director of the Wellman Center for Photomedicine, MGH. “There is a large and growing unmet need to improve the gastroenterologist’s ability to detect, diagnose and make critical treatment decisions for patients with Barrett’s esophagus, and this technological advancement may significantly improve this paradigm. Provided these results can be confirmed in an ongoing, larger study, OFDI-based guided biopsy may soon be able to help clinicians make more precise and rapid diagnoses while taking fewer, but more targeted, biopsies allowing patients to receive more tailored management for diseases like Barrett’s esophagus.”
Eight patients were enrolled in the MGH study from January 2011 to May 2011, with one patient excluded due to the presence of an esophageal stricture. This study aimed to test OFDI with laser marking in humans and to determine the feasibility and safety of the procedure; to test the endoscopic visibility of the laser marks; and to evaluate the amount of mucosal damage produced by the laser on pathology. OFDI imaging of the entire distal esophagus and laser marking of OFDI-determined regions of interest were obtained in all seven eligible patients. Results from the study demonstrate:
- The laser mark was clearly visible in five of seven patients, and was confirmed by biopsy to be contained within the superficial layers of the esophagus in those patients.
- No complications related to the OFDI procedure occurred.
“Our goal is to utilize our Nvision VLE Imaging System to dramatically improve the ability for physicians to access, diagnose and treat soft tissue diseases, including those of the gastrointestinal tract,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “We believe this data demonstrates the strong foundation upon which our technology has been built and points to the tremendous potential of Nvision. By streamlining the timeline from diagnosis to treatment and potentially altering the frequency or necessity of follow-up medical procedures, we believe OFDI can significantly and positively impact patient care and health care costs, and we are excited to pioneer this new paradigm. We believe our technology will ultimately enable advances in the treatment of patients at risk for gastrointestinal conditions like Barrett’s esophagus by providing immediately actionable information to physicians, allowing them to go from diagnosis to treatment during one procedure.”
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 optical frequency domain imaging (OFDI), a next-generation frequency domain optical coherence tomography, NinePoint intends to bridge the gap between the diagnosis and treatment of disease. OFDI will enable physicians and pathologists, for the first time, to view real-time, high resolution imaging of entire organs. Initially, NinePoint is focusing on devices that enable real-time screening and surveillance of the gastrointestinal (GI) tract for patients with Barrett’s esophagus, one of the most common precursors to esophageal cancer. Eventually, the company intends to develop medical devices that provide physicians with immediately actionable information and that 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. Broader applications of NinePoint’s technology are expected to follow in a variety of areas including pulmonary medicine, gynecology, urology and ENT. 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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