Optical frequency domain imaging (OFDI)-guided biopsy technology has the potential to allow for more targeted biopsies and change the treatment paradigm for precancerous areas in the esophagus, according to recently presented data from a Massachusetts General Hospital study.
The OFDI technology, which was licensed to NinePoint Medical in 2010, was used with laser marking for the first time to conduct guided biopsies of the distal esophagi in 7 patients. Using OFDI, the NinePoint Medical Nvision VLE imaging system is expected to provide healthcare professionals with comprehensive, volumetric images of a patient's tissue in less than 60 seconds. Clinicians can then analyze and immediately act on these images, giving patients streamlined care and significantly shortening the time between detection, diagnosis and treatment. The product is being developed.
"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, professor of pathology at Harvard Medical School and associate director of the Wellman Center for Photomedicine at 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."
The results come as a good piece of news--especially with an increased incidence of adenocarcinoma of the esophagus, NinePoint President Chuck Carignan told FierceMedicalDevices. While the company is starting out in the gastroenterology arena, it foresees broader applications for its technology, including pulmonary medicine, breast cancer, gynecology, urology and ENT.
The company's technology is akin to a CT scan from the inside-out, and allows physicians to look deep within the tissue to gather more information about a patient's condition with better resolution, Carignan explained.
NinePoint has had a very exciting year, with it 510(k) submission and the completion of animal studies with its technology. Carignan, who said his 25-person company has been working hard to get its product to market, expects the clearance process to be relatively straightforward, and he also anticipates receiving CE Mark approval early next year.
NinePoint received $33 million Series A in October 2010 from Third Rock Ventures and Prospect Venture Partners. Carignan told FMD he expects that funding to carry the company through 2012. The company also has early images of the bile ducts, which Carignan said would likely be the company's next area of focus after the esophagus.