Technology | January 05, 2012

NinePoint Receives FDA Clearance for First Volumetric OCT Endoscopic Imaging System

 January 5, 2012 – NinePoint Medical Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Nvision VLE Imaging System, a next-generation, high-resolution optical imaging technology. The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional and real-time depth visualization.

The Nvision VLE Imaging System is the first volumetric optical coherence tomography (OCT) device cleared by the FDA for endoscopic imaging. It uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real-time. Clinicians can then analyze and immediately act on these images, thus providing patients with streamlined care and a significantly shortened timeline between detection, diagnosis and treatment.

The Nvision VLE Imaging System:

  • Is the only technology that can generate a volumetric image of the target organ in real-time that can be viewed simultaneously in cross-section and longitudinal vizualization.
  • Utilizes a high-resolution display and proprietary software to provide an image that can be reviewed to identify areas of suspicion such as inflammatory, metaplastic or dysplastic changes, or possible cancers.
  • Can image beneath the mucosal surface at less than 10 micron resolution up to a tissue depth of 3 mm, unlike white light endoscopy, which can only image surface detail. This also compares favorably to confocal microscopy, which only has up to 250-500 microns depth of penetration.
  • Offers a full field, circumferential view, compared with confocal microscopy, which only offers a 0.5 x 0.5 mm segment of tissue view.
  • Can image circumferentially or helically up to 6cm in length in less than 100 seconds.  

“We will be conducting clinical trials of the Nvision VLE Imaging System in 2012 and will be scaling up our manufacturing capabilities to support a commercial launch in 2013,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical.  “We believe our technology can improve patient outcomes, shorten the timeframes associated with diagnostic and treatment procedures and significantly reduce health care system costs.”

In 2010, NinePoint Medical entered into an intellectual property licensing agreement with Massachusetts General Hospital (MGH) supporting the development of the Nvision VLE Imaging System. Under the agreement, NinePoint obtained certain exclusive rights in multiple fields to 188 patents and patent applications owned by MGH.  

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