WIRE)–NinePoint Medical, Inc., an emerging leader in the
development of medical devices for in vivo pathology, today announced that it
has 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, 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 that uses a circumferential
scanning technique and an automatic pullback to generate cross sectional and
longitudinal images simultaneously in real-time.
NinePoint Medicals proprietary Nvision VLE Imaging System
is designed to enable physicians and pathologists, for the first time, to view
high-resolution, volumetric images of organs and tissues 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 of disease. 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 longitudinally.
- Utilizes a high-resolution display and proprietary software
to provide an image that can be reviewed by a physician to identify areas of
suspicion such as inflammatory, metaplastic or dysplastic changes, or possible
- Can image beneath the mucosal surface at less than 10 micron
resolution up to a tissue depth of 3mm, 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 capability.
- Offers a full field, circumferential view, compared with
confocal microscopy, which only offers a 0.5×0.5mm segment of tissue view.
- Can image circumferentially or helically up to 6cm in length
in less than 100 seconds.
“The Nvision VLE Imaging System can provide high-resolution
images of potentially diseased tissue, which are deeper than can be imaged with
endoscopy alone,” said Charles Carignan, M.D., president and chief executive
officer of NinePoint Medical. “We believe this will improve upon the existing
standard of care, which currently relies on endoscopic technology and random
biopsy protocols due to an inability to see deep into tissue where disease may
exist. Our initial focus is on providing physicians with higher-resolution
cross sectional and longitudinal images of diseased tissue in the epithelium of
various organs, which impacts millions of adults in the United States.
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. In addition, we are focused on developing additional features
of our system to bring even more value to physicians and patients. We believe
our technology can improve patient outcomes, shorten the timeframes associated
with diagnostic and treatment procedures and significantly reduce health care
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, NinePoints
proprietary, next-generation, high-resolution optical imaging technology. Under
the agreement, NinePoint obtained certain exclusive rights in multiple fields
to 188 patents and patent applications owned by MGH.
“FDA 510(k) clearance of the Nvision VLE Imaging System
represents a significant milestone for NinePoint Medical,” said Cindy Domecus,
acting vice president of regulatory affairs of NinePoint Medical. “This is the
first volumetric OCT device cleared for endoscopic imaging, and we believe the
high-resolution images will provide additional, important detail to physicians
who are diagnosing disease that is often not visible on the surface. We look
forward to developing the Nvision VLE Imaging System into a tool to improve
patient care across a broad spectrum of disease states.”
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 Nvision VLE Imaging System,
NinePoint intends to bridge the gap between the diagnosis and treatment of
disease. The Nvision VLE 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 less 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
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.
Headquartered in Cambridge,
Mass., NinePoint is backed by
Third Rock Ventures and Prospect Venture Partners. For more information, please
Posted by Sean Fenske, Editor-in-Chief, MDT