NinePoint Medical Announces FDA Clearance for Pancreatic and Biliary Applications of the NvisionVLE® Imaging System

BEDFORD, Mass.--(BUSINESS WIRE)-- NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time optical imaging platform for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE^® Imaging System for use in the pancreas and bile duct. These anatomical indications add to the previously existing esophageal applications for NinePoint’s state-of-the-art Optical Coherence Tomography (OCT) imaging platform.

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The NvisionVLE Imaging System provides physicians real-time, high-resolution volumetric images of the tissue surface and subsurface. This allows gastroenterologists to thoroughly evaluate tissue for regions of interest that may not be visible with other medical imaging technologies. The newly cleared application is associated with NinePoint’s Low-Profile Optical Probe, a 7 French diameter imaging probe designed to handle small and tortuous anatomies, such as those found in the pancreatico-biliary system. In the pancreas and bile duct, the ability to see beneath the tissue surface could help physicians answer a number of important clinical questions.

“When a patient enters our care with an undiagnosed condition in the pancreatico-biliary system, the stakes can be very high,” said Isaac Raijman, MD, previously the Chief of Gastroenterology at Baylor St. Luke’s Medical Center. “We have a number of tools today to help evaluate a patient’s condition within this anatomy. Unfortunately in many cases, our current toolset is unable to provide enough information to determine the best course of action. This is especially concerning for strictures or blockages of unknown origin. We are hopeful and excited that imaging beneath the surface with the NinePoint technology will supply the missing link and will enhance our clinical decision-making for these critically ill patients.”

This clearance marks another significant step for the strategic collaboration between NinePoint Medical and their exclusive worldwide distributor, Merit Medical Systems, Inc. (NASDAQ: MMSI). “NinePoint continues to produce innovative and high quality products that our team has been very impressed with,” said Fred P. Lampropoulos, Chairman and CEO of Merit Medical. “The addition of new applications for the NvisionVLE Imaging System is important to demonstrate not just the quality but breadth of value the technology brings to hospitals and patients. We’re thrilled to add this to our suite of Merit Medical endoscopy products, and look forward to more great things from our collaboration with NinePoint.”

The pancreatico-biliary clearance marks a very productive 12 months of product development activity for NinePoint Medical. In November of 2018, NinePoint announced the first FDA-cleared artificial intelligence imaging technology for gastroenterology applications, the Intelligent Real-time Image Segmentation^TM (IRIS) product. “I’m so proud of the team here at NinePoint,” commented Eman Namati, Ph.D., President and CEO of NinePoint Medical. “Our group over the years has really pushed the limits of engineering innovation to help patients. This past year has been especially fruitful, with the clearance and market launch of a first-of-its-kind artificial intelligence technology, and now with the clearance of a pancreatico-biliary application for the Low-Profile Optical Probe. The ability to promote to this new anatomical space really strengthens the platform of the NvisionVLE Imaging System, and continues to build the opportunity for this technology to help patients.”

About the NvisionVLE Imaging System

The NvisionVLE Imaging System is designed to help gastroenterologists care for their patients. Current methods to identify abnormalities in the esophagus and bile duct can leave disease undetected. The NvisionVLE Imaging System, which leverages state-of-the-art Optical Coherence Tomography (OCT) imaging hardware, provides physicians with a high-resolution volumetric view of both the tissue surface and subsurface to guide tissue acquisition and decision making using more complete information. With the first FDA-cleared artificial intelligence imaging product in gastroenterology to aid image review, and the ability to create real-time superficial laser marks to guide tissue acquisition, there is no technology on the market like it.

The NvisionVLE Imaging System has been cleared by the FDA and is commercially available in the U.S. It is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including hyper-reflective surface, layering, and hypo-reflective structures. The Low-Profile Optical Probe, as part of the NvisionVLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization. The NvisionVLE Imaging System is intended to provide an image of tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

About NinePoint Medical, Inc.

NinePoint Medical is a privately-held medical device company that designs, manufactures, and sells an Optical Coherence Tomography (OCT) imaging platform for clinical use in gastroenterology, pulmonology, urology, gynecology, and ENT. Using proprietary imaging and software technology while pushing the limits of engineering innovation, NinePoint Medical is committed to enabling earlier diagnosis of disease and therefore more effective treatments for patients. NinePoint Medical is located in suburban Boston, Massachusetts. For more information, please visit www.ninepointmedical.com.

About Merit

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 5,600 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore.

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