| May. 11, 2012 | NinePoint Medical to Unveil NvisionVLE Imaging System at DDW 2012 |
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NinePoint Medical to Unveil NvisionVLE Imaging System Next-Generation Optical Imaging Technology on Track for 2013 Commercial Launch Cambridge, Mass. – May 11, 2012 – NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, today announced that the company will preview its next-generation optical imaging technology, the NvisionVLE™ Imaging System, at Digestive Disease Week 2012 (DDW 2012), being held May 19 to 22 at the San Diego Convention Center in San Diego. NinePoint Medical will provide public demonstrations of the NvisionVLE Imaging System, which is designed to bridge the gap between diagnosis and disease treatment by enabling physicians and pathologists to evaluate high-resolution, volumetric images of organs and tissues in real time. “We are looking forward to providing DDW 2012 attendees with informative and interactive demonstrations of our proprietary NvisionVLE Imaging System,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “The NvisionVLE Imaging System is designed to provide real-time images that will enable physicians to visually assess diseased tissues deeper than is possible with endoscopy, the current standard of care. We’re continuing to make important progress and this has been an exciting year for us, with 510(k) clearance from the FDA and the initiation of our multi-center clinical trial for the evaluation of Barrett’s esophagus.” The NvisionVLE Imaging System is the first volumetric, optical coherence tomography (OCT) device cleared by the U.S. Food and Drug Administration (FDA) for endoscopic imaging that generates cross sectional and longitudinal images simultaneously, in real time. Unlike traditional imaging devices that image only the surface of organs and tissues, NinePoint Medical’s proprietary technology enables the generation of images up to 3mm deep and at better than 10-micron resolution. NinePoint Medical recently initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using the NvisionVLE Imaging System. Barrett’s esophagus is one of the most common precursors to esophageal cancer, which is ranked among the top 10 causes of cancer-related deaths worldwide. In addition, in January 2012 the company announced 510(k) clearance from the FDA to market its NvisionVLE Imaging System for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. Based on the rapid and significant progress made in the development of the NvisionVLE Imaging System this year, NinePoint Medical remains on track for a commercial launch of the System in 2013. For a demo of the NvisionVLE Imaging System at DDW 2012, please visit NinePoint Medical at booth 925. About Digestive Diseases Week 2012 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 NvisionVLE™ Imaging System, NinePoint intends to bridge the gap between the diagnosis and treatment of disease. The NvisionVLE 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 better 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, which 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 visit www.ninepointmedical.com. |
| Feb. 22, 2012 | NinePoint Medical Initiates Clinical Trial of Nvision VLE Imaging System; Program On Track for Commercial Launch in 2013 |
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NinePoint Medical Initiates Clinical Trial of Nvision VLE Imaging System; Program On Track for Commercial Launch in 2013 Trial to Evaluate High-Resolution Optical Imaging of Barrett’s Esophagus; Company Also Strengthens Leadership Team to Support Commercialization
Cambridge, Mass. – February 22, 2012 – NinePoint Medical, Inc.,an emerging leader in the development of medical devices for in vivo pathology,today announced that the company has initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using its proprietary Nvision VLE Imaging System, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this year. NinePoint Medical also announced the expansion of its executive leadership team with the appointment of Patrick MacCarthy to vice president of marketing. The single-arm, open-label observational trial is designed to evaluate the performance of the Nvision VLE Imaging System to visualize subsurface tissue in patients undergoing esophagogastroduoenoscopy (EGD) for suspected or confirmed Barrett’s esophagus, a condition that is one of the most common precursors to esophageal cancer. The trial is expected to enroll approximately 100 patients at five leading centers worldwide, including the Mayo Clinic in Jacksonville, Fla. and Rochester, Minn.; Kansas University Medical Center in Kansas City, Mo.; Academic In January, NinePoint Medical announced 510(k) clearance from the FDA to market its Nvision VLE Imaging System 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 a next-generation optical imaging technology designed to enable physicians and pathologists, for the first time, to view high-resolution, volumetric images of organs and tissues in real time. 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. “The Nvision VLE Imaging System has the potential to improve and accelerate the diagnosis and treatment of patients with potentially diseased tissues, including gastrointestinal conditions like Barrett’s esophagus, by providing physicians with high-resolution, volumetric images in real time,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “We have made rapid and significant progress in advancing the development of this technology, including 510(k) clearance from the FDA for a general indication and the initiation of this clinical trial for use in patients with Barrett’s esophagus as planned. We also are pleased to welcome Patrick to our team at this pivotal time. His broad medical device expertise will be invaluable as we continue to strengthen our management team and prepare for the commercial launch of the Nvision VLE Imaging System next year.” Mr. MacCarthy brings to NinePoint Medical more than 10 years of marketing and sales expertise within the medical device and technology sectors. Mr. MacCarthy joins NinePoint Medical from Olympus America, Inc., where he was an integral member of the leadership team for Olympus’ flagship medical device and equipment business. Most recently, Mr. MacCarthy was vice president of marketing, responsible for marketing and strategic planning in the endoscopy division. Prior to that, he held positions of increasing responsibility at Olympus, including vice president / business unit leader and executive director of marketing, both in the endotherapy division. Mr. MacCarthy holds a Bachelor of Science in mechanical engineering from Colorado School of Mines. For more information on NinePoint Medical’s clinical trial, please visit www.clinicaltrials.gov 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 |
| Feb. 1, 2012 | NinePoint Medical Announces Formation of Clinical and Technology Advisory Boards |
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NinePoint Medical Announces Formation of Clinical and Technology Advisory Boards Eleven Leading Experts Will Provide Strategic Counsel as Company Continues to Develop Nvision VLE Imaging System Cambridge,Mass. – February 1, 2012 NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, today announced the appointment of 11 leading experts to its newly formed clinical and technology advisory boards. These experts will support the continued growth of NinePoint Medical and will serve as strategic advisers to the company as it progresses a next-generation high-resolution optical imaging technology, the Nvision VLE Imaging System. “We look forward to working closely with these distinguished experts as we continue to develop our groundbreaking technology, which we believe can dramatically improve patient care,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical.“Their unique and diverse perspectives within the areas of endoscopy, pathology and imaging will be instrumental as we prepare to market the Nvision VLE Imaging System, which recently received 510(k) clearance from the FDA for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization.These appointments will be invaluable as we focus our efforts on further developing the technology to improve the detection, diagnosis and treatment of mucosal and soft tissue diseases.” The inaugural members of NinePoint Medical’s clinical and technology advisory boards include: Clinical Advisory Board:
Technology Advisory Board:
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 visit www.ninepointmedical.com. |
| Jan. 5, 2012 | NinePoint Medical Receives FDA 510(k) Clearance for Nvision VLE Imaging System |
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NinePoint Medical Receives FDA 510(k) Clearance for Nvision VLE Imaging System
First Volumetric OCT Device Cleared for Endoscopic Imaging
Cambridge,Mass. – January 5, 2012 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 forendoscopic imaging that uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real-time. NinePoint Medical’s 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:
“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 system costs.” In 2010, NinePoint Medical enteredinto an intellectual property licensing agreement with Massachusetts General Hospital (MGH) supporting the development of the Nvision VLE Imaging System, NinePoint’s 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 visit www.ninepointmedical.com. |
| Oct. 25, 2011 | NinePoint Medical Announces New Data Presented on Innovative OFDI Technology at 19th UEGW Meeting |
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NinePoint Medical Announces New Data Presented on Innovative Optical Frequency Domain Imaging Technology at 19th UEGW Meeting
Data Highlights First Image-Guided Biopsy of the Esophagus by Optical Frequency Domain Imaging in Patients
Cambridge Mass. -October 24, 2011 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 19thUnited 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:
“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. |
| Dec. 13, 2010 | NinePoint Medical Licenses 188 Patents and Patent Applications; Patents Support NinePoint's Broad-Based Platform Technology for Development of in vivo Pathology Devices |
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December 13, 2010 – NinePoint Medical, Inc., an emerging leader in the development of in vivo pathology medical devices, today announced it has entered into an intellectual property (IP) licensing agreement with Massachusetts General Hospital (MGH). Under the agreement, NinePoint has certain exclusive rights in multiple fields to 188 patents and patent applications owned by MGH. This is the largest IP agreement for medical device technology in the hospital’s history as well as one of the largest IP agreements overall for MGH. Financial details of the agreement were not disclosed. The patents and patent applications will support NinePoint’s high resolution optical imaging platform, which is based on a next-generation optical coherence tomography (OCT) technology. NinePoint is currently developing a suite of optical imaging devices based upon its innovative platform for use initially in the gastrointestinal tract.
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| Nov. 3, 2010 | NinePoint Medical Awarded Qualifying Therapeutic Discovery Project Program Grant |
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Cambridge, Mass., November 3, 2010 – NinePoint Medical, Inc., an emerging leader in the development of in vivo pathology devices, today announced it has been awarded a grant of approximately $250,000 from the Qualifying Therapeutic Discovery Project (QTDP) Program. The QTDP’s grants and tax credits are provided under the new section 48D of the Internal Revenue Code (IRC), enacted as part of the Patient Protection and Affordable Care Act of 2010.
About NinePoint Medical, Inc. NinePoint Medical, Inc. is a transformational medical device company developing innovative, real-time, in vivo pathology devices. The company’s first goal is to develop a device that enables remote pathology, or telepathology, which would facilitate immediate review of images during diagnostic procedures. This capability could potentially provide physicians with immediately actionable information and eventually allow them to pursue therapeutic remedies at the time of diagnosis. 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 healthcare system. Headquartered in Cambridge, Mass., NinePoint is backed by Third Rock Ventures and Prospect Venture Partners. For more information, please visit www.ninepointmedical.com. |
| Oct. 15, 2010 | NinePoint Medical Adds Optical Coherence Tomography Technology Expert to Board of Directors |
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Cambridge, Mass. – October 15 2010— NinePoint Medical, an emerging leader in the development of in vivo pathology medical devices, today announced the appointment of Eric Swanson as a new member of its board of directors, effective immediately. Mr. Swanson’s appointment expands NinePoint Medical’s board of directors to four members. Mr. Swanson is currently a research affiliate at the Massachusetts Institute of Technology (MIT), a consultant for Draper Laboratory, and an advisor to high-tech startup companies covering a wide range of technologies, including biomedical imaging and optical components.
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| Oct. 14, 2010 | NinePoint Medical Completes $33 Million Series A Financing to Develop Innovative Broad-Based Medical Platform for in vivo Pathology Devices |
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Company Establishes Cambridge, Mass. Headquarters with Charles Carignan, M.D., as President and CEO; Expects to Hire up to 25 People Over the Next 12 Months.
Proceeds from the financing will be used to develop NinePoint’s innovative in vivo pathology technology platform. NinePoint intends to utilize this platform to develop and commercialize a portfolio of medical devices designed to positively impact the existing access, diagnosis and treatment paradigm used in the examination of dysplastic, pre-cancerous and cancerous cells. The company also plans to expand its team with approximately 25 new hires over the next 12 months, and eventually intends to run a manufacturing facility at its Cambridge headquarters. |

