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NinePoint Medical was founded in partnership with Third Rock Ventures and Prospect Ventures.

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May. 11, 2012

NinePoint Medical to Unveil NvisionVLE Imaging System at DDW 2012

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NinePoint Medical to Unveil NvisionVLE Imaging System
at Digestive Diseases Week 2012

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
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19 - 22, 2012, at the San Diego Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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
Medical Center in Amsterdam; University College London; and University Hospital in Nantes, France.

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
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. 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:

    • Blair A. Jobe, M.D., FACS, is the Sampson Family Endowed Professor of Surgery within the department of cardiothoracic surgery at the University of Pittsburgh School of Medicine. He currently serves as the director of esophageal research and director of esophageal diagnostics and therapeutic endoscopy within the division of thoracic and foregut surgery. Dr. Jobe’s areas of interest are in esophageal cancer, Barrett’s esophagus, esophageal preservation in the face of early malignancy, minimally invasive surgery, endoscopic therapy, esophageal motility disorders and complicated gastroesophageal reflux disease.
    • Laurence Lovat, MBBS, Ph.D., is a consultant gastroenterologist at University College Hospital and reader in gastroenterology and laser medicine at University College London. Dr. Lovat’s research focuses on optical techniques for diagnosing and treating pre-malignant lesions arising within Barrett's esophagus. He developed photodynamic therapy for high-grade dysplasia in Barrett's and also worked on elastic scattering spectroscopy to detect dysplasia in patients undergoing endoscopic surveillance. He also serves as a specialist adviser to the UK Department of Health and NICE.
    • Norman S. Nishioka, M.D., is a gastroenterologist at Massachusetts General Hospital and an associate professor of medicine at Harvard Medical School. Dr. Nishioka has special clinical interest in the diagnosis and treatment of gastroesophageal reflux disease (GERD), Barrett’s esophagus and early esophageal cancer. He has contributed to the clinical development of various optical imaging technologies including optical coherence tomography and optical frequency domain imaging in the gastrointestinal tract.
    • Gary J. Tearney, M.D., Ph.D., is a co-inventor of NinePoint Medical’s optical imaging technology. As the associate director of the Wellman Center for Photomedicine at Massachusetts General Hospital and the optical diagnostics program leader at the Center for Integration of Medicine and Innovative Technology, Dr. Tearney’s research focuses on optical coherence tomography and other imaging modalities. He is also a professor of pathology at Harvard Medical School and an affiliated faculty member of the Harvard-MIT Division of Health Sciences and Technology.
    • Michael Wallace, M.D., is a professor of medicine with the Mayo Clinic College of Medicine and is the director of research for the department of medicine and the division of gastroenterology and hepatology at the Mayo Clinic in Jacksonville, Fla. Dr. Wallace's areas of interest are in endoscopic ultrasound (EUS), gastrointestinal oncology, clinical research, advanced endoscopic imaging technologies, endoscopic mucosal resection and intestinal stent placement. In collaboration with the Massachusetts Institute of Technology, Dr. Wallace pioneered the development of light scattering spectroscopy which has now been applied to the detection of early cancer in Barrett's esophagus, colon cancer and other non-GI cancers.
    • Kenneth Wang, M.D., is director of the Advanced Endoscopy Group and Esophageal Neoplasia Clinic and a consultant in the division of gastroenterology and hepatology at the Mayo Clinic. Additionally, Dr. Wang is editor in chief of the journal Diseases of the Esophagus and associate editor of the journal Clinical Gastroenterology and Hepatology. His areas of interest include laser therapy, Barrett's esophagus, esophageal cancer, photodynamic therapy, endoscopic ultrasonography, gastrointestinal bleeding, optical biopsy, laser confocal microscopy, radiofrequency abalation and endoscopic mucosal resection/dissection.
    • Herbert Wolfsen, M.D., is a professor of medicine at the Mayo Medical School and chief of gastrointestinal endoscopy at the Mayo Clinic in Jacksonville, Fla. Dr. Wolfsen’s areas of interest include advanced endoscopic imaging for detection of Barrett’s disease, dysplasia and esophageal cancer, and endoscopic therapy for Barrett's disease, including radiofrequency ablation, photodynamic therapy and cryotherapy.

Technology Advisory Board:

    • Michael Becich, M.D., Ph.D., is a professor and chairman of the department of biomedical informatics at the University of Pittsburgh School of Medicine. He is also associate director of the University of Pittsburgh Cancer Institute and co-director of the Clinical and Translational Science Institute at the University of Pittsburgh School of Medicine. Dr. Becich's research interests are focused on the interface between clinical informatics, imaging informatics and bioinformatics. He has been an innovator and entrepreneur in the area of whole slide imaging and digital pathology, and their use in improving patient care and safety.
    • Brett E. Bouma, Ph.D., is a co-inventor of NinePoint Medical’s optical imaging technology. He is a professor of dermatology and health sciences and technology at Harvard Medical School and an associate physicist at the Wellman Center for Photomedicine at Massachusetts General Hospital. Dr. Bouma’s research on optical technology has contributed to the development of imaging modalities such as optical coherence tomography, spectrally encoded confocal microscopy and spectrally encoded endoscopy.
    • Sanjiv Sam Gambhir, M.D., Ph.D., is the Virginia & D.K. Ludwig Professor of Cancer Research and the chair of radiology at Stanford University School of Medicine. He also heads up the Canary Center at Stanford for Cancer Early Detection. An internationally recognized researcher in molecular imaging with more than $75 million of NIH funding as the principal investigator, Dr. Gambhir’s lab has focused on interrogating fundamental molecular events in living subjects. He has developed and clinically translated several multimodality molecular imaging strategies, including imaging of gene and cell therapies.
    • Jacques Van Dam, M.D., Ph.D., is a professor of medicine at the University of Southern California and director of clinical gastroenterology at the USC University Medical Center. Dr. Van Dam’s areas of expertise include pancreatic, esophageal, gastric and colorectal cancer. Dr. Van Dam’s clinical expertise is in diagnostic and therapeutic endoscopy, advanced interventional endoscopy, and advanced endoscopic imaging including microendoscopy and optical biopsy.

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:

    • 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 cancers.
    • 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 0.5x0.5mm segment of tissue.
    • 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 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:

    • The laser mark was clearly visible in five of seven patients, and was confirmed by biopsy to be contained within the superficial layers of the esophagus in those patients.
    • No complications related to the OFDI procedure occurred.

“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.
NinePoint’s new suite of products is initially being developed to enable gastroenterologists and offsite pathologists to review advanced tissue images during biopsies and other therapeutic and diagnostic procedures, in real time. This capability would potentially provide physicians with immediately actionable information and eventually, the ability to treat questionable cells at the time of diagnosis. By streamlining the timeline and the steps required to go from diagnosis to treatment, NinePoint believes it can significantly improve patient experiences and outcomes, improve the efficiency of care and provide important savings to the healthcare system. Over time, the company believes that the technology will have broad applicability across a number of diagnostic and therapeutic categories.


“High quality images provided by optical frequency domain imaging – or OFDI – may one day enable physicians to implement routine, less invasive screening procedures for high-risk patients,” said Gary Tearney, M.D., Ph.D., a researcher in Pathology and the Wellman Center for Photomedicine at Massachusetts General Hospital and co-developer of the technology. “The ability to perform accurate diagnoses for conditions like Barrett’s esophagus could also provide significant improvements over random biopsies that are currently the standard of care for patients at risk for developing esophageal cancer.” OFDI is a form of frequency domain optical coherence tomography (FD-OCT). Based upon exclusive access to this technology in its licensed fields, NinePoint Medical believes it has the opportunity to create a family of innovative medical devices that can dramatically improve patient care.


NinePoint’s product development strategy is currently focused on novel devices that can significantly improve the access, diagnosis and treatment standards for gastroesophageal reflux disease (GERD) and Barrett’s esophagus, conditions that affect more than 19 million Americans annually and that are often precursors to dysplasia and esophageal cancer, as well as many other diseases and conditions. While NinePoint is initially focused on the GI tract, its technology and expertise will allow the company to expand into other indications in the future. NinePoint’s initial product introductions will focus on devices that can quickly deliver volumetric, clinically actionable images, and improve upon existing technology that is only able to image a small field of view, requires intravenous contrast and that has long acquisition times. Initially, NinePoint intends to develop proprietary devices that will allow physicians to image the entire distal esophagus, identify and mark abnormal sites in the mucosa and submucosa and perform guided endoscopic biopsies by routine methods during the normal upper endoscopy. This new treatment paradigm could become a more effective replacement for the existing standard of care that requires random biopsies of esophageal mucosa in areas that appear normal when Barrett’s esophagus is suspected. Over time, the technology is expected to enable the pathologist to view the tissue in-vivo, provide a real-time diagnosis and allow the gastroenterologist to perform treatment during the same endoscopy visit. NinePoint will work closely with MGH to advance the development of the technology and the company plans to introduce the first device prototypes for use in clinical trials in 2011.


“Previous generations of OCT technology produced precise, but small images with long image acquisition times that rendered them unfeasible for clinical use. For the first time, technology exists that can open the door to utilizing real-time images for immediate diagnosis and treatment,” said Brett E. Bouma, Ph.D., of the Wellman Center for Photomedicine at Massachusetts General Hospital and co-developer of the OFDI platform.
“Exclusive access to MGH’s broad and deep portfolio of imaging patents is a significant milestone for NinePoint and we are honored that MGH has chosen to partner with us on the development of this important technology,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “We believe our technology development roadmap will support the commercialization of novel medical devices that can significantly streamline the time and cost required to access, diagnose and facilitate treatment of pre-cancerous and cancerous cells. We are excited to be a pioneer in this convergence that we believe will positively impact patient care. While we are currently focused on the GI tract, we believe that our high resolution optical imaging platform may have broad applicability in other therapeutic areas, which we intend to explore in the future.”


About Frequency Domain Optical Coherence Tomography
Optical coherence tomography was initially created by James G. Fujimoto, David Huang, and Eric Swanson at the Massachusetts Institute of Technology (MIT), and OFDI was developed at the Wellman Center for Photomedicine at Massachusetts General Hospital by Gary Tearney, M.D., Ph.D., and Brett Bouma, Ph.D. The technology has been used extensively in the field of ophthalmology and more recently in coronary artery imaging. The platform is a high-resolution optical imaging technology that uses near infrared light, has 10 times higher resolution than ultrasound, and can create 3 dimensional images of the organ being imaged, without the need for ionizing radiation. The technology also supports the potential for the integration of additional imaging modalities.


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. With its advanced optical technology, 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, NinePoint 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 healthcare 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.

 
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.
“As a medical device company, we are very proud to receive this recognition from the QTDP and will utilize the award as we further our mission to develop and commercialize breakthrough products that enable real-time decision making and streamline patient care,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “We believe this acknowledgement underscores our unique potential to significantly improve upon the access, diagnosis and treatment paradigm used in the examination of dysplastic and cancerous cells and advance patient care. We have a number of important milestones upcoming over the next 12 months and look forward to deploying this grant to support our clinical and corporate strategies.”
NinePoint’s initial focus will be on developing devices for the examination of the gastrointestinal tract. The devices are designed to allow gastroenterologists and offsite pathologists to review advanced tissue images during biopsies and other therapeutic and diagnostic procedures in real time. This capability would potentially provide physicians with immediately actionable information and eventually, the ability to treat the questionable cells at the time of diagnosis. By streamlining the timeline and the steps required to go from diagnosis to treatment, NinePoint believes it can significantly improve patient experiences and outcomes, improve the efficiency of care and provide important savings to the healthcare system. Over time, the company believes that the technology will have broad applicability across a number of diagnostic and therapeutic categories.


About the Qualifying Therapeutic Discovery Project Program
The $1.0 billion in funding and credits allocated to the QTDP Program is being distributed to companies with fewer than 250 employees whose research shows the greatest potential to result in new therapies that address areas of unmet medical need, those that could prevent, detect or treat chronic or acute diseases and conditions, and those that could significantly advance the goal
of curing cancer within 30 years. Awards also took into consideration research that demonstrates the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences, along with research that promises to reduce the long-term growth of health care costs in the U.S.

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.


“Eric is widely considered to be a thought leader within the field of optical coherence tomography and telecommunications, and we believe his broad range of experience and expertise will meaningfully expand our board’s capabilities,” said Charles Carignan, president, chief executive officer and board member of NinePoint Medical. “As NinePoint continues to develop a suite of optical imaging devices focused on the convergence of the access, diagnosis and treatment paradigm for the GI tract, Eric’s extensive business experience, contacts and technical know-how will bring a unique and relevant perspective to NinePoint Medical. We are pleased to welcome Eric to our team and look forward to his many contributions.”
"I am excited to join NinePoint Medical’s board and continue to build on my experience working with startups composed of great people, great technology, great market opportunities and, most importantly, the potential to make a major impact. NinePoint Medical is at an exciting stage, and its technology platform has the potential to greatly improve the diagnostic and treatment options available to the medical community,” said Mr. Swanson. “I look forward to working closely with the rest of the board and management team to move NinePoint’s innovative technology forward in development.” Prior to his current roles as advisor and consultant, Mr. Swanson was the chief scientist at Sycamore Networks, which he co-founded. The company develops and markets intelligent optical switches and other products designed to create more effective communications networks and executed a successful NASDAQ initial public offering in 1999 that reached more than $14 billion in market capitalization at the end of its first day of trading. Before founding Sycamore,


Mr. Swanson co-founded and was the chief technology officer of LightLab Imaging, a biomedical imaging company that commercialized OCT for a wide range of medical markets including cardiology and endoscopy. Lightlab was ultimately acquired in 2010 by St. Jude Medical for $100 million. Prior to LightLab Imaging, Mr. Swanson co-founded Advanced Ophthalmic Devices (AOD), a startup focused on ophthalmologic imaging using OCT. AOD was acquired in 1994 by Carl Zeiss Meditec, a leading ophthalmic instrumentation company, and served as a foundation for Zeiss’s highly successful world leading ophthalmic OCT product line. Prior to AOD, Mr. Swanson was an assistant group leader of research and development at the Lincoln Laboratory at the Massachusetts Institute of Technology for 15 years.
Mr. Swanson has authored more than 180 technical papers and holds more than 27 US patents and numerous foreign patents. He is a fellow of the OSA and senior member of the IEEE. In 1992 he received the prestigious Rank Prize for contributions to mankind in Opto-Electronics for his work in the field of OCT. Mr. Swanson holds a B.S. summa cum laude in electrical engineering from the University of Massachusetts at Amherst and an M.S. in electrical engineering from the Massachusetts Institute of Technology.


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. With its advanced optical technology, 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, NinePoint 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 healthcare 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.

 
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.

CAMBRIDGE, Mass.-- NinePoint Medical, Inc., an emerging leader in the development of in vivo pathology devices, today announced it has completed a $33 million Series A financing led by Third Rock Ventures and Prospect Venture Partners. The company also announced the establishment of its corporate headquarters in Cambridge, Mass. where Charles Carignan, M.D., serves as president and chief executive officer.



“The NinePoint model fits well with Prospect’s investment philosophy of supporting commercially attractive biomedical enterprises with outstanding entrepreneurial management teams. We look forward to working with NinePoint to advance its programs and technology development".

 

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.

NinePoint’s initial focus will be on developing devices for the examination of the gastrointestinal tract. The devices are designed to allow gastroenterologists and offsite pathologists to review advanced tissue images during biopsies and other therapeutic and diagnostic procedures in real time. This capability would potentially provide physicians with immediately actionable information and eventually, the ability to treat the questionable cells at the time of diagnosis. By streamlining the timeline and the steps required to go from diagnosis to treatment, NinePoint believes it can significantly improve patient experiences and outcomes, improve the efficiency of care and provide important savings to the healthcare system. Over time, the company believes that the technology will have broad applicability.

“This is an exciting time for NinePoint,” said Dr. Carignan. “With the support and strategic guidance from our founders and advisors, we believe we can successfully develop and commercialize a groundbreaking portfolio of medical devices that may dramatically improve diagnostic and treatment options for patients and physicians. We also look forward to positively impacting the Boston-area economy with the creation of new jobs at our Cambridge facility as we focus on building out a dynamic team to achieve our goals.”

Dr. Carignan brings more than 20 years of experience in medical device development to the company. Prior to joining NinePoint, Dr. Carignan was executive vice president and chief medical officer of Novasys Medical, Inc., where he was responsible for the successful launch of a women’s health medical device. Prior to that, he was the chief medical officer at Boston Scientific, where he led all aspects of medical and clinical affairs for the endosurgery group, including women’s health, urology, gastroenterology, pulmonology, and oncology. Prior to this role he was the vice president of clinical research and medical affairs at Conceptus where he oversaw the clinical development of the Essure device for female sterilization, a device that has changed the standard of care for tubal ligation. He has conducted physician training in more than 50 countries and participated on various committees of the World Health Organization, the Population Council, the United Nations and the U.S. Agency for International Development. Dr. Carignan earned his undergraduate degree from Yale University, received his M.D. degree from the College of Physicians and Surgeons of Columbia University and trained in general surgery at Columbia-Presbyterian Medical Center.

“NinePoint Medical is the first medical device company that Third Rock Ventures has seeded and launched, and we are optimistic that the company’s unique positioning will successfully change the treatment paradigm in a market with significant unmet needs,” said Mark Levin, partner of Third Rock Ventures, and member of the board of NinePoint. “With Chuck’s extensive experience in developing and commercializing minimally invasive products and the company’s access to advanced, proprietary visualization technology, we believe NinePoint is well positioned to lead the convergence of access, diagnosis and treatment and develop truly transformational medical devices.”

“We are delighted to partner with Third Rock to fund an innovative medical device company that brings together state-of-the-art technology and the best minds in optics, software and medical device development,” said Russell Hirsch, M.D., Ph.D., managing director of Prospect Venture Partners, and member of the board of NinePoint. “The NinePoint model fits well with Prospect’s investment philosophy of supporting commercially attractive biomedical enterprises with outstanding entrepreneurial management teams. We look forward to working with NinePoint to advance its programs and technology development.”

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.