San Raffaele Cimena, Italy
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Two Studies Presented at DDW 2017 Showed Clinically Meaningful Reduction in Symptoms and Withdrawal or Reduction in Proton Pump Inhibitor Use by Two-Thirds of Patients Following Treatment with MUSE™ System Separate Presentation Supports HOF Criteria as a Potential Endoscopic Selection Criteria to Predict Amount of Reflux and Improve Treatment Outcomes OMER, ISRAEL--(Marketwired - May 9, 2017) - Medigus Ltd. ( : MDGS) ( : MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, today announced results from three clinical studies involving the company's MUSE™ System, a minimally invasive solution for gastroesophageal reflux disease (GERD). The data were presented in three posters at Digestive Disease Week® (DDW), taking place in Chicago from May 6-9, 2017. The MUSE system is a single-use flexible transoral stapler that merges the latest advancements in microvisual, ultrasonic and surgical stapling. The device comes equipped with an ultrasonic sight and range finder and a micro ScoutCam™ CMOS camera, which enables a single physician to perform an incisionless transoral fundoplication -- the procedure is intended to treat the anatomical cause of gastroesophageal reflux disease (GERD), commonly known as acid reflux. Giorgia Mazzoleni, fellow at the San Raffaele Scientific Institute at the San Raffaele Hospital in Milan, Italy, presented a poster entitled, "Transoral Anterior Fundoplication (TAF) with Medigus Ultrasound Surgical Endostapler (MUSE™) for the Treatment of Gastroesophageal Reflux Disease (GERD); 6-Month Results from a Single-Center Prospective Study," which enrolled 24 GERD patients to assess the six-month safety and efficacy of TAF with MUSE. GERD quality of life questionnaires (HRQL) improved from a baseline of 43 to 18 six months after TAF with MUSE (p < 0.003). The study also highlighted an improvement in Reflux Symptom Index (RSI), from 21 to 10 (p < 0.009). A 79% reduction or withdrawal in PPI therapy was observed six-months after treatment, with 50% of patients stopping PPI use, 28.6% of patients halving PPI use, and 21.4% remaining on the same dose prior to treatment with TAF with MUSE. Dr. Ali Lankarani, board member of the Advanced Therapeutic Endoscopy Center (ATEC) at the Broland-Groover Clinic in Jacksonville, FL, presented a poster titled, "Interim Results From A Multi-Center Post-Marketing Surveillance Registry Study for Endoscopic Anterior Fundoplication," reported data from an ongoing post-market registry study of 68 GERD patients who underwent Endoscopic Anterior Fundoplication (EAF) in 13 international centers. GERD-HRQL improved from 24.0 to 6.0 following treatment with MUSE (CI, 13.4 - 20.8, p < 0.00001), demonstrating patients experienced a clinically meaningful reduction in GERD-related symptoms. In addition, baseline patient satisfaction was reported at 0%, but improved to 70% (26/37) at 6 months and 90% (9/10) at 1 year. Of note, 76% (28/37; p < 0.00001) of patients have eliminated or reduced their use of proton pump inhibitors (PPI), with 96% of patients that responded favorably to treatment with the MUSE System stopping daily PPI therapy. Dr. Lankarani remarked, "These interim results, in conjunction with the data from the single-center study presented by Mazzoleni, highlight how the MUSE System can be a revolutionary, minimally-invasive treatment option for patients with GERD who are unsatisfied with PPI therapeutics and hesitant to pursue surgical intervention. In addition to the impressive findings, in another study we were able to access the value of the HOF criteria over the Hill classification, which we believe will play a pivotal role alongside the MUSE System in improving overall treatment outcomes in GERD." In addition, Dr. Lankarani presented a second poster, entitled, "Endoscopic Predictors of Decreased Reflux After Endoscopic Anterior Fundoplasty," which evaluated the HOF criteria as an endoscopic grading system of gastroesophageal junction (GEJ) geometry, as well as selection criteria to guide treatment decisions and predict treatment outcomes. Currently, Hill classification is the most commonly used criteria for antireflux procedures, however it has limited utility and still results in one-third of EAF-treated patients to continue experiencing reflux. HOF criteria categorizes GEJ geometry based on measurement of axial length of hiatal hernia (H), hiatus opening dimension (O) and flap valve size (F), with H and O openings less than 1cm considered normal (N) and 1cm or larger categorized as abnormal (A). GEJ is categorized as AAA if all three HOF landmarks are abnormal, NAA if one HOF landmark is normal and two are abnormal, and NNN if all three HOF landmarks are normal. Using the HOF criteria, the researchers identified and successfully treated 18 GERD patients, with Total Present of Time spent in Reflux (TPTR) showing a reduction in all patients with NAA configuration, and 75% and 71% TPTR reduction in individuals that had a 1 and 2 cm hiatal hernia, respectively. Average TPTR improvement was 53% for the NAA configuration patients, while average TPTR improvement in patients with 1 and 2 cm hiatal hernia was 56% and 46%, respectively. Chris Rowland, Chief Executive Officer of Medigus, commented, "As the developers of a completely new, minimally invasive solution for the treatment of GERD, we are extremely motivated by data presented this year at DDW. We are pleased with the results reported from the single center study, and look forward to continuing the ongoing post-market multi-center study, which have shown promising reductions in PPI reliance, as well as increases in patient quality of life and satisfaction. These studies continue to support the use of our MUSE System, which can reduce the need for pharmaceuticals and invasive surgical procedures." To learn more about MUSE, visit: www.medigus.com Medigus is a medical device company specializing in developing minimally invasive endosurgical tools and highly innovative imaging solutions. They are the pioneer developer of the MUSE™ system, an FDA cleared and CE marked endoscopic device to perform Transoral Fundoplication (TF) for the treatment of GERD (gastroesophageal reflux disease), one of the most common chronic conditions in the world. In 2016, the CMS established the Category I CPT® Code of 43210 for TF procedures, such as the ones performed with MUSE, which establishes reimbursement values for physicians and hospitals. MUSE is gaining adoption in key markets around the world -- it is available in world-leading healthcare institutions in the U.S., Europe and Israel. Medigus is also in the process of obtaining regulatory clearance in China. Medigus is traded on the Nasdaq Capital Market and the TASE (Tel-Aviv Stock Exchange). To learn more about the company's advanced technology, please visit www.medigus.com or www.RefluxHelp.com. This press release may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions and expectations of the company's management and its knowledge of the relevant market. The company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. These forward-looking statements represent Medigus' expectations or beliefs concerning future events, and it is possible that the results described in this news release will not be achieved. By their nature, Forward-Looking Statements involve known and unknown risks, uncertainties and other factors which may cause future results of the company's activity to differ significantly from the content and implications of such statements. Other risk factors affecting the company are discussed in detail in the Company's filings with the Securities and Exchange Commission. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind.


News Article | April 24, 2017
Site: globenewswire.com

NEW YORK, April 24, 2017 (GLOBE NEWSWIRE) -- Dr. Matilde Inglese, Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai has been selected to join the Education Board at the American Health Council. She will be sharing her knowledge and expertise on Neuroscience, Neuroimaging and Multiple Sclerosis.   As an Internationally recognized expert in the field of neuroimaging in demyelinating disorders, Dr. Matilde Inglese offers valuable insight in her role as the Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai for over fifteen years, Dr. Inglese’s day-to-day responsibilities include clinical research of Multiple Sclerosis patients using neuroimaging techniques. With support from the National Institute of Health, her research is geared towards the development and application of new structural and functional magnetic resonance imaging techniques at high and ultra-high field strength to analyze neurological diseases. Upon receipt of a medical degree magna cum laude from the University of Genoa, Italy in 1992, Dr. Inglese completed her residency at the University of Genoa in 1998.  In 1999, she completed a post-doctoral fellowship in Neuroimaging at San Raffaele Hospital, Milan, Italy. To further develop her professional career, she completed a fellowship in Radiology at the New York University in 2002. In 2004, Dr. Inglese obtained her PhD from the University of Genoa. Prior to her role as an Associate Professor of Neurology, Radiology and Neuroscience, at the Icahn School of Medicine at Mount Sinai in New York, Dr. Inglese joined the NYU faculty as an Associate Professor of Radiology, Neurology and Biomedical Imaging at New York University in 2011. Her interest in the field of Neurology began while in Italy, when she felt that very little was known about the pathophysiology of multiple sclerosis and the available treatments were only partially efficacious or not efficacious at all in subgroups of patients. Dr. Inglese thought that understanding how the disease progressed and why some patients have benefit from treatment and other not would eventually lead to improvement of patients’ care and quality of life. Dr. Inglese has authored over a hundred and fifty publications and received multiple grant funding from the National Institute for Neurological Disorders and Stroke, the National Multiple Sclerosis Society and the Congressionally Directed Medical Research Program in Multiple Sclerosis. Her publications have been featured in peer-reviewed journals such as the Lancet, Lancet Neurology, Annals of Neurology, Brain and Neurology. She has served on the editorial board of peer-reviewed journals and on grant advisory panels for the National Institute of Health, the National Multiple Sclerosis Society and for several international funding agencies. Dr. Inglese maintains affiliations with The American Academy of Neurology, International Society of Magnetic Resonance in Medicine, and the National Institute of Health study sections. In her free time, Dr. Inglese enjoys reading, bicycling and swimming. Her charitable organizations involvement includes participating in marathons for Multiple Sclerosis, completing peer reviews for the MS Foundation, and volunteering with MS Hope for a Cure. Considering the future, Dr. Inglese hopes to understand the pathophysiology of Multiple Sclerosis progression and contribute to provide new and effective biomarkers to monitor disease progression and response to treatment.


News Article | April 24, 2017
Site: globenewswire.com

NEW YORK, April 24, 2017 (GLOBE NEWSWIRE) -- Dr. Matilde Inglese, Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai has been selected to join the Education Board at the American Health Council. She will be sharing her knowledge and expertise on Neuroscience, Neuroimaging and Multiple Sclerosis.   As an Internationally recognized expert in the field of neuroimaging in demyelinating disorders, Dr. Matilde Inglese offers valuable insight in her role as the Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai for over fifteen years, Dr. Inglese’s day-to-day responsibilities include clinical research of Multiple Sclerosis patients using neuroimaging techniques. With support from the National Institute of Health, her research is geared towards the development and application of new structural and functional magnetic resonance imaging techniques at high and ultra-high field strength to analyze neurological diseases. Upon receipt of a medical degree magna cum laude from the University of Genoa, Italy in 1992, Dr. Inglese completed her residency at the University of Genoa in 1998.  In 1999, she completed a post-doctoral fellowship in Neuroimaging at San Raffaele Hospital, Milan, Italy. To further develop her professional career, she completed a fellowship in Radiology at the New York University in 2002. In 2004, Dr. Inglese obtained her PhD from the University of Genoa. Prior to her role as an Associate Professor of Neurology, Radiology and Neuroscience, at the Icahn School of Medicine at Mount Sinai in New York, Dr. Inglese joined the NYU faculty as an Associate Professor of Radiology, Neurology and Biomedical Imaging at New York University in 2011. Her interest in the field of Neurology began while in Italy, when she felt that very little was known about the pathophysiology of multiple sclerosis and the available treatments were only partially efficacious or not efficacious at all in subgroups of patients. Dr. Inglese thought that understanding how the disease progressed and why some patients have benefit from treatment and other not would eventually lead to improvement of patients’ care and quality of life. Dr. Inglese has authored over a hundred and fifty publications and received multiple grant funding from the National Institute for Neurological Disorders and Stroke, the National Multiple Sclerosis Society and the Congressionally Directed Medical Research Program in Multiple Sclerosis. Her publications have been featured in peer-reviewed journals such as the Lancet, Lancet Neurology, Annals of Neurology, Brain and Neurology. She has served on the editorial board of peer-reviewed journals and on grant advisory panels for the National Institute of Health, the National Multiple Sclerosis Society and for several international funding agencies. Dr. Inglese maintains affiliations with The American Academy of Neurology, International Society of Magnetic Resonance in Medicine, and the National Institute of Health study sections. In her free time, Dr. Inglese enjoys reading, bicycling and swimming. Her charitable organizations involvement includes participating in marathons for Multiple Sclerosis, completing peer reviews for the MS Foundation, and volunteering with MS Hope for a Cure. Considering the future, Dr. Inglese hopes to understand the pathophysiology of Multiple Sclerosis progression and contribute to provide new and effective biomarkers to monitor disease progression and response to treatment.


News Article | April 24, 2017
Site: globenewswire.com

NEW YORK, April 24, 2017 (GLOBE NEWSWIRE) -- Dr. Matilde Inglese, Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai has been selected to join the Education Board at the American Health Council. She will be sharing her knowledge and expertise on Neuroscience, Neuroimaging and Multiple Sclerosis.   As an Internationally recognized expert in the field of neuroimaging in demyelinating disorders, Dr. Matilde Inglese offers valuable insight in her role as the Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai for over fifteen years, Dr. Inglese’s day-to-day responsibilities include clinical research of Multiple Sclerosis patients using neuroimaging techniques. With support from the National Institute of Health, her research is geared towards the development and application of new structural and functional magnetic resonance imaging techniques at high and ultra-high field strength to analyze neurological diseases. Upon receipt of a medical degree magna cum laude from the University of Genoa, Italy in 1992, Dr. Inglese completed her residency at the University of Genoa in 1998.  In 1999, she completed a post-doctoral fellowship in Neuroimaging at San Raffaele Hospital, Milan, Italy. To further develop her professional career, she completed a fellowship in Radiology at the New York University in 2002. In 2004, Dr. Inglese obtained her PhD from the University of Genoa. Prior to her role as an Associate Professor of Neurology, Radiology and Neuroscience, at the Icahn School of Medicine at Mount Sinai in New York, Dr. Inglese joined the NYU faculty as an Associate Professor of Radiology, Neurology and Biomedical Imaging at New York University in 2011. Her interest in the field of Neurology began while in Italy, when she felt that very little was known about the pathophysiology of multiple sclerosis and the available treatments were only partially efficacious or not efficacious at all in subgroups of patients. Dr. Inglese thought that understanding how the disease progressed and why some patients have benefit from treatment and other not would eventually lead to improvement of patients’ care and quality of life. Dr. Inglese has authored over a hundred and fifty publications and received multiple grant funding from the National Institute for Neurological Disorders and Stroke, the National Multiple Sclerosis Society and the Congressionally Directed Medical Research Program in Multiple Sclerosis. Her publications have been featured in peer-reviewed journals such as the Lancet, Lancet Neurology, Annals of Neurology, Brain and Neurology. She has served on the editorial board of peer-reviewed journals and on grant advisory panels for the National Institute of Health, the National Multiple Sclerosis Society and for several international funding agencies. Dr. Inglese maintains affiliations with The American Academy of Neurology, International Society of Magnetic Resonance in Medicine, and the National Institute of Health study sections. In her free time, Dr. Inglese enjoys reading, bicycling and swimming. Her charitable organizations involvement includes participating in marathons for Multiple Sclerosis, completing peer reviews for the MS Foundation, and volunteering with MS Hope for a Cure. Considering the future, Dr. Inglese hopes to understand the pathophysiology of Multiple Sclerosis progression and contribute to provide new and effective biomarkers to monitor disease progression and response to treatment.


News Article | April 24, 2017
Site: globenewswire.com

NEW YORK, April 24, 2017 (GLOBE NEWSWIRE) -- Dr. Matilde Inglese, Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai has been selected to join the Education Board at the American Health Council. She will be sharing her knowledge and expertise on Neuroscience, Neuroimaging and Multiple Sclerosis.   As an Internationally recognized expert in the field of neuroimaging in demyelinating disorders, Dr. Matilde Inglese offers valuable insight in her role as the Associate Professor of Neurology, Radiology and Neuroscience at the Icahn School of Medicine at Mount Sinai for over fifteen years, Dr. Inglese’s day-to-day responsibilities include clinical research of Multiple Sclerosis patients using neuroimaging techniques. With support from the National Institute of Health, her research is geared towards the development and application of new structural and functional magnetic resonance imaging techniques at high and ultra-high field strength to analyze neurological diseases. Upon receipt of a medical degree magna cum laude from the University of Genoa, Italy in 1992, Dr. Inglese completed her residency at the University of Genoa in 1998.  In 1999, she completed a post-doctoral fellowship in Neuroimaging at San Raffaele Hospital, Milan, Italy. To further develop her professional career, she completed a fellowship in Radiology at the New York University in 2002. In 2004, Dr. Inglese obtained her PhD from the University of Genoa. Prior to her role as an Associate Professor of Neurology, Radiology and Neuroscience, at the Icahn School of Medicine at Mount Sinai in New York, Dr. Inglese joined the NYU faculty as an Associate Professor of Radiology, Neurology and Biomedical Imaging at New York University in 2011. Her interest in the field of Neurology began while in Italy, when she felt that very little was known about the pathophysiology of multiple sclerosis and the available treatments were only partially efficacious or not efficacious at all in subgroups of patients. Dr. Inglese thought that understanding how the disease progressed and why some patients have benefit from treatment and other not would eventually lead to improvement of patients’ care and quality of life. Dr. Inglese has authored over a hundred and fifty publications and received multiple grant funding from the National Institute for Neurological Disorders and Stroke, the National Multiple Sclerosis Society and the Congressionally Directed Medical Research Program in Multiple Sclerosis. Her publications have been featured in peer-reviewed journals such as the Lancet, Lancet Neurology, Annals of Neurology, Brain and Neurology. She has served on the editorial board of peer-reviewed journals and on grant advisory panels for the National Institute of Health, the National Multiple Sclerosis Society and for several international funding agencies. Dr. Inglese maintains affiliations with The American Academy of Neurology, International Society of Magnetic Resonance in Medicine, and the National Institute of Health study sections. In her free time, Dr. Inglese enjoys reading, bicycling and swimming. Her charitable organizations involvement includes participating in marathons for Multiple Sclerosis, completing peer reviews for the MS Foundation, and volunteering with MS Hope for a Cure. Considering the future, Dr. Inglese hopes to understand the pathophysiology of Multiple Sclerosis progression and contribute to provide new and effective biomarkers to monitor disease progression and response to treatment.


Bernardi R.,San Raffaele Scientific Institute | Gianni L.,San Raffaele Hospital
Cell Research | Year: 2014

Triple negative breast cancers (TNBC) are clinically heterogeneous but mostly aggressive malignancies devoid of expression of the estrogen, progesterone and HER2 (ERBB2 or NEU) receptors. Recent evidence shows that basal endoplasmic reticulum stress (ERS) is typically activated in TNBC and cooperates with hypoxia signaling to promote tumor progression and relapse; ERS and hypoxia response may therefore be among the long-searched hallmarks of TNBC. © 2014 IBCB, SIBS, CAS.

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