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Miranda's personal affinity for and experience with NONI FRUIT led to this special ingredient being one of KORA Organics key points of difference.  Miranda was introduced to Noni juice by her grandmother when she was 13 years old and has been consuming the powerful superfood ever since.  It is high in antioxidants and contains more than 100 vitamins and minerals with potent rejuvenating properties.  Noni Extract is found in all KORA Organics products, along with the purity and efficacy of other highly active key ingredients.  All products are also energized with ROSE QUARTZ during the manufacturing process to infuse the vibration of love.  Rose quartz is a special healing crystal for attracting love and acceptance for ourselves and others. KORA Organics has a new look and product assortment line up, with two topical skincare products, one ingestible and one aromatherapy-based SKU. This second generation of KORA Organics will bow nationwide in all Sephora doors (and Sephora.com) with the first four new products, followed by eleven additional products scheduled to hit in September 2017.  The first generation of KORA Organics was introduced in limited distribution in the US in 2013 through Net-a-Porter (who will continue to carry the brand) and at Koraorganics.com, where all new products will also be available. "I created KORA Organics because I wanted to use organic skincare that was healthy for my skin, both inside and out, and that also gave me the results that I need.  Having my products certified is so important to me so that you know exactly what you're putting onto your skin; because what you put on your skin soaks directly into your bloodstream.  I designed a range of products that collectively have a positive influence on the mind, body and skin, so you don't just look your best, but you feel your best too." says Kerr. KORA Organics mission is to nourish people's MIND BODY and SKIN – a wholly integrated approach: feed your mind with positive affirmations and self-love, feed your body with the nutrients it needs to function at its best, and feed your skin with products that help detoxify, nourish and revitalize.  By nourishing your MIND, BODY, SKIN you can get the "NONI GLOW," a phrase the brand has coined to reflect Miranda's unique 360 approach to beauty and wellness. The new KORA Organics Noni Glow Collection also bows in Australia in July 2017 via Department Store David Jones and Koraorganics.com. The Noni Glow Face Oil is a super nourishing treatment oil that is great for all skin types and especially good for sensitive skin.  It hydrates, leaving skin softer, smoother and plumper-looking while boosting skin's natural radiance and delivering a beautiful glow.  $68/30 ml Noni Glow Body Oil is a luxurious lightweight, multi-purpose body treatment oil that softens rough textures and replenishes skin's moisture levels leaving it healthier and more radiant. $58/100ml Noni Glow Skin Food is a potent, nutrient-dense superfood supplement for your daily beauty and wellness benefits, inside and out.  It has a smooth and delicate fruity taste with no added sugar, artificial colors, flavors or preservatives. $55/30 packets. Heart Chakra Aromatherapy Oil is an aromatic wellness essence – one of Miranda's personal blends of the finest supercharged oils to invoke, nurture and empower the energies of your heart chakra. $48/10ml To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/kora-organics-created-by-miranda-kerr-to-launch-new-noni-glow-collection-in-all-sephora-doors-nationwide-may-19th-300460504.html


News Article | April 26, 2017
Site: www.techtimes.com

Health experts advocate that one should drink alcohol in moderation to avoid any complications. A new study reveals that alcohol binge upsets the heart's rhythm of an individual. The Department of Medicine at University Hospital Munich led the new study and found that the higher the alcohol consumption, the greater was the individual's risk of developing cardiac arrhythmias or irregular heart rhythms. Oktoberfest, which is held in Germany, is the world's largest beer festival and usually spans over for 16 to 18 days. The festival generally starts mid-September or late-September and continues till the first weekend of October. For the purpose of the study, the researchers observed drinking behavior during the beer fest. Previous studies have revealed that acute alcohol consumption over a short span leads to the development of "Holiday Heart Syndrome." Individuals with no history of heart problems develop abnormal heart rhythms and sometime atrial fibrillation. However, the association of heavy drinking and cardiac arrhythmias was found in small conservative studies. The current Oktoberfest study is the world's first largest analysis till date to prove this association on a large scale basis. The researchers observed 3,028 voluntary participants who were Oktoberfest attendees in 2015. All the participants were given a smartphone-based ECG and their breath alcohol concentration or BAC measurements were also noted. The ECG results were analyzed and observed to detect cardiac arrhythmias, especially sinus arrhythmia, sinus tachycardia, premature atrial/ventricular complexes, and atrial fibrillation/flutter. The researchers applied the multi-variable adjusted logistic regression method to link the BAC measurements with cardiac arrhythmias. The researchers also studied the results of a community-based KORA S4 study, which involved 4,131 participants to delve further into the connection between acute alcohol consumption and heart arrhythmias. From the 2015 Oktoberfest study, the researchers found that the smartphone-based ECG measurements recorded 30.5 percent of cardiac arrhythmias amongst the 3,028 attendees cum participants of the fest. Most of the cardiac arrhythmias cases were of sinus tachycardia (25.9 percent). It was also discovered that the BAC measurements had significant links with cardiac arrhythmias cases in the participants and sinus tachycardia in particular. It was discovered that for "each one gram of alcohol per kilogram of blood above zero the likelihood of a cardiac arrhythmia increased by 75%." "Three grams of alcohol per kilogram of blood reflects a very high alcohol intake, approaching the border of intoxication, and not many people can tolerate it," the lead author of the study Stefan Brunner shared. Although the researchers established a significant association between heavy drinking and abnormal heart rhythm, not many physicians see how the results will aid clinical care. Kenneth J. Mukamal, a physician at Beth Israel Deaconess Medical Center remarked that the results don't concentrate directly on cardiac arrhythmias. "This does provide some interesting mechanistic insight into how alcohol influences risk of heart rhythm disturbances at high doses, but it does not otherwise identify new risks from drinking," Mukamal told MedPage Today. Even Daniel P. Morin, MD at the John Ochsner Heart and Vascular Institute in New Orleans shared that one can explain the irregular heart rates as a result of excitement in a high-charged festival like Oktoberfest. The study's findings have been published in European Heart Journal on Wednesday, April 26. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.


News Article | February 16, 2017
Site: www.eurekalert.org

The Helmholtz Zentrum München has published results of the largest genome-wide association study on proteomics to date. An international team of scientists reports 539 associations between protein levels and genetic variants in 'Nature Communications'. These associations overlap with risk genes for 42 complex diseases. Genome-wide association studies (GWAS) provide an opportunity to associate concentration changes in certain proteins or metabolic products with gene loci. Knowledge of these genes makes it possible to establish connections to complex diseases. Scientists utilize the fact that to date, hundreds of associations between genetic variants and complex diseases have been demonstrated. These associations are immensely important because they do help uncover the underlying molecular mechanisms. "In the world's largest proteomics GWAS to date, we worked with colleagues* to examine blood samples from 1,000 participants in the KORA study**," reports Dr. Gabi Kastenmüller. She is acting director and head of the Metabolomics Group at the Institute of Bioinformatics and Systems Biology (IBIS) at the Helmholtz Zentrum München. The team quantified a total of 1,100 proteins. Dr. Christian Gieger, head of the Molecular Epidemiology Research Unit (AME) at the Helmholtz Zentrum München, adds: "We found 539 independent associations between protein levels and genetic variants." These overlap with genetic risk variants for 42 complex conditions, such as cardiovascular diseases and Alzheimer's disease. "Our results provide new insights into the biological processes that are influenced by a very wide range of complex diseases and that can be used as a basis for the development of new strategies to predict and prevent these diseases," Gieger states. The team is now planning to investigate the exact mechanisms behind the new gene-protein associations. * Participants from the Helmholtz Zentrum München were: The Molecular Epidemiology Research Unit (AME), the Institute of Epidemiology 2 (EPI2), the Institute of Bioinformatics and Systems Biology (IBIS), and the Institute of Genetic Epidemiology (IGE). External partners were the German Center for Diabetes Research (DZD), the German Center for Cardiovascular Disease (DZHK), and Weill Cornell Medicine, Qatar and Doha, Qatar. ** KORA study: The "Kooperative Gesundheitsforschung in der Region Augsburg" (Cooperative Health Research in the Augsburg Region) study has been investigating the health of thousands of people living in the Greater Augsburg area for 30 years. The objective is to understand the effects of environmental factors, lifestyle and genes. Key topics of the KORA studies are issues involving the genesis and progress of chronic diseases, particularly cardiac infarction and diabetes mellitus. Risk factors from the area of health-related behaviour (such as smoking, nutrition, and physical activity), environmental factors (including air and noise pollution), and genetics are explored for this purpose. Issues regarding the utilization and costs of healthcare are examined from the point of view of healthcare research. http://www. Original publication: Karsten Suhre et al. (2017): Connecting genetic risk to disease endpoints through the human blood plasma proteome, Nature Communications, DOI: 10.1038/ncomms14357. The Helmholtz Zentrum München, as the German Research Center for Environmental Health, pursues the objective of developing personalized medicine for the diagnosis, therapy, and prevention of widespread diseases such as diabetes mellitus and lung diseases. To this end, it investigates the interactions of genetics, environmental factors, and lifestyle. The Zentrum's headquarters is located in Neuherberg in the north of Munich. The Helmholtz Zentrum München employs around 2,300 people and is a member of the Helmholtz Association, which has 18 scientific-technical and biological-medical research centres with around 37,000 employees. http://www. The Institute of Bioinformatics and Systems Biology (IBIS) concentrates on the analysis and interpretation of large, high-dimensional biological data sets in order to extract from them information on the molecular basis of complex diseases. In this framework, the institute systematically examines genetic variants, expression patterns, and protein and metabolite profiles and their associations. IBIS develops new bioinformatic and systems biology methods and resources that make it possible to model and visualize high throughput data and the results gained from them. http://www. The Molecular Epidemiology Research Unit (AME) analyses population-based cohorts and case studies for certain diseases with the help of genomics, epigenomics, transcriptomics, proteomics, metabolomics, and functional analyses. The objective is to explain the molecular mechanisms in complex diseases such as type 2 diabetes and obesity. The unit runs the epidemiology biosample bank and handles sample administration and storage for national and international projects. http://www.


News Article | December 22, 2016
Site: www.eurekalert.org

The extra pounds you gain during the holidays will not only show up on your hips but will also affect your DNA. This is the result of a large-scale international study coordinated by Helmholtz Zentrum München, a partner in the German Center for Diabetes Research, which has now been published in 'Nature'. The study shows that a high BMI leads to epigenetic changes at nearly 200 loci of the genome - with effects on gene expression. While our genes do not change in the course of life, our lifestyle can directly influence their surroundings. Scientists speak here of the epigenome (Greek epi: over, outside of, around), which refers to everything that happens on or around the genes. Up to now there has not been much research on how the epigenome is altered as a result of being overweight. "This issue is particularly relevant because an estimated one and a half billion people throughout the world are overweight," said first author Dr. Simone Wahl of the Research Unit Molecular Epidemiology (AME) at Helmholtz Zentrum München, "especially considering that being overweight can have adverse consequences and lead to diabetes and diseases of the cardiovascular and metabolic systems." For this reason, the international research team led by Dr. Christian Gieger and Dr. Harald Grallert of the AME (as well as Jaspal Kooner and John Chambers of Imperial College London) examined possible correlations between body mass index (BMI) and epigenetic changes.* Using state-of-the-art technology, the team carried out the world's largest study so far on the subject. The scientists examined the blood samples of over 10,000 women and men from Europe. A large proportion of these were inhabitants of London of Indian ancestry, who according to the authors are at high risk for obesity and metabolic diseases. In a first step with 5,387 samples **, the research team identified 207 gene loci that were epigenetically altered dependent on the BMI. They then tested these candidate loci in blood samples of an additional 4,874 subjects and were able to confirm 187 of these***. Further studies and long-term observations also indicated that the changes were predominantly a consequence of being overweight - not the cause. "In particular, significant changes were found in the expression of genes responsible for lipid metabolism and substrate transport, but inflammation-related gene loci were also affected," said group leader Harald Grallert. From the data, the team was also able to identify epigenetic markers that could predict the risk of type 2 diabetes. "Our results allow new insights into which signaling pathways are influenced by obesity", said Christian Gieger, head of the AME. "We hope that this will lead to new strategies for predicting and possibly preventing type 2 diabetes and other consequences of being overweight." Next, within the framework of translational research in the German Center for Diabetes Research, the researchers want to investigate in detail how the epigenetic changes affect the expression of the underlying genes. * Specifically, the team investigated the methylation patterns, i.e. the presence or absence of methyl groups on the DNA. By means of high-throughput measurements, these methylation patterns can now be investigated relatively quickly and on a large scale. ** Among others from the Augsburg KORA study, the London LOLIPOP study and a part of the EPICOR study population from Italy *** Some of these have also been confirmed in adipose tissue, indicating that changes in gene regulation in disease-relevant tissues are also visible in the blood. Helmholtz Zentrum München has extensive expertise in the field of genetic and epigenetic causal research on metabolic diseases: As recently as July 2016, the researchers were involved in the world's largest genetic study on type 2 diabetes, which was likewise published in the renowned journal Nature. Link to press release: https:/ Furthermore, already in March 2016 scientists of Helmholtz München showed that diet-induced obesity and diabetes can be passed on epigenetically to the offspring via both oocytes and sperm. Link to related press release: https:/ Wahl, S. et al. (2016): Epigenome-wide association study of body mass index, and the adverse outcomes of adiposity. Nature, doi:10.1038/nature20784 http://www. The Helmholtz Zentrum München, the German Research Center for Environmental Health, pursues the goal of developing personalized medical approaches for the prevention and therapy of major common diseases such as diabetes and lung diseases. To achieve this, it investigates the interaction of genetics, environmental factors and lifestyle. The Helmholtz Zentrum München is headquartered in Neuherberg in the north of Munich and has about 2,300 staff members. It is a member of the Helmholtz Association, a community of 18 scientific-technical and medical-biological research centers with a total of about 37,000 staff members. http://www. The Research Unit of Molecular Epidemiology (AME) analyses population-based cohorts and case studies for specific diseases, using genomics, epigenomics, transcriptomics, proteomics, metabolomics and functional analyses. The aim of this research unit is to decipher the molecular mechanisms of complex diseases like type 2 diabetes or obesity. The unit administers the biological specimen repository of the Department of Epidemiology and stores the samples for national and international projects. http://www. The Institute of Epidemiology II (EPI II) focuses on the assessment of environmental and lifestyle risk factors which jointly affect major chronic diseases such as diabetes, heart disease and mental health. Research builds on the unique resources of the KORA cohort, the KORA myocardial infarction registry, and the KORA aerosol measurement station. Aging-related phenotypes have been added to the KORA research portfolio within the frame of the Research Consortium KORA-Age. The institute's contributions are specifically relevant for the population as modifiable personal risk factors are being researched that could be influenced by the individual or by improving legislation for the protection of public health. http://www. Research at the Institute of Genetic Epidemiology (IGE) focuses on planning, realization and analysis of projects regarding the identification of genetic factors responsible for complex traits. This involves application, further development and implementation of a variety of statistical methods to address specific aspects such as rare genetic variants, mitochondrial DNA, gene-gene and gene-environment interactions, family studies, and the handling of population structures. The elucidation of disease-relevant genetic factors as well as their inclusion into models of disease risk provides the basis of individualized approaches to treatment or prevention. http://www. The Institute of Human Genetics (IHG) at the Helmholtz Zentrum München and the Technical University of Munich: The Institute is concerned with identifying genes associated with disease and characterizing their functions. The main aim of the research projects is to develop disease-related genetic variation in humans and mice as well as to develop chromosome analysis techniques and new methods for dealing with specific issues in the sphere of pre- and post-natal diagnostics and tumor cytogenetics. http://www. The German Center for Diabetes Research (DZD) is a national association that brings together experts in the field of diabetes research and combines basic research, translational research, epidemiology and clinical applications. The aim is to develop novel strategies for personalized prevention and treatment of diabetes. Members are Helmholtz Zentrum München - German Research Center for Environmental Health, the German Diabetes Center in Düsseldorf, the German Institute of Human Nutrition in Potsdam-Rehbrücke, the Paul Langerhans Institute Dresden of the Helmholtz Zentrum München at the University Medical Center Carl Gustav Carus of the TU Dresden and the Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the Eberhard-Karls-University of Tuebingen together with associated partners at the Universities in Heidelberg, Cologne, Leipzig, Lübeck and Munich. http://www.


News Article | December 7, 2016
Site: www.eurekalert.org

According to the authors headed by Dr. Hildegard Seidl from the Institute of Health Economics and Health Care Management (IGM) and Dr. Inge Kirchberger from the Institute of Epidemiology II (EPI II), regular contact and information programs provided by trained nurses additionally produce further positive effects: improved muscle strength and blood fat levels with less significant physical restrictions and healthier diets of the patients. The results are based on the evaluation of data from the KORINNA study, in which the scientists examined more than 300 cardiac infarction patients aged 65 years or older. After being discharged from the hospital, the patients were randomly divided into two groups. One group received the customary treatment in accordance with German standards, while the other additionally received so-called case management support from appropriately trained nurses. This included such measures as informative material at the time of the hospital discharge, home visits, and regular telephone contact (at least every three months). First author Seidl explains the hypothesis: "We wanted to test whether or not the greater information density on topics such as medication intake, nutrition, and psychosocial aspects, combined with instructions on the measurement of important parameters such as blood pressure, pulse or blood sugar levels in patients, leads to improved quality of life. Because according to the authors, older patients with myocardial infarction frequently suffer from concurrent conditions that can lead to multiple medications, reduced quality of life, and readmission to the hospital. In Germany, however, until now no case management program has been offered and evaluated for elderly patients with myocardial infarction. "Our health care system faces constantly increasing costs due to demographic developments and expensive innovations," reports study leader Prof. Dr. Rolf Holle. "Cost-effective solutions that improve the patients' health are more necessary than ever," the IGM deputy director states. It is therefore useful to see if the results that have now been published should also lead to possible treatment recommendations. "The study that we conducted creates a good information basis that the relevant healthcare policy authorities can use to make rational decisions," Seidl explains. "The results provide scientific evidence that supplementary care in a case management program can cost-effectively improve the health of elderly patients. It is worth considering adding a cardiac infarction diagnosis to the guideline for transferring a physician's activities to a nursing staff* in order to allow case management for this patient group." Myocardial infarction is one of the leading causes of death around the world. Patients who have already suffered a cardiac infarction have a high risk for a renewed heart attack, but this risk can be reduced if the patient makes certain life style changes and reliably takes the prescribed medication. These changes are facilitated by close and continuing contact with therapists, and this contact can be promoted by low-threshold programs. * This specifically refers to the guideline pursuant to Section 63 Par. 3c SGB V [German code of social law]. The KORINNA Study: Health economic evaluation of a case management program in elderly coronary infarction patients. In the monocentric study, 340 patients aged 65 years or more with acute myocardial infarction were recruited in the Central Hospital of Augsburg and randomly assigned to either the intervention or the control group. Patients in the intervention group received one home visit, or more if necessary, by trained personnel over a period of three years, as well as quarterly telephone consultations, while participants in the control group received the customary care. The state of health and the utilization of health services in both groups were polled every three months by telephone. The primary target criterion was the time from discharge from the base stay until the first unplanned readmission (or until death outside of the hospital). Secondary target criteria, such as clinical measurement parameters, functional capability, depressive tendencies, and health-related quality of life, were collected during the examination after three years. Costs of the hospitalizations were determined from the administrative data, while all other costs were estimated according to the unit cost approach on the basis of information provided by the patients. Further information is available at: http://www. Prof. Dr. Christa Meisinger (EPI II, MONICA/KORA Herzinfarktregister, NAKO Study Center), Prof. Dr. Bernhard Kuch (now chief physician at Stiftungskrankenhaus Nördlingen) and Prof. Dr. Rolf Holle (IGM) planned the study, which was performed at the Central Hospital of Augsburg. Data analysis was performed at IGM by Dr. Hildegard Seidl, Dr. Matthias Hunger und Dr. Björn Stollenwerk. The case management program offered for elderly patients did not show any statistically verifiable improvement in the quality of life in the first survey within the first follow-up year. Follow-up in the framework of the study was extended to three years in order to allow an additional analysis of the medium-term effects. This is where the current study comes in. No evidence could be provided for a longer time to the first readmission to the hospital or to death (combined endpoint) or for a gain in quality-adjusted years of life. Seidl, H. et al. (2016): The 3-year cost-effectiveness of a nurse-based case management versus usual care for elderly patients with myocardial infarction: Results from the KORINNA follow-up study. Value in Health, doi: 10.1016/j.jval.2016.10.001 Kirchberger, I. et al (2015): Effects of a 3-Year Nurse-Based Case Management in Aged Patients with Acute Myocardial In-farction on Rehospitalisation, Mortality, Risk Factors, Physical Functioning and Mental Health. A Secondary Analysis of the Randomized Controlled KORINNA Study. PLoS One, doi: 10.1371/journal.pone.0116693. The Helmholtz Zentrum München, the German Research Center for Environmental Health, pursues the goal of developing personalized medical approaches for the prevention and therapy of major common diseases such as diabetes and lung diseases. To achieve this, it investigates the interaction of genetics, environmental factors and lifestyle. The Helmholtz Zentrum München is headquartered in Neuherberg in the north of Munich and has about 2,300 staff members. It is a member of the Helmholtz Association, a community of 18 scientific-technical and medical-biological research centers with a total of about 37,000 staff members. http://www. The Institute of Health Economics and Health Care Management (IGM) examines approaches to improving the effectiveness and efficiency of health care. The health care system faces the challenge of delivering high-quality, economically viable medical services to meet the needs of the population. Rapid advances in medical technology and fast-changing demographics further aggravate this problem. A firmly based evaluation of the effectiveness and efficiency of health care structures and processes is therefore an essential prerequisite for a rational health care policy. http://www. The Institute of Epidemiology II (EPI II) focuses on the assessment of environmental and lifestyle risk factors which jointly affect major chronic diseases such as diabetes, heart disease and mental health. Research builds on the unique resources of the KORA cohort, the KORA myocardial infarction registry, and the KORA aerosol measurement station. Aging-related phenotypes have been added to the KORA research portfolio within the frame of the Research Consortium KORA-Age. The institute's contributions are specifically relevant for the population as modifiable personal risk factors are being researched that could be influenced by the individual or by improving legislation for the protection of public health. http://www. For almost 30 years, the Cooperative Health Research in the Region of Augsburg (KORA) has been examining the health of thousands of citizens in Augsburg and environs. The aim of the project is to increase understanding of the impact of environmental factors, behaviour and genes on human health. The KORA studies focus on matters relating to the development and progression of chronic diseases, in particular myocardial infarction and diabetes mellitus. To that end, research is conducted into risk factors arising from lifestyle factors (including smoking, diet and exercise), environmental factors (including air pollution and noise) and genetics. Questions relating to the use and cost of health services are examined from the point of view of health services research. http://www. Dr. Hildegard Seidl, Helmholtz Zentrum München - German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Ingolstädter Landstr. 1, 85764 Neuherberg - Tel. +49 89 3187 4485 - E-mail: hildegard.seidl@helmholtz-muenchen.de


News Article | November 21, 2016
Site: www.eurekalert.org

A study published today in the journal PLOS Medicine has identified the five genetic variants associated with higher levels of the branched-chain amino acids isoleucine, leucine and valine. The researchers also found that these genetic variants were associated with an increased risk of type 2 diabetes. The researchers, led by the Medical Research Council (MRC) Epidemiology Unit at the University of Cambridge, used large-scale genetic data together with detailed measurements of the branched-chain amino acids and their metabolites in the blood of more than 16,000 volunteers*. Branched-chain amino acids have fundamental roles in human metabolism and are building blocks of proteins. Unlike some of the other 20 amino acids, they cannot be made by the human body. This means that their levels depend entirely on external sources, from food sources or dietary supplements, and the ability of our body to metabolise them. To date, while higher circulating levels of branched-chain amino acids have been found to be associated with type 2 diabetes, no study has been able to establish whether this link is causal. This is important, because if the relationship is found to be causal, reducing dietary intake or altering the metabolism of these amino acids could help to prevent diabetes, an increasingly common and serious disease. The researchers studied over 10 million genetic variants in more than 16,000 men and women and discovered five regions of the human genome with genetic differences that are associated with higher levels of circulating branched-chain amino acids. They then found that in 300,000 individuals**, including 40,000 diabetes patients, those carrying the genetic differences associated with higher levels of branched-chain amino acids were also found to be at increased risk of type 2 diabetes, providing strong evidence of a causal link. PPM1K, the gene found to be most strongly associated with levels of all three amino acids and also with a higher risk of diabetes, encodes a known regulator of the key step in the breakdown of branched-chain amino acids. This suggests that an impaired breakdown of these amino acids may put individuals at higher risk of type 2 diabetes. Intervening on this pathway may reduce diabetes risk. "Our results suggest that treatment strategies which target metabolism of branched-chain amino acids could help to reduce the risk of diabetes, and we already know which molecules target this metabolic pathway", says Dr Claudia Langenberg from the MRC Epidemiology Unit at the University of Cambridge. Clinical trials will now need to be carried out to establish if drugs that target the breakdown of branched-chain amino acids can reduce the risks of type 2 diabetes. *16,000 volunteers were from the Fenland Study & meta-analysis of KORA and TwinsUK studies. ** 300,000 individuals were from the Diabetes Genetics Replication and Meta-analysis, EPIC_InterAct, GoDART and UK Biobank For further information or to request an interview with a researcher involved with the study, please contact the MRC press office on +44(0)207 395 2345 (Out of Hours: +44(0)7818 428 297) or email press.office@headoffice.mrc.ac.uk Paper details: Genetic Predisposition to an Impaired Metabolism of the Branched-Chain Amino Acids and Risk of Type 2 Diabetes: A Mendelian Randomisation Analysis. Luca Lotta et al. PLOS Medicine. After embargo paper will be available here: http://dx. The Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers' money in some of the best medical research in the world across every area of health. Thirty-one MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. http://www. The MRC Epidemiology Unit is a department at the University of Cambridge. It studies the genetic, developmental and environmental factors that cause obesity, type 2 diabetes and related metabolic disorders. The outcomes from these studies are then used to develop strategies for the prevention of these diseases in the general population. http://www.


News Article | March 1, 2017
Site: www.businesswire.com

LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN; LSE: LIVN) (“LivaNova” or the “Company”), a market-leading medical technology and innovation company, today reported results for the fourth quarter and full year ended December 31, 2016. For the fourth quarter of 2016, worldwide sales were $311 million, a decrease of 2.3 percent on a reported basis and a decrease of 1.6 percent on a constant-currency basis, as compared to the previous year. On a U.S. Generally Accepted Accounting Principles (GAAP) basis, fourth quarter 2016 loss per share was ($0.61). Fourth quarter 2016 adjusted diluted earnings per share were $0.85. For full-year 2016, worldwide sales were $1.2 billion, an increase of 0.8 percent on a reported basis and increase of 1.0 percent on a constant-currency basis, as compared to the previous year. On a GAAP basis, full-year 2016 loss per share was ($1.29). Full-year 2016 adjusted diluted earnings per share were $3.05. "Despite it being a challenging year for top-line growth, we were able to deliver adjusted earnings per share at the high end of our projected range," said Damien McDonald, chief executive officer. “2016 was LivaNova's first full year as a public company and we made significant progress in many areas – launching several key products, driving merger and restructuring synergies, aligning inventory levels and consolidating balance sheet strength. We implemented numerous measures to reinforce our foundation and simplify our business model. This positions LivaNova for a stronger future, driving sustainable growth, continued financial leverage and value to our shareholders.” The following table highlights worldwide sales for the fourth quarter of 2016 compared to the same period in 2015: For discussion purposes, all sales growth rates below reflect comparable, constant currency growth. The difference between constant currency growth and reported growth reflects the impact from currency fluctuations in the various currencies in which we operate. Worldwide sales for the fourth quarter were $311 million, down 1.6 percent compared to the fourth quarter of 2015. For the three business franchises, sales were as follows: Cardiac Surgery sales, which include cardiopulmonary products and heart valves, were $159 million, representing a 3.2 percent decrease versus the comparable period in 2015. Sales in cardiopulmonary products were $125 million, down 3.4 percent from the fourth quarter of 2015. A decline in the Company’s 3T Heater-Cooler devices, as a result of import restrictions in the U.S., the introduction of our loaner program across geographies and the timing of heart-lung machine orders in Europe offset share gains and strong demand in Europe and emerging markets for oxygenators. Heart valve sales, including tissue and mechanical heart valves, were $34 million, a decrease of 2.2 percent compared to the same period the previous year. Strength in tissue valves, driven by strong demand for Perceval in both the U.S. and Europe was offset by declines in mechanical valves globally, with on-going inventory alignment in emerging markets, particularly China. CRM sales for the period totaled $61 million, an increase of 1.3 percent as compared to the fourth quarter of 2015, primarily due to the launch of our KORA 250 pacemaker in Japan. Neuromodulation sales were $91 million in the fourth quarter, a slight decline from the prior year period, primarily due to four less selling days this quarter and inventory alignment in our European business, which offset favorable results from the continued adoption of the Company’s newest VNS Therapy device, AspireSR, in the U.S. On a U.S. GAAP basis, fourth quarter 2016 net loss from operations was $37 million, primarily due to costs related to the 3T Heater-Cooler Remediation Plan, impairment of goodwill in our CRM business franchise and restructuring expenses. Adjusted income from operations for the fourth quarter of 2016 was $57 million, an increase of 27.9% as compared to the fourth quarter of 2015, primarily driven by improvements in gross margin and a significant reduction in operating expenses resulting from merger synergy and restructuring activities. The following table highlights selected financial worldwide sales for the full-year 2016 compared to the same period in 2015: For discussion purposes, all sales growth rates below reflect comparable, constant currency growth. The difference between constant currency growth and reported growth reflects the impact from currency fluctuations in the various currencies in which we operate. Worldwide sales for full-year 2016 were $1.2 billion, up 1.0 percent compared to full-year net sales in 2015, primarily due to strong adoption of AspireSR and the U.S. launch of Perceval, our sutureless valve. For the three business franchises, sales were as follows: Cardiac Surgery sales, which include cardiopulmonary products and heart valves, were $612 million, down slightly versus full-year 2015. Sales in cardiopulmonary products were $474 million, relatively flat with the full-year 2015, primarily due to a decline in the Company’s 3T Heater-Cooler devices, as a result of import restrictions in the U.S. and more recently, the loaner program, offset by strong sales and share gains in INSPIRE, our newest oxygenator. Heart valve sales, including tissue and mechanical heart valves, were $137 million, a decrease of 1.6 percent compared to the previous year. Strength in tissue valves, driven by strong demand for Perceval in both the U.S. and Europe, was offset by declines in mechanical valves. CRM sales totaled $249 million, a decrease of 4.7 percent as compared to full-year 2015. Positive performance of the Company’s newest high-voltage device PLATINIUM and favorable year-over-year results with its KORA 250 pacemaker were offset by declines in our Europe low-voltage business, as a result of continued pricing pressure and delayed product launches. Neuromodulation sales were $351 million for the full-year 2016, an increase of 8.8 percent over the prior year period, driven primarily by continued adoption of the Company’s newest VNS Therapy device, AspireSR, and strong new patient growth in the U.S. On a U.S. GAAP basis, loss from operations for full-year 2016 was $28 million. Adjusted income from operations for full-year 2016 was $219 million, an increase of 26.9 percent as compared to full-year 2015. LivaNova expects worldwide net sales for full-year 2017 to grow between 1 and 3 percent on a constant-currency basis. Adjusted diluted earnings per share for 2017 are expected to be in the range of $3.25 to $3.45. Key non-GAAP reconciliation items to the projected 2017 adjusted diluted earnings per share are as follows: In 2017, the company estimates that adjusted cash flow from operations, excluding integration, restructuring and 3T remediation payments, will be in the range of $190 to $210 million. Capital expenditures are projected to range between $40 million to $50 million. Depreciation and amortization is expected to be in the mid-$30 million range. "We have created a solid foundation and are on track for continued progress in 2017 with initiatives to advance our growth, drive product launches and fund our equity investments, which remain exciting opportunities for the company," said McDonald. "We expect continued progress as we execute on our synergy targets and retain our focus, energy and discipline as a company. Together, we believe these efforts will enable LivaNova to most effectively serve the needs of our customers and patients, and deliver strong value to our shareholders." The conference call will be available to interested parties through a live audio webcast commencing at 8:00 a.m. Central time (9:00 a.m. Eastern time, 2:00 p.m. UK time) and accessible through the Investor Relations section of the LivaNova corporate website at www.LivaNova.com. To listen to the conference call live by telephone, dial (844) 239-5285 (if dialing from within the U.S.) or (512) 961-6524 (if dialing from outside the U.S.). The conference ID is 40640458. Within 24 hours of the webcast, a replay will be available under the "News & Events / Presentations" section of the Investor Relations portion of the LivaNova website, where it will be archived and accessible for approximately 12 months. LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively. Cyberonics Inc., the predecessor company to LivaNova, previously reported on a 52/53 week fiscal year calendar ending in April. With the formal change in the fiscal calendar to a fiscal year ended December 31, the historical Neuromodulation business franchise sales have been aligned to correspond as closely as possible to calendar quarters. Although LivaNova was a shell company with no business operations until the closing date of the merger on October 19, 2015, the sales results disclosed for periods up to and beyond that date are being provided on a combined basis, a non-GAAP formulation that combines the results of legacy Sorin Group S.p.A. (Sorin) and Cyberonics for the periods completed prior to the merger and periods that include results both before and after the closing of the merger. The Company believes that presenting the results of Sorin and Cyberonics in such a manner offers a meaningful representation to investors of the combined company’s sales for these periods. Non-GAAP operating results, unaudited, have been included for 2015. These results have been prepared by management and adjusted for non-GAAP items as if the merger had occurred on January 1, 2015 but should not be considered as an alternative to Proforma Income Statements to be provided in accordance with SEC filings. Certain adjustments to legacy Sorin operating results have occurred in order to present the results in U.S. dollars and to align these results as closely as possible to the presentation of LivaNova financial results. Company management uses these measurements as aids in monitoring the Company’s ongoing financial performance from quarter to quarter and year to year on a regular basis and for benchmarking against other medical technology companies. Management believes that the presentation of these results provides a meaningful representation of the combined company’s operating results for the periods presented. The sales and operating results for legacy Cyberonics for the quarters ended March 31, June 30 and September 30 were aligned to provide comparative information. The actual periods ended on March 27, June 26 and September 25 respectively. LivaNova (as the successor to Sorin and Cyberonics on a combined basis) operates under a Business Franchise structure with Cardiac Surgery, CRM and Neuromodulation accounting for substantially all of the sales during the periods referred to herein. The combined company also operates a New Ventures group, dedicated to developing new technologies. Use of Non-GAAP Financial Measures In this press release, management has disclosed financial measurements that present financial information not necessarily in accordance with Generally Accepted Accounting Principles (GAAP). Company management uses these measurements as aids in monitoring the Company’s ongoing financial performance from quarter to quarter and year to year on a regular basis and for benchmarking against other medical technology companies. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. These non-GAAP financial measures should be considered along with, but not as alternatives to, the operating performance measure as prescribed by GAAP. Unless otherwise noted, all sales growth rates in this release reflect comparable, constant currency growth. Management believes that referring to comparable, constant currency growth is the most useful way to evaluate the sales performance of LivaNova and to compare the sales performance of current periods to prior periods on a consistent basis. Constant currency growth, a non-GAAP financial measure, measures the change in sales between current and prior year periods using average exchange rates in effect during the applicable prior year period. This press release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe the Company’s future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this press release are based on information presently available to LivaNova and assumptions that the Company believes to be reasonable, but are inherently uncertain. As a result, the Company’s actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company’s control. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning achieving a stronger future, driving sustainable growth and value to our shareholders, projected net sales, adjusted diluted earnings per share, cash flow from operations, capital expenditures and depreciation and amortization for 2017, advancing our growth, driving product launches and funding our equity investments, executing on our synergy targets and retaining our focus, energy and discipline as a company, serving the needs of our customers and patients, and delivering strong value to our shareholders. Important factors that may cause actual results to differ include, but are not limited to: (i) risks that the legacy businesses of Cyberonics, Inc. and Sorin S.p.A. (together, the “combined companies”) will not be integrated successfully or that the combined companies will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected; (ii) the inability of LivaNova to meet expectations regarding the timing, completion and accounting of tax treatments; (iii) risks relating to unanticipated costs of integration, including operating costs, customer loss or business disruption being greater than expected; (iv) organizational and governance structure; (v) reductions in customer spending, a slowdown in customer payments and changes in customer demand for products and services; (vi) unanticipated changes relating to competitive factors in the industries in which LivaNova operates; (vii) the ability to hire and retain key personnel; (viii) the ability to attract new customers and retain existing customers in the manner anticipated; (ix) the reliance on and integration of information technology systems; (x) changes in legislation or governmental regulations affecting LivaNova; (xi) international, national or local economic, social or political conditions that could adversely affect LivaNova, its partners or its customers; (xii) conditions in the credit markets; (xiii) business and other financial risks inherent to the industries in which LivaNova operates; (xiv) risks associated with assumptions made in connection with critical accounting estimates and legal proceedings; (xv) LivaNova’s international operations, which are subject to the risks of currency fluctuations and foreign exchange controls; (xvi) and the potential of international unrest, economic downturn or effects of currencies, tax assessments, tax adjustments, anticipated tax rates, raw material costs or availability, benefit or retirement plan costs, or other regulatory compliance costs. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company’s business, including those described in the “Risk Factors” section of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, the Registration Statement on Form S-4 and other documents filed from time to time with the United States Securities and Exchange Commission by LivaNova. LivaNova does not give any assurance (1) that LivaNova will achieve its expectations, or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. All information in this press release is as of the date of its release. The Company does not undertake or assume any obligation to update publicly any of the forward-looking statements in this press release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this press release. For more information, please visit www.LivaNova.com.


News Article | September 13, 2016
Site: cleantechnica.com

A new study performed by researchers at Helmholtz Zentrum München, in collaboration with researchers at the German Center for Diabetes Research, has revealed that common levels of air pollution in homes notably increase the risk of developing insulin resistance as a pre-diabetic state of type 2 diabetes. What this means is that risk is strongly associated not just with “lifestyle” and genetics, but also with the environmental factors that most people have no control over, but which governments have the ability to regulate. Notably, the levels of air pollution observed in the study (in Germany) are well within European Union limits, but above those proposed by the World Health Organization (WHO). “Whether the disease becomes manifest and when this occurs is not only due to lifestyle or genetic factors, but also due to traffic-related air pollution,” commented Professor Annette Peters, director of the Institute of Epidemiology II at Helmholtz Zentrum München and head of the research area of epidemiology of the DZD. The press release continues, noting that, in collaboration with German Diabetes Center Düsseldorf and the German Heart Centre, the researchers “analyzed the data of nearly 3,000 participants of the KORA study who live in the city of Augsburg and two adjacent rural counties. All individuals were interviewed and physically examined. Furthermore, the researchers took fasting blood samples, in which they determined various markers for insulin resistance and inflammation. In addition, leptin was examined as adipokine which has been suggested to be associated with insulin resistance. Non-diabetic individuals underwent an oral glucose tolerance test to detect whether their glucose metabolism was impaired. The researchers compared these data with the concentrations of air pollutants at the place of residence of the participants, which they estimated using predictive models based on repeated measurements at 20 sites (for particle measurements) and at 40 sites (for nitrogen dioxide measurements) in the city and in the rural counties.” “The results revealed that people who already have an impaired glucose metabolism, so-called pre-diabetic individuals, are particularly vulnerable to the effects of air pollution,” stated Dr Kathrin Wolf, lead author of the new study. “In these individuals, the association between increases in their blood marker levels and increases in air pollutant concentrations is particularly significant! Thus, over the long term — especially for people with impaired glucose metabolism — air pollution is a risk factor for type 2 diabetes.” With regard to the implications of the findings, researcher Dr Alexandra Schneider, noted: “Lowering the threshold for acceptable air pollution levels would be a prudent step. We are all exposed to air pollution. An individual reduction by moving away from highly polluted areas is rarely an option.” The new findings are detailed in a paper published in the journal Diabetes.   Drive an electric car? Complete one of our short surveys for our next electric car report.   Keep up to date with all the hottest cleantech news by subscribing to our (free) cleantech newsletter, or keep an eye on sector-specific news by getting our (also free) solar energy newsletter, electric vehicle newsletter, or wind energy newsletter.  


News Article | September 8, 2016
Site: www.greencarcongress.com

« Civil Maps debuts augmented reality maps for self-driving cars | Main | KLM to operate biofuel flights out of Los Angeles » Exposure to air pollution increases the risk of developing insulin resistance as a pre-diabetic state of type 2 diabetes, according to a new study by scientists of Helmholtz Zentrum München, in collaboration with colleagues of the German Center for Diabetes Research (DZD). The researchers reported these results in the journal Diabetes. Whether diabetes becomes manifest and when this occurs is not only due to lifestyle or genetic factors, but also due to traffic-related air pollution, said Professor Annette Peters, director of the Institute of Epidemiology II at Helmholtz Zentrum München and head of the research area of epidemiology of the DZD. For the current study, the team analyzed the data of 2,944 participants of the KORA (Cooperative Health Research in the Region Augsburg) F4 study conducted in southern Germany (2006-2008). They analyzed associations between individual air pollution concentration estimated by land use regression and HOMA-IR (homeostasis model assessment-estimated insulin resistance), glucose, insulin, HbA (glycated hemoglobin), leptin, and hs-CRP (high-sensitivity C-reactive protein) from fasting samples using multivariable linear regression models. Effect estimates were calculated for the whole study population and subgroups of non-diabetic, pre-diabetic and diabetic individuals. Among all participants, a 7.9μg/m3 increment in particulate matter Nitrogen dioxide was associated with HOMA-IR, glucose, insulin, and leptin. Effect estimates for pre-diabetic individuals were much larger and highly statistically significant, while non-diabetic and diabetic individuals showed rather weak associations. No association was seen for HbA . The results revealed that people who already have an impaired glucose metabolism, so-called pre-diabetic individuals, are particularly vulnerable to the effects of air pollution. In these individuals, the association between increases in their blood marker levels and increases in air pollutant concentrations is particularly significant! Thus, over the long term—especially for people with impaired glucose metabolism—air pollution is a risk factor for type 2 diabetes. The authors are also concerned that the concentrations of air pollutants, though below EU threshold values, are still above the proposed guidelines of the World Health Organization (WHO). As a consequence, they demand changes in government policy. Moreover, the association between increased exposure to air pollution and respiratory and cardiovascular diseases has now been clearly established. Next, the scientists want to investigate the influence of ultrafine particles. A previous study of Helmholtz Zentrum München from 2013 showed that ultrafine particulate air pollution increases the risk of insulin resistance in childhood. In a meta-analysis from 2015 the same authors concluded that there is an association between long-term exposure to air pollutants and the development of type 2 diabetes.


News Article | November 2, 2016
Site: globenewswire.com

LONDON, Nov. 02, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology and innovation company, today reported results for the third quarter ended September 30, 2016.  For the third quarter of 2016, worldwide sales were $295 million, an increase of 3.2 percent on a reported basis and an increase of 2.4 percent on a constant-currency basis1, as compared to the previous year.  On a U.S. Generally Accepted Accounting Principles (GAAP) basis, third quarter 2016 loss per share was $0.03.  Third quarter 2016 adjusted2 diluted earnings per share were $0.78. “While sales performance was below expectations for the quarter, earnings results were positive due to significant leverage in the income statement,” said André-Michel Ballester, Chief Executive Officer.  “Many of our new products continue to perform well, including - AspireSR® used for VNS Therapy, PercevalTM sutureless heart valves, INSPIRETM oxygenators, KORA 250TM pacemakers and PLATINIUMTM defibrillators.  However, we have experienced challenges in Cardiac Surgery, and as a result, we are increasing our focus on driving merger synergies, implementing restructuring activities, maintaining disciplined cost controls and reprioritizing internal research and development spending to focus our efforts on the highest growth drivers.  Overall, I am extremely pleased in our ability to align operating expenses and deliver strong bottom line performance, while investing in short and long-term growth opportunities.” The following table highlights selected financial results3 for the third quarter of 2016 compared to the same period in 2015: For discussion purposes, all sales growth rates below reflect comparable, constant currency growth.  The difference between constant currency growth and reported growth reflects the impact from currency fluctuations in the various currencies in which we operate. Three months ended September 30, 2016 For the three business franchises, sales were as follows: Cardiac Surgery Cardiac Surgery sales, which include cardiopulmonary products and heart valves, were $149 million, representing a 0.4 percent decrease versus the comparable period in 2015.  The increase in cardiopulmonary was more than offset by the decline in heart valves. Sales in cardiopulmonary products were $115 million, up slightly from the third quarter of 2015. A decline in the Company’s 3T Heater-Cooler devices, as a result of import restrictions in the U.S. and the timing of heart-lung machine orders in Europe, were more than offset by several items including strong demand for oxygenators, particularly in emerging markets as well as Japan and Australia. Heart valve sales, including tissue and mechanical heart valves, were $34 million, a decrease of 2.4 percent compared to the same period the previous year.  Strength in Perceval in both the U.S. and Europe was more than offset by weakness in mechanical valves, primarily in China, and traditional tissue valves globally. Cardiac Rhythm Management (CRM) CRM sales for the period totaled $57 million, an increase of 3.6 percent as compared to the third quarter of 2015.  The increase was primarily due to positive performance of the Company’s newest high-voltage device PLATINIUM and favorable year-over-year results with its KORA 250 pacemaker. Neuromodulation Neuromodulation sales were $90 million in the third quarter, an increase of 6.8 percent over the prior year period, driven primarily by continued adoption of the Company’s newest VNS Therapy device AspireSR and strong new patient growth in the U.S. Financial Performance On a U.S. GAAP basis, third quarter 2016 income from operations was $23 million compared to $22 million in the second quarter of 2016.  Adjusted income from operations5 for the third quarter of 2016 was $55 million, an increase of 38 percent as compared to the third quarter of 2015.  This is primarily attributed to a positive mix of sales during the quarter which improved gross margin, sound cost control, delivery of planned synergies and the impact of previously announced restructuring efforts. 2016 Projections The Company is modifying its sales guidance and narrowing the range for earnings per share guidance for full year 2016. The Company now expects revenue growth on a constant-currency basis to be in the 1 to 2 percent range, and is narrowing the projected range for adjusted diluted earnings per share (EPS) to $2.95 to $3.05.  Webcast and Conference Call Instructions The conference call will be available to interested parties through a live audio webcast commencing at 8:00 a.m. Central time (9:00 a.m. Eastern time, 1:00 p.m. UK time) and accessible through the Investor Relations section of the LivaNova corporate website at www.livanova.com.  To listen to the conference call live by telephone, dial (844) 239-5285 (if dialing from within the U.S.) or (512) 961-6524 (if dialing from outside the U.S.).  The conference ID is 87431578. Within 24 hours of the webcast, a replay will be available under the "Events & Presentations" section of the Investor Relations portion of the LivaNova website, where it will be archived and accessible for approximately 12 months. 1 Constant currency growth measures the change in sales between the current and prior year periods using average exchange rates in effect during the applicable prior year period. 2 Adjusted measures are based on selected non-GAAP operating results and exclude certain specified items as described later in this press release and the attached schedules. 3 See the discussion of “Financial Alignment, Combined Sales & Operating Results, Business Unit Structure and Constant Currency” below.  The sales results presented are unaudited. 5 Adjusted measures exclude certain specified items as described later in this press release and the attached schedules.  Adjusted measures are based on selected non-GAAP operating results highlights in the 2015 Annual and Fourth Quarter Financial Results published on February 24, 2016. About LivaNova LivaNova PLC is a global medical technology company formed by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and Cyberonics Inc., a medical device company with core expertise in Neuromodulation. LivaNova transforms medical innovation into meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.  The Company employs approximately 4,600 employees worldwide and is headquartered in London, U.K. LivaNova is listed on NASDAQ and is admitted to the standard listing segment of the Official List of the UK’s Financial Conduct Authority and to trading on the London Stock Exchange (LSE) under the ticker symbol “LIVN”. Financial Alignment, Combined Sales & Operating Results, Business Franchise Structure and Constant Currency Cyberonics, the predecessor company to LivaNova, previously reported on a 52/53 week fiscal year calendar ending in April.  With the formal change in the fiscal calendar to a fiscal year ended December 31, the historical Neuromodulation business franchise sales have been aligned to correspond as closely as possible to calendar quarters. Although LivaNova was a shell company with no business operations until the closing date of the merger on October 19, 2015, the sales results disclosed for periods up to and beyond that date are being provided on a combined basis, a non-GAAP formulation that combines the results of legacy Sorin and Cyberonics for the periods completed prior to the merger and periods that include results both before and after the closing of the merger.  The Company believes that presenting the results of Sorin and Cyberonics in such a manner offers a meaningful representation to investors of the combined company’s sales for these periods. Non-GAAP operating results, unaudited, have been included for 2015.  These results have been prepared by management and adjusted for non-GAAP items as if the merger had occurred on January 1, 2015 but should not be considered as an alternative to Proforma Income Statements to be provided in accordance with SEC filings.  Certain adjustments to legacy Sorin operating results have occurred in order to present the results in U.S. dollars and to align these results as closely as possible to the presentation of LivaNova financial results.  Company management uses these measurements as aids in monitoring the Company’s ongoing financial performance from quarter to quarter and year to year on a regular basis and for benchmarking against other medical technology companies.  Management believes that the presentation of these results provides a meaningful representation of the combined company’s operating results for the periods presented. The sales and operating results for legacy Cyberonics for the quarters ended March 31, June 30 and September 30 were aligned to provide comparative information. The actual periods ended on March 27, June 26 and September 25 respectively. LivaNova (as the successor to Sorin and Cyberonics on a combined basis) operates under a Business Franchise structure with Cardiac Surgery, CRM and Neuromodulation accounting for substantially all of the sales during the periods referred to herein.  The combined company also operates a New Ventures group, dedicated to developing new technologies. Use of Non-GAAP Financial Measures In this press release, management has disclosed financial measurements that present financial information not necessarily in accordance with Generally Accepted Accounting Principles (GAAP). Company management uses these measurements as aids in monitoring the Company’s ongoing financial performance from quarter to quarter and year to year on a regular basis and for benchmarking against other medical technology companies. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly-titled measures used by other companies.  These non-GAAP financial measures should be considered along with, but not as alternatives to, the operating performance measure as prescribed by GAAP. Unless otherwise noted, all sales growth rates in this release reflect comparable, constant currency growth. Management believes that referring to comparable, constant currency growth is the most useful way to evaluate the sales performance of LivaNova and to compare the sales performance of current periods to prior periods on a consistent basis. Constant currency growth, a non-GAAP financial measure, measures the change in sales between current and prior year periods using average exchange rates in effect during the applicable prior year period. Safe harbor statement This press release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended.  Forward-looking statements are not historical facts but are based on certain assumptions of management and describe the Company’s future plans, strategies and expectations.  Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions.  Forward-looking statements contained in this press release are based on information presently available to LivaNova and assumptions that the Company believes to be reasonable, but are inherently uncertain.  As a result, the Company’s actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company’s control.  Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning developing novel opportunities in neuromodulation, heart failure, sleep apnea and percutaneous mitral valve, creating new innovative solutions that benefit patients, healthcare professionals, and healthcare systems, and building significant shareholder value.  Important factors that may cause actual results to differ include, but are not limited to:  (i) risks that the legacy businesses of Cyberonics, Inc. and Sorin S.p.A. (together, the “combined companies”) will not be integrated successfully or that the combined companies will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected; (ii) the inability of LivaNova to meet expectations regarding the timing, completion and accounting of tax treatments; (iii) risks relating to unanticipated costs of integration, including operating costs, customer loss or business disruption being greater than expected; (iv) organizational and governance structure; (v) reductions in customer spending, a slowdown in customer payments and changes in customer demand for products and services; (vi) unanticipated changes relating to competitive factors in the industries in which LivaNova operates; (vii) the ability to hire and retain key personnel; (viii) the ability to attract new customers and retain existing customers in the manner anticipated; (ix) the reliance on and integration of information technology systems; (x) changes in legislation or governmental regulations affecting LivaNova; (xi) international, national or local economic, social or political conditions that could adversely affect LivaNova, its partners or its customers; (xii) conditions in the credit markets; (xiii) business and other financial risks inherent to the industries in which LivaNova operates; (xiv) risks associated with assumptions made in connection with critical accounting estimates and legal proceedings; (xv) LivaNova’s international operations, which are subject to the risks of currency fluctuations and foreign exchange controls; (xvi) and the potential of international unrest, economic downturn or effects of currencies, tax assessments, tax adjustments, anticipated tax rates, raw material costs or availability, benefit or retirement plan costs, or other regulatory compliance costs.  The foregoing list of factors is not exhaustive.  You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company’s business, including those described in the “Risk Factors” section of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, the Registration Statement on Form S-4 and other documents filed from time to time with the United States Securities and Exchange Commission by LivaNova. LivaNova does not give any assurance (1) that LivaNova will achieve its expectations, or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. All information in this press release is as of the date of its release.  The Company does not undertake or assume any obligation to update publicly any of the forward-looking statements in this press release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law.  If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.  We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this press release. QUARTERLY SALES TREND BY BUSINESS UNIT U.S. dollar in Millions, REPORTED *Numbers may not add due to rounding. *Numbers may not add due to rounding. *Numbers may not add due to rounding. *The sales results presented are unaudited.  Numbers may not add due to rounding. *The sales results presented are unaudited.  Numbers may not add due to rounding. LIVANOVA PLC AND SUBSIDIARIES CONSOLIDATED STATEMENT OF INCOME (LOSS) U.S. dollars in Millions, except share and per share amounts (1)Adjusted financial measures are Non-GAAP measures and exclude specified items as described and reconciled to compare GAAP financial measures in the Reconciliation of GAAP to non-GAAP Financial Measures contained in the press release. *Numbers may not add due to rounding.  n/a is not applicable; there is no applicable adjusted net income or tax rate reported for 3Q15. LIVANOVA PLC AND SUBSIDIARIES CONSOLIDATED STATEMENT OF INCOME (LOSS) U.S. dollars in Millions, except share and per share amounts (1)Adjusted financial measures are Non-GAAP measures and exclude specified items as described and reconciled to compare GAAP financial measures in the Reconciliation of GAAP to non-GAAP Financial Measures contained in the press release. *Numbers may not add due to rounding.  n/a is not applicable; there is no applicable adjusted net income or tax rate reported for 3Q15. LIVANOVA PLC AND SUBSIDIARIES RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES U.S. dollars in Millions, except share and per share amounts *Numbers may not add due to rounding. Please see “Use of Non-GAAP Financial Measures” above *Numbers may not add due to rounding. Please see “Use of Non-GAAP Financial Measures” above *Numbers may not add due to rounding. LIVANOVA PLC AND SUBSIDIARIES CONSOLIDATED STATEMENT OF CASH FLOW U.S. dollars in Millions (Unaudited) *Numbers may not add due to rounding.

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