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Gene Therapy Market 2020 by Top Manufacturers, Growth, Trends, Size, Share, Analysis and Forecast to 2030 – The Daily Chronicle

October 2nd, 2020 10:57 am

Roots Analysis has done a detailed study on Gene Therapy Market (3rd Edition), 2019-2030, covering key aspects of the industrys evolution and identifying potential future growth opportunities.

Key Inclusions

For more information, please visit https://www.rootsanalysis.com/reports/view_document/gene-therapy-market-3rd-edition-2019-2030/268.html

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Key therapeutic areas

Type of vector

Type of therapy

Type of gene modification

Route of administration

Key geographical regions

The report includes detailed transcripts of discussions held with the following experts:

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https://www.rootsanalysis.com/reports/view_document/gene-therapy-market-3rd-edition-2019-2030/268.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If youd like help with your growing business needs, get in touch at [emailprotected]

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Cell and Gene Therapy Technology Update: ReNeuron Presents Positive Data | Roots Analysis – Crypto Daily

October 2nd, 2020 10:57 am

ReNeuron, the UK based, clinical-stage stem cell therapeutics company, announced that new data relating to its CTX stem cell platform will be presented today at the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT).

Get a complete list of the presentations,here.

Dr. Steve Pells, Principal Investigator at ReNeuron, will present new data showing the phenotypic stability and scalability of a mesenchymal stem cell line derived from the companys proprietary, conditionally immortalized, human neural stem cell line (CTX) following re-programming to a pluripotent state. The new data being presented today show for the first time that these CTX-iPSCs (induced pluripotent stem cells) can indeed be differentiated along different cell lineages to generate, for example, mesenchymal stem cell lines.

Further, the mesenchymal stem cell lines generated can be grown at scale by virtue of the companys conditional immortalization technology, enabling the efficient production of clinical-grade cell therapy candidates.

Cell and Gene Therapy Market:

Cell and gene therapies have garnered a lot of traction from several big pharma players and new drug developers in recent years. In fact, as per the Alliance of Regenerative Medicines recent findings, there has been more than 75% year on year increment in funding to support the development of various cell and gene therapies. With over 2,600 clinical trials registered to date, cell and gene therapies are playing in a league of their own.

For further information, check out the report here

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Roots Analysis Leaders in Pharmaceutical & Biotechnology Market Research

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About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If youd like help with your growing business needs, get in touch at [emailprotected]

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

[emailprotected]

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Stem Cell Banking Market is forecast to reach $6,956 million by 2023 | ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save – The Daily…

October 2nd, 2020 10:56 am

The global stem cell banking market was valued at $1,986 million in 2016, and is estimated to reach $6,956 million by 2023, registering a CAGR of 19.5% from 2017 to 2023. Stem cell banking is a process where the stem cell care isolated from different sources such as umbilical cord and bone marrow that is stored and preserved for future use. These cells can be cryo-frozen and stored for decades. Private and public banks are different types of banks available to store stem cells.

Top Companies Covered in this Report: Cord Blood Registry,ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save, New York Cord Blood Program, CordVida, Americord, CryoHoldco, Vita34

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Increase in R&D activities in regards with applications of stem cells and increase in prevalence of fatal chronic diseases majorly drive the growth of the global stem cell banking market. Moreover, the large number of births occurring globally and growth in GDP & disposable income help increase the number of stem cell units stored, which would help fuel the market growth. However, legal and ethical issues related to stem cell collections and high processing & storage cost are projected to hamper the market growth. The initiative taken by organizations and companies to spread awareness in regards with the benefits of stem cells and untapped market in the developing regions help to open new avenues for the growth of stem cell banking market in the near future.

The global stem cell banking market is segmented based on cell type, bank type, service type, utilization, and region. Based on cell type, the market is classified into umbilical cord stem cells, adult stem cells, and embryonic stem cells. Depending on bank type, it is bifurcated into public and private. By service type, it is categorized into collection & transportation, processing, analysis, and storage. By utilization, it is classified into used and unused. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Table Of Content

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW

CHAPTER 4: STEM CELL BANKING MARKET, BY CELL TYPE

CHAPTER 5: STEM CELL BANKING MARKET, BY BANK TYPE

CHAPTER 6: STEM CELL BANKING MARKET, BY SERVICE TYPE

CHAPTER 7: STEM CELL BANKING MARKET, BY UTILIZATION

CHAPTER 8: STEM CELL BANKING MARKET, BY REGION

CHAPTER 9: COMPANY PROFILES

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Why people with diabetes are being hit so hard by Covid-19 – STAT

October 2nd, 2020 10:55 am

Some of Mary-Elizabeth Pattis patients with diabetes are in a bind. Careful to practice social distancing, they tell her during telehealth visits they dont feel safe exercising outdoors in their congested neighborhoods though they know staying active and maintaining good blood sugar levels may be their best defense against severe Covid-19.

Im always happy when patients say, yes, Im not going out, Im wearing a mask, Im doing as much as I can. But it makes it harder for people to meet their fitness goal, which is such a critical element of overall health and metabolic health, said Patti, an adult endocrinologist at Joslin Diabetes Center in Boston. It underscores the health inequity problem, she added: Their exposures may be increased due to living in a densely populated neighborhood with multigenerational families [and] more essential workers who cannot work from home.

There are no easy answers to the coronavirus pandemic, but for people with diabetes, its dismayingly difficult to untangle the thicket of biological and socioeconomic factors that make them more likely to suffer severe illness and die should they catch the virus that causes Covid-19. That leaves prevention controlling blood sugar through diet, exercise, monitoring, and medication as the leading tactic to protect people, until a successful vaccine proven to work in people with diabetes, too, reaches a population bearing multiple burdens of chronic illness.

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The numbers are alarming. A Lancet Diabetes & Endocrinology study mining 61 million medical records in the U.K. says 30% of Covid-19 deaths occurred in people with diabetes. After accounting for potentially relevant risk factors such as social deprivation, ethnicity, and other chronic medical conditions, the risk of dying from Covid-19 was still almost three times higher for people with type 1 diabetes and almost twice as high for type 2, versus those without diabetes.

Data from the U.S. Centers for Disease Control and Prevention show more than three-quarters of people who died from Covid-19 had at least one preexisting condition. Overall, diabetes was noted as an underlying condition for approximately 4 in 10 patients. Among people younger than 65 who died from the infection, about half had diabetes.

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Juliana Chan, director of the Hong Kong Institute of Diabetes and Obesity, said the pandemic has intertwined with and exposed two other widespread problems: diabetes and disparities triggered by social determinants of health.

What we are seeing is nothing new, but it is really just on a massive and global scale, she said in an interview. I hope that there is something positive out of this, that people understand that we are hit by three epidemics.

While urging prevention as the first and best course, doctors and scientists are testing hypotheses to understand the biology behind the collision of a new infectious disease with an old metabolic one. The exact molecular mechanisms make for an emerging story, and there is disagreement about why, as case reports from around the world suggest, some people develop type 1 diabetes after their coronavirus infection clears. But clinicians and scientists told STAT there is no question that unless people with diabetes have their glucose under control, Covid-19 poses much more danger to them than to other people.

In people with type 1 diabetes, the insulin-producing pancreatic islet cells have been destroyed, meaning they cannot process the glucose their bodies need for fuel and the sugar accumulates in the blood. In type 2 diabetes, people cant make enough insulin to convert glucose into energy, or they grow insensitive to the insulin they do make.

Over a lifetime, problems with too much or too little glucose inflict widespread damage in the kidney, heart, and liver, as well as around nerves. Stroke, heart attack, kidney failure, eye disease, and limb amputations can be the legacy of poor glucose control. The linings of blood vessels throughout the body become so fragile they cant ferry needed nutrients as well as they should. Inflammation rises and the immune system does not perform well. Obesity, which is more common in type 2 diabetes but can also occur in type 1, makes all these conditions worse.

Once someone with diabetes or obesity became infected with Covid-19, then their outcomes were generally not as good, said Daniel Drucker, of the Lunenfeld-Tanenbaum Research Institute at Mt. Sinai Hospital in Toronto. They were more likely to be hospitalized, more likely to be intubated, more likely to have higher rates of death.

People with obesity as a rule have lower cardiorespiratory fitness, meaning they cant move as well due to poorer lung function, possibly severe sleep apnea, and blood vessel disease.

All of these things are important for when you become ill. You need to be able to breathe. You need to have optimal circulatory function, Drucker said. When we develop obesity, we have excess energy storage and the presence of that fat is inflammatory. And so once we get coronavirus infection, we are less able to mount an appropriate immune response because our immune system is already being set off in an inappropriate manner by the presence of obesity.

Some studies add support to the idea that its not just obesity, but also the downstream hypertension and other cardiovascular diseases that pose greater risk. Drucker said. Its those comorbidities that seem to be affecting the increased risk or poor outcomes.

It isnt clear at what point those comorbidities take their toll. Does the course of disease become severe because of those comorbidities, or is there a difference in the biology of early infection, which may lead to increased viral burden in patients with both uncontrolled glucose and obesity?

For years doctors, patients, and scientists have known from epidemiologic data that infections of any kind viral, bacterial, or fungal can do more harm to people with diabetes because their bodies do not process glucose as well during illness, their immune response is weaker, and their circulation is impaired.

Covid-19s impact on people with diabetes fits that pattern. Janelle Ayres, a professor at the Salk institute in La Jolla, Calif., points to what diabetes and Covid-19 have in common.

The organ systems that the virus targets are the same organ systems that are compromised in diabetic patients, so having both may have synergistic effects that push patients down a more severe disease trajectory, she said. This makes it incredibly difficult to parse out the cause and effect of whats going on in these patients.

People with diabetes tend to live in a chronic inflammatory state, setting them up for a more severe inflammatory response to Covid-19 that can culminate in a life-threatening cytokine storm. That immune overreaction is thought to harm some people more through organ damage than via the actual viral infection. But diabetes can also weaken how well the immune system fights viruses. People with type 2 diabetes also have more ACE2 receptors in many tissues, including those lining blood vessels, Ayres pointed out, opening many more doors to Covid-19 invasion. ACE2 is one receptor that the coronaviruss spike protein uses to gain entry into cells.

There is only one target to control in hospitalized Covid-19 patients with diabetes, Drucker and others said: glucose.

People who have really poorly controlled diabetes are more susceptible to more severe infection, whether its influenza or tuberculosis, he said. Elevated blood sugar directly impairs our immune function.

Age and poor glucose control are the two major drivers of poor outcomes in Covid-19. Someone under 65, not obese, and whose glucose control is good is unlikely to have as much increased risk.

Its very difficult to reverse obesity or to meaningfully lose a sufficient amount of weight during the pandemic. Its very difficult for me to take away your coronary artery disease same thing with hypertension, Drucker said. But if you have poorly controlled diabetes, I can fix that in days to weeks if I had the resources.

Not every person with diabetes and Covid-19 needs to be hospitalized, but if they do require that level of care, controlling and monitoring glucose levels are key. There arent any results from controlled clinical trials yet, Joslins Patti pointed out, but lowering glucose safely to as normal a range as possible is the goal she and other doctors pursue. That can be challenging in the hospital, where typically glucose levels are measured in drops of blood obtained from patients fingertips.

You dont want to ask nursing staff to go in repeatedly to be doing fingerstick glucoses for someone whos severely ill and having to use more PPE, Patti said. So theres more and more use of whats called continuous glucose monitors, which allow frequent every five minutes remote monitoring of glucose levels from outside the room.

Vaccines promise prevention in a shot (or two), but clinical trials will have to answer questions about how well they work in people with diabetes, given differences in immune function. There is some evidence in the scientific literature that flu vaccination is not quite as effective in older people with diabetes, or in people of any age with poorly controlled diabetes.

Will the vaccines that are being developed [provide] equal immunity and equal protection to people with diabetes and obesity? Drucker asked. When you have the added complication of a preexisting abnormal state of inflammation and immune response in people with diabetes and obesity who are not very healthy, thats an additional unknown.

Tight glucose control is number one, but healthy people with diabetes must also remain vigilant about masks and social distancing. Thats been more effective in Hong Kong than in Western countries, Chan said.

Seventeen years ago, when Hong Kong and China were first hit by the SARS-1 virus, we already knew that people with diabetes were three times more likely to die, she said. Thats a painful memory for us. We have 100% compliance on masks now. We never really had a lockdown.

Even with such caution, and even in countries that offer citizens universal health care, disparities driving the social determinants of health persist, she said. Income will always divide those who are homeless, live in crowded conditions, or work in jobs that place them at risk, even if Covid-19 subsides. That makes prevention essential, especially for those who dont have the luxury of protecting themselves.

Currently a lot of the care is focused on acute care, not on educating patients, protecting them, supporting them so that they never come to the hospital, she said about Covid-19.

We must not forget. We have to learn from this.

This story has beenupdated to correctthe percentage of Covid-19 deaths in people with diabetes.

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NIH funds first nationwide network to study rare forms of diabetes – National Institutes of Health

October 2nd, 2020 10:55 am

News Release

Wednesday, September 30, 2020

A nationwide study funded by the National Institutes of Health will seek to discover the cause of several unusual forms of diabetes. For years, doctors and researchers have been stymied by cases of diabetes that differ from known types. Through research efforts at 20 U.S. research institutions, the study aims to discover new forms of diabetes, understand what makes them different, and identify their causes.

The Rare and Atypical Diabetes Network, or RADIANT, plans to screen about 2,000 people with unknown or atypical forms of diabetes that do not fit the common features of type 1 and type 2 diabetes.

A person with atypical diabetes may be diagnosed and treated for type 1 or type 2 diabetes, but not have a history or signs consistent with their diagnosis. For example, they may be diagnosed and treated for type 2 diabetes but may not have any of the typical risk factors for this diagnosis, such as being overweight, having a family history of diabetes, or being diagnosed as an adult. Alternately, a person with atypical diabetes may respond differently than expected to the standard diabetes treatments.

Its extremely frustrating for people with atypical diabetes when their diabetes seems so different and difficult to manage, said the studys project scientist, Dr. Christine Lee of NIHs National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Through RADIANT, we want to help patients and the broader healthcare community by finding and studying new types of diabetes to shed light on how and why diabetes can vary so greatly.

RADIANT researchers will build a comprehensive resource of genetic, clinical, and descriptive data on previously unidentified forms of diabetes for the scientific and healthcare communities.

The studys researchers will collect detailed health information using questionnaires, physical exams, genetic sequencing, blood samples, and other tests. People found to have unknown forms of diabetes may receive additional testing. Some participant family members may also be invited to take part in the study.

With help from participants and their families, we aim to develop a comprehensive description of the genetic and clinical characteristics of these rare forms of diabetes, said study chair, Dr. Jeffrey Krischer, director of the Health Informatics Institute at the University of South Florida (USF), Tampa. This information could help to establish new diagnostic criteria for diabetes, find new markers for screening, or identify drug targets for new therapies that could ultimately bring precision medicine to diabetes.

USF is the studys coordinating center, and the lead centers include Baylor College of Medicine in Houston and the University of Chicago. The Broad Institute in Cambridge, Massachusetts, and Baylor serve as the genomic sequencing centers for the project. University of Florida, Gainesville, provides the studys laboratory services. Other participating centers are:

The RADIANT study will further clarify diabetes as a disease that has many different forms, and for which diagnosis and management for some of those forms remain a challenge, said NIDDK Director Dr. Griffin P. Rodgers. The discoveries of the study should provide critical understanding of the spectrum of diabetes and improve lives of people with rare forms of diabetes and everyone who cares for them.

The study opened recruitment on September 30, 2020 for people with atypical diabetes or a form of diabetes that seems different from known types of diabetes. Visit http://www.atypicaldiabetesnetwork.org for more information on the study and how to join.

Support for the study is provided through NIDDK grants U54DK118638 and U54DK118612.

The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see https://www.niddk.nih.gov/.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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NIH funds first nationwide network to study rare forms of diabetes - National Institutes of Health

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Call to Action for Screening, Early Treatment of Diabetes – Medscape

October 2nd, 2020 10:55 am

People with type 2 diabetes derive benefit from earlier detection and treatment, suggests a decade-long follow-up of the Anglo-Danish-Dutch Study in General Practice of Intensive Treatment and Complication Prevention in Type 2 Diabetic Patients Identified by Screening(ADDITION-Europe).

"The 10-year follow-up findings support the use of intensive treatment of type 2 diabetes soon after diagnosis and have implications for policy relating to early detection and subsequent management of type 2 diabetes in primary care," said Simon Griffin, MD.

Griffin, the study lead from the University of Cambridge, UK, presented the findings at the virtual European Association for the Study of Diabetes (EASD) Annual Meeting 2020.

Although the difference in the primary outcome between the intensive treatment and routine care groups favored the former, the difference was not statistically significant.

Still, "It looks like early intensive treatment of multiple risk factors soon after diagnosis is safe and seems to lower cardiovascular events and mortality...patients benefit from early detection, and in turn, early treatment," Griffin emphasized.

Asked to comment, Andrew Boulton, MD, told Medscape Medical News that these results highlight the importance of recognizing type 2 diabetes not simply as a metabolic disease but as a cardiometabolic problem.

"The nonsignificance of these outcomes should not detract physicians in both primary and secondary care in their quest to achieve optimal control of not only diabetes, but also cholesterol, triglycerides, blood pressure, and body weight...and to avoid therapeutic inertia, which is frequently reported," said Boulton, of University of Manchester and Manchester Royal Infirmary, UK.

The 10-year results from ADDITION-Europe were also published in Lancet Diabetes & Endocrinology. And in an accompanying editorial, Takayoshi Sasako, MD, a diabetologist from the University of Tokyo, Japan, and colleagues say the effects of an intensive treatment program on cardiovascular outcomes and mortality seen at 5 years were largely sustained for an additional 5 years.

"Despite the lack of statistical significance probably partly due to improvements in clinical practice when the study was done these findings lend support to early multifactorial intervention in type 2 diabetes," they stress.

Sasako and colleagues add that it will be interesting to see whether the postulated benefits from intensive multifactorial treatment in ADDITION-Europe will become more evident in the next decade or whether they will fade, as in the Veterans Affairs Diabetes Trial (VADT).

"It will also be important to follow-up the ADDITION-Europe study cohort for the incidence of diabetes complications and mortality in the next decade and beyond, because such a prospective cohort in which patients are exposed to good control of risk factors in the first decade after diagnosis is rare," they add.

ADDITION-Europe aimed to assess the long-term effects of guidelines, education, and training on outcomes for people with diabetes detected by screening, and to quantify the effect of differences in treatment and risk factors in the first 5 years following detection. The 10-year results looked at any effects, including lasting effects on cardiovascular events, after the intensive intervention was stopped at 5 years.

"Most intervention studies informing the management of people with type 2 diabetes focus on treatment of individual risk factors, but in practice, patients receive lifestyle advice and simultaneous pharmacological treatment of several risk factors," explained Griffin.

"Most studies that have looked at multifactorial treatments tend to have been in patients with long-standing disease, whereas here we looked at whether multifactorial treatment given early after diagnosis would make a difference," he explained.

Primary care practices from Denmark, the Netherlands, and the UK used stepwise screening to identify people with previously undiagnosed type 2 diabetes.

A total of 3057 patients with newly diagnosed type 2 diabetes, according to 1999 WHO criteria, took part in the trial.

Patients were randomized to intensive management (n = 1678) and given lifestyle advice on diet, physical activity, and the importance of medication adherence and smoking cessation. Appropriate treatment was begun if A1cwas 6.5%, blood pressure was 120/80 mm Hg, and/or total cholesterol was > 3.5 mmol/L. There were also educational materials for patients and practice-based educational meetings for physicians.

Routine care (n = 1379) was based on national guidelines, and decisions around medication use were made by the individual treating clinician. The very few exclusion criteria make the study highly generalizable.

After 5 years of the intervention, there were no further efforts to encourage primary care teams to continue intensive treatment.

Patient characteristics between groups were similar. There were slightly more men than women, mean age was 60 years, around 95% were White, mean BMI was 31.6 kg/m2, approximately 6% had a history of myocardial infarction, and 28% were current smokers. Median A1c was 6.5% and 6.6% in the routine and intensive groups, respectively, mean systolic blood pressure was 149.8 and 148.5 mm Hg, and mean cholesterol was 5.6 and 5.5 mmol/L.

At 10-years post-randomization, participants were not recalled, but data on mortality, cardiovascular events, laboratory and clinical measures were collected from national registers and national audits, as well as electronic and manual searches of general practice and hospital medical records.

The primary endpoint was a composite of first cardiovascular event including cardiovascular mortality, nonfatal myocardial infarction, stroke and revascularization, and nontraumatic amputation.

Medscape Medical News reported the 5-year results from ADDITION-EUROPE in 2010. Although those in the intensive multifactorial treatment group were less likely to suffer events than those in the routine care group, the difference between groups was not statistically significant in terms of the primary endpoint.

At the time, Griffin said this likely reflected the fact that routine care of diabetes had been improving in the three countries that the patients were from. The results nevertheless illustrate that "intensive treatment in people with screen-detected diabetes is feasible," he emphasized.

For the 10-year analysis, 14 patients were lost to follow-up and 12 withdrew. Primary endpoint data were available for 99% of 3057 participants, and mean duration of follow-up was 9.6 years.

"By 10 years, the significant differences in treatments and [individual] risk factors [seen at 5 years] had largely attenuated except [those] from blood pressure medication and aspirin, which were still significantly different between groups," said Griffin at the virtual EASD.

Regarding treatment, overall, 85% of patients were prescribed antihypertensive medication, 78% statins, and 76% glucose-lowering medication (most commonly metformin).

Aspirin was used by 30.4% of the routine care group and 42.3% of the intensive treatment group. Antihypertensive agents were used by 82.4% in the routine care group and 86.4% in the intensive treatment group.

The primary endpoint at 10 years had occurred in 15.3% of patients in the routine care group versus 13.8% in the intensive treatment group.

"The small differences in treatment and risk factors seen in the first 5 years after diagnosis were associated with a nonsignificant 13% reduction (hazard ratio, 0.87; P = .14) in risk of cardiovascular disease events [composite primary endpoint] over 10 years," said Griffin when reporting the main finding.

There was also a nonsignificant 10% reduction in risk of all-cause death over 10 years (hazard ratio, 0.90); 219 patients (15.9%) in the routine care group died compared with 246 (14.7%) of those receiving intensive treatment.

"It looks like the 13% and the 10% were related to the small differences in treatment and risk factors after 5 years, suggesting a potential legacy effect," asserted Griffin.

"The UK ProspectiveDiabetesStudy has found that if you lower glucose early in disease it can have a lasting effect, whereas the effect for blood pressure, for example, only happens while on treatment. Effectively, treating people earlier will make a difference," he said.

The results overall suggest that identifying people with type 2 diabetes earlier and starting treatment promptly is beneficial, Griffin emphasized.

Also reported at the virtual EASD meeting was a study from the UK Biobank that found that 1% of individuals in the UK have undiagnosedtype 2 diabetes, and that it can take more than 5 years for people to be diagnosed.

Reporting those findings, Katherine Young, PhD, College of Medicine and Health at the University of Exeter, said the study shows "that population-level screening could identify cases of type 2 diabetes far earlier and potentially reduce complications."

Griffin said: "There is a question of how to find people and whether to do a national screening program. I suggest inviting highest risk people for screening. In the UK, the Health Checks [over 40 years] and risk assessments are sensible as long as they're being done systematically, and acted on."

Griffin has reported receiving fees from Novo Nordisk, Napp, AstraZeneca, and Eli Lilly. Sasako has reported receiving fees from Astellas, AstraZeneca, Daiichi Sankyo, MSD, Mitsubishi Tanabe, Nippon Boehringer Ingelheim, Novartis, Ono, Sanofi, Sumitomo Dainippon, Taisho Toyama, and Takeda; and grants from MSD, Nippon Boehringer Ingelheim, and Novo Nordisk. Boulton has reported no relevant financial relationships.

EASD Annual Meeting. Presented September 23, 2020.

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Call to Action for Screening, Early Treatment of Diabetes - Medscape

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Global $6 Billion Diabetes Reusable Insulin Delivery Pen Market to 2026 with Sanofi, Ypsomed, Biocon, Novo Nordisk, Eli Lilly and Co, Owen Mumford…

October 2nd, 2020 10:55 am

TipRanks

President Trumps announcement that he has tested positive for the corona virus has grabbed headlines, but the dog that didnt bark presents a more interesting point. Wall Street isnt so worried about corona virus anymore; the perception is, that the virus will fade away or a vaccine will be developed, but in either case, the economy will improve.According to an RBC survey of portfolio managers, however, the coming November election presents a clear risk to the markets. A large majority of investors surveyed, 76%, worry that the election will be contested, resulting in weeks possibly months on uncertainty. And uncertainty is bad for the markets.Recent events, and some not-to-distant history, bear them out. For the history, we must only look back to 2000, when it took until December 12, and an appeal to the Supreme Court, to decide the results of the Florida recount. The S&P 500 slipped 5% during those weeks and that was uncertainty caused by one state, recounting a limited number of votes. The point here is not that this election will be fraudulent or illegitimate. Rather, like Caesars wife, the election should be above the perception of impropriety and this year, that bar may be too high. And then the challenges will begin. In the RBC survey, 83% of portfolio managers believed that such challenges, contesting the election results (from either direction) would be a net negative for the stock market. And only a small minority, 14%, believe that the final results will be known when the polls close on Election Day, November 3.And this is what brings us to dividend stocks today. When investors get nervous, they go looking for a way to protect their portfolios and dividends, making the promise of a steady income stream, may be just the answer skittish shareholders are looking for.Analysts from research firm Compass Point agree. They have picked three stocks whose dividends are yielding 7% or more. Weve pulled up the TipRanks data to find out what else makes these compelling buys in turbulent times.Saratoga Investment Corporation (SAR)Well start with Saratoga Investment Corporation, a mid-market investment management company that specializes in debt, appreciation, and equity investments. Saratoga has over $480 million in assets under management, and its portfolio includes home security, industry, software, and waste disposal. The variety, and the stocks chosen, are designed to give the company a resilient income stream.That doesnt mean that Saratoga has been able to dodge the corona bullet. The company saw revenues turn negative in Q2, and has seen EPS slip from 61 cents in the first quarter to 51 cents in the second. As a result, Saratoga announced that it was deferring its fiscal Q4 dividend, as a cash-saving measure during the pandemic crisis.Saratoga, in July, declared its fiscal Q1 dividend for 40 cents per common share and paid it out in August. There are grounds for confidence. The company has $9 million in committed, but undrawn, lending available, along with $155 million in available credit facilities, a new $43.1 million baby bond issue, and $282 million equity all set against just $60 million in long-term debt.As for the restored dividend, while down 28% from the companys last dividend payment, the new distribution reflects Saratogas liquidity position. The current payment annualizes to $1.60, and gives a yield of 9.2%, or more than 4.5x the average yield found among S&P-listed companies.Covering the stock for Compass Point, analyst Casey Alexander writes of the new dividend, [With] the dividend now officially reset at $0.40 per quarter, it's time to make lemonade from the lemons investors were handed In our view, while we may not be done with credit issues, SAR has set the dividend at a level that allows the BDC to return to the pattern of QoQ dividend increases as the current earnings power of the BDC well exceeds the level of the new dividend.Taking everything into account, Alexander rates SAR stock a Buy, and gives it a $19.75 price target implying an upside of 16% for the coming year. (To watch Alexanders track record, click here)Overall, Saratoga gets a unanimous Strong Buy rating from the analyst consensus, based on 3 recent positive reviews. The shares are selling for $17.02 and have an average price target of $22.58, slightly more bullish than Alexanders and suggesting a one-year upside of ~33%. (See SAR stock analysis on TipRanks)Solar Capital, Ltd. (SLRC)The next stock on our list, Solar Capital, is an investor in senior secured loans and subordinated debt, with an investment portfolio of middle-market companies. The company puts capital into investment-grade loan instruments, making additional financing available to its customer base. Solar Capital has a portfolio worth $1.4 billion invested in 183 companies across 80 business sectors.Solar Capital has been able to keep earnings positive during the corona half, despite a sharp fall in the bottom line for Q1 and Q2. In a bright spot, revenues, which turned negative in Q1, were back to positive in Q2, and projections for Q3 earnings show that the fall-off is either slowing or stopping we will find out which in the Q3 report on November 5.Through all of this uncertainty, Solar Capital has kept up its stable dividend. The company has a 7-year history of reliable dividend payments, and the current quarterly dividend of 41 cents has been paid out consistently for the last 11 quarters. At an annualized payment of $1.64, the dividend currently yields 10.5%. In a time of near-zero official interest rate policy, this gives SLRC an enviable return.Compass Point's Casey Alexander, who also covers SAR, points out that SLRCs dividend is the main attraction for investors and that management has cultivated it for just that purpose. Management stated their intention to continue to pay the $0.41 per share dividend because they believe there is visibility to dividend coverage as they begin to originate new assets at higher spreads. This is the environment that SLRC has been waiting for, and has been the principal reason for maintaining an under-leveraged posture for the last several years, Alexander noted.With dividend coverage visible ahead, Alexander gives SLRC a Buy rating. His price target, at $17.75, indicates confidence in a 12% upside potential.This is another stock with a unanimous Strong Buy consensus rating. SLRC is sitting pretty with 5 positive reviews on record. The average price target is $18.20, representing a ~15% upside from the current share price of $15.86. (See SLRC stock analysis on TipRanks)First Hawaiian (FHB)Our last stock today, First Hawaiian, is the holding company owning the First Hawaiian Bank. First Hawaiian offers the usual array of banking services to retail and commercial customers, with 53 branches throughout the Hawaiian Islands along with three others in Guam and two on Saipan. Banking services include loans, deposit accounts, credit and debit cards, mortgages, insurance, and retirement plans.The recently ended second-quarter showed some mixed results. Top line revenues showed a sequential slip, from $164 million to $152 million, but that was mild compared to the 46% drop in earnings. EPS for Q2 came in at 16 cents, on $20 million in net income. Bright spots for the quarter were total loans, which grew 3% to $383 million, and deposit balances, which increased 13% sequentially to reach $2.3 billion. The banks total assets at the end of 2Q20 were $23 billion, up 10% from the end of the first quarter.That is the background behind managements July dividend declaration. The company Board approved a 26-cent regular quarterly dividend, which was paid out in early September. At $1.04 annualized, this dividend yields 7.2%, putting it well above the average yield and far higher than the current yield on Treasury bonds. FHB has a 4-year history of reliable dividend payments, and the current declaration marks the seventh quarter in a row at the current level.Compass Point analyst Laurie Havener Hunsicker believes a macro look at FHB justifies a bullish stance. FHB was a clear outperformer on credit during the last crisis. While past results do not dictate future performance, we are impressed with the FHB management team and their credit culture; further, we believe that FHB is well-postured to again outperform on credit during the COVID-19 crisis, the analyst noted.In line with her comments, Hunsicker rates FHB a Buy and sets a $21 price target that suggests room for a robust share appreciation of 46% over the next year. (To watch Hunsickers track record, click here)However, Wall Street is unsure on FHB, and the analysts are evenly divided, with recent reviews coming in at 1 Buy, 1 Hold, and 1 Sell for an analyst consensus rating of Hold. FHB shares are selling for $14.42 and have an average price target of $16.67, making the upside potential 15%. (See First Hawaiians stock analysis at TipRanks)To find good ideas for dividend stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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Global $6 Billion Diabetes Reusable Insulin Delivery Pen Market to 2026 with Sanofi, Ypsomed, Biocon, Novo Nordisk, Eli Lilly and Co, Owen Mumford...

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DreaMed’s AI solution for diabetes expands across the US | TeleHealth & COVID-19 – Healthcare Global – Healthcare News, Magazine and Website

October 2nd, 2020 10:55 am

DreaMed Diabetes, an AI-based remote diabetes solution, is to be made available in clinics across the US, with a particular focus on rural communities.

The new tool, which is the first of its kind to be approved by the FDA, is cloud-based and uses AI to monitor glucose levels as well as lifestyle habits, providing clinicians with an analysis of this patients data. Its aim is to enable clinicians to treat patients remotely, by providing a fast, accurate and thorough analysis. Research found its insulin management to be just as effective as treatment programmes managed by humans.

The Center for Disease Control and Prevention (CDC) estimates that 10% of the USA's adult population, or 34 million people have diabetes. The USA's healthcare system is under pressure due to the pandemic, and additionally diabetes has proven to be a factor in increasing the risk of mortality in patients with Covid-19. As a result tech companies are stepping with telehealth solutions that can ease the burden on healthcare staff.

DreaMed will now be available in clinics across the country, including Lucile Packard Childrens Hospital Stanford, the Billings Clinic in Montana, Hassenfeld Childrens Hospital at NYU Langone and University of Florida Health.

These clinics will implement DreaMeds programme into their existing protocols. It will provide patients with personalised optimisation of their insulin therapy management. Recommendations are based on its AI-driven analyses of information derived from glucometers, insulin pumps, and event-oriented data.

Its wonderful to see our remote diabetes solution being rolled out in so many clinics across the country, particularly at a time when people need it most Eldad Postan-Koren, COO of DreaMed Diabetes said.

Our mission is, and always will be, to provide people with diabetes and their health care professionals with a reliable, insulin-therapy management tool that enables the best care possible wherever they are.

DreaMed Diabetes, headquartered in Tel Aviv, was founded in 2014 as a spin-off of the DREAM International Consortium, to commercialise the insulin control technology behind the Glucositter .

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Diabetes in Pregnancy Tied to Heart Risks in Young Adult Children – The New York Times

October 2nd, 2020 10:55 am

People whose mothers had diabetes before or during pregnancy have an increased risk for heart disease as young adults, new research suggests. The risk was apparent both for children of mothers with pre-existing Type 2 diabetes and for children whose mothers developed gestational diabetes during pregnancy.

The study, in the journal CMAJ, included 293,546 people born to mothers in Manitoba between 1979 and 2005. Almost 3 percent were exposed to gestational diabetes and 1.1 percent to maternal Type 2 diabetes. The scientists followed the offsprings health through age 35.

They found that after adjustment for other factors, exposure to gestational diabetes was associated with a 27 percent increased risk for a cardiovascular event heart attack, cardiac arrest, coronary artery disease or stroke. The group was also 85 percent more likely to have a cardiovascular disease risk factor such as high blood pressure, high cholesterol or diabetes.

For people whose mothers had pre-existing diabetes, the risks were even greater: a 48 percent increased risk for a cardiovascular event, and more than three times the risk for having a cardiovascular disease risk factor compared with people whose mothers were not diabetic.

Not only is the risk for heart disease increased in people exposed to maternal diabetes, said the lead author, Jonathan McGavock, an associate professor of pediatrics at the University of Manitoba, but they develop risk factors four years earlier than the unexposed, thereby compounding their lifetime risk for heart disease.

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Vancouver Island mom calls on government to fund breakthrough diabetes monitoring system – vancouverislandfreedaily.com

October 2nd, 2020 10:55 am

A Comox Valley family is urging the government to provide coverage for a breakthrough diabetes monitoring system.

Lisa Christensens 11-year-old daughter, Lillithe, was diagnosed with Type 1 diabetes three years ago.

Type 1 diabetes involves continuous monitoring of blood glucose a finger poke to draw blood, which is then applied to a strip, so a machine can calculate the numbers.

You must constantly be aware of your blood glucose number, as if it gets too high for too long, you can develop both acute and long-term complications, said Lisa. If it gets too low, you are in danger of unconsciousness, or if you do not receive help it could lead to potential death.

Type 1 diabetics are dependent on insulin, either by syringe or by pump. The glucose monitoring tells the diabetic if insulin is needed.

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Lisa said when the family first began monitoring Lillithes glucose levels, a good nights sleep was not an option.

In order to be safe, because blood glucose can change quickly for many reasons especially with children we had to get up and poke her fingers multiple times a night, explained Lisa. We caught some lows this way before they could become dangerous but we were constantly feeling exhausted by the lack of quality sleep and the worry.

Thanks to a grant from Bear Essentials (Childrens Health Foundation of Vancouver Island), and the Help Fill a Dream Foundation, the family secured funding for a flash glucose monitor, which was a marked improvement, but still had its drawbacks.

We found that while the quantity of the data greatly improved our experience in treating our daughters condition, the results were not always accurate, so we were still doing a lot of finger poke tests to confirm we were dosing off of accurate information, said Lisa. A flash monitor does not come with the ability to broadcast your results to a phone or device, it must be physically scanned. This means you still have to get up in the night to go and check on things.

The Christensens were introduced to a continuous glucose monitor the Dexcom G6. Administrators of the aforementioned grant program agreed to switch funding over to the Dexcom G6, and Lisa says the switch has been life-changing.

This is an amazing life- and sanity-saving device, said Lisa. The accuracy of the G6 has been pretty much spot on for us, you can dose insulin without the need for painful finger pokes. Because of the transmitting ability of the device, both my husband and I can access the blood glucose at any time on our phones.

I no longer have to get out of bed to check her numbers at night, and I can rest assured that if numbers climb or fall the G6 will automatically alert me. When she goes over to see a friend, I can keep an eye on her numbers from any distance, and she can call me to get advice on how to treat.

The government is investigating if this technology could be beneficial enough to warrant providing PharmaCare coverage.

We need them to say yes, said Lisa. It is unconscionable to force people who have to take a medication that has the potential, when dosed incorrectly or affected by activity, to be extremely dangerous to make decisions based off of insufficient and inaccurate data when there is an easy alternative.

PharmaCare only considers coverage if manufacturers apply to have their products covered by PharmaCare. Every submission is reviewed by the Drug Benefit Council (DBC), an independent advisory body, after which, the DBC will make recommendations to PharmaCare.

When contacted by The VI Free Daily, a Dexcom spokesperson confirmed that Dexcom Canada has applied to have Dexcom G6 coverage with BC PharmaCare.

The VI Free Daily has also reached out to the DBC to inquire about whether the board has made a recommendation to the government regarding the G6.

Meanwhile, Lisa said her grant money has run out and the family will have to revert to the poking method to test glucose levels.

This causes deep anxiety as I am not sure how I will go about finding the funds if the government does not accept the G6 to fair PharmaCare, she said.

Lisa added that CGM technology is only marginally more expensive than using the outdated technology of strips and the painful finger pokes that the government plan currently covers. She said the upfront costs would pay for themselves over time.

I would argue that that cost is far more than recovered in the savings from reducing complications and hospital stays in the long run, she explained. As well as increasing productivity of type ones and their caregivers who are no longer exhausted by chasing numbers. And perhaps most importantly of all, by reducing the risks of death for people with this manageable, yet potentially dangerous condition.

For more information on the Dexcom G6 continuous glucose monitoring system, go to http://www.dexcom.com

For more news from Vancouver Island and beyond delivered daily into your inbox, please click here.

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Loneliness Linked to Higher Type 2 Diabetes Risk – Everyday Health

October 2nd, 2020 10:55 am

Genetics, diet, and lifestyle are well-known factors that contribute to type 2 diabetes risk. But there may be a social component that strongly affects your chances of developing the disease, too, suggests a study published in September 2020 in Diabetologia.

Specifically, feeling lonely even if you dont live alone and you do have social interactions in your daily life is associated with a higher risk for type 2 diabetes, the authors found.

For the study, researchers assessed loneliness by asking more than 4,000 adults without type 2 diabetes how often they felt they lacked companionship, felt left out, or felt isolated from others. Responses were averaged on a scale from 1 to 3 points, with higher scores indicating more frequent feelings of loneliness.

After about a decade of follow-up, a total of 264, or 6.4 percent, of participants developed type 2 diabetes. People with type 2 diabetes by the end of the study started out with average loneliness scores of 1.42, compared with 1.33 for individuals who didnt develop type 2 diabetes.

Loneliness was associated with 46 percent greater odds of developing type 2 diabetes, the study found.

The study shows a strong relationship between loneliness and the later onset of type 2 diabetes, says the lead study author,Ruth Hackett, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience at Kings College London in the United Kingdom.

What is particularly striking is that this relationship is robust even when factors that are important in diabetes development are taken into account, such as smoking, alcohol intake, and blood glucose, as well as mental health factors such as depression, Hackett says. There was an independent effect of loneliness on the development of diabetes, above and beyond health behavior.

RELATED:9 Secret Signs of Loneliness

This is the first study to demonstrate that loneliness is linked to an increased risk of developing type 2 diabetes, says Andrew Steptoe, a doctor of science and doctor of philosophy and the head of the department of behavioral science and health at University College London in the United Kingdom.

Previous research has tied social isolation to a risk of type 2 diabetes, but this isnt the same thing as loneliness, says Dr. Steptoe, who wasnt involved in the current study. Loneliness is a subjective experience of dissatisfaction with social and personal relationships, and may not necessarily be linked objectively with how many close friends or social activities people have, Steptoe says.

Fewer close friends and social contacts are, however, associated with an increased risk of developing type 2 diabetes, according to a study published in December 2017 in BMC Public Health. This study looked at how many close friends and family members people had regular contact with in their daily lives and found that each one-person reduction in the size of these social networks was associated with a 12 percent higher chance of developing type 2 diabetes for men and 10 percent greater chance for women.

Isolation has also been tied to a greater risk of premature death in previous research, including a study published in December 2019 in Heart. For one year, this study followed individuals who had been hospitalized for heart problems. Women in the study who reported high levels of loneliness were three times more likely to die during the study, and lonely men were about twice as likely to die.

RELATED: Connected but Alone: What Toll Does Loneliness Take on Our Health?

One limitation of the current study is that researchers assessed loneliness only at a single point in time. Another is that the three-question loneliness evaluation used in the study didnt enable researchers to examine nuanced variations in how people experience loneliness, social isolation, or living alone.

The study wasnt designed to show how loneliness might cause type 2 diabetes. But its possible that so-called psychosocial stress that develops as a result of feeling lonely might lead people to have persistently elevated levels of the stress hormones epinephrine and cortisol, both of which can play a role in the development of type 2 diabetes, says Yacob Pinchevsky, PhD, of the faculty of health sciences at the University of the Witwatersrand in Johannesburg, South Africa.

Put simply, the regular activation of stress-related biological systems due to chronic loneliness may lead to further wear and tear on the body, which could result in increased risk for the development of type 2 diabetes, says Dr. Pinchevsky, who wasnt involved in the latest study.

RELATED: Introvert or Extrovert: What Are Your Best Options for Social Connection?

Its not clear from the study whether managing stress or making an effort to make more friends or to create a more active social life might reduce the risk of developing type 2 diabetes, says Sabine Rohrmann, PhD, MPH, of the Epidemiology, Biostatistics, and Prevention Institute at the University of Zurich in Switzerland.

Because loneliness can be subjective, more friends or social contacts dont necessarily mean people will feel less lonely, says Dr. Rohrmann, who wasnt involved in the study. Some people who push outside their comfort zone to socialize more may also feel stress as a result that triggers a surge in the cortisol and inflammation that contribute to the development of type 2 diabetes, Rohrmann adds.

This means people who worry about loneliness leading to type 2 diabetes may want to focus their prevention efforts on things that dont cause stress for them, like eating healthier foods or exercising more.

A walk in the park even by oneself is a good start, Rohrmann suggests.

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Advanced Diabetic Retinopathy Linked to Choroidal Thickening – MD Magazine

October 2nd, 2020 10:55 am

New technology could allow doctors new insight into the link between choroidal thickness and diabetic retinopathy (DR).

A team based in South Korea, led by Min Gyu Choi, Department of Ophthalmology, College of Medicine, Chung-Ang University Hospital, analyzed the effects of systemic and ocular profiles on subfoveal choroidal thickness (SFChT) in treatment-nave eyes with diabetic retinopathy.

In the retrospective, observational, cross-sectional study, the investigators examined 136 total eyes from 136 patients with diabetes and 30 eyes from 30 age-matched healthy controls between September 2016 and April 2018.

Only patients with treatment-nave eyes without any previous ocular treatment for diabetic retinopathy or diabetic macular edema were included in the study.

The ophthalmologic examination included the measurement of best-corrected visual acuity (BCVA), intraocular pressure (IOP), and refractive error; slit lamp examination; fundus examination and photography; and swept-source optical coherence tomography (SS-OCT).

For the regular systemic workup, the investigators examined body weight, height, body mass index (BMI), blood pressure (BP), complete blood cell count, hemoglobin A1c (HbA1c) level, liver function tests, and kidney function tests and analyzed microalbumin and creatinine levels in urine and the urinary (micro)albumin/creatinine ratio (ACR).

The study included only patients who underwent systemic workups within a span of 4 weeks of the ophthalmologic evaluations.

The investigators excluded patients with prior retinal surgery or panretinal photocoagulation (PRP), intravitreal injection, sub-Tenon's injection, history of ocular trauma or any other eye diseases (such as retinal and choroidal diseases), refractive error greater than 3.0 diopter (D), and systemic diseases besides diabetes or hypertension.

Using generalized linear model analyses, the investigators found that the SFChT in treatment-nave eyes positively associated with the diabetic retinopathy grade and estimated glomerular filtration rate (eGFR) (P = 0.001).

However, the study drug was negatively associated with age (P <0.001) and serum phosphorus levels (P = 0.001). Treatment-nave eyes with proliferative diabetic retinopathy(PDR; 313.4 9.0 m) or severe nonproliferative DR (NPDR; 299.7 9.7 m) had thicker choroid than eyes with mild to moderate NPDR (251.7 11.1 m) or no DR (231.2 14.5 m) after adjusting for age, eGFR, and phosphorus levels.

Choroid is affected by renal function and the grade of DR in patients with diabetes, the authors wrote. Advanced retinopathy is associated with choroidal thickening, and the severity of concomitant renal disease is associated with choroidal thinning.

Diabetic retinopathy is currently the leading of vision loss and blindness in both advanced and developing countries.

The use of enhanced-depth imaging optical coherence tomography allows investigators to view the choroidal thickness in patients with diabetic retinopathy.

Previously, the researchers found SFChT increases as the disease progresses in severity, while several other studies have suggested it decreases in patients with diabetes.

The study, Effects of Systemic Profiles on Choroidal Thickness in Treatment-Nave Eyes With Diabetic Retinopathy, was published online in Investigative Ophthalmology & Visual Science.

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Coffee before breakfast could give you diabetes, experts warn – msnNOW

October 2nd, 2020 10:55 am

Provided by Daily Mail MailOnline logo

For millions of us, starting the day without a coffee doesnt bear thinking about.

But experts warn it is better to hold off from the caffeine hit until after breakfast because regularly drinking coffee beforehand may raise the risk of developing type 2 diabetes in the long term.

Researchers at the University of Bath asked 29 volunteers to drink a strong black coffee about an hour after getting up to understand how this would affect their blood sugar after breakfast.

After then having a sugary drink similar in calorie content to cereal or toast with jam their blood sugar was around 50 per cent higher than when they went without a coffee. The caffeine in the drink is thought to prevent muscles from absorbing the sugar.

This may not be an immediate problem, but frequently raised blood sugar over the years can lead to diabetes and heart disease, the study in the British Journal of Nutrition said.

Professor James Betts, senior author of the study, said: 'Nearly half of us will wake in the morning and, before doing anything else, drink coffee - intuitively the more tired we feel, the stronger the coffee.

'I love coffee too, and I'm not necessarily telling people to go without it, as it has some benefits.

Gallery: The Worst Things You Can Do for Your Health This Fall, According to Doctors (Best Life)

'Perhaps people should wait just a little while later, or until they get to work, so they don't have caffeine in their system when they eat a breakfast containing carbohydrates and sugar.'

Around 40 per cent of people in the UK are believed to drink a coffee as soon as they wake up.

Researchers wanted to see its effects in sleep-deprived people, so asked study participants to set an alarm to go off every hour during the night.

When they woke, to make sure they didn't fall asleep, researchers texted them questions such as simple sums every 30 seconds, to which they had to reply.

The study looked at people's blood sugar and insulin levels on three occasions - after a full night's sleep at home with no coffee, after broken sleep in their bed with no coffee, and after broken sleep and coffee.

This was 300mg of strong black coffee - about the equivalent of two standard cups.

Participants' blood sugar was tested following the breakfast drink, which they had around 30 minutes after the coffee.

The study, published in the British Journal of Nutrition, did not find coffee or sleep deprivation had an impact on insulin levels.

However, strong black coffee consumed before breakfast substantially increased the blood glucose response, repeated blood tests over two hours showed.

Professor Betts said: 'This study is important and has far-reaching health implications as up until now we have had limited knowledge about what coffee is doing to our bodies, in particular for our metabolic and blood sugar control.'

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Diabetes and Weight Loss Linked to Increased Pancreatic Cancer Risk – Diabetes In Control

October 2nd, 2020 10:55 am

The case for expanding screening for pancreatic cancer in those with new onset of diabetes and weight loss.

Pancreatic cancer is a major cause of cancer-related deaths worldwide due to a lack of effective screening and resistance to chemotherapy. It is also difficult to diagnose during the early stages due to the lack of distinct symptoms. Symptoms associated with pancreatic cancer typically include weight loss, fatigue, jaundice, abdominal pain, and nausea and can be associated with many other conditions. The location of the pancreas also makes it difficult for physicians to see during routine physical exams. Therefore, diagnosis is generally made at advanced stages when it has already affected other organs such as the lungs, liver, and lymph nodes. Pancreatic cancer is commonly known as Pancreatic Ductal Adenocarcinoma. There is a 5-year survival rate in the United States. Unfortunately, no screening test has been shown to lower the risk of dying from this cancer. However, radiologists, gastroenterologists, surgeons, pathologists, and genetic counselors work together to find new tests to detect pancreatic cancer early. Currently, the most common tests used are endoscopic ultrasound or MRI.

A high body mass index or obesity has been associated with pancreatic cancer for many years. Diabetes, along with weight changes, has recently been associated with an increased risk of pancreatic cancer....

Agreement to pay later is required for access to the full text of this article. You will be charged only after your use reaches $5.00 (US) of site content. The costs of producing a newsletter like Diabetes in Control have been increasing, which is why we are asking our readers to help support our ability to continue to bring you quality information about diabetes through charging a minimal price to read certain articles. Thank you for helping to support Diabetes in Control.

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Sugar can cause headaches, and it’s more likely if you have diabetes – Insider – INSIDER

October 2nd, 2020 10:55 am

There are many different types of headaches, and your diet can play a role in how often you get them. In fact, your sugar consumption may be an important factor, especially if you have diabetes, as abnormal blood sugar levels are known to trigger headaches.

Eating too much or too little sugar can lead to headaches. This is because how much sugar you consume impacts your blood sugar levels. For example, eating too much sugar can cause your blood sugar to become too high, which is called hyperglycemia.

"With high blood sugar, small amounts of swelling can happen in and around blood vessels and surrounding brain tissue, which can cause headache," says Evan Barnathan, MD, a family physician at Central Maine Healthcare in Maine.

Additionally, high blood sugar is often accompanied by dehydration, which may trigger headaches.

On the other hand, eating too little sugar can cause blood sugar to become too low, which is known as hypoglycemia. When your blood sugar is too low, your body turns to alternate sources of energy from fat and protein, called ketones. The process is called ketosis, and it can lead to headaches, too.

For most healthy individuals, their bodies are able to regulate blood sugar levels and keep them within normal levels, even if they eat a big piece of cake. But those with diabetes aren't able to effectively regulate blood sugar, so what they eat will have a bigger impact.

As a result, people with poorly controlled diabetes will experience headaches from high or low blood sugar more often, says Barnathan. If you don't have diabetes, you're most likely to experience sugar-related headaches if you go on a sugar detox or start a no-carb diet like the Keto diet, because your body may start ketosis for energy after a few days.

Normal blood sugar levels are between 80 mg/dL and 130 mg/dL. When your blood sugar is higher or lower than that, it can cause headaches.

Hypoglycemia is when blood sugar levels are lower than 70 mg/dL. In addition to headaches, the symptoms of hypoglycemia can include:

If untreated, hypoglycemia can lead to more severe symptoms, like blurred vision and seizures.

Hyperglycemia is when your blood sugar is 130 mg/dL or higher before eating, or 180 mg/dL or higher two hours after eating. Other symptoms can include:

Barnathan says headaches will occur more often when blood sugar levels are above 200 mg/dL. For people with type 1 diabetes, hyperglycemia can lead to a dangerous condition called diabetic ketoacidosis (DKA), which can lead to coma or even death.

If you have a headache and you suspect it is from high blood sugar levels, make sure you are hydrated, says Barnathan. Your headache may be partly from the dehydration caused by hyperglycemia. You can also take an over-the-counter pain medicine like acetaminophen (Tylenol) or ibuprofen (Advil) to help relieve your headache.

If your headache is a result of hypoglycemia, it is usually because you haven't eaten, so eating a healthy meal will help. For example, eating small meals throughout the day full of whole grains, fiber, and lean protein can help avoid hypoglycemia.

If you have diabetes, make sure you always have a fast-acting carbohydrate with you, like juice or glucose tablets. These carbs can be quickly broken down into sugar, so you can raise your blood sugar fast before it drops dangerously low.

If you don't have diabetes, but recently cut sugar out of your diet and are experiencing headaches, make sure your body has complex carbs to break down for energy. That will help avoid ketosis and the accompanying headaches. Complex carbs include:

While anyone can experience a headache from eating too much or too little sugar, it is most common for people with diabetes.

It is important for diabetes patients to follow the treatment plan designed by their doctor in order to maintain healthy blood sugar levels, says Barnathan. This will help prevent headaches and other diabetes-related symptoms.

"If you're experiencing chronic headaches and you're worried this is due to poorly controlled diabetes, you should discuss this with your doctor," says Barnathan.

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Sugar can cause headaches, and it's more likely if you have diabetes - Insider - INSIDER

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City of Hope Distinguished Scientist Debbie Thurmond Named New Director of Diabetes & Metabolism Research Institute – Business Wire

October 2nd, 2020 10:55 am

DUARTE, Calif.--(BUSINESS WIRE)--Leading diabetes scientist Debbie C. Thurmond, Ph.D., has been named the new director of City of Hopes Diabetes & Metabolism Research Institute, which continues diabetes research at City of Hope that was started more than 70 years ago. Arthur Riggs, Ph.D., who developed the technology in 1978 that resulted in the first synthetic human insulin, impacting millions of lives worldwide, will continue to conduct research within the institute.

Debbies depth of experience as a highly successful diabetes scientist and leader, as well as her vision for the DMRI, will lead us to continue to be one of the premier diabetes institutes in the nation, said Riggs, Samuel Rahbar Chair in Diabetes & Drug Discovery and director emeritus of Beckman Research Institute of City of Hope. A rising star in the diabetes field, Debbie will continue to be an excellent mentor to younger, independent scientists who, along with our senior scientists, are working on innovative diabetes research.

Thurmond joined City of Hope in 2015 as professor and founding chair of the Department of Molecular & Cellular Endocrinology within the Diabetes & Metabolism Research Institute. She became deputy director of the institute last year.

I am absolutely delighted and humbled to be named director of City of Hope's DMRI," said Thurmond, Ruth B. & Robert K. Lanman Chair in Gene Regulation & Drug Discovery Research. Art has built a phenomenal institute, and I have the great pleasure of facilitating its continued growth and prominence in the diabetes space.

In addition to leading the institutes support of ongoing diabetes research, Thurmond will support its focus on the intersection of diabetes and cancer, helping to answer the reasons why diabetes is significantly associated with an increase in cancer. As such, the institute recently established a new department the Department of Diabetes & Cancer Metabolism. The institute also provides endocrinology care to cancer patients, since type 2 diabetes significantly increases the risk of cancer. In addition, a growing number of highly effective cancer therapies can also cause insulin-dependent diabetes.

With the power of City of Hopes comprehensive cancer center alongside us, we are the only diabetes institute uniquely designed to focus on how to cure both diseases and to develop treatments to help prevent them, Thurmond added.

The Diabetes & Metabolism Research Institutes research in other initiatives includes cellular therapies to treat type 1 and type 2 diabetes; discovering new biomarkers to identify those at risk for developing type 2 diabetes and its complications; developing drugs that precisely target the receptor molecules responsible for diabetes; improving islet cell transplantation; and reviving and/or replacing the cells that make insulin.

The institute plans to open a clinical trial for the first type 1 diabetes vaccine tested in the U.S., part of The Wanek Family Project for Type 1 Diabetes, a $50 million initiative to find a cure for type 1 diabetes.

Thurmond and her teams research efforts include identifying cellular and molecular mechanisms in diabetes development and finding therapies to stop or reverse the diseases progression. One project focuses on boosting the bodys ability to create and preserve insulin-producing beta cells in order to maintain healthy blood sugar levels, as well as to boost muscle insulin responsiveness to combat prediabetes and type 2 diabetes.

Thurmonds work is supported by five research awards from the National Institutes of Health (NIH), the JDRF and Larry L. Hillblom Foundation. In fall 2018, Thurmond and her lab team were highlighted in an issue of the journal Diabetes for their discovery and identification of a new potential target that can keep the immune system stable and islet beta cells healthy, ultimately keeping type 1 diabetes in check. She was also awarded the prestigious John K. and Mary E. Davidson Lectureship and Award in the Department of Physiology at University of Toronto, Canada, in 2018, being the first female recipient in the history of the award.

Thurmond is also one of 21 accomplished female leaders, representing health organizations from across the U.S., awarded the Carol Emmott Fellowship in 2020. The fellowship expands the leadership capacity of women, who are already influential in their fields, so that they may increase their ability to make an impact and ultimately contribute to improving gender equity in health leadership through their own career advancement.

Prior to City of Hope, Thurmond was a professor of pediatrics and associate director of the Basic Diabetes Research Group within the Herman B. Wells Center for Pediatric Research at Indiana University School of Medicine, where she received the Trailblazer in Research Award in 2010.

Thurmond received her Ph.D. and postdoctoral training at University of Iowa, and her M.S. and B.S. degrees from University of California Davis. She serves on multiple editorial boards, including as associate editor for Frontiers in Endocrinology and a past associate editor of Diabetologia, as well as on national and international grant review panels, including as chair as one of the five NIH metabolism-focused grant review panels.

City of Hope has a long and impressive history of groundbreaking discoveries in the field of diabetes. It spans more than four decades of investigation since Rachmiel Levine, M.D., who discovered the role of insulin in glucose transport, launched diabetes research at City of Hope.

In 1978, Riggs and his colleagues synthesized human insulin from bacteria, a legendary scientific first. Synthetic human insulin was the first biologic approved by the U.S. Food and Drug Administration, and the product that launched the biotechnology industry. Decades later, millions of diabetes patients benefit from the daily medication they use to manage the disease. In another landmark contribution, Riggs led the team that developed the technology for creating monoclonal antibodies. Custom humanized antibodies produced using bacteria are behind numerous treatments addressing a host of conditions, including cancer and autoimmune conditions such as arthritis, multiple sclerosis and Crohns disease.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope has been ranked among the nations Best Hospitals in cancer by U.S. News & World Report for 14 consecutive years. Its main campus is located near Los Angeles, with additional locations throughout Southern California. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

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Heart to heart: Novo Nordisk teams with ACC to open diabetes discussion – FiercePharma

October 2nd, 2020 10:55 am

Novo Nordisk wants the heart disease community to join the diabetes conversation. As Type 2 diabetes drugs nab approvals for reduced cardiovascular risksincluding Novos own Ozempic and Victozathe need to communicate across specialties has grown.

To help bridge the gap, Novo Nordisk is partnering with the American College of Cardiology (ACC) in a two-year, two-pronged initiative. First, the partners will studyreal-world data to determine patterns and adherence to guidelines. Next, they'll explorehow to help Type 2 patients improve their heart health, workingthrough ACC clinicians and healthcare providers, Novo Chief Medical Officer Todd Hobbs said.

RELATED: Novo's Ozempic scores major win with heart-helping FDA approval. Is Rybelsus next?

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The effort is a natural progression of Novo Nordisks relationships built up in the cardiovascular community over the past several years, he said.

Weve looked at smaller cuts of research, like with Cleveland Clinic and others, that show theres a lot of people out there with diabetes who really should be on one of the agents, either GLP-1 or SGLT2, that are proven to lower (cardiovascular) risk, and they just arent, Hobbs said.

While not an explicitpart of the study, COVID-19 has magnified the risks for people with diabetes and with heart disease. The partnership was in the works before the pandemic, but the novel coronavirus has made the initiative even more timely and relevant, Hobbs said.

The first part of the workevaluating data assessing adherence to ACC guidelines among a cohort of people with CV diseasewill be done within a year. The second stage will roll out specific treatment strategies to selected regional practices and hospitals, delivered through ACC healthcare ambassadors.

RELATED: Novo shifts Victoza ad message with spots highlighting heart-benefit trifecta

In January, Novo's next-gen GLP-1 drug Ozempic won an FDA toadd CV risk-reduction language to its label, specifying the benefits for patients with Type 2 diabetes andestablished cardiovascular disease.

Ozempic launched in early 2018 and took off quickly, nabbing $1.64 billion in 2019 sales. It's expected to reach $2.64 billion this year.

Novos newly launched Rybelsus, the oral version of Ozempic, is currently being studied as a CV preventive for patients with Type 2 diabetes. The company'solder GLP-1 diabetes med Victoza got a similar CV approval from the FDA in 2017 to add that it reduces the risk of heart attack, stroke and cardiovascular death.

While the ACC partnershipdoesnt includeany specific products, Hobbs said, If we can highlight the guidelines, whether thats ACC or ADA treatment guidelines, then our products will do well because theyre on the data.

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Diabetes raises the risk of liver damage in people with HIV – aidsmap

October 2nd, 2020 10:55 am

Almost half of people with HIV with unexplained liver enzyme elevations or other abnormal liver markers had NASH and a third had stage F3 or F4 fibrosis, and advanced liver damage was strongly associated with type 2 diabetes, a four-country study reports in Clinical Infectious Diseases.

Fatty liver disease occurs when fat builds up in the liver. Greater fat accumulation can lead to non-alcoholic steatosis (NASH), in which liver cells balloon and become inflamed. Unchecked, NASH leads to scarring of liver tissue (fibrosis) and eventually to cirrhosis, in which normal liver functions decline.

Although a high prevalence of non-alcoholic fatty liver disease (NAFLD) has been reported in people living with HIV, its unclear what proportion of these cases already have NASH or advanced fibrosis. The only way that these conditions can be diagnosed definitively is through liver biopsies (direct sampling of liver tissue).

Thickening and scarring of connective tissue. Often refers to fibrosis of the liver. See also cirrhosis, which is more severe scarring.

Non-alcoholic fatty liver disease (NAFLD) is a very common disorder and refers to a group of conditions where there is accumulation of excess fat in the liver of people who drink little or no alcohol. The most common form of NAFLD is a non-serious condition called fatty liver, by which fat accumulates in the liver cells. A small group of people with NAFLD may have a more serious condition named non-alcoholic steatohepatitis (NASH).

A procedure to remove a small sample of tissue so that it can be examined for signs of disease.

In NASH, fat accumulation is associated with liver cell inflammation and different degrees of scarring. NASH is a potentially serious condition that may lead to severe liver scarring and cirrhosis. It sometimes affects older people living with HIV.

A group of diseases characterized by high levels of blood sugar (glucose). Type 1 diabetes occurs when the body fails to produce insulin, which is a hormone that regulates blood sugar. Type 2 diabetes occurs when the body either does not produce enough insulin or does not use insulin normally (insulin resistance). Common symptoms of diabetes include frequent urination, unusual thirst and extreme hunger. Some antiretroviral drugs may increase the risk of type 2 diabetes.

To learn more about the frequency of NASH in people living with HIV, investigators at hospitals in the United Kingdom, Italy, Canada and the United States carried out a retrospective study of biopsy samples from 166 people with HIV who had been referred for investigation of unexplained increases in liver enzymes or other abnormalities in laboratory markers of liver disease between 2001 and 2019.

The analysis excluded people with hepatitis B or C, any active cancer, alcohol consumption above 21 units a week for men or 14 units for women, or any other cause of chronic liver disease.

Study participants had a median age of 48 years, 93% were male, 72% were white and the median duration of antiretroviral treatment was nine years. The median CD4 cell count was 638 cells/mm3. None had taken older nucleoside analogues associated with steatosis (stavudine, didanosine). The median body mass index was 29 kg/m2 (borderline obesity), 53% had high blood pressure and 25% had diabetes.

Biopsies showed that 63 of 116 people had NAFLD (54%) and 57 (49% of the entire cohort) had NASH. Thirty-six people (31%) had F3 stage fibrosis and three (2%) had F4 fibrosis (cirrhosis).

"Theinvestigators recommend consideration of liver biopsy as a screening tool in people with HIV who are obese, especially those with type 2 diabetes."

Multivariate analysis showed that after controlling for metabolic factors associated with NAFLD (model 1) or HIV-related factors (model 2), the only factor associated with NAFLD was higher body mass index (adjusted odds ratio 1.20 in both models, p=0.001).

Advanced fibrosis (F3 or above) was the only factor associated with type 2 diabetes in multivariate analysis (aOR 3.42, 95% CI 1.00-11.71) and this association was on the borderline of statistical significance (p=0.05).

Using biopsy results as a gold standard, investigators also assessed whether laboratory markers could accurately identify patients with advanced fibrosis. They found that both the FIB-4 and NAFLD Fibrosis scores performed poorly in identifying advanced fibrosis but showed good sensitivity (93%) in ruling out cases where the collagen proportionate area (CPA) was above 7.6%. CPA measures the percentage of liver tissue that is fibrotic and a level above 7.6% has been shown to predict long-term adverse liver disease outcomes.

The poor prognostic value of non-invasive markers for liver fibrosis in people living with HIV leads the investigators to recommend consideration of liver biopsy as a screening tool in people with HIV who are obese, especially those with type 2 diabetes.

However, they also note that 41% of people referred for biopsy did not have NAFLD. Their liver enzyme elevations remained unexplained but 15 of these 53 patients had advanced fibrosis (Ishak score 3 or above). The only factor associated with advanced fibrosis in those without NAFLD was time since HIV diagnosis (21 years vs 11.5 years, p= 0.005), even though age was similar between the two groups.

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Pulse Biosciences Announces FDA IDE Approval and Initiation of Sebaceous Hyperplasia Study – BioSpace

October 2nd, 2020 10:53 am

Oct. 1, 2020 11:30 UTC

Completes First Procedures in CellFX System Specific Indication Study

HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System. The data generated from this study is intended to support a 510(k) submission to expand the indication for use of the CellFX System specifically to treat SH lesions.

Following IDE approval, several patients have been enrolled, with the first patient procedure completed on September 28, 2020. The multicenter prospective comparative study is intended to evaluate the safety and efficacy of procedures to clear facial SH lesions performed with the CellFX System versus those performed by electrodessication in a comparator group. Enrollment of 60 patients across five study sites is expected to be completed in approximately three months. All subjects will have up to two treatments and will be evaluated through the primary safety and efficacy endpoints at 60-days following their last treatment. The ClinicalTrials.gov Identifier for the study is NCT04539886.

We are pleased to have received FDA IDE approval and to have begun this important SH comparative study slightly ahead of the fourth quarter start we had previously communicated. Understanding the COVID-19 pandemic has increased the demand on FDA resources, we appreciate their attention throughout the IDE process. Barring delays in enrollment, we expect to conclude the study in the first quarter of 2021 and plan to quickly follow with a 510(k) submission for the corresponding specific indication. We have long viewed SH as a top addressable market priority for the CellFX System based on patient demand in clinics today and the CellFX Systems early demonstration of procedure effectiveness, said Darrin Uecker, President and CEO of Pulse Biosciences. As we have communicated previously, in parallel we are completing our GLP preclinical study in support of the initial CellFX System 510(k) submission for a general dermatologic indication. We remain on track to submit this 510(k) in the next several weeks.

About Sebaceous Hyperplasia

Sebaceous hyperplasia (SH) is a very common skin condition that presents as shiny, yellowish or white raised bumps, or lesions, that most frequently occur on the face and are often oily in appearance. SH lesions form on the skin surface when the sebaceous glands, which are located in the deeper layer of the skin, become enlarged and form bumps between 2 and 4 millimeters wide on the facial skin surface. These deeper sebaceous glands that cause the SH lesion are difficult to treat with current thermal technologies without damaging the skin surface.

Based on a 2019 survey1, dermatologists who specialize in aesthetic procedures see an average of over 40 patients per week with SH lesions and their surveyed aesthetic patients diagnosed with this common problem are highly motivated to seek treatment as a cash-paying procedure to improve the appearance of their facial skin. Yet the majority of these patients diagnosed with SH are untreated, likely due to limitations of existing treatments that either cannot reach the sebaceous gland or that damage the skin surface, making the skin appearance worse than prior to treatment. Given the profile of NPS technology as a new option to reach these sebaceous glands with more desirable cosmetic effects, in the same survey, 88% of these aesthetic dermatology specialists reported a clear interest in a new procedure to address SH lesions. Previously published clinical data by the Company demonstrated that over 90% of SH lesions were cleared or mostly cleared by 60 days post-NPS treatment.

1 2019 Physician (n=304) and Patient (n=405) surveys conducted by third-party market research firm on behalf of Pulse Biosciences, Inc.

About Pulse Biosciences

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If cleared, the CellFX System will be the first commercial product to harness the distinctive advantages of the Companys proprietary Nano-Pulse Stimulation (NPS) technology to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a broad range of dermatologic conditions that share high demand among patients and practitioners for improved and durable aesthetic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across an expanding spectrum of clinical applications. To learn more please visit http://www.pulsebiosciences.com.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Caution: Pulse Biosciences CellFX System and Nano-Pulse Stimulation technology are for investigational use only.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences expectations regarding regulatory clearance and the timing of FDA and other regulatory filings or approvals, including meetings with FDA and the ability of the Company to successfully complete a 510(k) submission for the CellFX System or for a specific indication for the treatment of sebaceous hyperplasia (SH) lesions, the ability of the Company to prepare and provide data to FDA and other regulatory bodies, NPS technology including the effectiveness of such technology and the effectiveness of related clinical studies in predicting outcomes resulting from the use of NPS technology, the CellFX System including the benefits of the CellFX System and commercialization of the CellFX System, current and planned future clinical studies and the ability of the Company to execute such studies and results of any such studies, other matters related to its pipeline of product candidates, the Companys market opportunity and commercialization plans, including the market for the treatment of SH, future financial performance, the impact of COVID-19 and other future events. These statements are not historical facts but rather are based on Pulse Biosciences current expectations, estimates, and projections regarding Pulse Biosciences business, operations and other similar or related factors. Words such as may, will, could, would, should, anticipate, predict, potential, continue, expects, intends, plans, projects, believes, estimates, and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201001005320/en/

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Zebrafish Embryo Model Helps Understand the Workings of Nanoparticles in Blood – AZoNano

October 2nd, 2020 10:53 am

Written by AZoNanoOct 1 2020

When nanoparticles are injected into the bloodstream, for instance, to kill solid tumors, it is not known what exactly happens to them.

Now, with new results reported in the ACS Nano journal, scientists from Aarhus University are set to deal with this challenging query by using zebrafish embryos as a new research model in nanotoxicology and nanomedicine.

A wide range of nanoparticles are engineered for targeted drug delivery, but regrettably, just a few of the injected nanoparticles reach the site of target, such as solid tumors. The reason for this low targeting efficiency is frequently considered a black box and thus had not been investigated thoroughly for a number of years.

An international research group, headed by Yuya Hayashi from the Department of Molecular Biology and Genetics (MBG), Aarhus University, has now shown the beauty of zebrafish embryos in nano-bioimaging that can view dynamic interactions between nanoparticles and target cells in a living entity.

Currently, in association with scientists from Interdisciplinary Nanoscience Center (iNANO), Yuya aims to answer the unexplained mysteries in bionanosciencethe first one is the biological identity concept, which elucidates how cells detect nanoparticles via a corona of proteins surrounding each particle.

For the first time, this concept has now been demonstrated in a living organism through the use of zebrafish embryos, revealing what exactly occurs to nanoparticles when they are injected into the blood.

What the Cell Sees in Bionanoscience is one of the initial publications that have established how a protein corona develops around a nanoparticle and how this protein corona indicates the need for reconsidering the way one observes nanoparticles within a biological setting. From elaborate research made in the last several years, researchers have now understood that two opposing effects mostly play a role in the cellular uptake of nanoparticles.

Generally, the protein corona inhibits the surface of the nanoparticle from direct physical interactions with the cell membrane. But what if the protein corona sends a signal that activates a particular biological interaction with receptors positioned on the cell membrane? That is something the cell detects and therefore confers a biological identity to the nanoparticle.

Currently, the scientists from Aarhus University have thus given the first visual proof for the excellent influence of the protein corona with regard to the clearance of nanoparticles from the blood that involved adverse results in the zebrafish embryo model.

The researchers employed a species-mismatched source of proteins for the formation of corona to produce a non-self biological identity and traced the movement of nanoparticles traveling via the blood and to their final targetthat is, endolysosomes in the cell.

This showed an unexpectedly quick uptake and acidification of the nanoparticles by scavenger endothelial cells (functional counterpart to the liver sinusoidal endothelial cells in mammals) followed by pro-inflammatory stimulation of macrophages.

It sounds like a crazy idea to inject nanoparticles with proteins from another animal, but for example, biomolecule-inspired nanomedicines are tested in a mouse model without particular concerns for the species-mismatched combination.

Yuya Hayashi, Department of Molecular Biology and Genetics, Aarhus University

Hayashi continued, Or else some clever folks humanise the mouse to take care of the species compatibility problem. In fact, even at the cell culture level nanoparticles are still routinely tested following the tradition to use serum supplement derived from cows while knowing that nanoparticle-protein interactions are a key driver of cellular uptake.

What makes this kind of experiments rather challenging is to maximally retain the original protein corona in a living organism. If the pre-formed corona gets quickly exchanged by endogenous blood proteins, the hypothesis tested becomes invalid. We have made quite some efforts to characterise the protein corona to ensure the nanoparticles preserve the non-self-biological identity.

Hossein Mohammad-Beigi, Study First Author, Aarhus University

The maximum benefit of the zebrafish model is its power in multicolor immediate imaging, whereby numerous combinations of reporter proteins and fluorescence tracers can be viewed in a basic arrangement at high spatio-temporal resolution. This offers a new chance that lies between less lifelike cell culture systems and more complex rodent experiments, like intravital microscopy.

Using cell cultures, we have learnt quite a lot about how cells recognise nanoparticles rather as dynamic aggregates of proteins but it was never tested in a more realistic situation. With establishment of the zebrafish model, we have finally acquired a means to further explore this question in a living organism.

Yuya Hayashi, Department of Molecular Biology and Genetics, Aarhus University

It was a simple approach with an extreme scenario tested in a very complex system, but I believe we are now one step closer to understanding what the protein corona can really mean to nanoparticles. In an environment rich in proteins, nanoparticles can wear a mask that gives them a biological identity, and its non-selfness can make them a foe. What defines the degree of the non-selfness? Well, it's the next big question we have to address, Hayashi concluded.

Mohammad-Beigi, H., et al. (2020) Tracing the In Vivo Fate of Nanoparticles with a Non-Self Biological Identity. ACS Nano. doi.org/10.1021/acsnano.0c05178.

Source: https://mbg.au.dk/en

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