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As the worsening coronavirus pandemic continues to spread across the country, millions of Americans living with diabetes face heightened risks from COVID-19.

Around 30 million Americans have diabetes, mostly of the type II (previously called adult-onset) variety. A quarter of U.S. adults with diabetes are over 65, an age that has been shown to delineate increased COVID-19 mortality rates.

One issue is you have the confounding factor of age. As people age, type II diabetes becomes more and more prevalent, Dr. Mark Snyder, an endocrinologist in San Francisco, told Yahoo News. Its hard to tease out all of these issues. Aging is also a risk factor for complications with COVID-19.

Diabetes is a disease of the pancreas that impairs the bodys ability to process blood glucose. When left untreated, high blood sugar levels can lead to a variety of life-threatening complications, such as heart disease, kidney failure and stroke.

COVID-19 is especially worrisome for older diabetics, who may already be suffering from heart disease, another risk factor for those who contract the virus.

Diabetes and high glucose levels are associated with increased complications, respiratory failure and mortality in hospitalized patients with COVID-19, the American Association of Clinical Endocrinologists states on its website.

Data compiled on the 2,112 U.S. deaths from COVID-19 through March 28 showed 10.9 percent had diabetes, the most frequent underlying health condition among those who had died. Still, health experts caution that more still needs to be learned about the link between diabetes and COVID-19.

There is not enough data to show whether people with diabetes are more likely to get COVID-19 than the general population, the American Diabetes Association says on its website. The problem people with diabetes face is primarily a problem with worse outcomes, not greater chance of contracting the virus.

In China, where the virus is believed to have originated, the data does show that people with diabetes had much higher rates of serious complications and death from COVID-19 than people without it, the ADA reported.

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The complications from viruses pose a heightened risk for diabetics, which is why they are encouraged by doctors to receive a flu shot every year. Roughly 30 percent of the adults hospitalized with influenza each year have diabetes, according to the CDC.

People with high blood sugar from diabetes can be more severely affected by common infections, such as influenza and pneumonia, the University of Michigan wrote on its website. This is why immunizations for influenza (the flu) and pneumococcal disease are recommended for people who have diabetes.

Given that initial data shows COVID-19 is three times more infectious than the seasonal flu, diabetics should take extra precautions, health officials warn.

If you do get one of these common illnesses, your diabetes is going to be messed up and youre likely going to end up in the hospital, Snyder said.

In part thats because viral infections in diabetic patients greatly increase the risk of diabetic ketoacidosis (DKA), a condition that occurs when cells dont receive sufficient glucose. It can lead to coma and death.

DKA can make it challenging to manage your fluid intake and electrolyte levels which is important in managing sepsis. Sepsis and septic shock are some of the more serious complications that some people with COVID-19 have experienced.

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Click here for the latest coronavirus news and updates. According to experts, people over 60 and those who are immunocompromised continue to be the most at risk. If you have questions, please reference the CDC and WHOs resource guides.

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Coronavirus poses special risk to millions of Americans with diabetes - Yahoo News

Diabetes is a killer, and Texas has a higher percentage of diabetes cases than the national average.

According to the American Diabetes Association, the disease is among the leading causes of disability and death in the United States. Uncontrolled diabetes causes blindness, nerve damage, kidney disease and other health problems, but nine out of 10 adults with pre-diabetes dont know they have it, according to The National Institute of Diabetes and Digestive and Kidney Diseases Health Information Center and more than half of type 2 diabetes is preventable.

Find out if you are at risk with a 60-second test and then see your primary care physician if you are.

The good news? People who are at risk for type 2 diabetes can improve their prospects with simple lifestyle changes. Heres how to get started.

Your doctor can do a blood test called A1c. It uses red blood cells to create a picture of average blood sugar levels over the last two to three months. For people without diabetes, the normal A1c range is 4% to 5.6%. A test reading of 5.7% to 6.4% means you have a higher chance of getting diabetes. A level of 6.5% or higher means you have diabetes. Knowing where your A1c falls can guide your next steps.

Fruits, vegetables and legumes are loaded with vitamins, minerals and fiber and chances are good youre not eating enough of them. (Most Americans arent.) Working with a dietitian or nutritionist can help. So can joining a whole-foods, plant-based diet Facebook group. Not sure what to eat? The American Diabetes Association has a long list of cookbooks that will help you solve that dilemma.

The sugar found in fruits and vegetables isnt what you need to be concerned about. Its the added sugars in processed foods that are harmful. Among the fastest ways to get sugar out of your diet are to replace soda with unsweetened tea or water; skip desserts and sugary snacks; forgo condiments such as ketchup, barbecue sauce and sweet chili sauce; and trade cold breakfast cereal for oatmeal.

Change begins with a single step sometimes literally. If you dont already have an exercise regimen and you can walk, do it. A 15-minute walk around the block once a day is a start. So is a gentle yoga class once a week. If you cant walk, you can still exercise! Start with light hand weights or resistance bands and find a YouTube video with an easy upper-body routine. Work up to longer walks or heavier weights. To get all the health benefits of physical activity, work up to a combination of aerobic and strength exercises at least five times a week.

Being overweight impacts more than your risk of developing type 2 diabetes. According to the American Diabetes Association, it leads to unhealthy cholesterol, high blood pressure, heart disease, high blood sugar and even stroke. Losing just 10 pounds can make a big difference. If youre overweight and engage in the first four activities listed here, weight loss may happen without additional effort. Improving your diet and exercising regularly are the best ways to lose weight and keep it off.

If you have been diagnosed with diabetes, these tips still apply to you. Additionally, Baylor Scott & White Health has local programs to teach people of every age to manage the disease and improve their overall quality of life. Find a diabetes education program near you.

Original post:
Learn what you can do to prevent diabetes during National Diabetes Month - The Dallas Morning News

In light of the COVID-19 pandemic, ENDO 2020, the annual meeting of the Endocrine Society, was postponed until June 2020. In lieu of the meeting, which was originally scheduled for March 2831, 2020, in San Francisco, organizers held virtual news conferences March 30 and 31 to share the latest emerging science in endocrinology. All ENDO 2020 studies will be published in a supplemental issue of the Journal of the Endocrine Society.

The worlds first use of a drone to deliver insulin to a patient living in a remote community was performed late last year in Ireland, an accomplishment that has implications for wider use of drones to deliver medications in trying circumstances. Such circumstances might include infectious-disease pandemics like the COVID-19 outbreak.

An international team of researchers spent a year planning the drone test flight from Galway, Ireland, to the Aran Islands, about 12 miles off the west coast of Ireland. The drone was used to drop off insulin and return with the patients blood sample so that a doctor could check the patients glucose levels, says Spyridoula Maraka, MD, an endocrinologist at the University of Arkansas for Medical Sciences and the Central Arkansas Veterans Healthcare System in Little Rock.

The project was conceived after healthcare professionals in Ireland noted the difficulties people faced obtaining critically needed medications during a 2017 hurricane and a 2018 blizzard in Ireland, Dr. Maraka says. People with diabetes who require insulin could fall critically ill if they run out of their medication, she says. Drones are already used in remote parts of Africa to deliver blood supplies.

Medicine has a track record of practicing for emergencies before they happen, Maraka said. There are multiple medical delivery drone opportunities.

Irelands Diabetes Drone Mission was launched with a team of experts across different fields, including medical, pharmaceutical, technical, flight operations, telecommunications, and regulatory agencies. The team selected a Wingcopter 178 drone for the first flight and received Irish Aviation Authority approval to conduct the mission.

The team plans to scale up the program to deliver medications to remote areas in the future. It will be important to gain the publics confidence in the program, as well as negotiate with airspace authorities to allow delivery access, Maraka says. That may be challenging in more densely populated areas.

RELATED: 9 Diabetes Care Tips During the COVID-19 Pandemic

A common chemical called PFAS detected in the blood of pregnant women is linked to a higher risk of obesity in their granddaughters. PFAS per- and polyfluoroalkyl substances are man-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles, according to the Environmental Protection Agency. They are known as endocrine-disrupting forever chemicals because they persist when released into the environment and accumulate over time.

The study, by researchers at the Public Health Institute in Berkeley, California, featured an analysis of data from a project known as the Child Health and Development Studies. Blood samples from pregnant and postpartum women in the 1960s were collected and stored. In the early 2000s, the researchers measured the weight, height, and waist circumference of a subset of the study participants daughters and granddaughters. They determined the risk of total obesity and abdominal obesity in the daughters and granddaughters. The study included 213 sets of grandmothers, mothers, and granddaughters. The California Department of Toxic Substance Control then measured PFASs and other chemicals in the stored blood of the grandmothers.

The study showed that a granddaughters combined risk of abdominal and whole-body obesity increased 53 percent with a doubling of PFAS blood levels in her grandmother, when her grandmother also had lower cholesterol (in the bottom 25 percent). This translated to an estimated 2.3-fold increase in the combined risk of abdominal obesity and whole-body obesity for women whose grandmothers were in the top 25 percent of PFAS exposure compared with the bottom 25 percent of PFAS exposure. Cholesterol is somehow involved in the transport and metabolism of the chemicals, the researchers note.

Pregnancy appears to be based on our study and animal research and other work in progress a critical window of exposure for three generations in humans, says the lead author of the study, Barbara A. Cohn, PhD, the director of Child Health and Development Studies, who is based in Oakland, California.

These findings may help to explain the current U.S. and worldwide increases in obesity in young adults, she says. We dont understand the mechanisms for this association. We do know it has implications for the current epidemic of obesity if this can be confirmed.

Consumers can reduce their exposure to the chemicals by avoiding eating out of take-out and to-go food containers and using glass or stainless steel food storage containers. Another source of exposure is stain- and water-resistant carpet.

But, she says, Personal measures probably are not going to be enough because, like other legacy compounds, they have been so ubiquitous. There is so much everywhere.

RELATED: New Report Finds Toxic Forever Chemicals in Drinking Water in 31 States

People with diabetes who have a stroke have a better chance of preserving cognitive function if they have good blood glucose control after the stroke, according to a study from the Sheba Medical Center and the Sackler School of Medicine of Tel Aviv University in Israel.

The study involved patients who had lacunar strokes, which are a common type of stroke that occurs in a blocked artery deep within the brain. The stroke can cause neurological damage. Researchers looked at 942 adults with diabetes who had a lucunar stroke to assess their A1C management following the stroke. A1C is a measurement doctors use to assess how well a person with diabetes is managing his or her glucose. Its also used to diagnose diabetes, according to the Centers for Disease Control and Prevention. The study showed better glucose management was linked to greater cognitive function and less cognitive decline. The research was observational, meaning that it only links better glucose management with cognitive benefits following stroke. A clinical trial could help prove a causal effect between the two, the authors said.

Still, Understanding potentially modifiable risk factors has large public health implications. One such factor may be A1C control, says the study's lead author, Tali Cukierman-Yaffe, MD, a physician and researcher at the Sheba Medical Center and the Sackler School of Medicine of Tel Aviv University. For example, she says, It may be that individuals with cognitive impairment who have difficulty managing their disease would have worse glucose control.

Current medical recommendations urge healthcare providers to screen older people with diabetes for cognitive impairment, she notes.

Cognitive assessment should be part of the routine checkup of older people with diabetes, she said. The reasons for that are, one, the relationship between cognitive dysfunction and diabetes self-care; and the other is that cognitive function is another complication of diabetes that we should be looking for.

RELATED: Why Some Researchers Are Calling Alzheimers a Type 3 Diabetes

A minimally invasive endoscopic technique that has been approved in Europe can help people with poorly managed type 2 diabetes improve their A1C. The procedure, called Revita duodenal mucosal resurfacing (DMR), has not been approved for use yet in the United States.

During the procedure, doctors insert a balloon catheter through the mouth into the duodenum, which is part of the upper small intestine. They deliver thermal energy to remove or ablate the duodenal lining. After the damaged duodenal lining is removed, a new layer of tissue eventually forms.

Data from a new study of 70 people, dubbed REVITA-2, showed that people who received DMR had improved blood glucose levels and liver insulin sensitivity three months following the procedure compared with patients who underwent a sham procedure.

The novel technique is based on research that shows the duodenal lining is critical to the hormone changes and hormone signaling that lead to insulin resistance. Destroying the lining can interrupt the process underlying diabetes, the study authors say.

A major question about DMR is how long the effects last. Researchers reported evidence that some patients have improved diabetes control for up to two years. But its not known if the procedure will have to be regularly repeated.

This procedure would be for patients who have not been helped by previous treatments, says the study investigator David Hopkins, MBChB, a physician and the director of the Institute of Diabetes, Endocrinology, and Obesity at Kings Health Partners in London. But, he adds, treatment earlier in the course of diabetes could likely produce the most benefit by changing the course of disease.

RELATED: How to Stabilize Your Blood Sugar

In another study on bariatric surgery released from ENDO 2020, researchers at the University of Michigan in Ann Arbor have found that bariatric surgery that takes place prior to the development of diabetes is more effective in facilitating weight loss.

Researchers studied 714 participants who had either gastric bypass or sleeve gastrectomy surgery. All of them had a body mass index (BMI) of more than 40 prior to surgery. Those without diabetes at the time of surgery had a 1.6 times higher chance of losing at least 50 percent of total body weight, regardless of the type of surgery.

The presence of diabetes before surgery is a predictor of future weight loss outcomes, says a study coauthor, Yingying Luo, PhD, of the University of Michigan.

The study suggests that having bariatric surgery before developing diabetes may be an important preventive strategy, says a lead researcher,Elif A. Oral, MD, of the University of Michigan. More research is needed to confirm the study results, the authors said. Yet doctors and patients should consider the timing of bariatric surgery.

We know that bariatric surgery may protect or delay the onset of diabetes, Dr. Luo says. We need a larger sample size. If we can find a true impact on the presence of diabetes, maybe it suggests we should take a step forward to have the surgery.

RELATED: Bariatric Surgery Cuts Heart Risks in People With Obesity and Diabetes

People with diabetes who lose a gland that helps lubricate the eye by producing tears may have elevated blood glucose levels, say the authors of a study from the University of California in San Francisco.

People with diabetes can experience dry eye and eye discomfort. They may have a loss of the meibomian glands in the eyes. The study looked at people with type 2 diabetes diagnosed with dry eye. People with higher A1C levels, a measure of blood glucose levels, were more likely to have the loss of the meibomian glands compared with those with more controlled A1C levels. Even among people who did not have diabetes, those with higher A1C levels had greater loss of meibomian glands.

Doctors should check the eyelids of individuals with diabetes who complain of dry eye, says the coauthor Gloria Wu, MD, an adjunct faculty member at the University of California in San Francisco.

Some people have severe discomfort and pain, she says. This is an easy diagnostic way of looking at diabetes.

RELATED: 5 Ways to Lower Your A1C Levels

People with type 1 diabetes using the Medtronic MiniMedTM 670G insulin pump system are able to maintain blood glucose levels in the targeted range over 71 percent of the time, according to a study that analyzed some 6 million days of real-world data.

The data compares favorably to the results found in clinical trials that led to approval of the device. The MiniMed TM 670G system is the first hybrid closed-loop system approved by the U.S. Food and Drug Administration (FDA) for people with type 1 diabetes.

Sometimes referred to as an artificial pancreas, the device consists of an insulin pump with a tiny infusion catheter worn under the skin and a small continuous glucose monitor that is also placed under the skin. The device measures glucose levels every five minutes and sends the results to the pump to dispense insulin as needed. Individuals upload data from the device to a website so that physicians can monitor their patients.

The real-world study involved more than 51,000 people. Researchers found that individuals were able to maintain blood glucose levels in the targeted range more than 71 percent of the time. When managing diabetes, the goal is to be in the target glucose range of 70180 milligrams per deciliter (mg/dL) more than 70 percent of the time.

Real-world experience does not necessarily live up to the results seen in a clinical trial that recruits highly motivated participants who are under close supervision, says the study's principal investigator, Robert Vigersky, MD, the chief medical officer of Medtronic Diabetes, in Northridge, California. Our results demonstrate that the glycemic control using the MiniMedTM 670G in the real world is excellent and mirrors the results of the small pivotal trials that led to the systems approval.

In February, the FDA announced Medtronic had recalled MiniMed 670G insulin pumps with broken or missing retainer rings following reports that a broken or missing part could lead to incorrect dosing. Insulin pumps with the retainer ring intact do not need to be returned to Medtronic.

Read the original post:
ENDO Online 2020: The Top Diabetes News From March 30 - Everyday Health

Roche is offering free access to its mySugr Pro diabetes management app in the UK to relieve pressure on the NHS during the COVID-19 coronavirus pandemic.

The Swiss pharma is offering a years free access to the app to help both patients and clinicians at a time when the UK is thought to be approaching a peak of patients with the disease.

Usually costing 20.99 per person per year, the app aims to improve the experience of digital and telephone appointments for people with diabetes by remotely providing blood glucose monitoring information.

mySugr allows users to enter blood glucose results from any monitor and is already used by more than 2 million registered users worldwide.

Eligible patients can use a code that can be redeemed until 30 September this year and supports NHS guidelines on management of diabetes, while protecting resources for response to the coronavirus.

As there is no capacity within the NHS currently for healthcare providers to install additional software, so the healthcare provider need only provide an email address for people with diabetes to send PDF reports to.

Dr Claire Marriott, medical affairs lead at Roche Diabetes Care, said: Supporting people with diabetes is essential at this time. Tools that support someone living with diabetes in their glucose management can also enhance remote consultations. This then has the added benefit of freeing up valuable time of our healthcare providers.

mySugr was founded in 2012 to provide an all-round care service for people with diabetes, combining coaching, therapy management, test strips and data tracking.

Roche had been partnering with mySugr since 2014 and decided to acquire the digital health firm in 2017 for an undisclosed sum.

The Swiss pharma is one of several that have invested in digital services to support patients with diabetes.

Eli Lilly is working closely with the diabetes digital health firm Livongo and in 2018 began a collaboration looking at how real-world evidence could be used to improve care and reduce the burden of disease.

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Roche offers free access to diabetes app to relieve pressure on NHS - - pharmaphorum

DUBLIN, April 1, 2020 /PRNewswire/ -- The "Digital Health: Diabetes Apps and Virtual Coaching" report has been added to ResearchAndMarkets.com's offering.

This special technology-based report provides an overview of diabetes, wearable glucose monitoring devices, smartphone-based digital health technologies, and attempts to answer the question: can digital health help improve diabetes?

Smartphone-based digital health technologies are expected to transform the diabetes management market over the next decade by substantially improving diabetes outcomes and reducing healthcare costs. These technologies are engaging and empowering patients, improving glycemic control, and lowering complications.

Digital health technologies are defined in this report as: diabetes smartphone apps integrated with blood glucose monitoring devices (both standard blood glucose meters and continuous glucose monitoring systems) and personalized virtual diabetes coaching services.

The adoption of smartphone-based digital health technologies for diabetes management is being driven by:

the large and growing prevalence of diabetes

heavy patient burden and treatment complexity

poorly controlled diabetes

spiraling diabetes-related healthcare costs

the rise in global smartphone usage and increased accessibility to smartphone-based telehealth

positive clinical data supporting reduced complications and healthcare costs

Key Topics Covered

Executive Summaryi. Digital health is transforming diabetes managementii. Benefitsiii. Clinical dataiv. Limitationsv. Security concernsvi. Conclusionvii. Bibliography

1. Diabetes Overview 1.1 Type 1 diabetes: 5% of the diabetes population are insulin dependent1.2 Type 2 diabetes: 95% of the diabetes population1.3 Diabetes prevalence: rising by 50% over next 25 years1.4 Complications: tight glycemic control can prevent complications1.5 Prevention1.6 Bibliography

2. New Guidelines for Achieving Glycemic Control2.1 ADA's target A1c: 2019 Standards of Medical Care in Diabetes2.2 The importance of self-monitoring of blood glucose2.3 The DCCT study2.4 New 2019 ADA guidelines for glycemic targets: time-in-range2.5 Medtronic's TIR goa2.6 Bibliography

3. Blood Glucose Monitoring and the Rise of Smartphone-Driven Diabetes Apps3.1 Ascens3.2 DarioHealth3.3 LifeScan3.4 Welldoc's BlueStar for diabetes3.5 Glooko3.6 mySugr3.7 BibliographyExhibit 3-1: Selected standard blood glucose meters and diabetes appsExhibit 3-2: OneTouch Verio Flex and OneTouch Reveal appExhibit 3-3: OneTouch Reveal Plus powered by Welldoc's BlueStar technologyExhibit 3-4: Welldoc's BlueStar AI-driven smart diabetes appExhibit 3-5: Glooko Mobile appExhibit 3-6: mySugr app

4. Virtual Diabetes Coaching4.1 Lark Technologies4.2 Livongo4.3 Onduo4.4 One Drop4.5 Virta Health4.6 BibliographyExhibit 4-1: Onduo for diabetesExhibit 4-2: The One Drop digital diabetes management portfolioExhibit 4-3: Virta app

5. Revolutionary Continuous Glucose Monitoring Systems5.1 Abbott5.2 Dexcom5.3 Medtronic5.4 Nemaura Medical5.5 Senseonics5.6 BibliographyExhibit 5-1: Selected continuous glucose monitoring systems with diabetes appExhibit 5-2: The FreeStyle Libre CGM 14-day sensor and LibreLink appExhibit 5-3: The Dexcom G6 CGM System with extended 10-day sensorExhibit 5-4: Dexcom CLARITY diabetes management software-Exhibit 5-5: The Guardian Connect CGM System with Sugar.IQ appExhibit 5-6: The SugarBEAT systemExhibit 5-7: The Eversense CGM and mobile app

6. Clinical data - Can Digital Health Help Improve Diabetes?6.1 Meaningful Reduction in HbA1c6.2 Clinical review of diabetes apps/digital health technologies6.3 Emerging full-service virtual diabetes clinics6.4 BibliographyExhibit 6-1: Selected studies, average reduction in HbA1c with use of diabetes apps and/ or digital app-based coaching programs

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Companies Mentioned

Abbott

Ascensia Diabetes Care

Dario Health

Dexcom

Glooko

IBM Watson Health

Insulet Corporation

Lark Technologies

LifeScan

Livongo Health

Medtronic

mySugr

Nemaura Medical

Omada Health

Onduo

One Drop

Roche

Sanofi

Senseonics

Tandem Diabetes Care

Virta Health

Welldoc

For more information about this report visit https://www.researchandmarkets.com/r/iklur6

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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The Future of the Diabetes Management: Apps & Virtual Coaching - Yahoo Finance

But what is most worrisome is the racial disparity in prior health conditions that exist in the United States. As Bloomberg reported about a study of the deaths in Italy: Almost half of the victims suffered from at least three prior illnesses, and about a fourth had either one or two previous conditions. More than 75 percent had high blood pressure, about 35 percent had diabetes and a third suffered from heart disease.

According to the Centers for Disease Control and Prevention, high blood pressure is most common in non-Hispanic black adults (54 percent), and black people have the highest death rate from heart disease.

As for diabetes, the 2015 National Medical Association Scientific Assembly, held in Detroit, where my friend died, delivered these stark statistics:

African-American patients are more likely than white patients to have diabetes. The risk of diabetes is 77 percent higher among African-Americans than among non-Hispanic white Americans. The rates of diagnosis of diabetes in non-Hispanic African-Americans is 18.7 percent compared to 7.1 percent.

The group went on to say that in 2006, African-Americans with diabetes were 1.5 times more likely to be hospitalized and 2.3 times more likely to die from diabetes than non-Hispanic whites.

In addition, many Southern states refused to expand Medicaid under the Affordable Care Act, and there is a rural hospital crisis in this country. But that crisis is compounded in the South, where, as the magazine Facing South points out, the rural areas have higher poverty rates, higher mortality rates, and lower life expectancies than other rural regions of the country.

This all worries me, because I take a lesson from the H.I.V./AIDS crisis. In the beginning, it was largely seen as a New York and San Francisco problem affecting white men who were gay. Over the decades, treatments became available, and those cities saw their new infection rates plummet.

But the disease remained very much alive, particularly in the South, particularly among black people, where it has reached epidemic proportions. In the United States, more than 40 percent of people living with H.I.V. and 40 percent of people with new infections are black, according to the C.D.C., and African-American men accounted for three-quarters of new H.I.V. infections among African-Americans in 2016, and 80 percent of these were among African-American gay and bisexual men.

See more here:
The Racial Time Bomb in the Covid-19 Crisis - The New York Times

The global diabetes care devices market is expected to reach US$ 39,382.3 Mn in 2027 from US$ 23,354.3 Mn in 2018. The market is estimated to grow with a CAGR of 6.1% from 2020-2027.

Premium market insights recently published a report titled Diabetes Care Devices Market Size and Forecast to 2026. The report includes an authentic and accurate research study into the global Diabetes Care Devices market based on a qualitative and quantitative assessment by leading industry experts. The report highlights the current market scenario and how it is likely to change in the future. This report examines growth determinants, micro and macroeconomic indicators, opportunities, developments and key market trends that are likely to have a major impact on global market growth for Diabetes Care Devices.

The Global Diabetes Care Devices Market is growing at a faster pace with substantial growth rates over the last few years and is estimated that the market will grow significantly in the forecasted period i.e. 2020 to 2026.

Request a Sample Copy of this Report @

https://www.premiummarketinsights.com/sample/AMR00013478

This report includes the following Companies; We can also add other companies you want:

World Health Organization, American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes UK

Diabetes Care Devices Market: A Competitive Perspective

The report also provides an in-depth analysis of the competitive landscape and behavior of market participants. In this way, market participants can familiarize themselves with the current and future competitive scenario of the global market for Diabetes Care Devices and take strategic initiatives to gain a competitive advantage. The market analysts have carried out extensive studies using research methods such as PESTLE and Porters Five Forces analysis. Overall, this report can prove to be a useful tool for market participants to gain deep insight into the global market for Diabetes Care Devices and to understand the main perspectives and ways to increase their profit margins.

Diabetes Care Devices Market: Drivers and Limitations

The report section explains the various drivers and controls that have shaped the global market. The detailed analysis of many market drivers enables readers to get a clear overview of the market, including the market environment, government policy, product innovation, development and market risks.

The research report also identifies the creative opportunities, challenges, and challenges of the Diabetes Care Devices market. The framework of the information will help the reader identify and plan strategies for the potential. Our obstacles, challenges and market challenges also help readers understand how the company can prevent this.

Diabetes Care Devices Market: Segment Analysis

The report section contains segmentations such as application, product type and end user. These segments help determine which parts of the market will improve over others. This section analysis provides information on the most important aspects of developing certain categories better than others. It helps readers understand strategies to make solid investments. The market for Diabetes Care Devices is segmented according to product type, applications and end users.

Inquiry before buying @https://www.premiummarketinsights.com/inquiry/AMR00013478

Diabetes Care Devices Market: Regional Analysis

This section of the report contains detailed information on the market in different regions. Each region offers a different market size because each state has different government policies and other factors. The regions included in the report areNorth America, Europe, Asia Pacific, the Middle East and Africa. Information about the different regions helps the reader to better understand the global market.

Table of Content

1 Introduction of Diabetes Care Devices Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Diabetes Care Devices

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Diabetes Care Devices Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Diabetes Care Devices Market, By Deployment Model

5.1 Overview

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Diabetes Care Devices Market Will Reflect Significant Growth Prospects during 2020-2024 by World Health Organization, American Diabetes Association,...

The Food and Drug Administration has quietly closed out an investigation of data violations tied to Novartis' gene therapy Zolgensma, indicating it will not penalize the Swiss drugmaker for submitting manipulated testing results last year.

The violations, documented in an August 2019 inspection of Novartis' AveXis unit, were at the center of a scandal which last year engulfed the pharma and marred a landmark approval for its high-profile spinal muscular atrophy treatment.

In securing the FDA's blessing for the therapy, Novartis had knowingly filed an application containing altered data from preclinical tests in mice. At the time, the FDA warned it would consider civil or criminal penalties against the company, indicating its displeasure that Novartis was aware of the issue but proceeded to ask for approval anyway.

The statement was highly unusual and a signal, former FDA officials said, to other companies in the fast-growing gene therapy field. After seven months of review, however, the FDA has decided against leveling such sanctions, a spokesperson for the agency confirmed to BioPharma Dive.

Instead, the FDA has classified its inspection review as "Voluntary Action Indicated,"or VAI, which means violations were found during the inspection but didn't cross the threshold for regulatory action.

"FDA has completed its review of the information and records of the inspection, the evidence collected, and the firm's responses as well as the corrective actions to the inspectional observations, and the agency has classified the inspection as Voluntary Action Indicated," the FDA spokesperson said.

"Based on its review of the information available, FDA continues to find Zolgensmato be safe and effective for its intended use," added the spokesperson. Throughout its investigation, the FDA maintained that it found no evidence human data were changed.

FDA inspections, such as the one conducted of AveXis last August,result in what are known as Form 483s, technical documents that detail potential violations of the Food Drug and Cosmetic Act. Companies are allowed to respond, after which the FDA decides whether to proceed with a formal warning.

Novartis submitted its responseto the FDA's inspection in late August last year,pledging to retrain employees and improve quality control oversight. The company placed much of the blame for the manipulation on two senior AveXisexecutives, Brian and Allan Kaspar, who were fired in mid August. Through his lawyer, Brian Kasparhas publicly denied any wrongdoing.

Novartis also committed to informing the FDA within five business days of any credible allegations related to data integrity questions with any pending drug application in the future.

Novartis disclosed the FDA's Form 483 classification in a presentation Monday of new clinical data for Zolgensma, briefly noting the FDA's decision.

"We are pleased with this positive outcome and reiterate our firm commitment to data integrity and transparency in our engagements with regulators," a Novartis spokesperson said in a statement.

Zolgensma was only the second gene therapy for an inherited disease to win U.S. approval, showing in clinical studies it could keep alive infants who otherwise were likely to die from spinal muscular atrophy, or SMA. The neuromuscular disease robs newborns of a protein needed for muscle development, usually leading in its most severe form to death or permanent ventilation by age two.

Some 200 infants received Zolgensma in 2019, earning Novartis $361 million last year. The one-time therapy costs $2.1 million per patient, making it the most expensive drug in the world on a per-dose basis.

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No sanctions for Novartis as FDA ends review of gene therapy violations - BioPharma Dive

DUBLIN--(BUSINESS WIRE)--The "Innovations in Bioreactors, Gene Therapy, Vermifiltration, and Membranes for Desalination Processes" report has been added to ResearchAndMarkets.com's offering.

This edition of the Industrial Bioprocessing TOE features trends and innovations in fixed bed and disposable bioreactors used for processing viral vaccines and for the production of recombinant proteins used in gene therapy. The TOE also provides intelligence on the transformation of cellulose waste and other plant waste in to bio-char, levulinic acid, and formic acid that can be used for production of biofuels. The TOE features innovations based on the novel gasification systems that can be vital in converting biomass in to renewable energy. Additionally, the TOE provides intelligence on the use of innovative membrane technologies that can enhance water permeability and selectivity to generate more freshwater from desalination processes. The TOE also focuses on innovations that are based on the use of modular vermifiltration processes for wastewater treatment, and the generation of bioplastics and biofertilizers from plant and food waste.

The Industrial Bioprocessing TOE provides intelligence on technologies, processes and strategic insights of industries involving bioprocessing, including innovations in the development and production of chemicals, pharmaceuticals, nutraceuticals, alternative fuels, chemical feedstocks, food and beverages, and consumer products.

Key Topics Covered:

Advancements in Bioreactors, Gene Therapy, Vermifiltration, and Membranes for Desalination Processes

For more information about this report visit https://www.researchandmarkets.com/r/xrab0l

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2020 Innovations in Bioreactors, Gene Therapy, Vermifiltration & Membranes for Desalination Processes - ResearchAndMarkets.com - Business Wire

Novartis is on the final straight to approval of its spinal muscular atrophy (SMA) gene therapy Zolgensma in the EU, after getting a recommendation for approval from the CHMP.

The positive opinion gets Novartis marketing application for Zolgensma (onasemnogene abeparvovec) back on track after the company revealed last year that regulators in Europe and Japan had asked for more information on manufacturing of the gene therapy which delayed approval by some months.

At the time, Novartis AveXis unit which developed Zolgensma said the questions raised by the regulators werent related to a data manipulation scandal that emerged with the therapy last year, shortly after it was approved in the US. It was approved in Japan on 19 March.

The delay to its approval in Europe prompted Novartis to set up a managed access programme for some patients, which operated like a lottery and is expected to provide free access to the therapy for 100 patients, although it has come in for criticism as being an unfair way to determine access.

SMA is a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. Approximately 550 to 600 infants are born with SMA in Europe each year.

Now, the CHMP has backed conditional approval of Zolgensma for babies and young children with SMA, which could lead to full EMA approval within the next couple of months.

Novartis says it will offer a day one access programme to EU governments and reimbursement agencies to enable immediate access if the EMA gives it the nod.

The recommendation covers children with 5q SMA with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1; or patients with 5q SMA with a bi-allelic mutation in SMN1 and up to three copies of the SMN2 gene.

Zolgensma is the worlds most expensive drug, with a price tag of more than $2.1 million per one-shot intravenous infusion, which Novartis argues is justified given the lifelong benefits the therapy can bring.

The company says SMA costs EU healthcare systems between 2.5 million and 4 million within the first 10 years of life alone.

The data scandal doesnt appear to have affected its uptake in the US sales in 2019 reached $361 million, more than half of that total from the last quarter of the year alone.

The quick uptake has come despite the established presence on the market of Biogens Spinraza (nusinersen), an antisense drug given by injection into the spine, which became the first treatment option for SMA when it was approved in 2016 and reached $2.1 billion in sales last year.

GlobalData recently predicted however that Zolgensma will generate global sales of $2.5 billion by 2025, overtaking Spinraza and leading the SMA market.

The CHMP recommendation is another shot in the arm for Novartis gene therapy, coming shortly after it reported additional safety and efficacy data with intrathecal delivery of the gene therapy i.e. delivery into the spinal column rather than intravenously.

Intrathecal administration is considered key to extending the use in therapy for children with milder forms of the disease who tend to exhibit symptoms later in childhood. Novartis also reported new data demonstrating long-term efficacy with Zolgensma, with patients showing benefits for up to five years after they were dosed with the therapy

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Novartis closes on EU approval for SMA gene therapy Zolgensma - - pharmaphorum

WALTHAM, Mass., March 31, 2020 (GLOBE NEWSWIRE) -- Affinia Therapeutics, an innovative gene therapy company with a platform for rationally designed adeno-associated virus (AAV) vectors and gene therapies and a mission to develop transformative medicines for devastating diseases, today announced it has closed an oversubscribed $60 million Series A financing. Seed venture investors F-Prime Capital and New Enterprise Associates (NEA) co-led the round alongside new investor Atlas Venture, with participation from seed investors Alexandria Venture Investments, Lonza and Partners Innovation Fund.

The proceeds will be used to advance the companys platform and develop transformative gene therapies for people affected by muscle and central nervous system (CNS) diseases with significant unmet need.

The company is led by recently appointed Chief Executive Officer Rick Modi, who has a proven track record of building value at companies including AveXis, InterMune, MedImmune and Centocor. Joining the board of directors as part of the financing are Dave Grayzel, M.D., Partner, Atlas Venture; Ed Mathers, General Partner, NEA; and Robert Weisskoff, Ph.D., Partner, F-Prime Capital. Industry veteran and gene therapy leader Sean Nolan will chair the board.

At Affinia Therapeutics, were setting a new standard in gene therapies by leveraging our proprietary platform to methodically engineer novel AAV vectors and gene therapies that have remarkable targeting properties, said Modi, CEO of Affinia. We are pleased to partner with such a distinguished syndicate to advance our platform and investigational product candidates toward the clinic for patients in need.

The companys technology was licensed from Lonza and Massachusetts Eye and Ear. It was developed at the Grousbeck Gene Therapy Center and further advanced under a sponsored research agreement with Lonza led by Luk Vandenberghe, Ph.D., Associate Professor at Mass. Eye and Ear and Harvard Medical School and a co-inventor of AAV9.

In addition to Vandenberghe, joining Affinia Therapeutics as scientific co-founders are Botond Roska, M.D., Ph.D., Director, Institute of Molecular and Clinical Ophthalmology Basel; Aaron Tward, M.D., Ph.D., Assistant Professor, University of California, San Francisco; and Eric Zinn, Ph.D. student, Mass. Eye and Ear and Harvard University. Together, these scientists have authored more than 200 papers and filed more than 20 patents in the field of gene therapy.

Affinia Therapeutics is bringing together complementary expertise allowing us to realize a rational design future for AAV vectors, promoters and other components of gene therapies. By leveraging synthetic and systems biology combined with high-throughput screening and tissue and single-cell resolution, we are aspiring to achieve much-needed improved pharmacological control of this novel modality in medicine, said Vandenberghe, Director, Grousbeck Gene Therapy Center at Mass. Eye and Ear.

The Series A financing comes after Vandenberghe and his team successfully developed AAVSmartLibraries comprising thousands of functional novel AAV vectors. Each vector is uniquely identified, and the libraries can be screened across species for parameters of high interest, including tissue tropism, manufacturing yield and pre-existing immunity. Observations arising from each library screen provide insights into the vectors structure-function, enabling the rational design of novel vectors and gene therapies with remarkably improved properties. Affinia Therapeutics has potentially the worlds largest library of patented functional AAV vectors.

Affinia Therapeutics methodical process for designing and evaluating vectors is a differentiated approach to gene therapy, and the highly experienced leadership team will help carry these discoveries to the development, manufacturing and commercialization of transformative medicines, said Mathers, General Partner at NEA. We are pleased to accelerate the impact of this exciting field.

About Affinia Therapeutics

At Affinia Therapeutics, our purpose is to develop gene therapies that can have a transformative impact on people affected by devastating genetic diseases. Our proprietary platform enables us to methodically engineer novel AAV vectors and gene therapies that have remarkable tissue targeting and other properties. We are building world-class capabilities to discover, develop, manufacture and commercialize gene therapy products with an initial focus on muscle and central nervous system (CNS) diseases with significant unmet need.www.affiniatx.com.

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Affinia Therapeutics Raises $60M in Series A Financing to Advance Rational Design AAV Platform and Transformative Gene Therapies - GlobeNewswire

Three years after a brain cancer failure sent the company reeling, VBL Therapeutics is touting its first hint of positive Phase III results.

The Israeli biotech announced its lead drug, VB111, met an interim efficacy benchmark in a trial testing it against standard-of-care alone in recurrent, chemotherapy-resistant ovarian cancer. The patients in the treatment arm had a CA-125 response rate a measure of cancer antigen often used as a proxy in ovarian cancer studies and in detecting ovarian cancer at least 10% higher than those in the control, the independent review determined.

The response rate in the first 60 enrolled and evaluable patients was 53%. That indicated a treatment response rate of at least 58% an encouraging number, the company said, because of the CA-125 data from their earlier Phase II trial.

We are very pleased by the outcome of this interim analysis, which demonstrates the potential benefit of VB-111 over standard-of-care in a randomized-controlled study, VBL CEO Dror Harats said. The OVAL Phase 3 interim data are at least as good as the CA-125 response results observed in our VB-111 Phase 2 study.

In that earlier study, which indicated a dose-dependent response, patients who showed a CA-125 response ultimately had an overall survival rate of808 days, versus 351 days for those who did not. The primary endpoint for this study, which is set to be completed in 2022, is overall survival.

The data come two years after VBL announced the combo of VB-111 and Avastin had failed to beat out Avastin alone in a Phase III study of glioblastoma, a notoriously hard-to-treat indication. It was their first Phase III trial after a smattering of Phase II trials in different solid tumors had turned up mixed results.

VB-111 is what the company deems a gene therapy agent. It uses an adenovirus the viral vector traditionally used for gene therapy that carries a gene to cause explosive cell death in tumors, rupturing blood cells. They have anti-inflammatory and other cancer programs in development.

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VBL and its 'gene therapy' cancer treatment are back with a peek at PhIII potential - Endpoints News

FILE PHOTO: The company's logo is seen at a building of Swiss drugmaker Novartis in Rotkreuz, Switzerland, January 29, 2020. REUTERS/Arnd Wiegmann

ZURICH (Reuters) - Swiss drugmaker Novartis on Friday won a key European recommendation for its gene therapy Zolgensma against spinal muscular atrophy (SMA), clearing a hurdle for $2.1 million per patient treatment for approval in Europe within months.

The European Medicines Agencys (EMA) Committee for Human Medicines (CHMP) recommended conditional approval for Zolgensma for certain patients: those with Type 1 SMA, the severest form of the disease, or for SMA patients with up to three copies of the so-called SMN2 gene, an indicator of the diseases severity.

The EMAs conditional approval is meant to speed up access to medicines for unmet needs, based on less-complete data than normally expected.

Typically the European Commission approves medicines for use shortly after a CHMP recommendation, and Novartis is expecting a decision by June. The medicine, the worlds costliest one-time treatment at its U.S. list price, has already been approved in the United States and Japan.

Novartis is counting on the gene therapy becoming a billion-dollar-per-year seller. Zolgensma is the second treatment for SMA to be approved after Biogens Spinraza three years ago. Roche is expecting its oral drug risdiplam to win U.S. regulators blessing in May.

Reporting by John Miller; Editing by Michael Shields

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Novartis wins key European recommendation for gene therapy Zolgensma - Reuters

The Food and Drug Administration (FDA) has granted Fast Track designation to PR006 (Prevail Therapeutics), an experimental gene therapy, to slow the progression of frontotemporal dementia with a GRN mutation (FTD-GRN).

FTD-GRN is a progressive neurodegenerative disease caused by mutations in the GRN gene. Patients with a GRN mutation have reduced levels of progranulin, a protein critical for lysosomal function, neuronal survival, and normal microglial activities. PR006 delivers a healthy GRN gene using an AAV9 vector to increase progranulin levels in these patients.

The Food and Drug Administration (FDA) recently accepted the Investigational New Drug application for PR006, allowing the Company to proceed with a phase 1/2 trial.

FTD-GRN progresses rapidly and there are currently no therapeutic options available, said Asa Abeliovich, MD, PhD, Founder and CEO of Prevail. We believe PR006 has the potential to fill this unmet medical need and make a significant impact for patients.

The FDA previously granted Orphan Drug designation to PR006 for the treatment of patients with frontotemporal dementia.

For more information visit prevailtherapeutics.com.

This article originally appeared on MPR

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Gene Therapy for Frontotemporal Dementia With a GRN Mutation Gets Fast Track Status - Neurology Advisor

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDAs orphan status for remdesivir reserved to encourage the development of rare disease therapies Gilead CEO Daniel ODay had some explaining to do about the companys approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, ODay also reassured some analysts who had been fretting that Chinas quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

ODay emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall at least to the most heavily threatened groups.

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David Hallal bags another whopper round, looking to recruit more cell and gene therapy upstarts to ElevateBio BaseCamp - Endpoints News

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A programme investigating the potential of gene therapy for the treatment of osteoarthritis in horses, dogs and cats, has begun at the Royal Veterinary College (RVC), led by Skeletal Regeneration expert, Dr Scott Roberts.

Dr Scott Roberts, who joined the RVC as Senior Lecturer in Translational Skeletal Research in the Department of Comparative Biomedical Sciences, has recently initiated the programme of investigative research.

The research is inspired by Dr Roberts interest in skeletal stem cell signalling and the effect of signal modulation on skeletal tissue regeneration. He initiated this work during his time at KU Leuven (Belgium) but has subsequently researched this topic as Principal Investigator at University College London and as Senior Principal Scientist at UCB Pharma. During his time at UCB, Dr Roberts identified musculoskeletal drug targets and led the subsequent drug discovery projects. His research has resulted in several patent applications on the use of cells and therapeutic antibodies to promote the regeneration of bone and cartilage.

The new gene therapy research programme in osteoarthritis will be undertaken in partnership with the LEP funded Vaccinology and Cell Therapy Hub at the RVC. This will not only provide an environment for further research on regenerative medicine but also the facilities to create reagents for clinical translation.

The Hub with its close connections to both scientists and veterinary clinicians is also well-placed to take the science from bench-to-bedside and facilitate clinical trials in veterinary patients. This will include horses at the Equine Referral Hospital, and dogs and cats at the Queen Mother Hospital for Animals at the RVC.

It is proposed that this treatment would transition into human clinical studies, exemplifying the RVCs commitment to the One Health approach which recognises and facilitates the synergy between animal and human health.

Dr Scott Roberts said:

This research has the potential to change the way that we approach degenerative joint disease and I am delighted to have access to the Vaccinology and Cell Therapy Hub while we undertake this work. We hope that this science will lead to a ground-breaking treatment for osteoarthritis in animals, and eventually humans. We are optimistic about the future of this research, particularly given its contribution to the RVCs One Health ethos. I look forward to taking advantage of the RVCs world-leading facilities, as well as the scientists and clinicians who will help us take this research forward.

Professor Jonathan Elliott, Vice Principal of Research and Innovation at the RVC, said:

We are delighted that Scott Roberts has joined the RVC and will pursue his translational research into novel therapies that stimulate repair of cartilage for osteoarthritis in horses, dogs and people. This appointment builds on the RVCs expertise in Skeletal Biology. Scotts links to the Pharma Industry are very important for his translational science to have impact. His work fits perfectly with the goals of our soon to open Vaccinology and Cell Therapy Hub, made possible by the funding from the Hertfordshire Local Enterprise Partnership.

The research Dr Roberts is undertaking is critical as cartilage has a very poor capacity to repair itself, with cartilage injuries often progressing to osteoarthritis. There is also currently no approved evidence-driven therapy for the treatment of this disease.

In addition to osteoarthritis, Dr Roberts research aims to create regenerative therapeutics for non-healing bone fractures. This is based on a comprehensive understanding of tissue development, as tissue repair is now regarded as a re-emergence of embryonic signalling cascades. Dr Roberts has used knowledge in this area to identify developmentally inspired methodologies to create laboratory grown tissue implants that have the capacity to drive bone fracture repair.

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Investigation Begins into Gene Therapy for Osteoarthritis - Everything Horse UK

Our first priority during this unprecedented time is the health of our employees, our patients and their communities, and the employees of our clinical sites, partners and vendors. In accordance with advice from health authorities, AVROBIO has moved quickly to virtual operations, except for essential laboratory work, which continues with additional COVID-19-related safety measures in place, said Geoff MacKay, AVROBIOs president and CEO. We continue to support patient identification efforts across our clinical trials in Canada, Australia and the United States. As the global healthcare community responds to the increase in COVID-19 cases, many hospitals, including our clinical sites, have temporarily paused elective medical procedures, which includes dosing of new patients in clinical trials of our investigative gene therapies. While were fully committed to moving our clinical programs forward, AVROBIO supports this temporary reallocation of resources to ensure hospitals can focus on meeting the needs of patients with COVID-19. We are closely monitoring this rapidly evolving situation and the potential impact on our clinical trial programs and business generally.

Program Updates AVR-RD-01 clinical trials in Fabry disease AVROBIO is conducting two clinical trials for its investigational gene therapy for Fabry disease (AVR-RD-01). Four patients have been dosed in the global Phase 2 trial (FAB-201), which is evaluating treatment-nave patients, and five patients in the fully enrolled Phase 1 (FACTs) investigator-led clinical trial of AVR-RD-01.

AVR-RD-04 Phase 1/2 clinical trial in cystinosis AVROBIOs investigational gene therapy for cystinosis (AVR-RD-04) is being studied in a Phase 1/2 investigational trial in collaboration with the University of California, San Diego (UCSD). The first patient was dosed in October 2019. The single-arm trial is expected to enroll up to six patients.

AVR-RD-02 Phase 1/2 clinical trial in Gaucher disease AVROBIO's investigational gene therapy for Gaucher disease (AVR-RD-02) is being studied in a Phase 1/2 clinical trial to evaluate the safety and efficacy in individuals with Gaucher disease type 1. The global trial is designed to enroll eight to 16 individuals with Gaucher disease type 1 including both those who are treatment-nave and those who are stable on enzyme replacement therapy.

Business Operations On March 10, AVROBIO created an internal, cross-functional COVID-19 Response Team to closely monitor the evolving situation and advise on the companys response. We have implemented a work-from-home policy for all employees excluding those providing essential services, such as our laboratory staff. For those employees, AVROBIO has implemented safety measures designed to comply with applicable federal, state and local guidelines in response to the COVID-19 pandemic. We may be required to take additional actions that impact our operations as required by applicable laws or regulations, or which we determine to be in the best interests of our employees. AVROBIO continues to evaluate the impact of the COVID-19 pandemic on its operations and will provide a further update in conjunction with its first quarter financial results announcement and Quarterly Report on Form 10-Q in May 2020. At this time, all preclinical programs and research activities remain on track, and we do not anticipate any material impact on our regulatory activities.

Financial Position In February 2020, the company raised gross proceeds of $100 million through a follow-on common stock offering. Based on the companys current operating plan, AVROBIO expects its cash and cash equivalents of $187.0 million as of Dec. 31, 2019, together with the net proceeds from the February 2020 follow-on common stock offering, will enable the company to fund its operating expenses and capital expenditure requirements into Q2 2022.

About AVROBIO Our mission is to free people from a lifetime of genetic disease with a single dose of gene therapy. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a program in Pompe disease. AVROBIO is powered by the plato gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

Forward-Looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as aims, anticipates, believes, could, designed to, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, the expected benefits and results of our implementation of the plato platform in our clinical trials and gene therapy programs, the expected safety profile of our investigational gene therapies, the potential impact of the COVID-19 outbreak on our clinical trial programs and business generally, as well as our plans and expectations with respect to the timing and resumption of any development activities that may be temporarily paused as a result of the COVID-19 outbreak, and statements regarding our financial and cash position and expected cash runway. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our development timeline and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs most recent Annual or Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Cautionary Note on Future Updates The statements contained in this press release reflect our current views with respect to future events, which may change significantly as the global consequences of the COVID-19 pandemic rapidly develop. Accordingly, we do not undertake and specifically disclaim any obligation to update any forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200330005703/en/

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AVROBIO Outlines Response to COVID-19 and Current Assessment of Business Impact - BioSpace

TOKYO & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Modalis Therapeutics Corporation (Modalis) today announced that the company has entered into a license agreement with Editas Medicine, Inc., under which Modalis has obtained a license to certain intellectual property that is controlled by Editas Medicine. Modalis is utilizing its proprietary epigenetic gene modulation technology, CRISPR-GNDM (Guide Nucleotide Directed Modulation), to treat patients with serious genetic disorders. Additional details including financial terms of the agreement were not disclosed.

"Our goal is to create CRISPR based gene therapies for genetic disorders, most of which fall into the orphan disease category. There should be no disease that is ignored because of its small patient population, and our mission to develop disease modifying treatments for these diseases reflects our belief that Every Life Deserves Attention. We are proud to be the pioneer in CRISPR based gene modulation therapy, said Haru Morita, Chief Executive Officer of Modalis.

We are pleased to establish this license agreement with Modalis Therapeutics as their mission is aligned with our mission to make transformative medicines for people living with serious diseases of unmet clinical need. CRISPR technology has many uses and applications, and we are pleased to include Modalis in our expanding portfolio of licensees so the greatest number of patients may benefit in the future from transformative medicines, said Cynthia Collins, president and chief executive officer, Editas Medicine.

About Modalis

Modalis Therapeutics is developing precision genetic medicines through epigenetic gene modulation. Founded by Osamu Nureki and leading scientists in CRISPR gene editing from University of Tokyo, Modalis is pursuing therapies for orphan genetic diseases using its proprietary CRISPR-GNDM technology which enables the locus specific modulation of gene expression or histone modification without the need for double-stranded DNA cleavage, gene editing or base editing. Modalis is focusing initially on genetic disorders caused by loss of gene regulation resulting in excess or insufficient protein production which includes more than 660 genes that are currently estimated to cause human disease due to haploinsufficiency. Headquartered in Tokyo with laboratories and facilities in Cambridge, Massachusetts, the company is backed by leading Japanese investors including Fast Track Initiative, SBI Investment, UTokyo-IPC, SMBC Venture Capital, and Mizuho Capital. For additional information, visit http://www.modalistx.com.

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Modalis Obtains Access to Foundational CRISPR IP - BioSpace

Vision and Eye Health Assurance and Protection in the Workplace

Vision and eye health go beyond the regular checkup dont skimp on appropriate vision PPE.

Eye injuries, suboptimal vision and eye health in the workplace are very common. The National Institute for Occupational Safety and Health (NIOSH) reports that every day about 2,000 U.S. workers sustain job-related eye injuries that require medical treatment.1 The Centers for Disease Control and Prevention (CDC) reports 61 million adults in the United States as being classified at high risk for serious vision loss, and that only half visited an eye doctor in the past 12 months.2

Most individuals surveyed by the CDC indicate no reason to go as the most common reason for not obtaining recommended regular vision and eye health care.3 Suboptimal eye and vision health in the workplace can lead to poor performance and increased potential for injury. Even minor eye injuries can cause life-long vision problems and suffering. A simple scratch can cause corneal erosion that is recurrently painful.4

Safety experts and doctors of optometry believe the right combination of eye protection and yearly comprehensive eye examination can reduce the severity of workplace injuries and prevent 90 percent of eye injuries.

Epidemiology of Work-Related Injuries

In 2008, injuries to the eyes accounted for 37 percent of all head injuries involving days away from work and 62 percent of all face injuries involving days away from work. Men experienced four times as many eye injuries as women, and men aged 25 to 44 suffered more eye injuries than men in other age groups. Workers who were most at risk of incurring an eye injury included those in the manufacturing, construction, and wholesale and retail trade industries, and educational and health services.5

In 2008, there were 27,450 nonfatal occupational injuries or illnesses involving at least one eye that resulted in days away from work. The typical eye injury resulted from the eye being rubbed or abraded by foreign matter, such as metal chips, dirt particles, and splinters, or by these types of items striking the eye. These injury events resulted commonly in abrasions, scratches, and embedded foreign bodies (splinters and chips).6

This article originally appeared in the April 1, 2020 issue of Occupational Health & Safety.

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Vision and Eye Health Assurance and Protection in the Workplace - Occupational Health and Safety

(PRESS RELEASE) Safilo Group, a worldwide leader in the design, manufacturing and distribution of eyewear, kicks off a new virtual education platform this week, offering a series of educational webinars for its customers on various topics to enrich their optical practices while offices are closed or operating on limited schedules due to COVID-19.

Running the full weeks of March 23 and March 30, one new course topic will be taught daily between two and four times each day with four sessions daily this week and repeated two times daily next week to accommodate participants in different time zones. The lectures are led by Robin Brush, a Safilo Key Accounts Manager and an ABOC-certified optician with 25 years of optical industry experience. The courses, taught live, are being offered in English and will soon be translated to other languages in the coming weeks to make available to international customers. The courses are also being recorded to make available later for those who missed them. ABO credits are not being issued for any of the online lectures.

To attend these virtual classes, North American customers can either contact their sales representatives or sign up directly by visiting the home pages of Safilos b2b websites: http://www.mysafilo.com (USA) or http://www.mysafilocanada.com (Canada). Internationally, Safilo customers can contact their sales rep for sign-up details. The WebEx course topics include: Advanced Eyewear Technology; A Visual Guide to Merchandising, J.O.B.S. Program: Joint Opportunity to Believe in Staying; Multiples Mindset and Optical 411 (full course descriptions can be found on the next page).

To promote the courses, a customer eblast was sent out last Friday to Safilo North America customers which contained the WebEx links needed for course sign-up. Members of Safilos North American sales force are also informing customers directly. The courses are additionally being promoted daily on Safilo Groups global Facebook page.

During these trying times, we wanted to continue showing our gratitude and support to our customers practices by offering courses to enrich their education portfolio. Weve worked diligently to create a free virtual education platform that will allow anyone within one of our customers practices to access the courses, even if their offices are closed temporarily, said Steve Wright, Safilo North Americas president and chief commercial officer. The classes were developed initially, with Safilo North America customers in mind, while many are at home this week and practicing social distancing. However, we decided to make the courses available internationally as believe this program can be beneficial to all Safilo customers around the globe, added Wright.

Course descriptions:

1. Advanced Eyewear Technology:Learn the anatomy and proper names for eyewear. Details and fitting examples of why different nose pads, bridges, temples and frame fronts are used to make eyewear. Learn about the different materials that eyewear is made from and why different materials are used and benefits to the patients.

2. A Visual Guide to Merchandising:Define visual merchandising as related to optical; learn how to apply visual merchandising to your optical for brand story telling; learn how the Pantone color of the year influences our world of retail and understanding merchandising secrets and customer behaviors.

3. J.O.B.S. Program: Joint Opportunity to Believe in Staying:In this course, you will learn how to involve the entire office staff in the process of making the sale. Each department will have defined responsibilities that educate and layer the selling process for the patient. You will also learn the art of seamless transition from patient to retail customer. Interpreting the prescription for lens and frame sales. Multiple pair sales will be your new normal and understanding and defusing sales objections will not be a problem.

4. Multiples Mindset:Selling multiple pairs is a mindset! How can you expect an optician to sell multiple pairs or sell luxury if theyve never experienced that personally? In this course, we will dive into the mindset of the optician getting to the bottom of why they dont sell multiples. Also, well be learning techniques to use as their managers to promote a multiples environment and culture.

5. Optical 411:In this course, you will understand the importance of being a good steward of the numbers in your optical. Frame return rate and frame turn ratio, why are they critical to the profitability of your business? Inventory management and how to analyze the data. Discover the two best methods for ordering frames to achieve the profitable numbers. Six easy steps to efficient sales rep appointments and tracking your orders and returns.

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Prevent Blindness Declares April as Women's Eye Health and Safety Month - InvisionMag