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Diabetes drug recalled over excess levels of cancer-causing agent

Heads up, consumers: A diabetes drug is facing recall because the medication contains excess levels of a cancer-causing agent, the U.S. Food and Drug Administration (FDA) announced this week.

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Marksans Pharma Limited, a pharmaceutical company in India, announced an expanded recalled of its Metformin hydrochloride extended-release tablets, a drug used to help those who suffer from type 2 diabetes to lower their blood glucose levels. The recall, which was initially announced in June, was expanded on Monday to include an additional 76 unexpired lots of the medication.

An example of the recalled medication. (FDA)

“Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled,” the FDA said when announcing the recall. 

NDMA is a “probable human carcinogen,” meaning it’s a substance that can lead to cancer, per the FDA.

“NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall,” the FDA said.

The recall impacts metformin tablets between 500 mg and 750 mg. The tablets were sold under the brand name Time-Cap Labs, Inc., according to the announcement.

The following products have been called back:

Metformin Hydrochloride Extended-Release Tablets, USP 500mg:

90 counts: 49483-623-09

100 counts: 49483-623-01

500 counts: 49483-623-50

1000 counts: 49483-623-10

Metformin Hydrochloride Extended-Release Tablets, USP 750mg:

100 counts: 49483-624-01

The 500 mg tablets are debossed with “101” on one side and are plain on the other. The 750 mg tablets, meanwhile, are also debossed with “102” on one side and are plain on the other, per the FDA.

“Consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” the FDA warned. The consumer “should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

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Why Use D'OXYVA?

D’OXYVA® (deoxyhemoglobin vasodilator) is a validated microcirculation and nerve stimulant for people suffering from the damaging effects of moderate to advanced neuropathy.

Subjects suffering from high blood sugar have reported noticeable neuropathy pain relief only minutes after the D’OXYVA solution protocol, including long-term blood sugar level improvements in just a few weeks.

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Impaired microcirculation in patients with diabetes mellitus

Diabetes mellitus is a disorder of sugar metabolism. The blood sugar level is regulated mainly by the hormone insulin. If the amount of insulin produced is insufficient (type 1 diabetes), or if the effect of insulin is reduced (type 2 diabetes), blood sugar levels are chronically elevated. After some time, this results in significant damage to blood vessels. The term used for this is therefore diabetic angiopathy. If larger blood vessels are affected, the risk of heart attack and stroke is increased. The microvascular changes caused by diabetes can also cause serious complications.

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Impaired microcirculation in patients with diabetes mellitus

Among the most feared long-term consequences of diabetic angiopathy are damage to the eyes (diabetic retinopathy), the kidneys (diabetic nephropathy) and the nerves (diabetic neuropathy).

Diabetic retinopathy is the main cause of blindness in middle age in Germany and other industrialized countries. The retina is supplied with nutrients and oxygen through very fine microvessels. Over time, diabetes can damage the microvessels so that this supply is no longer sufficient. Affected persons at first see everything blurred, as though through a veil. In advanced stages, pronounced vision disorders and even blindness may develop. According to estimates by the German Diabetes Society, 20 to 40 percent of diabetics suffer kidney damage in the course of their disease. One of the tasks of the kidneys is to filter toxins and waste products out of the blood so they can be excreted in the urine. This work is done via tiny blood vessels in the renal corpuscles. Persistently high blood sugar levels damage these microvessels.

As a result, the filtering capacity of the kidney is reduced and the body is no longer sufficiently detoxified. If left untreated, this can lead to chronic renal failure so that renal functions must be replaced by dialysis or a kidney transplant. Approximately 30 percent of diabetes patients suffer nerve damage. One cause of this is impaired nerve cell metabolism due to high blood sugar levels. Another factor is reduced oxygen supply to the nerve cells due to the damaged microvessels supplying them. The most evident consequences are abnormal sensations like tingling, burning pain or numbness, especially in the hands and feet. In addition, tactile and temperature sensations, as well as pain perception, may be reduced. This latter factor favours the  development of diabetic foot syndrome since wounds are not noticed in early stages and – also due to impaired microcirculation – heal poorly.

LONG-TERM DAMAGE RESULTING FROM IMPAIRED MICROCIRCULATION IN PATIENTS WITH DIABETES
MELLITUS

• Damage to eyes (diabetic retinopathy) with vision impairments

• Damage to renal function (diabetic nephropathy), possibly mandatory dialysis 

• Nerve damage (diabetic neuropathy) with abnormal sensations and impaired pain perception 

• Impaired wound healing (diabetic foot syndrome)

HOW D’OXYVA CAN HELP?

Accordng to Dr. Michael McGlamry of  Forsyth Foot and Ankle Associates, Cumming, GA, D’OXYVA® (deoxyhemoglobin vasodilator) is a groundbreaking noninvasive, painless transdermal delivery system based on widely established, groundbreaking, Nobel Prize-winning science and is shown to increase oxygen-rich blood flow in the local microcirculatory system, which in turn leads to better blood perfusion and tissue oxygenation. The increased peripheral perfusion plays a significant role in enhancing the wound healing process, which may lead to a reduction in the influence of preexisting conditions in cases of a coronavirus infection.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

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Company shares shocking model of future remote worker as pandemic continues

Millions of American workers became remote employees overnight when the coronavirus pandemic hit earlier this year, and the future isn’t looking too bright for those who fail to maintain healthy habits while working from home in the long-term, new findings claim.

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Job discovery platform DirectlyApply recently unveiled a visual model for what future remote workers might look like in 25 years if they don’t reform bad habits now, in a figure they’ve named Susan.

Suffering from digital eye strain, poor posture, “tech neck,” obesity, increased stress due to lack of human contact and more, Susan dramatically exemplifies the physical repercussions remote workers may suffer if they fail to prioritize their physical and mental health beyond their 9 to 5.

work from home
Suffering from digital eye strain, poor posture, tech neck, obesity, increased stress due to lack of human contact and more, Susan dramatically exemplifies the physical repercussions remote workers may suffer if they neglect to keep healthy habits.

Susan was created in partnership with a team of clinical psychologists and fitness experts to highlight the effects that isolated working can have on the body, according to DirectlyApply.

“With lockdown having forced people across the globe into what has been the world’s largest remote working experiment, our usual interpretation of the perk has been transformed forever,” a spokesperson for the job-searching site said in a statement shared with Fox News. “Whilst your bed-to-desk commute may allow for more free time and independence, will the physical repercussions to your mind and body be worth it in the future?”

With that being said, the London-based job searching site, which also operates in the U.S. and Canada, shared positive tips for improving physical and mental health while working remotely, amid an uncertain future.

To improve health and wellness during this time, remote workers are encouraged to stick to a routine to optimize productivity, nurture (virtual) social connections with colleagues, exercise outside, clearly delineate between working and living spaces to promote a healthy work-life balance and use free time wisely to support emotional health.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways, including but not limited to weight loss, recover from injury, improved performance, besides diabetes and heart health.

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Scientists just beginning to understand the many health problems caused by COVID-19

CHICAGO – Scientists are only starting to grasp the vast array of health problems caused by the novel coronavirus, some of which may have lingering effects on patients and health systems for years to come, according to doctors and infectious disease experts.

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Besides the respiratory issues that leave patients gasping for breath, the virus that causes COVID-19 attacks many organ systems, in some cases causing catastrophic damage.

“We thought this was only a respiratory virus. Turns out, it goes after the pancreas. It goes after the heart. It goes after the liver, the brain, the kidney and other organs. We didn’t appreciate that in the beginning,” said Dr. Eric Topol, a cardiologist and director of the Scripps Research Translational Institute in La Jolla, California.

In addition to respiratory distress, patients with COVID-19 can experience blood clotting disorders that can lead to strokes, and extreme inflammation that attacks multiple organ systems. The virus can also cause neurological complications that range from headache, dizziness and loss of taste or smell to seizures and confusion.

And recovery can be slow, incomplete and costly, with a huge impact on quality of life.

The broad and diverse manifestations of COVID-19 are somewhat unique, said Dr. Sadiya Khan, a cardiologist at Northwestern Medicine in Chicago.

With influenza, people with underlying heart conditions are also at higher risk of complications, Khan said. What is surprising about this virus is the extent of the complications occurring outside the lungs.

Khan believes there will be a huge healthcare expenditure and burden for individuals who have survived COVID-19.

LENGTHY REHAB FOR MANY

Patients who were in the intensive care unit or on a ventilator for weeks will need to spend extensive time in rehab to regain mobility and strength.

“It can take up to seven days for every one day that you’re hospitalized to recover that type of strength,” Khan said. “It’s harder the older you are, and you may never get back to the same level of function.”

While much of the focus has been on the minority of patients who experience severe disease, doctors increasingly are looking to the needs of patients who were not sick enough to require hospitalization, but are still suffering months after first becoming infected.

Studies are just getting underway to understand the long-term effects of infection, Jay Butler, deputy director of infectious diseases at the U.S. Centers for Disease Control and Prevention, told reporters in a telephone briefing on Thursday.

“We hear anecdotal reports of people who have persistent fatigue, shortness of breath,” Butler said. “How long that will last is hard to say.”

While coronavirus symptoms typically resolve in two or three weeks, an estimated 1 in 10 experience prolonged symptoms, Dr. Helen Salisbury of the University of Oxford wrote in the British Medical Journal on Tuesday.

Salisbury said many of her patients have normal chest X-rays and no sign of inflammation, but they are still not back to normal.

“If you previously ran 5k three times a week and now feel breathless after a single flight of stairs, or if you cough incessantly and are too exhausted to return to work, then the fear that you may never regain your previous health is very real,” she wrote.

Dr. Igor Koralnik, chief of neuro-infectious diseases at Northwestern Medicine, reviewed current scientific literature and found about half of patients hospitalized with COVID-19 had neurological complications, such as dizziness, decreased alertness, difficulty concentrating, disorders of smell and taste, seizures, strokes, weakness and muscle pain.

Koralnik, whose findings were published in the Annals of Neurology, has started an outpatient clinic for COVID-19 patients to study whether these neurological problems are temporary or permanent.

Khan sees parallels with HIV, the virus that causes AIDS. Much of the early focus was on deaths.

“In recent years, we’ve been very focused on the cardiovascular complications of HIV survivorship,” Khan said.

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HOW D'OXYVA CAN HELP?

Expert say D’OXYVA can help COVID-19 patients find relief. Preliminary medical data shows people with pre-existing conditions including diabetes may experience serious complications from COVID-19.

D’OXYVA helps by delivering transdermal ultra-purified medical gas directly to the blood stream delivering major outcomes for well over 90% of users.

Experts call D’OXYVA a gamechanger.

“Studies with D’OXYVA have shown unmatched results in noninvasive woundcare,” Dr. Michael McGlamry.

Anyone with an underlying condition should know this option is available.

physician-recommended easy to use daily

HOW D'OXYVA CAN HELP?

Expert say D’OXYVA can help COVID-19 patients find relief. Preliminary medical data shows people with pre-existing conditions including diabetes may experience serious complications from COVID-19.

D’OXYVA helps by delivering transdermal ultra-purified medical gas directly to the blood stream delivering major outcomes for well over 90% of users.

Experts call D’OXYVA a gamechanger.

“Studies with D’OXYVA have shown unmatched results in noninvasive woundcare,” Dr. Michael McGlamry.

Anyone with an underlying condition should know this option is available.

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An interview with Dr. Geoffrey Watson: Diabetic patients and Covid-19

About Dr. Geoffrey Watson

Watson Wellness Center in Oakland, CA

A native and resident of Oakland, California, Geoffrey Watson obtained a Bachelor of Science in Health Care Administration from the University of California at Davis and a medical degree from Vanderbilt University in Nashville, Tennessee. Dr. Watson completed two years of his medical residency at the Vanderbilt Medical Center with his final year of medical residency completed at the University of California Medical Center in San Francisco. In 1985, Dr. Watson started his medical career in Oakland as a specialist in the art of Internal Medicine working as a staff physician at the Arlington Medical Center alongside his father, Dr. James A. Watson.

Dr. Watson has a special interest in education and has earned the position of Director of Continuing Medical Education at Fairmont Hospital in San Leandro and Alameda County Medical Center of the East Bay. In 1992, as a Board Certified Internist, his love for teaching and medical education has earned him a position as Assistant Clinical Professor of Medicine at the U.C.S.F. Medical Center. Also in 1992, as the Co-Medical Director of the Arlington Medical Center, Dr. Watson became a key player in the Oakland community as a leader in managed care and positioned himself as a Founding Member of the Alta Bates Medical Associates. He developed medical groups, leading the way in managed care, and helped to organize a merger of prominent physicians resulting in a powerful African American Primary Care Group geared towards serving the needs of African Americans in the East Bay, including the development of preventive care programs focused in the areas of hypertension, asthma, diabetes, heart disease, substance abuse and weight control.

Dr. Watson has served as the Secretary for the Sinkler Miller Medical and the Golden State Medical Associations during 1994. In May, 1997, he was inaugurated into office as President of the Golden State Medical Association and served through 1998. From 1996 through 1997 he has been honored with serving as the President of the Sinkler Miller Medical Association of the East Bay. On March 1, 1997, Dr. Watson established a new medical facility, The James A. Watson Wellness Center, a legacy of his father, moving his practice to Pill Hill and continuing to provide high quality and sensitive care to patients by treating the physical, socioeconomic, spiritual and psychological ailments and employing medical and practical solutions with hopes of resulting in complete wellness.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

Those people who are at the highest risks of contracting covid-19, are those over the age 65, have heart disease, liver disorders, diabetes and other underlying health issues. Because it effects the immune system and compromises the bodies natural defenses fight off infections, it is critical for a person with diabetes to have good blood flow circulation, reducing the chance of infection, ulcers and at worse case amputations.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

D’OXYVA®  (deoxyhemoglobin vasodilator) is validated to significantly improve macro- and micro-circulation of blood flow and certain nerve activities in the body, which together are widely reported to form an effective non-invasive, pain-free solution option for many conditions. It provides accelerated and comprehensive wound care — plus infection protection — in a painless, affordable non-prescription solution available in a clinical setting, or in the comfort and privacy of your own home.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

3. Tell us about CO2, microcirculation, and its effects on the body.

D’OXYVA uses ultra-purified carbon dioxide, which has been shown to produce higher oxygen unloading by hemoglobin, thereby increasing oxygen-rich blood flow in the local microcirculatory system. This improved dermal microcirculation leads, in turn, to enhanced wound healing.

Good blood circulation has many important health benefits. Among the most prominent is the optimal oxygenation of bodily tissues and organs, which allows for efficient functioning of the heart, lungs and muscles. Active blood circulation also improves the immune response against disease by allowing the better transportation of white blood cells throughout the body. Furthermore, proper blood circulation improves cellular detoxification, while waste removal becomes more efficient. Among its other health benefits, D’OXYVA® has been also validated as a successful means of improving the autonomic nervous system.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Studies with D’OXYVA have shown increased oxygen concentration and lower carbon dioxide concentration in the blood just 30 minutes after treatment that can last upto 60 minutes. Over two dozen studies demonstrated convincing results at clinics and at home with no adverse events.

Many treatments make bold online claims to help cure various conditions and restore you to health — pills, shots, creams, procedures, and devices. But only science-backed, one-of-a-kind D’OXYVA stands alone, delivering the remarkable physical, mental, and emotionally rejuvenating results.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

The heart is the engine that makes the body function. The foot though a far distance from the heart requires consistent blood flow. It requires open pathways. If those pathways are constricted, which is fairly normal occurrence with diabetic patients, those areas have a tendency to die off, because of the poor blood circulation. That is why it is key to some type of vasodilation to promote microcirculatory blood flow to supply adequate oxygenation the the feet. There by likely helping to prevent infections, ulcers and wounds.

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How a New OTC Medical Device Backed by Nobel Prize-winning Science Can Protect You by Targeting Underlying Conditions

treat underlying condition in covid patients

Patients dealing with underlying health issues, including diabetes and chronic heart conditions, as well as COVID-19, may find fast and painless relief from an over the counter (OTC) device.

An easy-to-use , commercially-available device, D’OXYVA (deoxyhemoglobin vasodilator) by Circularity Healthcare, LLC, delivers transdermal ultra-purified medical gas directly to the blood stream and body tissues that are low in oxygen-rich blood flow.

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The handheld, lightweight device – which promotes  the rest and digest functions of the autonomic nervous system  and the circulation of the blood in the smallest blood vessels, known as microcirculation – has demonstrated over years of studies and user feedback great efficacy in treating a number of health issues, including treating and closing so-called non-healing diabetic wounds. 

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers,” says Dr. Michael McGlamry, a podiatrist in Georgia.

He says the device helps increase oxygen-rich blood flow in the local microcirculatory system, leading to better blood perfusion and tissue oxygenation.  

“Improved microcirculation leads to better tissue oxygenation and better heart function, as the heart does not need to exert extra force to bring the blood to all the organs of the body,” says Dr. McGlamry.

Wound healing

Foot wounds are a significant concern for diabetics: 15% will develop a foot ulcer, and 14-24% of individuals with a foot ulcer, will need amputation.  

Dr. Felix Sigal, a Los Angeles podiatrist, says this device is a game changer.

“Transdermal delivery of carbon dioxide has therapeutic effects on both the microcirculation and tissue oxygenation,” he says. “By improving tissue oxygenation and microcirculation, studies have shown greater progress in wound healing with respect to wound size and area of injury.”

The device was evaluated over eight years and three dozen human studies where zero adverse effects were reported. The CO₂ is approved by the FDA for anesthesia and oxygen therapy as a non-toxic, simple molecule under the Medical Gas Safety Act of 2012. It’s in the final phase of getting a combination device-drug approval. 

“D’OXYVA has recorded significant results, delivering major outcomes for well over 90% of users,” says Dr. McGlamry. 

Applications for COVID-19 patients

The device may help improved blood flow and tissue oxygenation for people with COVID-19 . Patients most at risk for the novel coronavirus include those over 65 who have heart disease, liver disorders, diabetes or other underlying health issues.

“Because it affects the immune system and compromises the body’s natural defenses fight off infections, it is critical for a person with diabetes to have good blood flow circulation, reducing the chance of infection, ulcers and at worst case amputations,” says Dr. Geoffrey Watson, who specializes in chronic care management in Oakland, California.

He says while the heart is a far distance from the foot, the foot relies on the heart for consistent blood flow, requiring open pathways. Often those pathways are constricted in diabetics, resulting in poor blood circulation

Dr. Watson says vasodilation is essential, “to promote microcirculatory blood flow to supply adequate oxygenation the feet, thereby likely helping to prevent infections, ulcers and wounds.” 

Clinical Trial

Circularity Healthcare’s Phase 3 clinical trial — which involves the use of an FDA-approved drug in addition to IDE device D’OXYVA® (deoxyhemoglobin vasodilator), a non-toxic, non-invasive  transdermal drug delivery device — is poised to help the most at-risk coronavirus patients experiencing complications due to diabetes, poor circulation, hypertension, high blood pressure, and cardiovascular disease. 

“Further studies are needed but this device has the potential to prevent symmetrical peripheral gangrene, a limb threatening complication of COVID-19,” says Dr. Sigal, who is helping conduct the D’OXYVA Phase 3 diabetic foot ulcer clinical trials.

This clinical trial represents the first biotech solution to improve a patient’s overall oxygen-rich blood flow. 

For more information: https://doxyva.com/covid-19/

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Biotech World Leader Announces Series A Fundraising on Heels of Groundbreaking COVID-19 and Phase 3 Diabetic Wound Treatment Trials

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An emerging biotech leader with operations in more than three dozen countries, Circularity Healthcare has announced its Series A fundraising campaign to raise growth capital as it prepares for its impending initial public offering. Poised to become a leader in proprietary circulatory health and noninvasive drug delivery technologies, the company has built a global infrastructure with impressive strategic partners in preparation for ramped-up manufacturing and marketing of its patented and patent-pending D’OXYVA® noninvasive rapid drug delivery devices, and D’OXYVA®-branded mini, single-use medical gas (gasotransmitter) cartridges.

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This groundbreaking transdermal system (which in human studies has been shown to significantly improve oxygen-rich blood flow) and Circularity’s new FDA-approved pharmaceutical-grade mini (14.5g) cartridges are expected to play a crucial role in the fight against COVID-19 for treating oxygen-starved, at-risk patients with underlying medical conditions. The D’OXYVA®-branded cartridges, the world’s first mini carbon dioxide cartridges approved by the U.S. FDA (and manufactured at the world’s largest specialty pharmaceutical gas producer’s FDA-audited factory in Pennsylvania), will be sold to doctors, clinics, and hospitals nationwide to treat a wide variety of conditions that can benefit from cellular and tissue oxygen therapy.

The fundraising campaign comes on the heels of Circularity’s expanded multi-year, multi-country, multi-site, Phase 3 human clinical trials led by David G. Armstrong, professor of clinical surgery at the University of Southern California’s Keck School of Medicine, and newly launched COVID-19 clinical trials led by H. Geoffrey Watson, M.D., of Oakland, California. The COVID-19 trial will focus on treating the most at-risk COVID-19 patients, 90 percent of whom suffer from low blood oxygen levels resulting from underlying conditions like diabetes, hypertension, blood pressure, cardiovascular complications, sepsis, and septic shock.

A big part of the science behind D’OXYVA® are the 2019 Nobel Prize in Physiology or Medicine-winning findings that showed how oxygen levels affect cellular metabolism and physiological function, paving the way for oxygen to be used as a promising new method to fight many diseases, including various types of cancer.

Circularity estimates that the total cost of the yearly treatments for the most critical and vulnerable millions of COVID-19 patients will amount to roughly $70 billion, and that more than 90 percent of deaths can be avoided. The company is also expected to capture a share of the COVID-19 vaccine market with its ability to deliver vaccines painlessly without needles (using its D’OXYVA transdermal delivery system) and with likely much higher efficacy. This is especially ideal for patients who are averse to needles.

Circularity is also nearing updated FDA approval because of its expanded Phase 3 diabetic foot ulcer human clinical trial. The trial has already produced promising evidence to support the safety, tolerability, and efficacy of Circularity’s patented D’OXYVA® device and pharmaceutical-grade carbon dioxide as an adjunctive treatment in speeding up the healing of diabetic foot ulcer wounds. The device uses medical-grade carbon dioxide delivered painlessly and gently through skin pores to significantly increase the oxygen-rich blood flow necessary for vital organs to function well.

“We are well-positioned right now for exceptional, immediate, and long-term growth,” says Circularity Healthcare president and CEO Norbert Kiss. “We have strategic partnerships with a combined market capitalization of over $100 billion to support our massive growth trajectory.”

“Unlike many companies in our current challenging economic climate, we have minimal debt on our balance sheets, significantly improved asset valuation, a rapidly growing customer base, and an established, large supply chain virtually all inside the United States, propelled by massive demands for many years to come, with an estimated current inventory retail value of millions of dollars,” says Norbert .

The growing demand for home healthcare and point-of-care options is expected to trigger a rise in demand for packaged medical-grade gases and equipment. The global medical gas market was valued at $7.5 billion in 2016 and is expected to witness a CAGR of 9 percent during the forecast period until the year 2024.

Due to growing concerns about aging, obesity, and diabetes, Research and Markets in December 2017 estimated that the global market for chronic wound care equipment would grow from $18 billion in 2017 to $22 billion by 2022. The United States accounts for 35-40 percent of the global market and is expected to grow at 7 percent CAGR. In contrast, D’OXYVA’s mass-market adoption will offset billions of unwanted healthcare expenditure, considering that a single diabetic foot ulcer standard of care in the United States annually costs about $30,000 in indirect and direct costs on average per person.

Eighty percent of cases still result in amputations, and 80 percent of amputees die within three years of amputation. This is the potential future for about 10 million people if D’OXYVA treatment is not adopted. Circularity’s Phase 3 human diabetic foot ulcer clinical trial centers on healing diabetic foot ulcers at one-tenth of the time and cost of competing modalities, while achieving zero reports of adverse side effects after eight years.

“We can produce devices for 100 million households and cartridges in various sizes for over 300 million people within 18 months with our dedicated production lines,” says Kiss. “Furthermore, Circularity is exploring the opportunity to work with the U.S. government to make the initial millions of applications widely available and affordable to those who need it most. This could generate roughly $50 billion in sales revenue from devices and $70 billion in sales of our drugs.”

The company’s clinical trials are led by some of the most respected medical professionals at top universities in the country, including the University of Southern California, Harvard University, Northwestern University, and Drexel University College of Medicine. Additionally, Circularity is represented by the leading FDA team at K&L Gates LLP (Circularity’s main global, corporate, regulatory, and IP law firm since its inception) and works closely with regulatory teams from the world’s largest specialty pharmaceutical gas producers.

D’OXYVA® is currently available for use in hospitals and at home (over the counter) through its Investigational Device Exemption status under FDA regulations. The company has seen impressive growth volumes over the past two months, with pending orders from some of the largest hospitals and healthcare networks around the world for its regulated D’OXYVA®-branded products, and an 86 percent repeat customer rate for orders of its over-the-counter products.

“This is in line with our original scheduled launch of our comprehensive PR, sales, and marketing campaigns, combined with the anticipated release of our clinical evidence,” says Joel Ellis, national VP of sales. “We have been aggressively expanding sales operations by continually hiring new sales representatives in virtually all areas of our business.”

Along with adding to its sales team, Circularity is launching half a dozen new clinics with leading doctors this week, with plans to multiply those new clinics to expand to hundreds of locations nationwide within the coming months.

The Series A fundraising is open to venture capitalists, private equity investors, qualified institutional buyers, angel investors, and angel investor groups. Potential investors can contact the company directly at (626) 817-6698. For more information on the clinical trials, please visit – https://doxyva.com/covid-19/.

Forward-Looking Information:
This press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to management’s expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

About Circularity Healthcare, LLC
Headquartered in Pasadena, California, Circularity Healthcare is an emerging biotech leader around the world in proprietary circulatory health and noninvasive skin delivery technologies. Since 2011, the company has been committed to radically changing the standard of care and improving lives by developing, manufacturing, and marketing affordable medical devices and pharmaceutical products to promote consumer health and wellness. For more information, please visit https://doxyva.com.

About Norbert Kiss
CEO and Co-Founder Norbert Kiss leads the Circularity Healthcare team, and spearheaded the development of the company’s technology and business platforms. Norbert has nearly a quarter of a century of executive and entrepreneurial experience, both domestically and in more than 60 countries involving startups; think and do tanks; and large brands in technology, intellectual property, regulatory affairs, and sales and marketing. He has been involved in the transdermal and cardiovascular space for more than a decade.

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FDA finds contamination in several brands of diabetes drug

WASHINGTON — U.S. health regulators are telling five drugmakers to recall their versions of a widely used diabetes medication after laboratory tests found elevated levels of a contaminant linked to cancer.

The Food and Drug Administration said late Thursday that several batches of the drug metformin tested positive for unsafe levels of a chemical called N-Nitrosodimethylamine. The agency has stepped up testing after the chemical was found in dozens of shipments of heartburn drugs last year, triggering recalls of Zantac and other popular over-the-counter and prescription medications.

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Metformin tablets are a staple of diabetes care, reducing excess sugar in the blood. People with Type 2 diabetes use metformin alone or with other drugs to help control their blood sugar levels. More than 34 million people in the U.S. have this disease.

Patients should continue taking metformin drugs until their doctor can prescribe a replacement, the FDA said in a statement, noting the risks of discontinuing. Regulators are still assessing whether the recalls will lead to shortages of metformin, but noted that a number of other companies make generic versions of the drugs that don’t appear to be affected by the issue.

Drugmaker Apotex Corp. recalled its extended-release metformin distributed in the U.S. earlier this week after the FDA found contamination in one lot. Apotex said in a statement it recalled all supplies of the drug “out of an abundance of caution.” The company said it stopped selling the drug in the U.S. in February 2019 and that little remains on the market.

The FDA announcement did not name the four other drugmakers who have been requested to recall their products.

The agency noted that no contamination problems have been found in immediate-release metformin.

The FDA is responsible for ensuring that medicines for the U.S. market are made in safe, sanitary conditions that meet federal quality standards. But government inspectors have repeatedly criticized the agency for falling short in reviewing overseas manufacturing plants as the pharmaceutical supply chain has increasingly spread to Asia.

In March, the FDA suspended nearly all U.S. and foreign inspections due to safety concerns and travel restrictions caused by the coronavirus outbreak.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

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An interview with Dr. Michael McGlamry: Diabetic patients and Covid-19

Michael Mcglamry

About Dr. Michael McGlamry

Forsyth Foot and Ankle Associates, Cumming, GA

Dr. McGlamry was born and raised in Atlanta.  He graduated from Tucker High School in 1982, and earned a Bachelor of Science in Engineering with honors from The University of Florida. In 1991, he earned a Doctorate of Podiatric Medicine from The Penn. College of Podiatric Medicine/Temple University.

In 1991, he began his residency training in reconstructive surgery of the foot and leg at Northlake Regional Medical Center in Tucker. After completion, he started a practice in Gainesville, Fl where he practiced for 11 years.

Currently, he teaches at DeKalb Medical Center, with the residency program. He also teach on the post graduate level with the Podiatry Institute, and AO North America; both of which are renowned for their dedication to physicians’ education, and for the improvement of quality patient care.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

In the middle of a global pandemic, like the one we’re living, it is very important to be able to assess risks and try to diminish their effects. Cardiovascular disease is one of the most relevant and impactful; that is why improving blood flow and tissue oxygenation is so important for improving the health outcomes of a COVID-19 infection.

People with diabetes, especially those over 65 years of age, have been shown to be affected more often and with greater severity by coronavirus infection. Diabetic patients, particularly those with more longstanding and poorly controlled disease, suffer from diminished oxygen-rich blood in their microcirculation, which may be a major risk factor for why COVID is so deadly for them. Reports from Chinese authorities and from top American institutions, such as Harvard Medical School, show that underlying cardiovascular disease is associated with an increased risk of in-hospital death for patients hospitalized with COVID-19.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

D’OXYVA® (deoxyhemoglobin vasodilator) is a groundbreaking noninvasive, painless transdermal delivery system based on widely established, groundbreaking, Nobel Prize-winning science and is shown to increase oxygen-rich blood flow in the local microcirculatory system, which in turn leads to better blood perfusion and tissue oxygenation. The increased peripheral perfusion plays a significant role in enhancing the wound healing process, which may lead to a reduction in the influence of preexisting conditions in cases of a coronavirus infection.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

3. Tell us about CO2, microcirculation, and its effects on the body.

D’OXYVA uses ultra-purified carbon dioxide (CO2), a naturally occurring nontoxic substance, which is delivered via the D’OXYVA noninvasive skin delivery system. The CO2 acts as a signaling agent for the body to help stimulate delivery of red blood cells loaded with fresh oxygen to the peripheral tissue. D’OXYVA’s over-the-skin route of administration has demonstrated a safer, more effective alternative route to inhalation — a routine CO2 delivery method in hospitals. Purified carbon dioxide is a nontoxic molecule and can be sold by Circularity over the counter (OTC) and online without the need for a prescription. Circularity’s products are manufactured in compliance with the highest standards.

Improved microcirculation leads to better tissue oxygenation and better heart function, as the heart does not need to exert extra force to propel the blood to all the organs of the body.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Over two dozen studies have demonstrated convincing results at clinics and in homes with no adverse events. D’OXYVA has recorded significant results, delivering major outcomes for well over 90% of users. Studies of D’OXYVA have shown unmatched results in noninvasive wound care — particularly when all other approaches have failed. D’OXYVA provides an adjunct to accelerate comprehensive wound care programs and infection protection in a painless, affordable nonprescription solution that is available in a clinical setting or in the comfort and privacy of your own home.

In an ongoing multiyear, multicountry, multicenter randomized clinical trial on patients with diabetic foot ulcers, D’OXYVA demonstrated hastened wound improvement and eventual wound closure in an average of 5 weeks**.

In addition, D’OXYVA eliminated pain and improved quality of life such as in regard to sleep, appetite, and mood in just a week in 100% of subjects.

No adverse events of any kind were reported during and for years after the studies.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

Microcirculation is often disregarded by diabetic patients, and I’d like to emphasize to them that microcirculation is important, especially in wound healing. In other words, microcirculation is the bridge between blood and single cells that supply oxygen and nutrients to human tissues, especially where it is needed the most. Without proper blood flow, their body will be prone to more complications, including the development of foot ulcers that could lead to amputation. Remember that having improved microcirculation and oxygenation promotes faster wound healing, promotes better performance, and enhances the renewal and replacement of damaged tissues.

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An interview with Dr. Felix Sigal: Diabetic patients and Covid-19

Felix Sigal

About Dr. Felix Sigal

Foot and Ankle Clinic, Los Angeles Podiatrist

Dr. Felix Sigal, DPM is a podiatry specialist in Los Angeles, CA. He graduated from California College of Podiatric Medicine and specializes in podiatry. He is the principal doctor at our clinic, graduated from California State University of Northridge and pursued his training at the California College of Podiatric Medicine, completing his residency at USC General Hospital. Throughout his training, Dr. Sigal expanded his interests in diabetic limb salvage and became one of the most distinguished specialists in the field. Dr. Sigal currently is on staff at both the St. Vincent Medical Center and the California Hospital Medical Center, where he focuses on wound care, diabetic limb salvage, as well as pursues his interest in clinical research to enable better treatment options for his patients. Dr. Sigal serves as a Principal Investigator on numerous clinical research studies in the field of diabetic complications, wound care and has contributed his expertise to the field of clinical research always searching for better treatment options to improve the lives of patients. Dr. Sigal is seeing patients in the Los Angeles and Lancaster offices.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

COVID-19 can infect people of all ages. However, two groups are at higher risk of developing severe complications secondary to COVID-19. These are older adults (over 60 years old) and individuals with underlying medical conditions such as obesity, cancer, diabetes, cardiovascular disease, and chronic respiratory disease. Because diabetic patients often have multiple comorbidities, such as obesity and cardiovascular disease, new data suggests that the death rate and hospitalization duration are four times higher for this subset of the population.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

Disseminated intravascular coagulation (DIC) is one of the severe complications related to COVID-19. This is a serious disorder in which the proteins that control blood clotting become overactive, which can result in symmetrical peripheral gangrene. The Circularity OTC device is a novel transdermal delivery system that can deliver carbon dioxide directly to body tissues low in oxygen. Further studies are needed, but this device has the potential to prevent symmetrical peripheral gangrene, a limb-threatening complication of COVID-19.

3. Tell us about CO2, microcirculation, and its effects on the body.

Inadequate wound healing in chronic wounds is secondary to poor blood perfusion at the level of the wound and surrounding tissues, defined as local hypoxia. Transdermal delivery of carbon dioxide has therapeutic effects on both the microcirculation and tissue oxygenation. By improving tissue oxygenation and microcirculation, studies have shown greater progress in wound healing with respect to wound size and area of injury.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Among patients with diabetes, 15% develop a foot ulcer, and 12-24% of individuals with a foot ulcer require amputation. The average cost of treatment ranges from $16,500 for patients without severely impaired circulation to about $63,000 for patients undergoing an amputation. Capillary microcirculation to foot skin has shown signs of significant impairment in diabetic patients when metabolic control is poor, resulting in poor healing rates for ulcers and worsening of diabetic peripheral neuropathy. The preliminary studies of the Circularity OTC medical device have shown increased oxygenation to tissue, resulting in improved wound healing.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

During the COVID-19 pandemic, it has become even more imperative for diabetic patients to avoid hospitalization from foot complications. To prevent foot complications, diabetic patients must continue to control their diabetes, look at their feet on a daily basis, and become comfortable with using telemedicine to communicate their medical needs to their physicians. During their daily exam, diabetics should look for blisters, minor injuries, sores, and any other abnormal changes to their feet. By following these simple steps, they can reduce the risk of foot complications and amputations.

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