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Inspiring Story: The Case of C.A., “D’Oxyva is my game changer “

For two years, living has been like trying to survive between a rock and a hard place, as the saying goes. I’ve been on death’s door more than once, from intense chronic hip pain and loss of mobility to oozing leg wounds and infections; surgeons refused to do hip surgery because of my wounds. There were definitely times when I didn’t think I’d make it through.

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One day, my best friend, Mo, called me up very excited and told me to check out DOxyva.com. She said there was evidence online that the application could assist with wound healing. I was living a nightmare of constant pain, stress, and little hope, struggling just to get myself through the next 24 hours. I called D’Oxyva and spoke with John, grilling him with what felt like a thousand questions. I just did not want to get my hopes up just to crash with disappointment. I waited for a sign. Each time my thoughts circled back to D’Oxyva, I started to hear the words “game changer” in my head. When a friend called to check in on me and I described the concept to her, she said outright, “CA, I think this could be your game changer.” My eyes filled with tears.

I ordered a full kit with five boxes and didn’t look back.

I have been so very sick while waiting almost five years for a much-needed hip replacement surgery! I developed a non-diabetic lower leg wound (from a scratch), becoming wheelchair bound and unable to walk. After over 17 months suffering from severe wound complications, neuropathy and extreme lymphedema (from a drug allergy), I am absolutely thrilled to embrace the full force of my healing journey with twice-daily D’Oxyva application! After a few short weeks using D’Oxyva, not only has the swelling in my legs subsided, the skin around my wound has completely healed, and the wound itself continues to shrink from over 1.5 inches to less than ¼ of an inch in depth (see progress photos). I continue to drop inches from swelling throughout my body, and my physical strength improves every single day. Before I began D’Oxyva, I could barely stand for 5 minutes; now, I can manage 30-40 minutes! I sleep more deeply, my anxiety is disappearing and my stamina grows each day. My nurses, health care aides and doctors have observed the tremendous changes in me with excitement, anticipation and support from week to week.

I still have much healing to get through; however, I know that I would not be living this daily miracle if not for MY D’OXYVA! It Is my game changer!

Follow this blog if you like; as my D’OXYVA journey continues, I will be sharing my progress, challenges, fears and joys.

Thanks for taking the time to read this. I hope you find YOUR game changer!  

My best to you,

C.A.

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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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Non-Invasive Treatments: What No One Is Talking About

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

Sometimes it seems like the best way to guess a person’s age is by how much medicine they take daily. This system is not perfect, as some people start medications early in life, but we all seem to accumulate pills and creams as we age. That is why it can be a relief to discover an application that can be used for multiple health disorders. 

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Alexa, a 58-year-old woman from Texas, United States, has suffered from type 2 diabetes for more than 6 years. She has been taking multiple medications and treatments such as inhibitors, metformin, pain relievers and antibiotics for her diabetic foot wound. After discovering D’OXYVA, a non-invasive application that significantly helped with her pain and wound management after 5 weeks of twice-daily application, she shared that she saved so much when she started decreasing the intake of other medications and avoided a possible amputation just by using this non-invasive application.

D’OXYVA, for example, can be applied for a variety of conditions related to poor circulation. This multi-application product helps consumers save money, space, and time while simplifying everyday life.

Here are a few things about non-invasive treatments that people seem unwilling to discuss.

In layman’s terms, non-invasive treatments do not break the skin or enter beyond the surface of body openings. Invasive treatments include surgery and injections. Because the needles actually penetrate the skin, acupuncture is also considered an invasive procedure. Certain procedures may be considered minimally invasive if they do not penetrate deeply into the body or only require a small incision.

Non-invasive procedures include massage and gas delivery systems such as D’OXYVA.

By nature, an invasive procedure can be hazardous. Even under a doctor’s care, for example, minimally invasive surgical procedures carry risks (Mayo Clinic). Patients can experience unforeseen complications related to anesthesia, infections, or bleeding. While these risks are mitigated with less serious regular treatments, any invasive procedure carries the potential for infections or bleeding complications.

While you should always trust your medical professional’s advice, many non-invasive treatments can be safer. Most doctors will attempt to find the least invasive, most effective treatment.

Although the human body contains many different cells and functional systems, most of them share the same basic processes. For example, every cell in the body depends on a healthy circulation system to receive nutrients and oxygen. Therefore, when a person has circulation problems, it can manifest as a number of issues. Your doctor may be able to recommend one product like D’OXYVA for multiple circulation-related issues.

Examples of Circulation Related Issues

  • Slow-healing wounds, especially those related to diabetes or other cardiovascular issues
  • Septic shock related to a severe infection or a compromised immune system
  • Many forms of chronic pain
  • Varicose veins and other blemishes

 

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.

If you suffer from symptoms related to poor circulation, you may not need to suffer in silence.

        BUY D’OXYVA

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7 Things You Should Know About Diabetic Foot Care

diabetes success story

Diabetes can lead to complications[1] involving the feet, including peripheral neuropathic pain, diabetic foot ulcers, poor circulation, decreased sensation and increased callus formation. This can lead to skin breakdown and the formation of ulcers that can become infected and even lead to amputations. Proper diabetic foot care can decrease the risk of developing these complications. Read on to learn about the case of Chase L., who suffered from severe diabetes with complications involving both feet and who experienced significant pain relief through the application of the non-invasive deoxyhemoglobin vasodilator D’OXYVA[2]

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Chase was a 64-year-old male patient with a 7-year history of type 2 diabetes mellitus. He had high blood sugar levels for a 3-year period before his diagnosis, as well as a history of elevated cholesterol and triglycerides and high blood pressure. On laboratory testing, Chase had an A1C level of 8.3% (normal A1C levels are less than 5.7%) and a blood sugar reading of 186 (normal readings are 70-110). 

On physical exam, Chase exhibited ingrown toenails, pallor of the feet, cyanosis of the toes and thick callus formation of the heels. In addition, he had decreased sensation over the dorsum of both feet and diminished pedal pulses bilaterally. After spending thousands of dollars on medications and trying various non-invasive treatments without relief, Chase experienced significant pain relief and a decrease in the cyanosis of his toes after 6 weeks of daily D’OXYVA applications and shared that he saved money by using D’OXYVA and beginning to wean off of other medications. 

#1 Check Your Feet Carefully Every Day for Diabetes Induced Changes
Diabetic patients must check their feet carefully every day to look for suspicious areas of skin breakdown, color changes, callus formation and skin infections. Areas that are especially vulnerable to skin breakdown include the big toe, the heel and the areas between the toes. Diabetics are extremely vulnerable to damage to the microcirculation (smallest blood vessels) of the feet. The application of transdermal vasodilators such as D’OXYVA can increase peripheral oxygenation to avoid further nerve damage and other diabetes induced changes while improving wound healing and avoiding amputations.
#2 Wear Properly Fitting Shoes
Shoes that are too tight can impair circulation. Care should be taken to ensure a proper fit so that circulation is adequate and there is no inordinate friction or rubbing.
#3 Keep Your Feet Dry, Especially in the Winter
Excessive moisture caused by sweating of the feet can lead to increased bacteria growth, which can cause infections. Socks should be changed regularly in the winter especially, if they become wet.
#4 Use Moisturizer on Your Feet After Bathing
The nerve damage and vascular changes to the feet caused by diabetes lead to dysfunction of the moisturizing glands and result in increased dryness, which can cause further skin breakdown. Applying a moisturizer to the feet (but not between the toes) after bathing can restore lost moisture and reduce dryness.

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.

Experience Significant Pain Relief Now!

        BUY D’OXYVA

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D’OXYVA® improves dermal microcirculation and promotes wound healing in the diabetic foot (clinical trial update)

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

Prof. Puruhito and colleagues have released the results of three observational trials showing that D’OXYVA® (Circularity Healthcare LLC), a deoxyhemoglobin vasodilator, improves vasodilation in the treatment of diabetic foot ulcers (DFUs), boosts dermal microcirculation, and helps in the healing process of DFUs.

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Published in PRWeb

D’OXYVA® is a validated circulatory and nerve stimulant. The system was used by Prof. Puruhito for CO2 transdermal delivery, which has been shown to produce higher oxygen unloading by hemoglobin, thereby increasing oxygen-rich blood flow in the local microcirculatory system1. This improved dermal microcirculation leads, in turn, to enhanced wound healing2.

The American Diabetes Association standards of care for DFUs refer to microvascular complications and their treatment via improvements in microcirculation; therefore, Prof. Puruhito’s team set out to test CO2 transdermal delivery via D’OXYVA® in their patients. They have been gathering data since 2015, which led to the following results.

During the course of a 5-day treatment, O2 saturation increased in patients treated with transdermal CO2 in comparison to controls (15 patients/group)3 over the whole measurement range (up to 120 minutes post application). Moreover, a consistent heart rate decrease was found in patients undergoing transdermal CO2 treatment. Furthermore, the perfusion index (PI) showed an upwards tendency in the treatment group, whereas it remained stable for untreated controls. See figure 1.

diabetic wound

Figure 1: Changes observed after a 5-day transdermal CO2 treatment with D’OXYVA®. H1-H5: pre-treatment, 10, 30, 60, 90, and 120 minutes after; blue trace: control, orange trace: treatment. (A) Changes in O2 saturation (B) Decrease in heart rate due to treatment (C) Masimo® measurements of PI.

In light of these results, Prof. Puruhito’s team performed extra measurements of transcutaneous carbon dioxide (TcPCO2), O2 saturation, and PI in the 15 patients treated with D’OXYVA® for transdermal CO2 delivery3–5. This data show that the oxygen saturation reached almost 100% in some patients, whereas the TcPCO2 remained relatively stable throughout the treatment time (120 minutes). For more detailed information, see figure 2.

Figure 2: Transcutaneous CO2 pressure (TcPCO2), O2 saturation, and PI assessment in the 15 patients subjected to transdermal CO2. (A) SENTEC TcPCO2 measurements for all patients at various time points after D’OXYVA® application (pre-treatment, 5, 60, 90, and 120 minutes after) (B) O2 saturation (C) PI.

Finally, Prof. Puruhito’s team demonstrated the positive effects of transdermal CO2 delivery via D’OXYVA® on the healing of DFUs5 (fig. 3), proving the clinical potential of this intervention to improve the quality of life of people suffering from this common complication of diabetes.

Figure 3 Wound healing after 5-day treatment with transdermal CO2 delivery via D’OXYVA® in cases of DFU Wagner-1 and Wagner-2

In conclusion, the use of a D’OXYVA® device for transdermal CO2 delivery improves the outcomes of DFUs by enhancing dermal microcirculation and increasing perfusion rates and tissue oxygenation, therefore assisting in the healing process of the ulcers typical of diabetes neuropathy.

ABOUT PROF. ITO PURUHITO

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

Ito Puruhito, MD is professor in the Department of Thoracic and Cardiovascular Surgery at Dr. Soetomo General Hospital as well as a senior lecturer in the Faculty of Medicine at Universitas Airlangga (Indonesia). From 2001 to 2016, he was the rector of the aforementioned university. Prof. Puruhito finished his medicine studies at Universitas Airlangga in 1967, and in 1972 he received a doctorate degree, graduating cum laude from Frederich-Alexander University (Erlangen-Nürnberg, Germany). In his native country, he developed the Department of Thoracic-Cardiovascular Surgery at his former university, Universitas Airlangga, Surabaya. In 1978, he co-founded the Indonesian Association of Thoracic, Cardiac and Vascular Surgery. Prof. Puruhito has authored numerous indexed research articles in Scopus, ISI-Thompson or PUBMED, and scientific presentations and written several books in Indonesian, English, and German. He acted as reviewer for peer-reviewed journals such as Medical Tribune, Annals of Thoracic and Cardiovascular Surgery, Asian Annals of Surgery, Medicinus, and many more Indonesian medical-surgical journals. Currently, apart from lecturing, Prof. Puruhito actively researches stem cells, cardiovascular medicine, and surgery at the Institute of Tropical Disease as well as some work in microcirculation. Further, he acts as coordinator of research affairs at the Department of TCV-Surgery at Dr. Soetomo General Hospital Surabaya. Since 2014, he has been the chairman of the Council of Research in the Ministry of Research Technology and Higher Education of the Republic of Indonesia.

ABOUT D’OXYVA

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

D’OXYVA® (deoxyhemoglobin vasodilator) is a novel, clinically validated blood flow and nerve stimulant for people suffering from neuropathy. In various clinical trials, D’OXYVA® has validated leading independent research results and demonstrated above-average results in improving a host of physiological functions.

Subjects suffering from high blood sugar have reported neuropathy pain relief minutes after D’OXYVA® was administered and long-term blood sugar level improvements after just a few weeks.

Rapid and gentle skin delivery (over-the-skin) with the D’OXYVA® lightweight, handheld device has prompted improvements in blood microcirculation or PI by 33%* on average in all participants. Lasting results have been measured at 5-60 minutes and up to 4 hours after a single 5-minute D’OXYVA® delivery on the skin surface without reduction in PI levels.6

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What You Need to Know About Non-Healing Wounds

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.
Chronic wounds are wounds that do not heal in a normal amount of time. This delay in healing can be due to a number of factors. Read on to learn about the case of a 63-year-old female patient with a large chronic wound on her lower, left extremity that was resistant to healing. Lena was a 63-year-old, White female who had developed a large, non-healing wound on her lower, right leg. She could not remember what had caused the lesion other than having dropped a heavy mirror on her right shin several weeks earlier. Lena had a past medical history of high blood pressure, diabetes, heart failure, liver failure, and blood clots in her legs. She had been a cigarette smoker for the last 50 years. Lena’s physical examination showed a large, deep, non-healing wound on her right shin. Surgical treatment and debridement, along with antibiotic treatment, had failed to result in significant treatment. After 8 weeks of adjunctive application with deoxyhemoglobin vasodilator D’OXYVA[1], the chronic wound improved without any further complications.
Main Reasons Chronic Wounds Do Not Heal
Chronic wounds normally do not heal for a number of reasons, including[2]:
  • Increased age of the patient leading to slower healing time
  • Decreased functioning of the immune system due to illnesses or chronic disease processes
  • Decreased circulation due to diabetes affecting the peripheral vascular system
  • Decreased circulation due to peripheral vascular disease
  • Peripheral neuropathy leading to loss of sensation and the inability to feel wound and ulcer formation
  • Insufficiency of the venous system leading to pooling of blood in the extremities and resultant poor perfusion
  • Poor nutrition leading to decreased ability to heal wounds normally
  • Impaired mobility leading to impaired limb perfusion
  • Increased general stress levels leading to decreased wound healing
  • Decreased general health causing general debilitation and loss of normal healing ability
Variations of Chronic Wounds

There are several different variations of chronic wounds, including pressure ulcers, arterial and venous ulcers, and diabetic ulcers.

Pressure ulcers[3], such as “bed sores,” occur when an area of the skin is under constant pressure, often when a patient is confined to a bed or wheelchair.

This causes the skin to break down in areas such as the coccyx, heel, ankles, and dorsum of the foot.

Arterial ulcers[4] form when there is a blockage in an artery causing reduction in blood flow to the lower extremities and subsequent reduction in the supply of oxygen to the affected area.

Venous ulcers[5] occur when the valves within veins become damaged leading to pooling of blood in the veins and reduced blow flow and oxygenation to the extremities.

Diabetic ulcers occur when high blood sugar levels cause damage to the nerves, especially in the lower extremities.

This leads to numbness, causing the patient to ignore cuts or ulcers until they enlarge, often becoming infected.

Diabetes also depresses the immune system, leading to slowed healing.

Treatments for Chronic Non-Healing Wounds

There are a number of treatments for non-healing wounds [7]. These include:

  • Antibiotics to treat bacterial infections
  • Antifungals to treat fungal infections
  • Hyperbaric oxygen treatments to improve chronic wound healing
  • Surgical debridement to remove necrotic tissue
  • Specialty wrapping of chronic wounds
  • Skin grafting to close chronic wounds
  • D’OXYVA[8]skin delivery deoxyhemoglobin vasodilator as a wound solution to improve blood flow and oxygenation to chronic wound areas

HOW D’OXYVA CAN HELP?

D’OXYVA® (deoxyhemoglobin vasodilator) provides advanced, painless, complete and fast wound care solution. It has demonstrated speeding up diabetic wound improvement to an average of 5 weeks**.

In addition, D’OXYVA  improved quality of life such as sleep, appetite and mood in just a week in 100% of subjects. No adverse events of any kind were reported during, and years after the studies.

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Defects in Microcirculation and the Effect on Wound Healing: New Non-Invasive Treatments

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

The effects of defects in and poor functioning of the microcirculation on wound healing, especially in diabetic patients, can be devastating and life changing. As one particular example, Joseph L was a 63-year-old White male with a 24-year history of diabetes mellitus, hypertension, elevated cholesterol and arthritis. Joseph had been taking insulin for the past 12 years but his blood sugar levels were still poorly controlled.

On physical exam, Joseph had several very large, oozing and foul smelling deep ulcers located on the dorsum (top) of the left foot. After 8 weeks of intensive therapy utilizing the non-invasive D’OXYVA transdermal deoxyhemoglobin vasodilator, Joseph’s ulcers healed entirely and he avoided amputation of his left foot. Read on to learn more about this new non-invasive wound treatment that helps in wound healing.

 

What is the microcirculation?

The microcirculation refers to the smallest blood vessels in the body that supply oxygen to the tissues and remove waste products. This includes the arterioles, the venules and the capillaries. When the vessels of the microcirculation become damaged, it leads to decreased blood flow with lower oxygen blood levels and resultant damage to the skin resulting in a wound or ulcer.

Risk Factors for the Creation of Chronic Wounds

Patients with the following risk factors are at greater risk for non-healing wounds or ulcers (ulcers are the most common type of chronic wounds):

  • A history of decreased blood flow to a specific area (ischemia)
  • A history of uncontrolled diabetes (which leads to poor circulation, nerve damage and breakage of the skin)
  • A history of uncontrolled hypertension (high blood pressure)
  • A history of high cholesterol and atherosclerosis (cholesterol plaques in the arteries)
  • A history of blood clots (thrombosis)

 

Diabetic Foot Ulcers

Diabetic foot ulcers are a common complication of uncontrolled diabetes mellitus.1 Chronically elevated blood sugar levels damage the microcirculation of the lower extremities, which leads to ischemia and neuropathy (damage to the nerves). Diabetic patients often lose feeling in the feet and so are not aware of friction and pressure, which leads to breaks in the skin. This subsequently leads to open wounds that often do not heal over a 30 day period. These wounds can then become infected, leading to gangrene and eventual amputation.

 

An Example of a New Non-Invasive Treatment to Enhance Wound Healing

D’OXYVA is a non-invasive transdermal deoxyhemoglobin vasodilator that delivers FDA-approved ultra-purified CO2 molecules which diffuse through the skin leading to increased skin perfusion. In studies of the treatment of diabetic foot ulcers with D’OXYVA, increased diabetic wound healing was observed with wound closure often observed within 5 weeks.

 

Conclusion

Chronic conditions like uncontrolled diabetes and hypertension can cause damage to the microcirculation, which leads to delayed wound healing. New treatment methods like D’OXYVA deliver transdermal CO2-enhanced oxygen and nutrients to wound areas through the microcirculation. This speeds up wound healing and wound closure and helps avoid devastating complications such as amputations.

HOW D’OXYVA CAN HELP?

In an ongoing multi-year, multi-country, multi-center, randomized clinical trial on patients with diabetic foot ulcers, D’OXYVA has demonstrated speeding up diabetic wound healing and ultimately wound closure to an average of 5 weeks**.

In addition, D’OXYVA eliminated pain and improved quality of life such as sleep, appetite and mood in just a week in 100% of subjects. No adverse events of any kind were reported during, and years after the studies.

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The Importance of Microcirculation in Wound Healing

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

The importance of microcirculation in wound healing cannot be overemphasized. Microcirculation enhances blood flow for better health benefits. D’OXYVA helps actualize the efficient flow of blood in the body. D’OXYVA utilizes carbon dioxide (CO2) and soft water vapor, popularly accepted as a natural vasodilator, to aid chronic wound healing processes. This enhances skin microcirculation and pressure, which bring about faster wound healing. Before we proceed to the core importance of microcirculation in wound healing, let’s look at the real meaning of microcirculation and how it relates to healing.

What Does Microcirculation Imply?

A healthy body is able to replace and renew injured tissues and heal wounds easily, and this can be achieved through effective and efficient blood flow. Microcirculation is the flow of blood through the tiniest blood vessels—the venules, capillaries, and arterioles the circulatory system.

In other words, microcirculation is the bridge between blood and single cells that supply oxygen and nutrients to the human body. Without proper blood flow, the body is prone to health dangers. Apart from the cornea, microcirculation exists in all tissues and organs. Microcirculation in wound healing can be made more effective if the enormous benefits of D’OXYVA are properly utilized.

What is the Function of Microcirculation in Wound Healing?

As mentioned, the role of microcirculation is enormously important for the speedy healing of chronic wounds. The primary function of microcirculation is the delivery of oxygen and nutrients, and it also enhances the removal of carbon dioxide. The core aim of microcirculation in wound healing is to regulate blood flow and tissue perfusion at all times. Now, let’s look at the importance of microcirculation in wound healing.

What is the Importance of Microcirculation in Wound Healing?

For the sake of this article, we shall review some core aspects of microcirculation related to wound healing, which include the following:

Microcirculation Enhances Fast Healing

As we know, effective blood flow results in healthy living. Microcirculation eases inflammation and calms all kinds of chronic wounds. This core objective can be effectively carried out with the help of D’OXYVA, which guarantees the highest concentration of carbon dioxide and increases consistent blood flow in the body’s microcirculatory system. It is safe, painless, and very simple to use.

Microcirculation Promotes Better Performance

Another salient aspect of microcirculation regarding wound healing is that it encourages healthy living by providing an easy flow of blood throughout the body. It enhances individual health at all ages and fosters general fitness. Microcirculation helps rebuild damaged tissues, thereby facilitating fast healing.

Enhances Renewal and Replacement of Damaged Tissues

The human body requires a recovery phase after a physical injury. The effectiveness of this recovery phase can be guaranteed by a constant flow of blood and a continuous supply of nutrients and oxygen. This is one of the reasons why microcirculation is vital to wound healing; it ensures that the necessary nutrients are readily available for cell renewal. Microcirculation facilitates the continuous flow of blood to the human body by supplying the cells with vital products and removing waste through the microvessels.

Treatment for Chronic Wounds and Other Respiratory diseases

The best way to achieve optimal microcirculation in wound healing is through D’OXYVA. D’OXYVA has become a household name in the health industry due to the health benefits it offers. It is a viable option to eliminate all kinds of chronic pain, wounds and forms of respiratory complications. This product is versatile in nature and guarantees the highest concentration of carbon dioxide, which fosters continuous blood flow. D’OXYVA is affordable, safe, painless, and easy to use. It does not cause any side effects.

Conclusion

Finally, the importance of D’OXYVA to microcirculation in wound healing cannot be underestimated; it is imperative to engage D’OXYVA for any kind of wound to promote fast and easy recovery.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless transdermal (over-the-skin) microcirculatory solution that has been clinically tested to significantly improve microcirculation.

Clinical studies with D’OXYVA® (deoxyhemoglobin vasodilator) have shown* extraordinary results for the role of transdermal non-invasive wound care using ultra-purified, non-toxic FDA-cleared molecules, such as CO2, especially when all other approaches failed.

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Circularity Enters Talks to Close Institutional Financing Round, Announces Phase 3 Clinical Research and Human Trials of Diabetic Foot Ulcer Treatment and Microcirculation at Multiple Sites in Seven Countries

Published in PRWeb

Los Angeles, CA May 8, 2019.

Circularity Healthcare is emerging from a successful conference on Microcirculation in Maastricht, the Netherlands, organized by the European Society for Microcirculation (ESM-EVBO.) The company secured multiple new high-quality research projects that are planned to start in the near future in the United States, Canada, France, Germany, Holland, Sweden, and Hungary. In addition, management secured several high-profile commercial deals at the event, including one of the top equine groups in Europe.

The new studies will demonstrate the effectiveness of Circularity’s D’OXYVA (deoxyhemoglobin vasodilator) device. D’OXYVA is a novel non-invasive transdermal (over-the-skin) technology, which is the leader in the field of microcirculation and microvascular therapy in terms of the depth and breadth of the clinical evidence obtained by Circularity over the past six years. The clinical work has demonstrated outsized benefits results, laying the groundwork for a broad range of existing and potential commercial applications.

Prof. Ito Puruhito presents the Efficacy of Transdermal CO2 administration using D’OXYVA medical device to treat diabetic foot ulcers during a lunch symposium sponsored by Circularity Healthcare.
 

The company also announced at the Microcirculation event that it has recently appointed a leading global clinical research organization (CRO) called the Professional Education and Research Institute, Inc. (PERI) to launch a phase 3 human clinical trial. The trial will be performed under the leadership of Prof. David G. Armstrong, a world renowned expert in diabetic foot classification, treatments, and limb salvage. Dr. Armstrong has assembled an expert team with his colleagues at MIT, Yale, Harvard, and other top global research institutions to carry out the clinical trial at multiple sites, with the goal of obtaining FDA approval for applying D’OXYVA to treat and close diabetic foot ulcers.

“I look forward to this opportunity to conduct highly important and truly groundbreaking research with distinguished scientists. Our company’s institutional funding round under negotiations with a number of large private equity and corporate venture capital funds is focused around financing this critical new research, as well as translating our existing results into general practice at the bedside and in-home health care,” stated Circularity CEO, Norbert Kiss. “We may end up with a larger funding round than originally planned, sourced from multiple funds. This can only be a benefit, as it will provide additional resources for our teams to carry out Circularity’s mission to transform the delivery of critical health care with real measurable results to multiple massive patient populations that are currently underserved and in need of what D’OXYVA can provide.”

Prof. Ito Puruhito standing beside his presentation poster gallery.

Circularity’s Business Development Officer and CFO, Dr. Paul Kirkitelos added, “All the latest scientific evidence in microcirculation is pointing to the need for the underlying benefits D’OXYVA is already delivering to patients on a regular basis. Our path forward is to collect additional data to support the applications we have already studied and bring it to the scientific, medical, and consumer communities for the benefit of millions of diabetics suffering from chronic wounds and amputations with a high mortality rate.” 

Circularity Healthcare’s presence at the latest 3rd Joint International Microcirculation – ESM-EVBO 2019 – Conference in Maastricht, The Netherlands was a success. “Attending this kind of event is a great way to get top professionals in the Microcirculation scientific and medical field discover Circularity’s mission, giving people opportunity to interact with our brand which definitely impacts customer acquisition rates positively. It was also a great platform to build many relationships. Such distinguished long-term relationships are especially helpful as these connections can be the first step to improving our access both to repeat and new customers in a variety of markets,” said Jennifer Boadilla-Pelaez, Circularity’s Senior Sales and Marketing Manager and Creative Director.

Maastricht City Hall dinner function

Prof. Ito Puruhito said during his presentation at the event, “I am supporting the adoption of D’OXYVA in the university and hospitals in Surabaya and across Indonesia to benefit as many of our people as possible.”

Download Prof. Puruhito’s presentation delivered at the conference and get access to additional free educational material. (Warning: images of open wounds are included.) You can watch the 15-minute video recording of the presentation by simply registering your email, name, and occupation at this link.

Advertisement banners at the event.

About Circularity Healthcare

Circularity Healthcare, LLC, headquartered in Los Angeles, California in the U.S., is an emerging world leader in proprietary circulatory health and noninvasive delivery technologies, committed to helping significantly improve lives by developing, manufacturing, and marketing medical, pharmaceutical, and consumer health products. Circularity specializes in groundbreaking noninvasive technologies for affordable and portable transdermal delivery systems, and is pursuing regulatory approvals worldwide for device usage as a treatment of disease states related to cardiovascular and microcirculatory blood flow, immunological and autonomic nervous system disorders.

About ESM (European Society for Microcirculation)

The European Society for Microcirculation was founded in Hamburg in 1960 following a first meeting of interested scientists in Lund, Sweden in 1959, and now has 500-600 regular members. The aims of the Society are to advance understanding of the microcirculation by bringing together clinicians and scientists from a wide range of specialists, but including physiology, vascular biology, genetics and biophysics.

Since 1980, the Society has its own journal, the Journal of Vascular Research, an international publication of growing impact, through which the worldwide scientific community is informed of the Society’s endeavors.

About EVBO (European Vascular Biology Organization)

EVBO was launched in 2006, after discussion between European vascular biologists who recognized that there is a need for a democratic society to provide a united focus and forum for vascular biologists in Europe, primarily by organizing conferences but also by maintaining and enhancing an interactive network of researchers; evolving from the experience of the previous European Vascular Biology Association and building on the achievements of the FP6 European Vascular Genomics Network (EVGN).

About Professional Education and Research Institute, Inc. (PERI)

Professional Education and Research Institute (PERI), a global clinical research organization, was established in 2005 as a premier CRO with a goal to work closely with our sponsors throughout the world to manage Phase I through IV clinical trials in the most efficient and cost effective manner possible, while maintaining the highest standards in good clinical practice and human protection.

PERI offers top-quality facilities with a staff including regulatory and pharmacovigilance specialists, clinical research coordinators, as well as specialists in statistical analysis and data management.

For more information, please visit http://www.circularityhealthcare.com or http://www.doxyva.com or doctors (Rx only) visit http://www.doxyvaforwound.com and send your general inquiries via the Contact Us page. For specific inquiries contact Circularity Customer Care at info@doxyva.com info@circularityhealthcare.com or by phone toll free at 1-855-5DOXYVA or at 1-626-244-8090.

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.