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Improved Microcirculation Against Diabetes, Stroke and Several Other Diseases

Exercise has been shown to protect against diabetes, stroke and several other diseases and to improve our moods.

But does it also make us more likely to engage in other activities? Do people who exercise tend to have better social lives or achieve more of their goals?

All clinical evidence so far validates that the science of exercise physiology best explains the outsized and unmatched vast health benefits of D’OXYVA® (deoxyhemoglobin vasodilator) and opens up entirely new ways of thinking about the treatment of the underlying causes of the most severe and widespread medical conditions.

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D’OXYVA as endorsed by Dr. Stephen Pfeifer

I was introduced several years ago to the transdermal COD’OXYVA® delivery system and had the chance to utilize this modality in my practice as well as see the benefits noted by other clinicians who have started implementing the protocols. I was initially skeptical that such an affordable and simple system could have such profound health benefits. But after witnessing improvements in blood pressure, chronic venous insufficiency, diabetic wound healing, mood, and athletic performance enhancement, I realized that this treatment has the potential to help millions of patients with chronic health conditions. So, like most scientists, I began to investigate the reasons why this technology could be so effective.

Could it be possible that one of the main causes of most of our patients’ health problems is rooted in physiologic imbalances in the autonomic nervous system and microcirculation? Have we clinicians been chasing imperfect treatment options with medications and interventions that may certainly ameliorate symptoms initially, but which fail to address critical root causes of physiologic dysfunction and dysregulation?

There is an increasing consensus that microcirculation is critical in many ways. Our vascular system works in such a way that the great arteries have little impact on blood pressure, but small ones control almost 70% of the blood-flow resistance. Each adult organ can have more that 2 miles of capillaries inside it. Each capillary bed is in charge of exchanging small molecules between organ cells and the blood to maintain a healthy cell microenvironment or a state of homeostasis. The vascular system reacts to the concentration of metabolism’s by-products by deciding where to allocate resources and remove waste. However, with time and the accumulation of microcirculation damage due to bad health care habits, poor diet, and sickness, our bodies lose their ability to maintain homeostasis, resulting in poor wound healing, pain, infections, and so on. In other words, the microcirculation system helps our bodies maintain uninterrupted blood flow where it is needed the most.

Another overlooked system is the autonomic nervous system. Many books have been written in the functional medicine arena regarding the concept of adrenal exhaustion, as holistic doctors are realizing that this fundamental imbalance contributes to so many health conditions today. Today, we are bombarded with bad news on TV, we have work and financial challenges, and we have constant interruptions from our cell phones and emails. This constant attack on our survival cortisol hormones can be overwhelming. In functional medicine, we can even document this phenomenon with salivary cortisol hormone levels measured 4­–6 times per day. Typically, we see three progressive levels at play. The adrenal system starts as stressed and wired, then progresses to stressed and tired, followed by burned out and exhausted. At each level, this autonomic imbalance takes its toll on our health. Mother nature provided us with a wonderful adaptive capability to mount a stress response when, in the caveman days, we were running from a pack of wolves. It diverts all energy away from the parasympathetic system (rest and digestion) to a sympathetic response (fright and flight) so we can respond physically, using muscle strength, increased heart rate, and increased cardiac output to respond to a physical challenge. After the challenge is gone, the body should return to homeostasis and a calming parasympathetic mode for rest and digestion. Well, that is just not happening in today’s world, as we are in constant overdrive trying to escape the pack of wolves. So, we primary care doctors are always recommending stress-reduction strategies like yoga, better sleep hygiene, blood sugar stabilization diet strategies, and vitamin supplements that support adrenal balance.

It is refreshing to see a new technologic advancement that can help the many health problems exacerbated by autonomic imbalances. A simple and safe 5-minute transdermal COdelivery device has been shown to work immediately, and there is scientific proof that the physiologic effects continue for many hours. Scientific evidence is available that transdermal COdelivered by the D’OXYVA® device works through several mechanisms:

Reduces inflammation by reducing free radical plasma levels

Raises antioxidant levels and induces vasodilation (microcirculation) through humoral pathway communication

Decreased R-R heart rate interval variation

Activation of the PNS parasympathetic system, causing a vasodilation response

D’OXYVA® is a class 1 low-risk medical device using the natural properties of CO(a FDA-cleared drug) to activate our body’s chemoreceptors and increase organ blood flow through microcirculation while promoting oxygen delivery in capillary beds and organ tissue.

My name is Dr. Steve Pfeifer, and I am a consultant for Circularity and a retired functional medicine doctor. I am proud to be part of the Circularity scientific team that is partnering with clinicians to continue independent research regarding these benefits. More than two dozen research projects have been performed to test D’OXYVA® ‘s potential and safety, and much more are ongoing throughout the world. In fact, at the D’OXYVA® University here in Indianapolis, our doctors are studying the athletic enhancement potential in elite Indy Car race drivers and general athletes to document objective benefits with recovery and pulse oximeter readings reflecting perfusion indexes.

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Peripheral Edema and D’OXYVA Transdermal Application as a Potential Treatment Option

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

Peripheral edema is the result/manifestation of many diseases, inflammation processes, and loss of body compensatory mechanism of chronic conditions, but the first pathophysiology disturbance is at the capillary level (microcirculation). D’OXYVA® transdermal COapplication has demonstrated to be beneficial to improve blood flow by decreasing microcirculation blood resistance and improving venous insufficiency. COis one of the few local humoral mediators with the potential to modulate blood flow in capillary beds. COenhances the following capillary bed functions:

– Arteriole elastic retractions and vasomotion that allows constant blood flow through the capillary bed.

– Reconstruct the role of adjacent closed capillaries.

– Promote vasodilation of the arterio-venous anastomosis without increased venous return.

Also, COis a natural anti-inflammatory agent that helps one’s circulatory system to perform better. CO2  especially helps one’s circulatory system by increasing venous blood return to the heart and systolic output by passive peripheral vasodilation, without increasing mean arterial blood pressure.
It is important that any patient who has edema needs to be followed/supervised by a physician because there is the need to assess critical organ functions and etiology of the disease, like BP, venous obstruction, low plasma protein concentration, or lymphatic obstruction among others.

 

 

References:
Cellulite and carbon dioxide bath. (2009, May 9).

Dogaru gabriela, r. A. (2015). Therapeutic effects of carbonated mineral waters in cardiovascular rehabilitation . Balneo research journal, 36-39.

Maria vitória carmo penhaveli, v. H. (2013). Effects of carbon dioxide therapy on the healing of acute skin wounds induced on the back of rats1. Acta cirúrgica brasileira , 334-339.

Nouvong, j. S. (n.d.). Assessment of microcirculation and the prediction of healing in diabetic foot ulcers. Western University of Health Sciences, College of Podiatric Medicine United States of America:

www.intechopen.com.

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An interview with key opinion leader Dr. Ito Puruhito

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

D’OXYVA® technology is a fast, reliable and effective approach for boosting circulation and promoting wellness for patients with diabetes and varicose veins. An interview with key opinion leader Dr. Ito Puruhito

Effective Oand nutrient distribution from our lungs and guts to our organ tissues depends on micro-circulation. Microcirculation is where the vascular system allows the intravascular volume to interact with the extravascular space to deliver Oand nutrients and in exchange pick up metabolic waste. When these physical processes are interrupted, our body becomes stressed.

Physiologic stress is useful and essential for our survival. For example, when we are sick it plays a crucial role in recruiting the immune cell protagonists to help us overcome infections and sickness. But when the stress transforms from a transitory state to a permanent state, our body loses the capacity to self-heal and achieves homeostasis over time. D’OXYVA® technology and its revolutionary CO2 transdermal delivery allow our body to regain proper micro-circulation blood flow to our organs.

One of the most common public health problems related with poor microcirculation is diabetic foot ulcers. Diabetic foot ulcers are a healthcare problem that affects more than 6.5 million patients in the USA alone. It is expected that 15% of this population are at risk of developing diabetic ulcers. Further epidemiological studies have identified that almost 25% of diabetic patients are at risk of lower extremity amputation and foot ulcers preceded 85% of all amputations.

Diabetic patients with concomitant foot ulcers represent a per patient annual health-care cost that ranges between $12,000 and $17,000. Nationally the USA spends $13 billion in healthcare management of diabetic foot ulcers complication in addition to the expenses associated with diabetes itself.

To help our community to better understand the disease and the new proposed technology for improving diabetic patients’ quality of life, we interviewed Prof. Ito Puruhito, a world renowned cardio-thoracic surgeon based in Indonesia who has shared his knowledge at several top universities including Harvard. Prof. Puruhito has focused his research and efforts on better understanding micro-circulation, particularly in the wound healing process.

In our interview, Prof. Puruhito pointed out the importance of microcirculation health literacy among diabetic patients. He stated: “The better the circulation, the better the body can function in general. Micro-circulation delivers blood and oxygen directly to tissue, and when it is impaired, virtually every bodily function suffers.” Improving micro-circulation—especially in ulcers developed in diabetic patients—leads to improved treatment response, shorter healing time, and ulcer prevention. In other words, it will improve patient quality of life and may prevent extremity amputation.micro-circulation health literacy among diabetic patients. He stated: “The better the circulation, the better the body can function in general. Micro-circulation delivers blood and oxygen directly to tissue, and when it is impaired, virtually every bodily function suffers.” Improving micro-circulation—especially in ulcers developed in diabetic patients—leads to improved treatment response, shorter healing time, and ulcer prevention. In other words, it will improve patient quality of life and may prevent extremity amputation.

Prof. Puruhito has dedicated the last 50 years to researching how to improve microcirculation in his patients. During this time he tested several strategies and products intended to improve microcirculation and found D’OXYVA® technology to be the most efficient medical device.

Prof. Puruhito stated: “The D’OXYVA® technology caught my attention because of its remarkable ability to deliver such a high concentration of COdirectly to the bloodstream.” He also said: “The ability to interact directly with dermal capillary and cellular receptors near the skin gives it the ability to produce the desired systemic effects, which is critical for improving micro-circulation and wound healing.”

Prof. Puruhito is part of the D’OXYVA® independent researcher team. He has been studying D’OXYVA®’s positive impact on his patients and has documented a remarkable success rate with difficult-to-treat wounds and diabetic ulcers. Also, his preliminary findings indicate clear improvements in health care indicators such as peripheral Oconcentration and perfusion indexes among his patients (scientific article pending for publication). Shortly after he recognized D’OXYVA® ’s healthcare benefits for general body health, he started to use D’OXYVA® on a daily basis and said: “As a researcher, it is one thing to observe results in your patients, but another to experience them in your body. With D’OXYVA® ’s transdermal technology, I had both!”

D’OXYVA® ’s consistent positive impact in improving microcirculation and health quality is leading to new treatment options for other pathologies such as varicose veins and cellulite, among others. We are confident that D’OXYVA® technology and effective transdermal delivery of COwill continue to prove its capacity to help the body improve its microcirculation and its capacity to self-heal and achieve homeostasis.

Bibliography

Chandan K. Sen, P. G. (2003, Nov–Dec). Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy. Wound Repair Regen., 17(6), 763–771.

Doupis, K. A. (2012). Management of Diabetic foot ulcer . Diabetes Ther.

McCall, B. (2014, march 13). Medscape. Retrieved from Medscape/News & Perspective .

 

Special thanks to Prof. Puruhito for allowing us to perform the interview at the International Wound Care and Biotherapy Conference in Kuala Lumpur (2015). Dr. Ito Puruhito is a cardiothoracic surgeon with more than 50 years of experience and Professor of Surgery at Airlangga University Medical School in Surabaya, Indonesia. This article was published thanks to: “Circularity Healthcare” – D’OXYVA® , interviewer: Dr. Paul Kirkitelos.

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D’OXYVA AND ITS POSITIVE IMPACT ON PATIENTS’ HEALTH

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

What is D’OXYVA?

The D’OXYVA®  device is a simple, commercially- available device to deliver transdermal carbon dioxide (CO2). It consists of a patented and patent-pending ergonomic polymer shell that is propelled by a patented single-use mini steel pressurized cartridge (45 psi) filled with pharmaceutical-grade (99.5%) liquid, purified CO2. The mini-steel cylinder is GMP-compliant, and recyclable.

D’OXYVA was identified by the IRB in a human clinical trial as a non-significant risk (NSR) device.

The D’OXYVA device is manufactured in the United States and other countries. D’OXYVA is an ISO-complaint device, which means that Circularity Healthcare, LLC has received a certification to certify that D’OXYVA fulfills all of the international requirements for medical device regulations, like risk assessment and maintaining effective processes for safe design, manufacture and distribution.manufacture and distribution.

 

WHO IS INVOLVED IN IMPROVING HEALTHCARE FOR PATIENTS?

CO2 is the protagonist in D’OXYVA’s revolutionary approach to improving healthcare and patients’ quality of life. The medical device causes controlled ischemia-like stress in a local area of the body to promote central nervous system activity and circulate humoral agents that favor micro-circulation, especially at the organ capillary beds.

Adequate blood flow in the capillary bed is essential for tissue survival and optimal organ function. If blood passes too fast or does not pass at all, the tissue cannot extract O2 efficiently and will generate what is known as capillary dysfunction, which is related to chronic pain, poor wound healing, diabetic neuropathy and Alzheimer’s disease, among other conditions.

 

WHAT DO WE USUALLY REMEMBER ABOUT CO2?

· It is a key player in regulating extracellular hydrogen concentrations and pH through various systems, like the respiratory system, kidneys and various buffers.

· Biochemistry: An increase or decrease in 1 mmHg pCO2 will cause a decrease or increase in pH of 0.08 units in acute patients. In chronic patients, a pCO2 change of 1 mmHg will cause a pH change of 0.03 units.

· The Bohr and Haldane effects determine the interaction of O2 and CO2. At the cellular level, pCO2 concentration causes Hb-O2 dissociation.
· It is attained by our body through inhalation.

 

WHAT DO WE USUALLY FORGET ABOUT PCO2?

· Increased pCO2 promotes arteriolar dilatation in various tissues, while a modest effect has been shown in skeletal muscle tissues.

· CO2 can be delivered into our body through the skin (transdermal).

It is used in the medical industry to:

· Rapidly increase the depth of anesthesia when volatile agents are being administered—it increases the depth of respiration and helps to overcome breath holding and bronchial spasm

· Facilitate blind intubation in anesthetic practice

· Facilitate vasodilation and thus lessen the degree of metabolic acidosis during the induction of hypothermia

· Increase cerebral blood flow in arteriosclerotic patients undergoing surgery

· Stimulate respiration after a period of apnea

· Prevent hypocapnia during hyperventilation

 

It is also used in:

· Clinical and physiological investigations

· Gynecological investigations for insufflation into the fallopian tubes and abdominal cavities

· Tissue-freezing techniques (as dry ice) and to destroy warts by freezing.

· The CO2 concentration increment potentiates the S-shaped hemoglobin (Hb) to O2 dissociation curve. It helps Hb to unload O2 from 40% O2 dissociation under normal conditions to 70% O2 dissociation under increase CO2 concentration.

 

WHERE DOES CO2 VAPOR DELIVERED THROUGH THE SKIN TAKE ACTION IN THE BODY?

Transdermal delivery of CO2 has proved to improve local microcirculation (capillary beds) blood flow and tissue perfusion, but it also positively improves systemic blood pressure and TcpO2 (most likely due to the Bohr effect). As mentioned before, therapeutic medical-grade CO2 is used for vasodilatation in the medical field for several conditions and procedures.

Local, CO2 therapy has shown great success rates to improve the healthcare of patients through:

· Treatment for diabetic foot

· Increased microcirculation blood flow and dissociated O2 in healthy and diabetic individuals

·Treatment for arterial stenosis obliterans

· Chronic wound healing

· Adipose tissue treatment

 

Systemically, CO2 therapy has shown great success to improve:

· The healthcare of patients with high blood pressure

· General vital organ function, like that of the: – Pancreas – Liver – Brain – Kidneys

We are currently finding clinical researchers who are interested in participating in clinical trials with our medical device. Our goal is to produce scientific evidence of D’OXYVA’s potential to improve healthcare.

 

OUTSTANDING CLINICAL RESEARCH RESULTS

More than two dozen research projects have been performed to test D’OXYVA potential and its capability to help patients obtain wellness. We have tested the efficiency, tolerability and safety of the D’OXYVA medical device in delivering a gentle, highly concentrated CO2 mist to the body through the skin and prove the reproducibility of its effects beyond doubt. To do so, we measured body CO2 concentration before and after treatment as well as the expected physiological response to CO2 treatment. In addition, we have partnered with healthcare leaders and clinicians to perform independent research studies.

Research end points:

1) Safety and tolerability  Up to date, no adverse side effects or negative healthcare responses have been recorded from our clients using D’OXYVA. Also, no participants in our research projects had any documented side effects from treatment. We encourage you to discuss with your healthcare professional if D’OXYVA medical device is right for you.

· Up to date, no adverse side effects or negative healthcare responses have been recorded from our clients using D’OXYVA. Also, no participants in our research projects had any documented side effects from treatment. We encourage you to discuss with your healthcare professional if D’OXYVA medical device is right for you.

· Measured transcutaneous carbon dioxide (TcPCO2)

· Within the first 5 minutes of D’OXYVA treatment, TcPCO2 increases in the body, followed by a decline slope that lasts approximately 240 minutes until returning to baseline values.

· In healthy individuals, D’OXYVA does not increase pCO2 beyond the body buffer’s manageable range, making it completely safe.

 

2) Efficiency CO2 delivery

a. Measured blood perfusion index (PI)
· The results of each research project consistently showed a significant increment on PI in 100% of participants within the first 5 minutes of treatment, peaking at 60 minutes after treatment. From 60 minutes after treatment until 240 minutes (our largest time period evaluated after treatment), PI decreased slowly to baseline levels. PI studies on diabetic patients has demonstrated a greater response to CO2 that in non-diabetic healthy individuals. Our studies have recorded that the PI change (from baseline) in diabetic patients was double the PI change recorded in healthy patients (Graph 1).
Graph 1: Skin perfusion index (SPP) in healthy and diabetic participants vs. time after using the D’OXYVA medical device

b. O2 concentration
 D’OXYVA has consistently reported increased free O2 molecules in our patients’ blood streams. The effective transdermal CO2 delivery allows the body to increment O2 availability through the Bohr effect, which helps hemoglobin cells to unload O2 more easily by decreasing its affinity.

c. Blood pressure
All of the research projects performed up to date have consistently recorded a significant decrease in systolic blood pressure (from the heart) and diastolic (return to the heart) blood pressure. These results have been consistent throughout all study time periods up to 240 minutes (our longest time period evaluated after treatment).

d. Diabetic ulcer
A research project focusing on D’OXYVA’s impact on diabetic ulcers recorded significant changes in wound healing, like significant granulation of tissue and improved ulcer borders, as soon as 1 week into the D’OXYVA treatment plan (Image 1).

e. Sports
Amateur and professional athletes are always searching for ways to improve cardiovascular function and increase the vascular transport capacity of skeletal muscle. Better vascular transport capacity translates to more O2 and nutrients delivered to our muscles, which means better performance in the field.
D’OXYVA research focusing on the perfusion index (PI) of superficial skeletal muscles has recorded excellent results. The most important findings demonstrate that participants who use D’OXYVA doubled their PI in comparison to the control group.

f. Blood alkalinity
Use of D’OXYVA has consistently been shown to improve local cellular homeostasis. It has the potential to improve body pH values by promoting an alkaline ambiance. A slightly alkaline microenvironment After 7 days of treatment with D’OXYVA (1x per day) – same wound dressing as before within the body promotes good health and optimal body organ performance.

 

WHEN WILL PATIENTS BEGIN TO PERCEIVE HEALTHCARE BENEFITS AFTER STARTING D’OXYVA?

The SENTEC digital monitor system has confirmed successful and constant CO2 transdermal delivery to the skin capillary bed after a 5-minute period of exposure to highly concentrated CO2 vapor produced by D’OXYVA.
The perceived healthcare benefits occur almost instantly, with local microcirculation improvements followed by an increment of SPO2 that last up to 240 minutes.

Nonetheless, adherence to a D’OXYVA regiment has demonstrated benefits to individuals suffering from difficult-to-heal skin wounds like diabetic ulcers, who demonstrated significant clinical improvements after two weeks of D’OXYVA.
Patients who achieved D’OXYVA device adherence for more than a month have shown wellness that persists in clinical trials.

Why can the D’OXYVA medical device and its capacity to produce highly concentrated CO2 vapor improve general health care? Judy M. Delp, Ph.D. in physiology and professor at the Florida State University, described D’OXYVA as a simple commercially available device used to deliver transdermal CO2 that has shown remote vasodilation, which may be mediated through the release of a circulating humoral agent.**

CO2 improves general healthcare in several ways:

· It has natural anti-inflammatory characteristics.

· It increases blood flow through microcirculation, by arteriolar/venous dilatation.

· It produces a rightward shift in the O2 dissociation curve.

· It enhances oxygen delivery at the cellular level in the muscles, organs, brain, skin and other parts of the body.

· It is a fat-dissolving compound.

· It naturally sedates and calms the central nervous system.

· It can be used to reconstruct functionally closed capillaries.

· It can improve venous response.

· It improves blood-flow properties.  It can be used to sedate the central nervous system.

 

IS D’OXYVA SAFE FOR MY PATIENTS (HUMANS AND PETS)?

Circularity Healthcare operates a state-of-the-art supply chain and quality management system (QMS) for manufacturing. Circularity has certificates of registration for IS EN ISO13485:2012 (European Union) and ISO13485:2003 under CMDCAS (Canada), which it has been implementing since 2013.

D’OXYVA is a CE-marked medical device (Class I, low risk) for delivery of medications via the skin. Circularity is seeking approval from the U.S. FDA and other countries for delivery of medical gases such as medical carbon dioxide (USP UN1013) via a novel, patented, non-invasive transdermal route with D’OXYVA to treat various widespread conditions.

Medical carbon dioxide is manufactured and delivered under applicable standards per each country’s regulatory requirements. In the United States, the Food and Drug Administration has cleared the use of medical carbon dioxide through inhalation for humans but not yet through transdermal delivery with D’OXYVA. Transportation of medical carbon dioxide via any postal or courier service requires a certification for handling dangerous goods (HAZMAT) by the U.S. Department of Transportation (DOT).