A Push for Non-Invasive Transdermal CO2 Delivery

Several major long term trends are reshaping the healthcare industry worldwide driving the demand for solutions that truly help patients in a cost-effective way.
 
A few of the key long-term trends includes:
- The movement towards the outpatient setting
- Care for wounds, illness, and discomfort are facing increasing demands for expediency and non-invasiveness
- Increasing demand for post hospitalization care, driving a need for home based wound care and inexpensive home health option
- The increasing role of telemedicine and telediagnostics
- Tracking patient progress and satisfaction making patient comfort and quick recovery a top priority
- Shrinking healthcare budgets
- Decreasing reimbursement for hospital stays
- Hospital outpatient centers and treatments
A quick look around the marketplace shows lots of prescription drugs, natural supplements, cremes, invasive needle-based devices, mobility/flexibility devices and a slew of other specialty products

One non-invasive transdermal medical gas device that I have thoroughly checked out and investigated over a short period of time is a product called D' Oxyva, invented by Invisiderm Healthcare, Pasadena, Calif.

Medical studies that I have read show extraordinary results for the role of transdermal carbon dioxide (CO2) in treating wounds. Apparently, patients report quicker, more comfortable recovery from both simple and chronic wounds, and physicians report lower instances of infection.

According to Invisiderm, D' Oxyva was developed on the premise that CO2 added to the tissue is well-known to engage two natural processes called the Bohr Effect and vasodilation, which signals the body to increase the amount of blood flow and the delivery of oxygen – especially to the parts of the body where it is needed.

By combining CO2 and water (H2O) together as a vapor mist to the skin, these elements are absorbed by the skin layers and eventually into the capillaries, arterioles and venules.

D' Oxyva is a patent-pending portable device that you hold in the palm of your hand and each application takes only five minutes. The vapor exiting the water capsule is almost imperceptible when misted onto the skin.

The effect of each application can apparently last up to four hours, or even more. The key attributes are that it is painless, safe and non-invasive.

Additionally, the device instantly increases lasting activation of oxygen-rich cellular tissue respiration and metabolism in the skin's microcirculatory system based on a recently concluded clinical study and independent research.

After doing some additional checking, I found that the D' Oxyva product is considered an “investigational device” when used for medical purposes and is deemed to have an “investigational device exemption” (IDE) in place because it has been the subject of a non-significant risk device study.

In its first pilot test study performed by Dr. Lee Rogers, D.P.M, at the Amputation Prevention Center at Valley Presbyterian Hospital, Van Nuys, Calif., a total of 14 subjects (6 with diabetes and 8 without diabetes) were enrolled for one year in the study.

Comparisons between subjects with and without diabetes of the absolute change from pre-treatment for SPP (skin perfusion pressure) were performed using the Mann-Whitney Test. Each post-treatment study through four hours showed a significant increase in the SPP. Systolic and diastolic blood pressures were also significantly reduced.

Although this was a small pilot study, a significant increase in a measure of microvascular perfusion was found with D' Oxyva. Future study is required to determine the effect on disease states and complications such as diabetic foot ulcers, peripheral artery disease and Raymond's disease.

According to information posted on Invisiderm Healthcare's web site, its stated mission is to make D' Oxyva the first Food and Drug Administration (FDA)- cleared device for transdermal medical gas delivery. The company is in the process of conducting over a dozen clinical trials into various health outcomes of D' Oxyva.

Several circulatory related health issues and conditions that D' Oxyva may help address includes:

Diabetes & Obesity
Chronic Non-Healing Wounds, Often Caused by Diabetes
Prevention of Amputation Due to Limb Ischemia
Heart Attack & Stroke
High Blood Pressure & Hypertension
Faster Wound Healing & Patient Recovery for Burns and Trauma
Facial/Skin Care Improvement
Energy/Stamina
Pain Management
 
If you are an individual or medical professional/practice with a Wisconsin zip code, and would like to try or purchase D' Oxyva, you can send an email to dakeup@gmail.com or call 414-469-7451.

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New Program: Centers of Excellence Program

InvisiDerm Healthcare has started a new Centers of Excellence Program. In a nutshell, the company has created a program that allows medical doctors and researchers from various disciplines to use their

D'Oxyva transdermal device in a clinical or academic study.

As part of the FDA approval process the company is recruiting investigators for our IRB Approved Studies. The facilities who participate in these studies will be considered Centers of Excellence.

Centers of Excellence

●Receive products free or nearly free for research purposes

●Have 10 –50 subjects avaialable per study

●Use Invisiderm Healthcare approved protocols for your study

●Usually publish or present your findings as white papers or at scientific meetings

●Serve as references for new customer accounts

●Will be listed on Invisiderm Healthcare's Web site

Please contact CTC Medical Practice Solutions at 414-469-7458, or send an email to dakeup@gmail.com to let them know when the doctor or key decision-makers would be available to discuss this program in further details. 


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