The study results have far-reaching implications for D`OXYVA® as an effective Microcirculatory Therapy.
Pasadena, CA (PRWEB) March 27, 2013
InvisiDerm Healthcare (“InvisiDerm”), developer and manufacturer of noninvasive gas and drug delivery methods, recently presented the results of its successful clinical study with its innovative D`OXYVA® transdermal delivery system at the DFCon 2013 medical conference in Hollywood, California. The study results have far-reaching implications for D`OXYVA® as an effective Microcirculatory Therapy. The full study paper is expected to be published in an international peer-reviewed medical journal soon.
The study explored and demonstrated D`OXYVA®’s successful transdermal delivery of carbon dioxide directly to the body tissues, where it has shown to stimulate greater oxygen-rich capillary blood flow. The study protocol included the use of skin perfusion pressure readings taken by the FDA-approved Vasamed Sensilase® vascular measurement system as an indicator of carbon dioxide delivery.
The clinical trial results (http://www.doxyva.com/Articles.asp?ID=254) reflected outstanding transdermal carbon dioxide delivery in both diabetic and non-diabetic patients, as demonstrated by significant sustained increases in microcirculation in all study subjects. Not only was the response rate remarkably high, but the efficacy observed was beyond what has been reported in previous trials employing different transdermal delivery systems.
D`OXYVA®’s superior performance is due to its novel flow regulation mechanism for controlling the injection of medical gases into liquids, gels, and other substances for mixture into a supersaturated solution. The proprietary regulator system is groundbreaking in its design, manufacturability, and capabilities in high-pressure gas regulation.
Optimizing the blood flow as a microvascular therapy system is believed to have direct applications to many different conditions, including hypertension therapy, diabetes, wound healing, sexual dysfunction, respiratory illness, skin health and appearance, and brain function.
D`OXYVA®’s introduction to the field is timely, because the role of microcirculation deficiency as a critical factor in these and other disease states affecting large percentages of the population has been made clear only in the past several years.
InvisiDerm’s findings were presented at DFCon 2013 to an international audience of vascular surgeons, podiatrists, wound care specialists, and other medical professionals who work with diabetic foot ulcer patients. As the rate of diabetes has skyrocketed, so has the need for a treatment to improve blood flow and prevent amputation for these patients. The primary cause of diabetic foot ulcers is impaired microcirculation, and D`OXYVA® is thus seen as a major opportunity for this community.
The principal investigator of the D`OXYVA® study was Dr. Lee Rogers, Co-Medical Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, CA. Dr. Rogers is highly visible for his work on conditions such as diabetic ulcers and non-healing wounds caused by microcirculation and tissue oxygenation deficiencies.
Dr. Rogers and InvisiDerm have recently launched two follow-on studies with D`OXYVA® as a transdermal therapy in order to directly examine the required dosing, the duration of the microcirculation improvements beyond four hours, and the wound-healing ability of the treatment. The studies are expected to be completed in the next several months.
To learn more about D`OXYVA®, please visit http://www.DOXYVA.com.
About InvisiDerm Healthcare
InvisiDerm Healthcare is a company based in the USA that designs, develops and manufactures medical devices and consumer health products. It specializes in groundbreaking noninvasive technologies for highly portable medical gas-powered transdermal delivery systems. The company is pursuing regulatory approvals in the United States, Europe, Middle East, and Asia for device usage as treatment of disease states related to microcirculation and blood flow.
For More Information
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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 InvisiDerm Healthcare, its resources, progress in development, demand and market outlook for noninvasive 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 InvisiDerm Healthcare assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. InvisiDerm Healthcare 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.
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