InvisiDerm Announces Zero Adverse Effects Two Years After Successful D`OXYVA® Landmark Human Clinical Study - New Randomized Human Clinical Study at Penn State University
Pasadena, California (PRWEB) June 10, 2014 -- InvisiDerm, LLC d/b/a/ InvisiDerm Healthcare (“InvisiDerm” or the "Company"), an emerging world-leading developer and manufacturer of proprietary pain-free, non-invasive circulatory health and transdermal delivery methods under ISO13485 QMS implementation and certification, recently announced it has not received any adverse effect report by the study subjects who participated in its successful landmark IRB-approved human clinical study completed in mid-2012 using its patent pending D`OXYVA® transdermal delivery system. Furthermore, InvisiDerm has never received any adverse health effect report from its customer users in the past three years who have been reporting significant and fast benefits with a wide range of mild to severe health and cosmetic conditions such as numb hands and feet, the appearance of dry skin, acne breakouts, acne and stretch mark scars, varicose and spider veins, and difficult to heal chronic, trauma and burn wounds. This advanced microvascular solution works by bolstering the body’s natural healing foundation: microcirculation. Restrictions in this form of circulation impede the flow of antibodies, white blood cells and platelets, and rob the body of oxygen.
The overwhelmingly positive results of this study led by Dr. Lee Rogers, D.P.M were presented at the Diabetic Foot Global Conference (DFCon) in Hollywood, California in March 21-23, 2013. The overwhelmingly positive study results with no adverse events have far-reaching implications for D`OXYVA® becoming an approved, effective, and complete Wound Care and Cardiovascular Solution, especially, when combined with other beneficial therapies. The study manuscript was co-authored by Associate Professor at the Department of Physiology and Functional Genomics at the University of Florida, Judy M. Delp PhD, and is intended for publication in an international peer-reviewed medical journal.
The study explored and demonstrated D`OXYVA®’s successful transdermal delivery of GMP-compliant, purified Carbon Dioxide (CO2) directly to the body tissues via a skin absorption process unique only to InvisiDerm’s patent pending process achieved by its Supersaturated CO2 + H2O Vapor™. The study has recorded unmatched oxygen-rich capillary blood flow volume or Skin Perfusion Pressure (SPP) in every subject, indicating powerful increase in the activation of vasodilation, tissue perfusion, cell respiration and metabolism as the Bohr effect is widely known to facilitate oxygen unloading when the red blood cells’ hemoglobin exchange CO2 and H2O, in turn signaling the body to increase endothelial function, oxygen and blood levels. The study protocol included the use of SPP readings taken for four hours after a single 5-minute D`OXYVA® application on the thumb by the FDA-cleared Vasamed Sensilase® 3000 microvascular assessment system as an indicator of CO2 delivery.
The clinical trial results reflected outstanding transdermal CO2 delivery in both diabetic (Type 1 and 2) and non-diabetic subjects, as recorded by significant and unmatched sustained increases in blood flow volume in the microcirculation in all study subjects for four hours. 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.
Poor circulation is a gateway for a litany of ailments: slow healing, depression, poor complexion, sores, slow metabolism, and more. Optimizing and even improving the blood flow for the microvascular system is increasingly and widely being reported by independent experimental and clinical research to have direct applications to a wide variety of different conditions for people of all ages and backgrounds, including hypertension, 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.
Diabetic Foot Global Conference - DFCon 2013
InvisiDerm’s findings were presented at DFCon 2013 to an international audience of vascular surgeons, podiatrists, wound care specialists, and other medical professionals who also work with diabetic foot ulcer patients. As the rate of diabetes has skyrocketed, so has the need for a solution to improve blood flow and prevent amputation for these patients. The primary cause of diabetic foot ulcers is impaired microcirculatory blood flow to the affected areas, 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 DPM, 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.
Clinical Study at Penn State University
InvisiDerm has been sponsoring an IRB-approved, double-blind, placebo-controlled, and randomized study with D`OXYVA® in dozens of subjects at Penn State University since early 2014 for measuring skeletal muscle tissue perfusion, skin receptor signaling, neurological signaling, heart rate and other vital mechanisms of action throughout the entire body. The results are intended for publication in an international peer-reviewed medical journal and for regulatory clearance submissions.
About InvisiDerm Healthcare
InvisiDerm, LLC d/b/a InvisiDerm Healthcare, headquartered in the U.S. is an emerging world leader in proprietary circulatory health and non-invasive transdermal technologies, committed to helping improve lives by developing, manufacturing, and marketing proprietary consumer health, dermatology, and beauty products. InvisiDerm specializes in groundbreaking non-invasive technologies for highly portable medical gas-powered transdermal delivery systems and is pursuing regulatory approvals in dozens of countries for device usage as treatment of disease states related to cardiovascular blood flow.
About Diabetic Foot Global Conference
The Global Medical Conference on Amputation Prevention, Diabetes Management, and Diabetic Foot and Diabetic Wound Care. Its mission is to help educate medical professionals worldwide on diabetic foot research and care with the goal of significantly reducing amputations and saving lives and limbs. DFCon annually attracts some 1,000 diabetes, limb salvage, diabetic foot and wound care specialists from all 50 U.S. states and 50 foreign countries to its conference in Los Angeles, CA.
About Penn State University
The Pennsylvania State University is a public, state-related research university with campuses and facilities throughout Pennsylvania. Founded in 1855, the university has a stated threefold mission of teaching, research, and public service.
For More Information
To contact us, please visit http://www.MyInvisiDerm.com or http://www.DOXYVA.com or for specific inquiries, contact InvisiDerm Public Relations at pr(at)myinvisiderm(dot)com or by phone at +1(626) 817-6685 or +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 InvisiDerm, 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 InvisiDerm, LLC 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.
Jennifer R. Boadilla, InvisiDerm Healthcare, http://www.myinvisiderm.com, 1-626-244-8090, [email protected]
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