D’Oxyva™ trial is designed to demonstrate effectiveness in boosting blood flow, which has many critical benefits in the body
Pasadena, CA (PRWEB) September 20, 2011
(Read article on PRWeb.com: http://www.prweb.com/releases/2011/9/prweb8809057.htm)
InvisiDerm Healthcare (“InvisiDerm” or “the Company”), an emerging developer and manufacturer of novel transdermal drug delivery (TDD) methods, has recently begun clinical effectiveness testing of its groundbreaking regenerative cellular oxygen-rich capillary blood flow therapy, D’Oxyva™, for potential use in treating a variety of conditions related to low blood flow and oxygen delivery.
An adequate flow of oxygen-rich blood in microcirculation is critical to proper body function. In the United States and many other countries, the rapidly growing incidence of obesity and cardiovascular disease has created an epidemic of poor blood flow, with very damaging and costly results. Poor blood flow is potentially linked to such conditions as edema, kidney damage, memory loss, low sex drive, limb ischemia, non-healing wounds, diabetic ulcers, and stroke.
D’Oxyva™ is a device intended to increase the flow of oxygen-rich blood and better oxygenate cells and tissues by the transdermal (through the skin) delivery of molecular carbon dioxide (CO2) to the bloodstream. The presence of CO2 is thought to initiate a gas-exchange balancing process called the Bohr effect (oxygen curve shift), which may signal the body to deliver additional oxygen-rich blood, especially where demand is the highest, such as areas of low blood flow.
D’Oxyva’s transdermal delivery method is completely noninvasive. It is designed to use the pores and sweat glands of the hands to deliver the CO2 to the bloodstream via InvisiDerm’s patent-pending flow regulation method.
Pilot testing of D’Oxyva™ using FDA-cleared measuring instruments has shown blood flow increases with a single treatment. These positive results have propelled the launch of the first phase of InvisiDerm’s full-scale clinical trial. The trial is being led by Dr. Lee Rogers, an expert in diabetic limb salvage and Co-Medical Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, California. InvisiDerm anticipates completion of the trial within the next several months.
Commenting on the trial, InvisiDerm CEO Norbert Kiss stated, “We are extremely enthusiastic about the blood flow results we have seen thus far. We are hopeful that we will see more of the same results in the full study, resulting in blood flow improvements that have the potential to improve the treatment options for many serious conditions that demand greater delivery of oxygen-rich blood.”
Medical professionals interested in participating in a clinical study of the D’Oxyva™ device should contact the Company for further information.
Depending on the outcome of the clinical studies, InvisiDerm is considering further research with the D’Oxyva™ device for use as a multi-purpose transdermal drug delivery (TDD) method. InvisiDerm is also planning to work with other pharmaceutical products that can benefit from the Company’s novel delivery mechanism, including an upcoming clinical trial of the feasibility of using D’Oxyva for drug delivery in veterinary medicine applications. In an R&D environment where the productivity of drugs coming out of clinical trials is declining rapidly, and the cost per drug reaching the market is increasing, the potential for beneficial applications of D’Oxyva™ in pharmaceutical drug delivery is vast and represents a strong market opportunity for InvisiDerm.
About InvisiDerm Healthcare (http://www.MyInvisiDerm.info) InvisiDerm, LLC, d/b/a/ InvisiDerm Healthcare, is an early stage medical device company in the United States that designs, develops, manufactures and markets groundbreaking, proprietary, truly noninvasive, and highly portable medical gas-powered transdermal delivery devices and accessories made in the USA. The Company has started manufacturing its initial product line in 2011, using its D’Oxyva™ oxygen therapy platform with the intention of targeting the spa, health-and–beauty, and anti-aging markets in the future. More broadly, InvisiDerm is aiming to make hypodermic needle drug delivery obsolete and rapidly revolutionize the double-digit growth, multi-billion dollar transdermal drug delivery (TDD) industry with its next-generation products. The Company is a spin-out of The NKGroup and is headquartered in Pasadena, California.
Forward-Looking Information This press release may contain “forward-looking information”. This forward-looking information 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, and demand and market outlook for noninvasive transdermal delivery medical devices in general. 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 and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. These factors include the inherent risks involved in the launch of a new medical device, the uncertainties involved in innovation and market acceptance, fluctuating component and other raw and 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.
For More Information Please visit http://www.MyInvisiDerm.info and send your general inquiries via the Contact Us page, or for specific inquiries contact InvisiDerm Public Relations at pr(at)myinvisiderm(dot)info or by phone at +1 (626) 817-6685.