|
Groundbreaking Study Results of Transdermal Medical Gas Delivery to be Published Soon; Will Indicate Effectiveness of InvisiDerm's Gas-Injection Technology for Noninvasive Transdermal Applications PASADENA, Calif., Nov. 12, 2012 (GLOBE NEWSWIRE) (Read article on Globenewswire.com: https://globenewswire.com/news-release/2012/11/12/504410/10012130/en/InvisiDerm-Healthcare-Completes-Successful-Clinical-Trial-of-Transdermal-Delivery-Discusses-Medical-Applications.html) InvisiDerm Healthcare ("InvisiDerm"), developer and manufacturer of noninvasive gas and drug delivery methods, announced the completion of the initial clinical study using its innovative D'Oxyva® transdermal delivery platform. The company has submitted the results to a peer-reviewed medical journal for publication in Q1 2013. The study explored and demonstrated InvisiDerm's successful transdermal delivery of carbon dioxide directly to the body tissues, where it is believed 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 reflected outstanding and effective transdermal carbon dioxide delivery in both diabetic and non-diabetic patients. 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 platforms. Detailed results will be forthcoming upon journal publication of the study findings. The study's principal investigator was Dr. Lee Rogers, Co-Medical Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, CA. As a specialist in diabetes-related lower-extremity complications and diabetic limb salvage, Dr. Rogers focuses on conditions such as diabetic ulcers and non-healing wounds caused by microcirculation and tissue oxygenation deficiencies. These conditions may be positively impacted by transdermal delivery of carbon dioxide. Marking the significance of InvisiDerm's D'Oxyva® study, Dr. Rogers has commented, "Successful transdermal delivery of high concentration molecular carbon dioxide has exciting implications for treating many conditions resulting from poor blood flow, which have unfortunately become prevalent with today's modern lifestyle." Dr. Rogers also noted that research findings in recent years have led to an increased understanding of the importance of microcirculatory health in preventing and reversing disease states such as sepsis, non-healing wounds leading to amputation, diabetes, hypertension, obesity, inflammation, metabolic syndrome, sexual dysfunction, and age-related syndromes. "We anticipate that positive results on this initial clinical study will capture significant attention in the field and open up many avenues for new treatments based on increased oxygen-rich blood flow," stated Dr. Rogers. In addition to InvisiDerm's immediate focus on its regenerative capillary blood flow therapy, the Company is exploring further research into its technology platform as a multi-purpose transdermal drug delivery method. InvisiDerm plans to work with pharmaceutical products that can benefit from D'Oxyva®'s non-invasive delivery mechanism, including an upcoming clinical trial of the feasibility of using the technology for drug delivery in veterinary medicine applications. InvisiDerm CEO Norbert Kiss stated, "We are not only excited about the results we have seen with D'Oxyva®'s transdermal delivery of carbon dioxide, but also about the potential to revolutionize drug delivery across the board." InvisiDerm's growth from a pre-revenue medical technology startup to an active company with an advanced clinical evaluation program has triggered further efforts to emphasize its position as a leader in the transdermal industry. As such, the Company has introduced a new website, utilizing an updated branding and messaging strategy. The new messaging rests on three key areas of application for the treatment: medical, beauty/skin care, and sports performance. To see the new site and learn more about InvisiDerm Healthcare and its D'Oxyva® product, please visit www.MyInvisiDerm.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 devices. The company is pursuing regulatory approvals in the United States, Europe and Asia for device usage as treatment of disease states related to microcirculation and blood flow. The Company is a spin-out of The NKGroup and is headquartered in Pasadena, California. For More Information Please visit www.MyInvisiDerm.com and send your general inquiries via the Contact Us page, or for specific inquiries contact InvisiDerm Public Relations at [email protected] or by phone at +1(626) 817-6685. 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 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. |