Successful Late Stage Diabetic Wound Pilot Studies were Recently Completed at Hospital Kuala Lumpur with D`OXYVA® that Launched Randomized Diabetic Foot Ulcer Trials

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The results of the study clearly demonstrated significant quality of life benefits and speeding up wound healing using Circularity's D`OXYVA® proprietary, noninvasive, handheld transdermal delivery system as an adjunct therapy.

Dr. Harikrishna R. K. Nair

Dr. Harikrishna R. K. Nair

"I'm enthusiastic to test and potentially offer this advanced wound care modality to our patients as soon as possible as an adjunct application to speed up healing for difficult-to-heal wounds at our Hospital in Kuala Lumpur, Malaysia", said Dr. Hari

All volunteers enrolled in the pilot study experienced significant reduction of pain, typically from an 8 on the Visual Analog Scale for Pain (VAS Scale) down to 1 in a week or two. In addition, all subjects saw an increase in appetite, mood and markedly better sleep. Patients suffering from stage IV gangrene experienced improvements in wound healing within a few weeks. No adverse events of any kind were reported by the subjects.

Further studies are needed to design proper frequency and length of applications with D`OXYVA® to maximize benefits and better determine time of healing of such difficult wounds. As such, Dr. Hari is now designing a randomized clinical trial on 90 volunteers with stage II diabetic ulcer wounds, and he will act as the principal investigator on the study. The goal is to measure various parameters for wound healing using FDA-cleared noninvasive diagnostics, including continuous and noninvasive capillary blood flow volume change, continuous and noninvasive real-time monitoring of transcutaneous CO2 partial pressure (PCO2), functional oxygen saturation (SpO2), pulse rate (PR), pulsation index (PI), heart rate (HR), and perfusion index (PI).

Stage II pressure ulcers are characterized by partial-thickness skin loss into but no deeper than the dermis. This includes intact or ruptured blisters and abrasions. Stage II is an ideal stage to catch and potentially reverse the worsening of these painful wounds that are sometimes called non-healing wounds. However, with current methods, the vast majority of these cases end up in loss of limbs via amputation.

"From its inception, Circularity Healthcare has set out to significantly reduce the suffering of patients with diabetes and cardiovascular related complications that often surface in mostly untreatable wounds, and to help reverse these conditions. Besides significantly reducing pain, improving sleep and appetite in nearly all cases, we have had great success with D`OXYVA® in fully healing and even closing some of the most severe lower extremity wounds related to burns, trauma, metabolic syndrome, and cardiovascular disorders such as Peripheral Artery Disease (PAD) in pilot studies in patients from the U.S, Europe, and Asia. Most of these positive results have been observed in just 4-8 weeks at the most," said Norbert Kiss, Circularity Healthcare President & CEO.

"I'm enthusiastic to test and potentially offer this advanced wound care modality to our patients as soon as possible as an adjunct application to speed up healing for difficult-to-heal wounds at our Hospital in Kuala Lumpur, Malaysia," said Dr. Harikrishna K. R. Nair, Head of the Wound Care Unit at Hospital Kuala Lumpur, Founding President, Malaysian Society of Wound Care Professionals, President, Malaysian Biotherapy Society, Vice Director, Asian Academy of Wound Technology (AAWT).

About Circularity Healthcare

Circularity Healthcare, LLC, headquartered in the U.S. is an emerging world leader in proprietary circulatory health and non-invasive delivery technologies, committed to helping improve lives by developing, manufacturing, and marketing consumer health and wellness products. Circularity specializes in groundbreaking non-invasive technologies for highly portable medical gas-powered transdermal delivery systems and is pursuing regulatory approvals worldwide for device usage as treatment of disease states related to cardiovascular blood flow.

About Hospital Kuala Lumpur

Hospital Kuala Lumpur is now the largest hospital under the Ministry of Health of Malaysia and is considered to be one of the biggest in Asia. It is a government tertiary referral hospital, located on 150 acres of prime land with 83 wards and 2,300 beds. The Kuala Lumpur Hospital or commonly known as HKL (Hospital Kuala Lumpur) has 53 different departments and units. These include the administration & finance department, the pharmaceutical department, training and research, 28 clinical departments and 12 clinical support services.

For More Information

Please visit http://www.circularityhealthcare.com or http://www.doxyva.com and send your general inquiries via the Contact Us page, or for specific inquiries contact Circularity Public Relations at pr(at)circularityhealthcare(dot)com or by phone toll free at 1-855-5DOXYVA or 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 Circularity Healthcare, 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 Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC 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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Jennifer R. Boadilla

Gilmore Agatep Jr.
D'Oxyva
since: 03/2011
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