CE Mark for D’OXYVA® Obtained by Circularity Healthcare, Sales to Customers in the European Union Commences
April 19, 2016
Los Angeles, CA
Circularity Healthcare announced today that it has received CE marking for its D’OXYVA transdermal medical gas delivery device and has begun shipping the latest version of the CE-marked product to customers in the European Union. The company also announced that it has recently begun a multi-center randomized clinical trial for diabetic foot ulcers, which is one of the primary applications initially being targeted by D’OXYVA. Circularity is also in the process of filing for clearance of D’OXYVA with the Food and Drug Administration in the United States.
Circularity Healthcare, LLC, headquartered in Los Angeles, CA with subsidiary offices in Kuala Lumpur, Malaysia and London, United Kingdom is a multinational biotech leader in noninvasive circulatory health applications. In today’s announcement, the company stated that its most advanced D’OXYVA product line is now available as a Class I, low risk Noninvasive Transdermal Delivery (NTD) medical device.
D’OXYVA (deoxyhemoglobin vasodilator) is the worlds most used, most studied, most affordable, and lowest risk non-invasive medical gas-powered transdermal delivery device. The simple to use handheld device is intended for significant improvements in tissue microcirculation with cellular oxygenation via the well-known Bohr & Haldane effect. D’OXYVA is being recognized in a rapidly growing number of published randomized clinical trials, yielding impressive results in producing a variety of significant health outcomes that is targeting to combat the underlying cause of some of the most widespread chronic illnesses across a range of fields. D’OXYVA has a track record of hundreds of thousands of successful applications, as validated and reproduced by prestigious institutions and researchers around the world since 2011.
D’OXYVA is a one-of-a-kind health product, as we are not currently aware of any devices producing similar benefits. Our recently acquired CE mark, coupled with our use of approved medical gases and our registration to ISO13485:2012 in the EU and ISO13485:2003 in Canada, further establishes Circularity as a leader in both the microcirculation and transdermal drug delivery space, said Circularity Healthcare Chief Executive Officer, Norbert Kiss. Our strategy of obtaining the CE mark based on a claim to deliver already-approved medical gases like Carbon Dioxide (UN1013) allows us to make D’OXYVA available for sale much sooner around the world, since such low risk devices utilizing previously approved non-toxic active pharmaceutical ingredients typically obtain registration by local regulatory agencies much more quickly than devices posing more risk to the user, Mr. Kiss added.
During the process of working with the EU Notified Body, Circularity had compiled a Clinical Evaluation Report (CER) to demonstrate accuracy, reproducibility, and other key performance indicators. The results demonstrated a success ratio of all enrolled human subjects of about 97% and unmatched sustained beneficial effects.
The results described in our CER were fantastic on all of the key performance metrics, said Dr. Paul Kirkitelos, Chief Business Development Officer at Circularity Healthcare. European regulatory registration for D’OXYVA is a significant validation of our unique method of rapidly delivering gas molecules noninvasively via the skin into microcirculation, and these results clearly demonstrate the superiority of our targeted approach to treating the underlying cause of many of the most widespread chronic illnesses like diabetic and venous foot ulcers, hypertension, and types of cancer like multiple myeloma, Dr. Kirkitelos added.
Among the early adopters of D’OXYVA Dr. Damian Kelleher at Pennine Hospital Trust noted, obtaining the CE mark for Circularity’s D’OXYVA is welcome news and a significant step towards enabling our hospital networks use of this new modality in the clinical setting. D’OXYVA shall allow us to reduce time, cost, and readmission rates. Additionally, Prof. Ito Puruhito of Airlangga University noted, It’s very encouraging to learn that Circularity has achieved the CE mark. As we’ve been using D’OXYVA for several months with flawless results, our university hospital staff will be glad to be introducing the CE-marked D’OXYVA system to as many patients as we can.
Receipt of the CE mark greatly enhances Circularity’s ability to ramp up sales rapidly through the sales and distribution networks it has already put in place. The company has a comprehensive Early Access Program for healthcare providers under D’OXYVA Investigational Device Exemption (IDE) status. With reproducibility rates demonstrated through over 300,000 applications in over five years in multiple countries, Circularity has trained over 300 sales experts and doctors, and more than a dozen hospitals and clinics are in the process of conducting randomized multicenter human clinical trials around the world, including Florida State University, Pennine Hospital Trust, Hospital Kuala Lumpur, Airlangga University, and University of Szeged.
Additionally, D’OXYVA has been used routinely at wellness and integrative alternative medicine centers since 2013, where users have reported major reductions in various chronic pains, fatigue, and weight while improving energy, cardiac functions, and overall quality of life. Several manuscripts are pending peer-reviewed journal publication that is expected to garner significant attention from the medical community worldwide and establish Circularity’s D’OXYVA as the most tested, most trusted, and most used noninvasive transdermal delivery for treating major disease states by addressing the pervasive issue of microvascular disorder.