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 multicenter 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 todays 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 world's 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 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 venus 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 network's 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 Arlingga University noted, Its 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 Circularitys 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's 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, Arlingga
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.