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Benefit from D’OXYVA’s IDE status

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

By virtue of the fact that Institutional Review Boards (IRBs) approved human clinical studies with D’OXYVA®  and concluded that it was a Non-Significant Risk (NSR) device, D’OXYVA®  has an approved Investigational Device Exemption (IDE). See 21 CFR 812 reference below in section (b) and (1) highlighted in CAPITAL LETTERS.

This means D’OXYVA can be used for any medical purposes under testing (investigations). Doctors can ask their patients if they would like to try and test D’OXYVA®  for a certain period of time to see if it helps their condition. First, D’OXYVA should be used as an adjunct application combined with other therapies (no negative interference with other modalities has been reported to date). Typically, patients should test D’OXYVA®  for the first time for 6-8 weeks twice a day for the first two weeks and then once a day to achieve best results according to various clinical trial results and user feedback with D’OXYVA® . Severe cases should continue using it twice a day for 4 weeks and then based on progress lower dosing to once a day.

(b) Abbreviated requirements. THE FOLLOWING CATEGORIES OF INVESTIGATIONS ARE CONSIDERED TO HAVE APPROVED APPLICATIONS FOR IDE’S, unless FDA has notified a sponsor under 812.20(a) that approval of an application is required:

(1) AN INVESTIGATION OF A DEVICE OTHER THAN A SIGNIFICANT RISK DEVICE, if the device is not a banned device and the sponsor:

(i) Labels the device in accordance with 812.5;

(ii) OBTAINS IRB APPROVAL OF THE INVESTIGATION AFTER PRESENTING THE REVIEWING IRB WITH A BRIEF EXPLANATION OF WHY THE DEVICE IS NOT A SIGNIFICANT RISK DEVICE, AND MAINTAINS SUCH APPROVAL;

(iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator’s care, informed consent under part 50 and documents it, unless documentation is waived by an IRB under 56.109(c).

(iv) Complies with the requirements of 812.46 with respect to monitoring investigations;

(v) Maintains the records required under 812.140(b) (4) and (5) and makes the reports required under 812.150(b) (1) through (3) and (5) through (10);

(vi) Ensures that participating investigators maintain the records required by 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7); and

(vii) Complies with the prohibitions in 812.7 against promotion and other practices.

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CE Mark for D’OXYVA Obtained by Circularity Healthcare, Sales to Customers in the European Union Commences

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

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.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless transdermal (over-the-skin) microcirculatory solution that has been clinically tested to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

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Successful D’OXYVA Launch at International Wound and Biotherapy Conference 2015

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

October 16-18, 2015. Kuala Lumpur, Malaysia – Internationally recognized authorities in the field of wound care and biotherapy came together in one single platform to have an in-depth discussion on recent scientific advances and innovations to improve the management of complex and chronic wounds.


” President and CEO of Circularity Healthcare, Mr. Norbert Kiss at the launch of D’OXYVA®  in Malaysia accompanied by the organizers and local authorities.”

Circularity Healthcare as one of the platinum sponsors had its first successful launch of D’OXYVA®  in Asia, with the aim to be the pioneer in non-invasive transdermal delivery to help optimize microcirculation for wound care, health and wellness. In the span of three days, several hundred medical experts from more than 30 countries visited our exhibition and showed interest in bringing D’OXYVA® to their countries.

A lunch symposium was held with two renowned cardiovascular experts speaking about their recent findings on how the science of D’OXYVA® can lead the way for better wound care tomorrow.

1. Professor Ito Puruhito: “Enhancing healing with transdermal carbon dioxide delivery with D’OXYVA®

2. Dr. Yu Tarng-Jenn: “Treatment of Spider Telangiectasias: Current status and a new trend”

In the next issue, we will feature our interview with both of these experts, conducted during the conference. Stay tuned.

We are as excited as you are, and we thank you for supporting our ongoing efforts to advance the study of microcirculation.

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Breaking News from the Surabaya Vascular Update 2015

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

Circularity Healthcare Launches Clinical Trials, Business Initiatives with Influential Experts Across the Region

Legal Disclaimer:
No association or collaboration whatsoever is implied or expressed between InvisiDerm Healthcare and the organizers of SURVUE 5 2015 in the following content. The opinions and statements found herein, expressed or implied constitute the sole private initiatives of InvisiDerm Healthcare and InvisiDerm Healthcare takes full responsibility for their accuracy and completeness.
SURVUE 5 2015 was organized by leading doctors from thoracic, cardiac, and vascular faculty department of Kedukteran Universitas Airlangga Surabaya, Indonesia. Their 5th conference was held to discuss vascular updates on March 6 – 8, 2015 at RSUD Dr. Seotomo Hospital.
Circularity’s CEO, Norbert Kiss and Senior Sales and Marketing Manager, Jennifer Rose Boadilla were invited by Professor Puruhito, the organizer of the event and got the chance to meet some of the most influential thoracic, cardiac, vascular, and wound care experts in Indonesia at the this event.
The event was professional and had high level of participation. The speakers included experts from France and Germany and all presentations were high quality and informative showcasing the latest in technologies and approaches to thoracic, cardiac, and vascular surgery.

With the personal introductory presentation of D’OXYVA by Prof. Puruhito, Circularity’s CEO, Norbert Kiss delivered two presentations of 30 minutes each on two separate days to the attending doctors about the importance of measuring and improving microcirculation, the latest research in the field, and the various clinical evidence of D’OXYVA for unmatched improvements of microcirculation, related physiological functions, and their benefits in humans coupled with case studies.

We are glad to announce that Circularity has secured some of the most influential thoracic, cardiovascular, and wound care medical thought-leaders from Indonesia via strategic relationships at this event. Participation in our comprehensive multicenter, multicountry study coupled with advanced diagnostics for diabetic foot wound healing on hundreds of subjects at leading hospitals is being expanded to Indonesia. Attending doctors discussed in private meetings with Circularity initiating studies and the potential significant benefits of D’OXYVA for pre-, and post-operative vascular applications, cerebrovascular disease, and ischemic heart disease, which is the most common cause of death in most western countries.

Circularity’s affordable, safe, and fast applications for a wide variety of significant clinical outcomes make it clearly a leader in a number of aspects if not most based on the feedback received.

With the help of PT Regenesis, we had a chance to showcase D’OXYVA’s use and debut our new catalog with an exhibit booth to participants of this event. Special thanks to PT Regenesis for their warm hospitality.

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InvisiDerm Healthcare Unveils Successful Transdermal Microcirculation Application Results with D’OXYVA® at DFCon 2013

Prof David Armstrong Diabetic Foot Global Conference DFCON 2013

Groundbreaking transdermal medical gas delivery results presented to scientific community at international medical conference; potential seen for a wide range of direct applications to microcirculatory health.

Pasadena, CA (PRWEB) March 27, 2013
(Read article on PRWeb.com: http://www.prweb.com/releases/2013/3/prweb10570164.htm)

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InvisiDerm Healthcare (“InvisiDerm”), developer and manufacturer of noninvasive gas and drug delivery methods, recently presented the results of its successful clinical study with its innovative D’OXYVA® transdermal delivery system at the DFCon 2013 medical conference in Hollywood, California. The study results have far-reaching implications for D’OXYVA® as an effective Microcirculatory Therapy. The full study paper is expected to be published in an international peer-reviewed medical journal soon.

The study explored and demonstrated D’OXYVA®’s successful transdermal delivery of carbon dioxide directly to the body tissues, where it has shown 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 (http://www.doxyva.com/Articles.asp?ID=254) reflected outstanding transdermal carbon dioxide delivery in both diabetic and non-diabetic patients, as demonstrated by significant sustained increases in microcirculation in all study subjects. 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 systems.

D’OXYVA®’s superior performance is due to its novel flow regulation mechanism for controlling the injection of medical gases into liquids, gels, and other substances for mixture into a supersaturated solution. The proprietary regulator system is groundbreaking in its design, manufacturability, and capabilities in high-pressure gas regulation.

Optimizing the blood flow as a microvascular therapy system is believed to have direct applications to many different conditions, including hypertension therapy, diabetes, wound healing, sexual dysfunction, respiratory illness, skin health and appearance, and brain function.

D’OXYVA®’s introduction to the field is timely, because the role of microcirculation deficiency as a critical factor in these and other disease states affecting large percentages of the population has been made clear only in the past several years.

DFCon 2013

InvisiDerm’s findings were presented at DFCon 2013 to an international audience of vascular surgeons, podiatrists, wound care specialists, and other medical professionals who work with diabetic foot ulcer patients. As the rate of diabetes has skyrocketed, so has the need for a treatment to improve blood flow and prevent amputation for these patients. The primary cause of diabetic foot ulcers is impaired microcirculation, and D’OXYVA® is thus seen as a major opportunity for this community.

The principal investigator of the D’OXYVA® study was Dr. Lee Rogers, Co-Medical Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, CA. Dr. Rogers is highly visible for his work on conditions such as diabetic ulcers and non-healing wounds caused by microcirculation and tissue oxygenation deficiencies.

Dr. Rogers and InvisiDerm have recently launched two follow-on studies with D’OXYVA® as a transdermal therapy in order to directly examine the required dosing, the duration of the microcirculation improvements beyond four hours, and the wound-healing ability of the treatment. The studies are expected to be completed in the next several months.

To learn more about D’OXYVA®, please visit http://www.DOXYVA.com.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.