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Circularity Healthcare Negotiating $100 million Institutional Funding, Expands Successful D’OXYVA Phase 3 Diabetic Foot Ulcer Treatment Clinical Trials, Expects Fast-Track FDA Approval

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[Los Angeles, CA, July 16, 2019] Circularity Healthcare LLC, developer and manufacturer of transdermal drug delivery and wound healing products, has announced that the company has entered into negotiations with institutional investors to inject up to $100 million in growth capital into the company. The capital is to be used to drive Circularity’s launch of product sales in collaboration with several global multinational partners, with a target of several hundred million dollars. The company’s overarching fundraising goal is to access public equity markets through a multibillion-dollar U.S. IPO in the near future.

Privately-held, Los Angeles-based Circularity Healthcare is capitalizing on its completed successful and expanded Phase 3 clinical studies led by prominent researchers, such as Prof. David Armstrong, Prof. Ito Puruhito and Dr. Felix Sigal, and leading institutions, such as MIT, Airlangga, Harvard, Yale, University of Texas at Arlington, and many others. The clinical studies are expected to lead to the company’s highly anticipated Food and Drug Administration FDA approval as a non-significant risk (NSR) combination drug-device for the rapid and highly effective treatment of diabetic foot ulcers.

These exciting developments come on the heels of the rapidly growing market demand for Circularity’s existing product line with a proven technology, manufacturing and fulfillment base. Circularity has recently begun production of its unique, branded, pharmaceutical-grade platform drug molecules.

Already well positioned as an emerging global biotech and medtech product manufacturer, Circularity is now shifting more focus from its non-regulated wellness and cosmetic products to its premium FDA-approved patented and patent-pending drug solutions. These solutions are delivered with the company’s patented and patent pending, non-invasive and painless, rapid transdermal drug delivery systems. The expanded focus is due to Circularity’s exceptionally positive Phase 3 multicenter, multicountry, and multiyear human clinical trials on diabetic foot ulcers, as well as its overall regulatory development path.Recently, the company launched sales of MicroScan, a clinical diagnostics tool with an installed base at intensive care units (ICU) in 35 countries worldwide. MicroScan enables Circularity to generate much higher average revenue per customer, while providing highly affordable insights, both for patients and health professionals, into the inner workings and mechanisms ofactions underpinning the exceptional clinical outcomes of Circularity’s flagship D’OXYVA product line. Until recently, D’OXYVA was available only under test-marketing programs. Together with the diagnostic tools, health experts implementing D’OXYVA can accurately predict wound healing and other major clinical outcomes, such as achieving healthy blood sugar or blood pressure.Once D’OXYVA has helped the patient achieve healthy levels in such key areas, physicians typically recommend a less frequent dosing schedule in order to remain symptom-free long-term.During the past seven years, Circularity has assembled a world-class clinical research, regulatory and legal team comprised of several dozen experts mainly from the U.S. and from several influential European and Asian countries for its comprehensive global market development.
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Circularity Healthcare accepted into Forbes Los Angeles Business Council

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Forbes Los Angeles Business Council Is an Invitation-Only Community for Successful Business Owners and Leaders in Greater Los Angeles

 

[Los Angeles, May 28, 2019] — Mr. Norbert Kiss, President & CEO at an emerging international private drug delivery and circulatory health biotech and medical equipment technology leader, has been accepted into Forbes Los Angeles Business Council, the foremost growth and networking organization for successful business owners and leaders in Greater Los Angeles.

Mr. Kiss was vetted and selected by a review committee based on the depth and diversity of his experience. Criteria for acceptance include a track record of successfully impacting business growth metrics, as well as personal and professional achievements and honors.

“We are honored to welcome Norbert into the community,” said Scott Gerber, founder of Forbes Councils, the collective that includes Forbes Los Angeles Business Council. “Our mission with Forbes Councils is to bring together proven leaders from every industry, creating a curated, social capital-driven network that helps every member grow professionally and make an even greater impact on the business world.”

As an accepted member of the Council, Mr. Kiss has access to a variety of exclusive opportunities designed to help him reach peak professional influence. He will connect and collaborate with other respected local leaders in a private forum and at members-only events. Norbert will also be invited to work with a professional editorial team to share his expert insights in original business articles on Forbes.com, and to contribute to published Q&A panels alongside other experts.

Finally, Mr. Norbert Kiss will benefit from exclusive access to vetted business service partners, membership-branded marketing collateral, and the high-touch support of the Forbes Councils member concierge team.

“On behalf of every woman and man working for and at Circularity Healthcare, I am humbly honored to accept this invitation to become a member of the distinguished Forbes Los Angeles Business Council, and I intend to utilize this excellent medium to help others learn from my professional experiences in the leading companies of various sizes from a variety of industry sectors at home in the United States and in over 60 countries in Latin America, Asia, Europe and the Middle East,” said Norbert Kiss.

ABOUT FORBES COUNCILS

Forbes Councils is a collective of invitation-only communities created in partnership with Forbes and the expert community builders who founded Young Entrepreneur Council (YEC). In Forbes Councils, exceptional business owners and leaders come together with the people and resources that can help them thrive.

For more information about Forbes Los Angeles Business Council, visit forbeslacouncil.com. To learn more about Forbes Councils, visit forbescouncils.com.

 

ABOUT CIRCULARITY HEALTHCARE

 

Circularity Healthcare, LLC, headquartered in Los Angeles, California in the U.S., is an emerging world leader in proprietary circulatory health and noninvasive delivery technologies, committed to helping significantly improve lives by developing, manufacturing, and marketing medical, pharmaceutical, and consumer health products. Circularity specializes in groundbreaking noninvasive technologies for affordable and portable transdermal delivery systems, and is pursuing regulatory approvals worldwide for device usage as a treatment of disease states related to cardiovascular and microcirculatory blood flow, immunological and autonomic nervous system disorders.

For more information, please visit http://www.circularityhealthcare.com or http://www.doxyva.com or doctors (Rx only) visit http://www.doxyvaforwound.com and send your general inquiries via the Contact Us page. For specific inquiries contact Circularity Customer Care at info@doxyva.com info@circularityhealthcare.com or by phone toll free at 1-855-5DOXYVA or at 1-626-244-8090.

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Circularity Enters Talks to Close Institutional Financing Round, Announces Phase 3 Clinical Research and Human Trials of Diabetic Foot Ulcer Treatment and Microcirculation at Multiple Sites in Seven Countries

Published in PRWeb

Los Angeles, CA May 8, 2019.

Circularity Healthcare is emerging from a successful conference on Microcirculation in Maastricht, the Netherlands, organized by the European Society for Microcirculation (ESM-EVBO.) The company secured multiple new high-quality research projects that are planned to start in the near future in the United States, Canada, France, Germany, Holland, Sweden, and Hungary. In addition, management secured several high-profile commercial deals at the event, including one of the top equine groups in Europe.

The new studies will demonstrate the effectiveness of Circularity’s D’OXYVA (deoxyhemoglobin vasodilator) device. D’OXYVA is a novel non-invasive transdermal (over-the-skin) technology, which is the leader in the field of microcirculation and microvascular therapy in terms of the depth and breadth of the clinical evidence obtained by Circularity over the past six years. The clinical work has demonstrated outsized benefits results, laying the groundwork for a broad range of existing and potential commercial applications.

Prof. Ito Puruhito presents the Efficacy of Transdermal CO2 administration using D’OXYVA medical device to treat diabetic foot ulcers during a lunch symposium sponsored by Circularity Healthcare.
 

The company also announced at the Microcirculation event that it has recently appointed a leading global clinical research organization (CRO) called the Professional Education and Research Institute, Inc. (PERI) to launch a phase 3 human clinical trial. The trial will be performed under the leadership of Prof. David G. Armstrong, a world renowned expert in diabetic foot classification, treatments, and limb salvage. Dr. Armstrong has assembled an expert team with his colleagues at MIT, Yale, Harvard, and other top global research institutions to carry out the clinical trial at multiple sites, with the goal of obtaining FDA approval for applying D’OXYVA to treat and close diabetic foot ulcers.

“I look forward to this opportunity to conduct highly important and truly groundbreaking research with distinguished scientists. Our company’s institutional funding round under negotiations with a number of large private equity and corporate venture capital funds is focused around financing this critical new research, as well as translating our existing results into general practice at the bedside and in-home health care,” stated Circularity CEO, Norbert Kiss. “We may end up with a larger funding round than originally planned, sourced from multiple funds. This can only be a benefit, as it will provide additional resources for our teams to carry out Circularity’s mission to transform the delivery of critical health care with real measurable results to multiple massive patient populations that are currently underserved and in need of what D’OXYVA can provide.”

Prof. Ito Puruhito standing beside his presentation poster gallery.

Circularity’s Business Development Officer and CFO, Dr. Paul Kirkitelos added, “All the latest scientific evidence in microcirculation is pointing to the need for the underlying benefits D’OXYVA is already delivering to patients on a regular basis. Our path forward is to collect additional data to support the applications we have already studied and bring it to the scientific, medical, and consumer communities for the benefit of millions of diabetics suffering from chronic wounds and amputations with a high mortality rate.” 

Circularity Healthcare’s presence at the latest 3rd Joint International Microcirculation – ESM-EVBO 2019 – Conference in Maastricht, The Netherlands was a success. “Attending this kind of event is a great way to get top professionals in the Microcirculation scientific and medical field discover Circularity’s mission, giving people opportunity to interact with our brand which definitely impacts customer acquisition rates positively. It was also a great platform to build many relationships. Such distinguished long-term relationships are especially helpful as these connections can be the first step to improving our access both to repeat and new customers in a variety of markets,” said Jennifer Boadilla-Pelaez, Circularity’s Senior Sales and Marketing Manager and Creative Director.

Maastricht City Hall dinner function

Prof. Ito Puruhito said during his presentation at the event, “I am supporting the adoption of D’OXYVA in the university and hospitals in Surabaya and across Indonesia to benefit as many of our people as possible.”

Download Prof. Puruhito’s presentation delivered at the conference and get access to additional free educational material. (Warning: images of open wounds are included.) You can watch the 15-minute video recording of the presentation by simply registering your email, name, and occupation at this link.

Advertisement banners at the event.

About Circularity Healthcare

Circularity Healthcare, LLC, headquartered in Los Angeles, California in the U.S., is an emerging world leader in proprietary circulatory health and noninvasive delivery technologies, committed to helping significantly improve lives by developing, manufacturing, and marketing medical, pharmaceutical, and consumer health products. Circularity specializes in groundbreaking noninvasive technologies for affordable and portable transdermal delivery systems, and is pursuing regulatory approvals worldwide for device usage as a treatment of disease states related to cardiovascular and microcirculatory blood flow, immunological and autonomic nervous system disorders.

 

About ESM (European Society for Microcirculation)

The European Society for Microcirculation was founded in Hamburg in 1960 following a first meeting of interested scientists in Lund, Sweden in 1959, and now has 500-600 regular members. The aims of the Society are to advance understanding of the microcirculation by bringing together clinicians and scientists from a wide range of specialists, but including physiology, vascular biology, genetics and biophysics.

Since 1980, the Society has its own journal, the Journal of Vascular Research, an international publication of growing impact, through which the worldwide scientific community is informed of the Society’s endeavors.

 

About EVBO (European Vascular Biology Organization)

EVBO was launched in 2006, after discussion between European vascular biologists who recognized that there is a need for a democratic society to provide a united focus and forum for vascular biologists in Europe, primarily by organizing conferences but also by maintaining and enhancing an interactive network of researchers; evolving from the experience of the previous European Vascular Biology Association and building on the achievements of the FP6 European Vascular Genomics Network (EVGN).

 

About Professional Education and Research Institute, Inc. (PERI)

Professional Education and Research Institute (PERI), a global clinical research organization, was established in 2005 as a premier CRO with a goal to work closely with our sponsors throughout the world to manage Phase I through IV clinical trials in the most efficient and cost effective manner possible, while maintaining the highest standards in good clinical practice and human protection.

PERI offers top-quality facilities with a staff including regulatory and pharmacovigilance specialists, clinical research coordinators, as well as specialists in statistical analysis and data management.

 

 

 

For more information, please visit http://www.circularityhealthcare.com or http://www.doxyva.com or doctors (Rx only) visit http://www.doxyvaforwound.com and send your general inquiries via the Contact Us page. For specific inquiries contact Circularity Customer Care at info@doxyva.com info@circularityhealthcare.com or by phone toll free at 1-855-5DOXYVA or at 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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Circularity Healthcare Presenting D’OXYVA Diabetic Wound Healing Microcirculation Therapy Clinical Evidence and Sponsoring the 3rd International Microcirculation Conference – ESM-EVBO 2019

It is with our great pleasure to announce that we were invited by the organizers to participate in the 3rd joint ESM-EVBO 2019 and become a sponsor.

The 2019 ESM-EVBO (European Society for Microcirculation – European Vascular Biology Organization) Conference will be held on April 15-18 and hosted at the MECC in Maastricht, The Netherlands.

The conference focuses on advancing scientific research and medicine in all areas of vascular biology/medicine. Biennially, the ESM-EVBO hosts a four-day conference, where vascular enthusiasts from biology, preclinical and clinical research groups, and opinion leaders gather to share new fundamental scientific insights and current pre-clinical advances. Its network now has over 500 members worldwide, including representation in over 30 countries.

Besides being accepted into the poster sessions, Circularity is sponsoring the international symposium on Microcirculation.

Prof. Ito Puruhito, a distinguished thoracic vascular surgeon at Airlangga University, in Surabaya, Indonesia has been conducting several successful human clinical studies with D’OXYVA at the university over the past few years, and he is presenting some of his latest clinical evidence on diabetic foot ulcer treatment with D’OXYVA on April 17, 2019: http://esm-evbo2019.org/program/lunch-symposium/.

Want to stay updated on this event and what will happen next? Register your email for free now and follow the news about groundbreaking health discoveries!

About ESM (European Society for Microcirculation)

The European Society for Microcirculation was founded in Hamburg in 1960 following a first meeting of interested scientists in Lund, Sweden in 1959, and now has 500-600 regular members. The aims of the Society are to advance understanding of the microcirculation by bringing together clinicians and scientists from a wide range of specialists, but including physiology, vascular biology, genetics and biophysics.

Since 1980, the Society has its own journal, the Journal of Vascular Research, an international publication of growing impact, through which the world wide scientific community is informed of the Society’s endeavors.

About EVBO (European Vascular Biology Organization)

EVBO was launched in 2006, after discussion between European vascular biologists who recognized that there is a need for a democratic society to provide a united focus and forum for vascular biologists in Europe, primarily by organizing conferences but also by maintaining and enhancing an interactive network of researchers; evolving from the experience of the previous European Vascular Biology Association and building on the achievements of the FP6 European Vascular Genomics Network (EVGN).

 

About Circularity Healthcare

Circularity Healthcare, LLC, headquartered in Los Angeles, California in the U.S., is an emerging world leader in proprietary circulatory health and noninvasive delivery technologies, committed to helping significantly improve lives by developing, manufacturing, and marketing medical, pharmaceutical, and consumer health products. Circularity specializes in groundbreaking noninvasive technologies for affordable and portable transdermal delivery systems, and is pursuing regulatory approvals worldwide for device usage as a treatment of disease states related to cardiovascular and microcirculatory blood flow, immunological and autonomic nervous system disorders.

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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Did you know when used in a regimen, D`OXYVA users have reported a number of health and beauty benefits?

doxyva benefits

OPTIMIZE BLOOD CIRCULATION FOR A WIDE VARIETY OF SIGNIFICANT OUTCOMES

D’OXYVA® (deoxyhemoglobin vasodilator) in various clinical trials has validated leading independent research results and demonstrated above-average results in improving a host of physiological functions at the same time.

People using D’OXYVA® have recorded significant improvements in cardiovascular activity leading to much improved physical activity. As part of a healthy lifestyle, D’OXYVA may help significantly reduce the risk of high blood pressure, hypertension, cholesterol, and diabetes in just two or three months, with an average use of 5 minutes a day and 5 times a week.

Poor circulation is a gateway for a litany of ailments: slow healing, depression, poor complexion, sores, slow metabolism, and more.

D’OXYVA significantly improves sustained oxygen-rich microcirculatory blood flow locally and throughout the body. Its patented method of fully non-invasive, painless, and harmless transdermal delivery is unique only to D’OXYVA.

When used daily, D’OXYVA users have reported a number of health and beauty benefits, including but not limited to:

  • Relief from symptoms of microvascular complications
  • Significantly increased cardiac function, physical fitness, endurance and strength, muscle size, body tone, faster recovery from sports injuries and surgical trauma
  • Improved self-esteem via promoting healthy and radiant skin, complexion, dry skin relief, and acne reduction
  • Significant reduction in downtime from other skin treatments and cosmetic procedures when used in combination, reduction in the appearance of scars, cellulite, fat, spider veins and stretch marks
  • Promoting and maintaining a healthy weight, improving general mobility, deeper, more restful sleep
  • Significant improvement of mental acuity; concentration, problem solving, multitasking, eye-hand coordination, heightened stamina, energy, and focus while managing stress
  • Improved vitals across the board during checkups with zero adverse event reports after years of regular use by people with various health, demographic, and ethnic backgrounds

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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Breaking News from the PWCS Regional Conference

Following Successful Wound Healing Pilot Study, Circularity Launches Multicenter Clinical Trials, Business Initiatives with Influential Experts Across the Region

The Philippine Wound Care Society is a non profit, non stock, SEC registered organization. It was founded on September 09, 2009 with the purpose of improving the wound management in the Philippines through education. The society which is composed of physicians from different specialty groups and allied services (wound care nurse, physical therapy) brings together professionals involved in wound care.
 
The organization held its 1st regional meeting last February 26-27, 2015 at Cebu City Philippines. InvisiDerm’s CEO, Norbert Kiss and Senior Sales and Marketing Manager, Jennifer Rose Boadilla were invited by the President of the organization, Dr. Martin Anthony A. Villa and got the chance to meet some of the most influential cardiovascular and wound care KOLs at the said event.
 
The event was professional and had overwhelming participation exceeding the initially registered numbers. The speakers and their presentations were high quality and informative showcasing the latest in technologies and approaches to wound management.
 
We are glad to announce that InvisiDerm has secured some of the most influential cardiovascular and wound care KOLs from Taiwan, Singapore, Japan, Korea, Philippines and a few other countries via strategic relationships at this Philippine Wound Care Society Regional Meeting. In addition, a protocol for a comprehensive multicenter study coupled with diagnostics for diabetic foot wound healing on hundreds of subjects at leading hospitals, and an academic level study into the biochemical properties of D’OXYVA in wound healing, and a study for erectile dysfunction in diabetics was finalized, agreed and initiated with several KOLs based on the successful pilot study conducted by Dr. Harikrishna R. Nair at Hospital Kuala Lumpur, Malaysia. The quality of life benefits for patients such as significantly improved sleeping, eating, mood and pain makes D’OXYVA a distinct winner besides being noninvasive and fast without negative side effects. Furthermore, InvisiDerm has met regional directors of several leading wound care products multinationals and their distributors for in-depth private discussions about business models and development challenges across Asia. Circularity is clearly a leader in a number of aspects if not most. Special thanks to the team at Getz Bros. Philippines for their warm hospitality.
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Benefit from D’OXYVA’s IDE status

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

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

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 CHC, Mr.Norbet 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

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.