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Circularity Healthcare Announces Expansion with Global CRO of Series of Successful Pivotal Human Clinical Trials to Study Use of D’OXYVA® for Rapid, Economical and Noninvasive Home Treatment of Diabetic Foot Ulcers (DFU)

PASADENA, Calif., Feb. 1, 2021 5:31 AM PST (MORNINGSTAR)

Addressing urgent and increased DFU problem related to pandemic lockdowns.

Circularity Healthcare announced it had successfully executed a contract with the Professional Educational Research Institute (PERI) in 2020 to immediately begin a new clinical trial to study the use of D’OXYVA® to help prevent amputations and treat human diabetic foot ulcers at one-tenth the time and cost, and at least five times the efficacy of competing modalities.

A widely recognized global clinical research organization (CRO), PERI will specifically study at multiple sites at prestigious U.S. universities the use of D’OXYVA® to help address the recent epidemic of DFUs occurring in diabetic patients due to long-term pandemic quarantines and stay-at-home orders. Manufactured by Circularity, D’OXYVA® is a painless, noninvasive transdermal delivery system used in minutes to significantly improve blood perfusion, tissue oxygenation, and wound healing even where standard treatments have failed.

“D’OXYVA®‘s pivotal human clinical trial for complete healing of diabetic foot ulcers has been approved by the Western Institutional Review Board (WIRB), the largest in the world, and will include over a dozen high profile research sites at top U.S. universities and clinics,” said Senior Sales and Marketing Manager for Circularity, Jennifer Boadilla-Pelaez, RN. “Thousands of competing products in the past nearly twenty-five years have failed in achieving what D’OXYVA® has obtained in terms of regulatory approvals, clinical safety and efficacy in the past seven years. This is truly a game-changing milestone, not just for the company itself, but the entire medical community and the world and a preliminary report with meaningful results is expected within 6 months from starting the pivotal trial,” said Dr. Charles M. Zelen, PERI’s CEO.

DFUs are a major wound complication arising out of diabetes mellitus and occur in 3–13% of global diabetes patients, affecting millions of people. DFUs are caused by a variety of factors including decreased activity, diminished blood circulation, and people with underlying health conditions like diabetes are at higher risk for complications from COVID-19. Healthcare workers can expect to see far more instances of this persistent problem, especially with quarantine lockdowns, and it represents a significant health and economic risk to both patients and the overall healthcare system. Effective treatments that can reduce DFU recovery time, like D’OXYVA®, are absolutely crucial to combatting this newest wound epidemic.

About Circularity Healthcare LLC

Circularity Healthcare is an emerging world leader in proprietary circulatory health and noninvasive delivery technologies, committed to helping improve quality of life 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 currently pursuing regulatory approval worldwide as a way of treating cardiovascular and microcirculatory blood flow issues, as well as immune and autonomic nervous system disorders. Learn more at: www.CircularityHealthcare.com.

About Professional Education and Research Institute, Inc.

PERI was established in 2005 as a premier CRO to manage Phase I – IV clinical trials around the world. PERI conducts clinical trials in both pharmaceutical and orthopedic research and performs specialty research in diabetic wound care, venous leg disease, neuropathy, peripheral vascular disease and gene therapy. One of the most unique advantages of choosing PERI as a partner in clinical trial management is a feature few CRO’s can match, which is our contracted sites throughout the United States, including IBC-certified sites. Learn more at: www.periedu.com

Media Contact:
Jennifer Boadilla-Pelaez
626-240-0956

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Innovative Collaboration: The Cutting Edge of Medicine Goes “Behind The Scenes”

LOS ANGELES (PRWEB) DECEMBER 11, 2019

Circularity is partnering with Telly Award-Winning “Behind the Scenes” to provide regular, ongoing, high-quality content from leading experts in a variety of fields with an initial focus on microcirculation science, regenerative medicine, and advanced wound healing and related symptoms. The show reaches 60 million households domestically.

“Behind The Scenes with Host Laurence Fishburne” is a public television icon that has won numerous awards and delivers precision idea-telling at its best. Circularity is an innovative healthcare organization that is health-bent on their trademarked slogan: “Improving Lives by Improving Blood Flow.” Their coming together to bring forward the ideas of modern health science on a stellar entertainment platform can only make for riveting content going forward. Viewers will find themselves in a win-win situation.

Watching informative content via this stylized venue will leave viewers feeling quite satisfied with their television watching experience. It is time well spent and information precisely delivered.

A Little More About Circularity

Circularity is concerned with bringing the very best in healthcare innovation to the public. In so doing, they have manufactured a product called D’OXYVA. This product has a two-pronged approach to health. First, it can be quite effective in reducing the debilitative effects of many of the diseases that are affecting the world today, such as COPD, diabetes, and cardiovascular illnesses. Secondly, Circularity’s D’OXYVA can be used in a preventative capacity to improve microcirculation. The concept of microcirculation has far-reaching implications in neurology, oncology, endocrinology, cardiovascular health, respiratory health, dermatology, diabetic wound healing or diabetic wound care and other major fields.

Circularity Healthcare, LLC is the power behind D’OXYVA. This noninvasive trans-dermal and circulatory health technology is just the first product to be offered. Circularity is invested in revolutionizing the healthcare space. They plan to do this by creating cutting edge medical products and procedures that are both patient and physician friendly while being effective in minimizing and eradicating diseases.

What “Behind The Scenes with Host Laurence Fishburne” Will Bring to the Table

Behind The Scenes has been an innovator in bringing information to the forefront in the public television space. The award-winning series features segments on the newest technologies, as well as fresh takes on existing entities, phenomenon, and natural occurrences. The show’s website boasts that the television series “highlights the evolution of education, medicine, science, technology and industry through inspiring stories.”

Aside from the Emmy-winning and Academy Award nominated actor Lawrence Fishburne as host, the program has an award-winning creative development team. Viewers walk away with a rich knowledge of the subject. Viewers may have known about this subject their whole lives, or it may be about something completely new. Viewers learn an evolving aspect of the topic which keeps the perspective fresh.

The dawning of a new age has appeared with this collaboration. Individuals who want to know more about what the health science field is bringing into our hospitals and doctors’ offices will not be disappointed. In today’s world, it is imperative that we are advocates for our own health.

Coming Soon: Miami ReLife’s Dr. Steven Gelbard

The first series is with Dr. Steven Gelbard, a nationally-famed authority with his ReLife Miami Institute on stem cells. Dr. Gelbard presents D’OXYVA’s Nobel Prize-winning science as a regenerative medicine. Dr. Gelbard is involving his direct contacts with top NFL players and other top sports celebrities in the monthly series, along with 25—40 top neurosurgeons and other experts working under ReLife.

Imagine having the ability to receive D’OXYVA and other innovative treatments and non-invasive procedures for chronic wound care amid the luxury of a five-star hotel. Behind The Scenes guest, Dr. Gelbard, a Tufts School of Medicine educated neurosurgeon, makes it happen right now. Medicine has left the hospital building and has become the proactive choice of the health conscious. We can all look forward to learning more about how to live a healthier and more informed lifestyle from this awe-inspiring episode.

According to Norbert Kiss, President and CEO of Circularity Healthcare, this collaboration is door busting. Mr. Kiss tells us, ”[We] can offer unprecedented access to this amazing Emmy-winning show called Behind the Scenes with very competitive terms due to our strategic involvement. We welcome any expert.”

Laurence Fishburne, host of Behind The Scenes,” beckons, “Join me as we all discover the endless ways to enjoy the skills and imagination.”

Don’t miss the evolution. It’s being televised. Circularity and Behind The Scenes—Stay tuned for a mind-fortifying experience!

Circularity Values:

We, at Circularity believe in a long-sought-after goal in health care; people should have access to one health application that solves most of their short and long term health issues without compromising other aspects of their health while doing this quickly, affordably, and without pain. Circularity develops, manufactures and markets advanced technologies that significantly improve quality of life by improving some of the most essential physiological functions in the body.

About Behind The Scenes With Laurence Fishburne

Behind The Scenes is an award-winning program that highlights new stories and innovative concepts through groundbreaking short-form and long-form documentary presentation. The program, which is anchored by a veteran production team with decades of industry experience, is able to effectively communicate the most critical stories to a wide and diverse audience.

Behind The Scenes with Laurence Fishburne, has established an impressive and heralded career, amassing over one-hundred credits across the varied platforms of stage, television and film. He’s well known for major for roles in such films as; John Wick 2, Fantastic 4 Rise of the Silver Surfer, Mission Impossible III, Mystic River, Boyz n the Hood, What’s Love Got to Do With It, and Apocalypse Now. On the small screen, the award-winning and versatile actor played compelling roles in shows such as CSI: Crime Scene Investigation, CSI: Miami, CSI: New York and Hannibal. The Behind The Scenes Actor currently stars as Pops on the hit TV comedy Black-ish.

About Circularity Healthcare, LLC

Circularity Healthcare, LLC, located in Los Angeles, CA is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes and licenses its own patented and patent pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, D’OXYVA®. One of the main mechanisms underlying D’OXYVA’s science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products and with large and small clinics and hospitals in order to help them enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital and also patient financing at industry-leading terms and speed.

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World-Famous Institute in Miami Has Reopened as ReLife Miami Institute Under the New Leadership of Famed Neurosurgeon Dr. Gelbard, Funding Led by Circularity Healthcare

The World Famous Institute in Miami, which specialized in cosmetic and plastic surgery as well as anti-aging and wellness treatments and catered to such famous celebrities as Kim Kardashian, has reopened as ReLife Miami Institute under the new leadership of famed neurosurgeon Dr. Steven Gelbard. ReLife Miami Institute is a private Florida Domestic Profit Corporation located at 1441 Brickell Avenue, Sky Lobby Suite, within the 5-star Four Seasons Hotel in Miami, Florida.

Read article in PRWeb

LOS ANGELES, October 24, 2019

ReLife Miami Institute™, which offers the latest in stem cell therapy and regenerative medicine through its ReLife Stem Cell Institute℠ as well as neurosurgical, orthopedic and pain management services, is now under the leadership of Steven Gelbard, MD a physician licensed in the state of Florida and board certified by the American Board of Hospital Physicians.

Dr. Gelbard is a leading neurosurgeon who has been practicing medicine in South Florida for over 20 years. He specializes in treating disorders of the brain, including bleeding in the brain, head and spinal trauma, neurological tumors, spinal disorders, and infections of the brain.

"We conduct a 360-degree patient-centric evaluation and create a treatment plan with a dream team comprised of medical, nutritional, and wellness experts.” -Dr. Steven Gelbard, ReLife Miami Institute, CEO

“I perform a number of procedures, including microsurgery, laser surgery, lumbar laminectomy, cervical laminectomy, evaluation and treatment of injuries to the brain and spine surgery for trauma to the brain and spine, reconstructive spinal surgery … as well as many other surgical procedures. We conduct a 360-degree patient-centric evaluation and create a treatment plan with a dream team comprised of medical, nutritional, and wellness experts.” —said Dr. Gelbard.

He received his medical degree from Tufts University School of Medicine in Boston and completed a surgical internship at New York University. Dr. Gelbard then graduated from the University of Vermont Neurosurgical Residency Program. Subsequently, he received additional training in neurosurgery and neurology at Brown University and Harvard University.

Dr. Gelbard has been granted several US patents for surgical instruments and has authored many publications in medical journals, including the Journal of Neurosurgery. Since 1991, Dr. Gelbard has operated a very successful private practice in a neurosurgery surgical center.

Circularity Healthcare, LLC, provides unique and advanced products and services for both small and large medical clinics and hospitals, helping them to structure financial transactions and obtain financing at very competitive terms in collaboration with its financing partners.

“We believe people should have access to a single medical device that solves a majority of their short- and long-term health issues quickly and without pain. D’OXYVA does that and much more when combined with stem cells and many other modalities. I am honored Dr. Gelbard’s ReLife selected our company, Circularity to manage and grow the new Miami Institute with industry-leading solutions that significantly improve chances of funding at terms that are difficult to beat by other market players.” —commented Norbert Kiss, President and CEO of Circularity.

“Circularity’s mission is giving people opportunities to interact with our brand, which definitely impacts customer acquisition rates positively. We care and that shows. As a registered nurse myself, my team’s first goal is to help patients.” —Jennifer Boadilla-Pelaez, Circularity’s Senior Sales and Marketing Manager and Creative Director supporting Relife’s marketing and public relations campaigns.

About ReLife Miami Institute

ReLife Miami Institute, LLC™ offers the latest in stem cell therapy and regenerative medicine through its ReLife Stem Cell Institute℠. It continues the long and successful history of the world-famous institute in Miami, offering plastic and reconstructive surgery, cosmetic products, IV therapy, dental surgery, sexual wellness, hair restoration, hormone replacement, anti-aging treatments and wellness counseling. ReLife Miami Institute is located inside the 5-star Four Seasons Miami hotel in Miami, Florida.

About Circularity Healthcare, LLC

Circularity Healthcare, LLC, located in Los Angeles, CA is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes and licenses its own patented and patent pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, D’OXYVA®. One of the main mechanisms underlying D’OXYVA’s science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products and with large and small clinics and hospitals in order to help them enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital and also patient financing at industry-leading terms and speed.

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

Read article 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 pivotal 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.”

ito puruhito
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.
ESM-EVBO
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.