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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 of actions 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 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

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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.”

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.

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Have you heard of Tere’s inspiring diabetic story?

“My Doctor told me I have less than a year to live if I won’t let them amputate my leg, but I didn’t let them . . . here’s how I am still alive now!”

 

When doctors initially told 60-year-old Theresa “Tere” Schaufer that she had diabetes, she went into denial for 20 years.

“I was diagnosed with diabetes 20 years ago, and only when my doctor told me that they needed to cut my leg, did I realize that my diabetes was serious,” she says.

A major contributing factor

“Doctors told me the only way to survive this fight was to amputate my leg,” Schaufer says.  

 

She acknowledges that she had lived an unhealthy lifestyle for many years. Working in a restaurant as a cashier, she did very little exercise, ate fast food and drank sodas on a regular basis.

“If the doctor tells you you’re a diabetic, don’t ignore it. You have to know why foot care is important for someone with diabetes. Don’t get to where I am. The sooner you accept things, the better it is for your health.”

Only after her doctor advised amputation did she realize the seriousness of her situation. Schaufer’s lifestyle had a hugely negative impact on controlling her diabetes

 

It was very painful!

Schaufer had puss from underneath her foot and necrotic toe. “After the doctor examined my foot, it was like decaying,” she says. “I couldn’t handle the pain. It was excruciating!” She was given less than a year to live because of her poor lifestyle.

 

I started to accept the situation.

Schaufer finally accepted her fate as a diabetic after the doctor told her that her leg would have to be amputated.

 

“I saw it coming. The pain was terrible. I could no longer handle it. At this point I was prepared; whatever came had to be.”

 

Unexpected turn of events

“I was browsing a support page I found on the web and read about a colleague’s experience with the microcirculation therapy she had tried. She noted that it had an amazing effect on her diabetic foot ulcer,” Schaufer says.

 

Right there on the support page, the woman raved, “There is this new technology you can buy online, D’OXYVA, which was voted one of the Top 10 Diabetes Care Solution Providers 2018! I didn’t have to amputate my leg because of this amazing product. In just four weeks, I can see my diabetic foot ulcer improving!”

 

“I read these words, and it gave me the hope I’d been praying for,” noted Schaufer.

She only had a month before her scheduled amputation, and without hesitation, she used the remaining days to try out D’OXYVA. She ordered the product online and closely collaborated with their in-house support.

 

“I was under D’OXYVA therapy for one month, taking it twice a day, once in the morning and once before bed as advised. It was very easy to use and non-invasive. In the first few days, I was skeptical as I wasn’t seeing any improvements, but I continued anyway and followed their suggested therapy guide,” Schaufer explains.

Thankful for D’OXYVA

When it was time for her to go back to her doctor and give her consent to amputate, her doctor was shocked to see her leg.

“What happened?” Those were the exact words my doctor asked upon seeing my leg after only a month. “Your wounds seemed to be healing from the inside,” my doctor said.

After a thorough check-up and the usual diagnostic check of my foot’s PI (perfusion index), he said the words that I never expected to hear. “We don’t need to amputate your leg anymore, but you need to continue whatever you’ve been doing for the past month.”

I then introduced him to D’OXYVA, and he was amazed by how this product had saved me.

 



Helping others

“I’m on my third month of D’OXYVA therapy, and it does amazing things for my health! I don’t think I have thanked D’OXYVA enough for this chance to live longer. I wouldn’t have the outlook on life that I have now,” Schaufer continues cheerfully. 
  

She is now also leading a healthy life. “This changed how I live my life, and I will continue sharing my experience as much as I can to help others.”

 

Schaufer often spends time with other “to-be-amputees” struggling to deal with their situation. “God gave me my situation to help others,” she maintains.

One of the ladies she counselled remarked how Schaufer had helped her tremendously. “She told me that I gave her her life back,” Schaufer says, breaking into tears.

“I’m in a way thankful for what I have been through with my diabetes because, without it, I wouldn’t have stumbled across my strength and my ability to help others.”

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Patients are transforming from passive recipients of healthcare services to active participants in their own health

This is a preview of a research report from Business Insider Intelligence, Business Insider’s premium research service. To learn more about Business Insider Intelligence, click here. Current subscribers can read the report here.

The consumerization of healthcare — a fundamental shift in patients’ preferences, behaviors, and demands around healthcare services — is threatening hospitals’ bottom lines. For the first time, patients are transforming from passive recipients of healthcare services to active participants in their own health. They’re flocking to online review sites to choose which doctor to see, skipping hospital visits in favor of a health clinic in their local CVS, and aren’t afraid to ditch providers that don’t offer them an engaging experience.

The superior customer service expectations of millennials, declines in hospital profitability, and threats from startup providers and retail pharmacies intensify the need for providers to revamp the patient experience. Providers’ current engagement capabilities are weak, and deficiencies around scheduling, appointment wait times, and billing are dragging on patient satisfaction, driving patients elsewhere and draining provider revenue.

In The Healthcare Consumerization ReportBusiness Insider Intelligence explores the trends that are driving providers to revamp their care services. We then outline how patients’ expectations for transparency, convenience, and access are transforming the way they interact with providers across each stage of care. Finally, we detail strategies health systems and hospitals can implement to create a consumer-centric patient experience that fosters satisfaction, loyalty, and patient volume.

The companies mentioned in this report are: 98point6, BayCare, Cleveland Clinic, CVS, Integris, Kaiser Permanente, Luma Health, New York-Presbyterian, One Medical, Publix, Target, Walgreens, Walmart, Yelp, and Zocdoc.

Here are some of the key takeaways from the report:

  • The consumerization of healthcare is redefining how consumers engage with providers across each stage of care.
  • But the vast majority of healthcare providers haven’t sufficiently altered their services to align with current patient expectations. Only 8% of US hospitals and health systems demonstrate strong consumer-centric performance, per a 2018 Kaufman Hall survey.
  • Failure to react to patient preferences hurts provider organizations’ bottom lines. US hospital profit margins are already thinning, and an emerging reimbursement model that ties a portion of providers’ compensation to patient satisfaction means providers can’t afford to preserve the status quo.
  • Alternative players with consumer-focused healthcare services threaten to poach patients from traditional health systems. Tech-focused primary care startups, like One Medical and 98point6, and retail outlets, like Target, Walmart, and CVS, offer patients on-demand access to healthcare providers via mobile apps and convenient locations to receive healthcare services, drawing them away from incumbent health systems.
  • In order to retain patients — and keep them from straying to alternative care services — providers must transform their services with an emphasis on transparency, access, and ongoing engagement outside of the clinic.
  • Healthcare providers that tailor their services to the new healthcare consumer will be well positioned to see growth. Alternatively, businesses that don’t implement these changes could find themselves falling behind the rest of the industry or closing their doors for good.

In full, the report:

  • Details how patient behavior, preferences, and expectations have changed.
  • Outlines the demographic and industry trends that should add a sense of urgency for providers to revamp the patient experience.
  • Summarizes how the patient experience providers currently offer isn’t conducive to loyalty and is likely driving patients to nonhospital services.
  • Explains strategies health systems and hospitals can implement to create a consumer-centric patient experience that fosters satisfaction, loyalty, and patient volume.
  • Offers examples of provider organizations that have successfully adopted new strategies to encourage patient-doctor communication, improve satisfaction, and drive scheduling capacity.

Reference: https://www.businessinsider.com/the-healthcare-consumerization-report-2018-11?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+businessinsider+%28Business+Insider%29