Biotech World Leader Announces Series A Fundraising on Heels of Groundbreaking COVID-19 and Phase 3 Diabetic Wound Treatment Trials

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Circularity’s ultra-purified, ultra-portable mini-medical gas solutions are poised to offset billions in healthcare costs

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This groundbreaking transdermal system and Circularity’s new FDA-approved pharmaceutical-grade mini (14.5g) cartridges are expected to play a crucial role in the fight against COVID-19 for treating oxygen-starved, at-risk patients with underlying medical conditions.

An emerging biotech leader with operations in more than three dozen countries, Circularity Healthcare has announced its Series A fundraising campaign to raise growth capital as it prepares for its impending initial public offering. Poised to become a leader in proprietary circulatory health and noninvasive drug delivery technologies, the company has built a global infrastructure with impressive strategic partners in preparation for ramped-up manufacturing and marketing of its patented and patent-pending D’OXYVA® noninvasive rapid drug delivery devices, and D’OXYVA®-branded mini, single-use medical gas (gasotransmitter) cartridges.

This groundbreaking transdermal system (which in human studies has been shown to significantly improve oxygen-rich blood flow) and Circularity’s new FDA-approved pharmaceutical-grade mini (14.5g) cartridges are expected to play a crucial role in the fight against COVID-19 for treating oxygen-starved, at-risk patients with underlying medical conditions. The D’OXYVA®-branded cartridges, the world’s first mini carbon dioxide cartridges approved by the U.S. FDA (and manufactured at the world’s largest specialty pharmaceutical gas producer’s FDA-audited factory in Pennsylvania), will be sold to doctors, clinics, and hospitals nationwide to treat a wide variety of conditions that can benefit from cellular and tissue oxygen therapy.

The fundraising campaign comes on the heels of Circularity’s expanded multi-year, multi-country, multi-site, Phase 3 human clinical trials led by David G. Armstrong, professor of clinical surgery at the University of Southern California’s Keck School of Medicine, and newly launched COVID-19 clinical trials led by H. Geoffrey Watson, M.D., of Oakland, California. The COVID-19 trial will focus on treating the most at-risk COVID-19 patients, 90 percent of whom suffer from low blood oxygen levels resulting from underlying conditions like diabetes, hypertension, blood pressure, cardiovascular complications, sepsis, and septic shock.

A big part of the science behind D’OXYVA® are the 2019 Nobel Prize in Physiology or Medicine-winning findings that showed how oxygen levels affect cellular metabolism and physiological function, paving the way for oxygen to be used as a promising new method to fight many diseases, including various types of cancer.

Circularity estimates that the total cost of the yearly treatments for the most critical and vulnerable millions of COVID-19 patients will amount to roughly $70 billion, and that more than 90 percent of deaths can be avoided. The company is also expected to capture a share of the COVID-19 vaccine market with its ability to deliver vaccines painlessly without needles (using its D’OXYVA transdermal delivery system) and with likely much higher efficacy. This is especially ideal for patients who are averse to needles.

Circularity is also nearing updated FDA approval because of its expanded Phase 3 diabetic foot ulcer human clinical trial. The trial has already produced promising evidence to support the safety, tolerability, and efficacy of Circularity’s patented D’OXYVA® device and pharmaceutical-grade carbon dioxide as an adjunctive treatment in speeding up the healing of diabetic foot ulcer wounds. The device uses medical-grade carbon dioxide delivered painlessly and gently through skin pores to significantly increase the oxygen-rich blood flow necessary for vital organs to function well.

“We are well-positioned right now for exceptional, immediate, and long-term growth,” says Circularity Healthcare president and CEO Norbert Kiss. “We have strategic partnerships with a combined market capitalization of over $100 billion to support our massive growth trajectory.”

“Unlike many companies in our current challenging economic climate, we have minimal debt on our balance sheets, significantly improved asset valuation, a rapidly growing customer base, and an established, large supply chain virtually all inside the United States, propelled by massive demands for many years to come, with an estimated current inventory retail value of millions of dollars,” says Norbert .

The growing demand for home healthcare and point-of-care options is expected to trigger a rise in demand for packaged medical-grade gases and equipment. The global medical gas market was valued at $7.5 billion in 2016 and is expected to witness a CAGR of 9 percent during the forecast period until the year 2024.

Due to growing concerns about aging, obesity, and diabetes, Research and Markets in December 2017 estimated that the global market for chronic wound care equipment would grow from $18 billion in 2017 to $22 billion by 2022. The United States accounts for 35-40 percent of the global market and is expected to grow at 7 percent CAGR. In contrast, D’OXYVA’s mass-market adoption will offset billions of unwanted healthcare expenditure, considering that a single diabetic foot ulcer standard of care in the United States annually costs about $30,000 in indirect and direct costs on average per person.

Eighty percent of cases still result in amputations, and 80 percent of amputees die within three years of amputation. This is the potential future for about 10 million people if D’OXYVA treatment is not adopted. Circularity’s Phase 3 human diabetic foot ulcer clinical trial centers on healing diabetic foot ulcers at one-tenth of the time and cost of competing modalities, while achieving zero reports of adverse side effects after eight years.

“We can produce devices for 100 million households and cartridges in various sizes for over 300 million people within 18 months with our dedicated production lines,” says Kiss. “Furthermore, Circularity is exploring the opportunity to work with the U.S. government to make the initial millions of applications widely available and affordable to those who need it most. This could generate roughly $50 billion in sales revenue from devices and $70 billion in sales of our drugs.”

The company’s clinical trials are led by some of the most respected medical professionals at top universities in the country, including the University of Southern California, Harvard University, Northwestern University, and Drexel University College of Medicine. Additionally, Circularity is represented by the leading FDA team at K&L Gates LLP (Circularity’s main global, corporate, regulatory, and IP law firm since its inception) and works closely with regulatory teams from the world’s largest specialty pharmaceutical gas producers.

D’OXYVA® is currently available for use in hospitals and at home (over the counter) through its Investigational Device Exemption status under FDA regulations. The company has seen impressive growth volumes over the past two months, with pending orders from some of the largest hospitals and healthcare networks around the world for its regulated D’OXYVA®-branded products, and an 86 percent repeat customer rate for orders of its over-the-counter products.

“This is in line with our original scheduled launch of our comprehensive PR, sales, and marketing campaigns, combined with the anticipated release of our clinical evidence,” says Joel Ellis, national VP of sales. “We have been aggressively expanding sales operations by continually hiring new sales representatives in virtually all areas of our business.”

Along with adding to its sales team, Circularity is launching half a dozen new clinics with leading doctors this week, with plans to multiply those new clinics to expand to hundreds of locations nationwide within the coming months.

The Series A fundraising is open to venture capitalists, private equity investors, qualified institutional buyers, angel investors, and angel investor groups. Potential investors can contact the company directly at (626) 817-6698. For more information on the clinical trials, please visit - https://doxyva.com/covid-19/.

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.

About Circularity Healthcare, LLC
Headquartered in Pasadena, California, Circularity Healthcare is an emerging biotech leader around the world in proprietary circulatory health and noninvasive skin delivery technologies. Since 2011, the company has been committed to radically changing the standard of care and improving lives by developing, manufacturing, and marketing affordable medical devices and pharmaceutical products to promote consumer health and wellness. For more information, please visit https://doxyva.com.

About Norbert Kiss
CEO and Co-Founder Norbert Kiss leads the Circularity Healthcare team, and spearheaded the development of the company’s technology and business platforms. Norbert has nearly a quarter of a century of executive and entrepreneurial experience, both domestically and in more than 60 countries involving startups; think and do tanks; and large brands in technology, intellectual property, regulatory affairs, and sales and marketing. He has been involved in the transdermal and cardiovascular space for more than a decade.

Connect with D’OXYVA on Social Media:
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For media inquiries (including interview requests with leading medical experts), please contact:
Jennifer Boadila-Palaez
Jennifer.Boadilla@doxyva.com
(626) 244-8090

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