Circularity Healthcare Negotiating $100M Institutional Funding, Expands Successful D'OXYVA Ph 3 Diabetic Foot Ulcer Treatment Clinical Trials, Expects Fast-Track FDA

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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," stated Circularity Healthcare CEO, Norbert Kiss.

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.

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(at)doxyva(dot)com info(at)circularityhealthcare(dot)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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Jennifer Boadilla
@doxyvahealth
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