A new clinical trial is being announced today that could significantly increase the rate of recovery for COVID-19 patients with underlying health conditions and save lives! Circularity Healthcare’s trial will help some of the most at-risk patients suffering from complications due to diabetes, poor circulation, hypertension, cardiovascular disease and high blood pressure. The trial will involve the use of Circularity’s already FDA-approved drug and IDE device D’OXYVA® (deoxyhemoglobin vasodilator) – a non-invasive transdermal device. It is the first biotech solution of its kind to improve overall oxygen-rich blood flow. The device has been shown to significantly heal diabetic wounds, reduce the risks of amputations, prevent sepsis and septic shock, improve blood pressure and general vital organ function of the pancreas, liver, brain and kidneys, while increasing overall health for some of the most vulnerable patients.
“Anyone who suffers from an underlying condition should know that this proven treatment option is available,” says Circularity Healthcare CEO Norbert Kiss. “Every medical report released so far shows that severe COVID-19 patients need blood oxygenation and blood thinners. The overwhelming majority of patients have diabetes and cardiovascular issues beyond pulmonary complications and they all have sepsis setting in early on. These are the exact main vitals and chronic conditions D’OXYVA targets with an exceptionally positive efficacy and safety profile.”
The recommendation for this new treatment is based on the following:
- After eight years of three dozen human studies with leading experts at some of the most prestigious universities and hospitals in the world (including Penn State and Airlangga University), zero adverse effects were reported. D’OXYVA is currently expanding its pivotal human trials to over a dozen sites at top U.S. universities.
- The pharmaceutical-grade CO2 utilized by the D’OXYVA device has already been approved by the FDA (it is the same CO2 drug already readily available in every hospital and provided by the same supplier). There is just an IRB approval to launch the trials at any location due to the investigational device exemption (IDE) status of D’OXYVA. Additionally, with the device factory in Fremont, CA, all the regulated products are also readily-available to launch the trial.
- The effects of transdermal CO2 have been widely noted in wound care as demonstrated in clinical studies. Healing, closure, prevention against sepsis and septic shock and recovery of an ulcer (non-healing) due to diabetes and cardiovascular complications are much faster and often successful where other modalities have failed.
- All research projects performed up to date have consistently recorded a significant decrease in systolic blood pressure (from the heart) and diastolic (return to the heart) blood pressure. These results have been consistent throughout all study time periods up to 240 minutes (the longest time period evaluated after treatment).
- Systemically, utilizing ultra-purified CO2 has shown great success to improve the healthcare of patients with high blood pressure, general vital organ function of patients with high blood pressure, and general vital organ function like that of the pancreas, liver, brain, and kidneys.
The clinical trials are now waiting IRB approvals and are about to launch under existing contracts at multiple sites including top U.S. universities such as Harvard, Yale, M.I.T, USC, and UCLA, with more physicians and patients being invited to participate. Since the product can be monitored at home, potential patients do not have to be currently admitted to a hospital in order to take part in the trial. For more information on the trial or to sign up, please visit https://doxyva.com/covid-19/ or call 626.240.0956.
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 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 in large and small clinics and hospitals to help 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 patient financing at industry-leading terms and speed.
For more information, please visit http://www.circularityhealthcare.com or https://doxyva.com; doctors (Rx only) visit http://wound.doxyva.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 1-626-240-0956.
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.