The trial will involve the use of Circularity's already FDA-approved drug and IDE device D'OXYVA (deoxyhemoglobin vasodilator) - a non-toxic, non-invasive microcirculation transdermal device
“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 diseases D’OXYVA improves like no other medication currently available on the market.”
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 Phase 3 trial with Professor David G. Armstrong and his colleagues.
- 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 a 1-2 week 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 U.S.-based 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, CO2 therapy 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.
Source: Company Press Release