AcelRx Pharmaceuticals, Inc.

or lead the Phamistat program. This amends a prior EUA submission to the FDA by Law Therapeutics, which received an encouraging response from the agency, but requested certain CMC information that was manufacturing related. These requests were addressed by the primary amendments to our recent EUA submission. Now it is being developed for use in the US as a novel anticoagulant for dialysis circuits. We cannot stress enough how important the availability of an alternative anticoagulant is for dialysis patients, including those undergoing continuous renal replacement therapy, or CRRT. This is because clotting of the circuit filter during CRRT can occur, resulting in major complications to the patient. Our interactions with leaders in the field of nephrology during our recent advisory board meeting reinforced the urgent medical need for an alternative anticoagulant for use during CURT. And this, combined with our recently conducted U.S. quantitative research, reaffirms the market potential for NIAID. At this point, I'd like to turn it over to Dr. Palmer to help explain the risks of not using an anticoagulant with inpatient dialysis.

Thank you, Vince. As a result of not using anticoagulants in the dialysis circuit, patients can experience a low-quality dialysis due to a clotted filter. In addition, when the clotted filter is changed, loss of red blood cells and platelets removed with the filter can often result in the patient requiring a transfusion. For these reasons, the international CRRT guidelines recommend the use of an anticoagulant infused into the dialysis circuit. But despite this, US physicians do not always use anticoagulants in patients undergoing CRRT. Our recent quantitative market research indicates 29% of patients undergoing CRRT get no anticoagulation in the dialysis circuit. So why would physicians not use an anticoagulant in some patients even though it's the internationally recommended standard of care? As we were told by many physicians, at the recent annual acute kidney injury and CRRT meeting held at the end of March in San Diego, they are stuck with, in their words, two bad options for CRRT anticoagulation, heparin and citrate, the latter of which was made available under an EUA at the start of COVID. Heparin has a relatively long half-life and recirculates back into the patient and can cause systemic bleeding, as well as other issues. Regarding citrate, it is difficult to use, requires calcium levels to be drawn every four hours, requires intensive nursing time, and our recent market research indicates physicians are concerned about its use due to its side effects, which include hypocalcemia, citrate safety, alkalosis, and other complications, including ventricular arrhythmias. Not surprisingly, when talking to one ICU physician from a major academic center who was at the recent AKI and CRRT meeting, he told us his hospital does not use any anticoagulant during CRRT at all due to the risks of both heparin citrate, even though it is against the international standard of care. Our recent study of 150 physicians specializing in CRRT showed that across the board, heparin was used in 43% of patients and citrate was used in 28% of patients, leaving 29% of patients with no anticoagulant due to the risks of the other two agents. Given the issues and fears physicians have with the two available anticoagulant options, this is not surprising and demonstrates a large unmet need for an easy to use, short half-life anticoagulants such as NIAID. We plan to submit this quantitative market research for peer-reviewed publication this quarter.

Thanks for that, Pam.