AEMD: Focusing on Oncology, Infectious Disease & Organ Transplants Initially
By M. Marin
NASDAQ:AEMD
READ THE FULL AEMD RESEARCH REPORT
R&D spending expected to go further by conducting current clinical efforts in Australia & India
Aethlon Medical (NASDAQ:AEMD) is studying its lead product, the Hemopurifier®, in oncology, infectious disease and, reflecting a recent initiative, to determine the device’s ability to improve the outcomes of organ transplantation. AEMD is launching a blanket oncology study in Australia and studying the Hemopurifier to treat severe COVID-19 in India, where it is also considering adding an oncology trial. In addition, AEMD has formed a research collaboration with 34 Lives, a PBC focused on improving the kidney transplant process.
The company’s goal is to maximize its R&D spending to advance the Hemopurifier. By recently shifting its clinical efforts to Australia and India for now, Aethlon expects to make its R&D dollars go further. The Australian government provides attractive economic incentives for clinical development efforts and clinical costs in India are substantially lower than in the U.S., according to management. AEMD currently is processing the paperwork for submission to Australia’s rebate program, which enables companies to receive a tax rebate of up to 43.5% on clinical trial related R&D costs and is expected to help it reduce costs, lower risk, and accelerate time to market. AEMD believes its recent initiatives can boost the company’s potential to receive regulatory approval and funding to advance clinical research and accelerate time to market.
Organ transplant initiative: potentially helping to increase the availability of viable organs
The company also recently announced an initiative to determine the Hemopurifier’s ability to improve the outcomes of organ transplantation in addition to its existing cancer and COVID-19 studies. Aethlon will investigate the Hemopurifier’s ability to remove viruses and exosomes from harvested organs to increase the number of organs that can be transplanted successfully.
The company will study whether the Hemopurifier can remove viruses and exosomes from harvested organs when it is incorporated into a machine perfusion organ preservation circuit. In vitro studies using a scaled-down version of the Hemopurifier demonstrated the removal of multiple viruses and exosomes from buffer solutions. The company believes that if the Hemopurifier can remove these substances from the organs, the device could lower the risk of complications following transplantation, including potentially viral infection, delayed graft function and organ rejection. The objective is to position the Hemopurifier as an additive way to increase the supply of viable organs available to be transplanted.
Incorporating device into existing organ preservation circuit will not extend preservation timeline…
The initial focused will be on kidneys and studies will be conducted through a research collaboration with 34 Lives, a PBC (public benefit company) that is focused on improving the kidney transplant process. The process potentially could reduce complications such as viral infection, delayed graft function and even rejection following transplant surgery. Because the Hemopurifier will be incorporated into the existing machine perfusion organ preservation circuit, it will not extend the organ preservation timeline, which is critical given that organs have a short window during which they remain viable for transplantation.
…which is critical given the short window during which organs remain viable for transplantation
Currently, the global transplantation market is in the multiple billions of dollars and is expected to grow substantially, driven by the aging of the population, higher rates of organ failure as people age and improvements in organ preservation and transplant procedures, among other factors. The NIH notes that kidneys are the most commonly transplanted organ. “In 2022, approximately 115,000 patients in the US were awaiting organ transplants. Of these, 96,000 [which equates to over 80%] were waiting for a kidney,” according to 34 Lives. Moreover, 34 Lives also notes that “In 2022, over 7,800 kidneys were recovered with the intent to be transplanted but were unused.” Reducing the number of unused organs could potentially lead to significant improvements in outcomes for patients waiting for organ transplant, in our view. AEMD is optimistic that the Hemopurifier can help increase the number of kidneys that are viable for transplant.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
