Aethlon Medical Publishes Preclinical Data on the Hemopurifier® in Transplant Immunology Journal

Rhea-AI Summary

Aethlon Medical (NASDAQ: AEMD) has published preclinical study results in Transplant Immunology demonstrating new potential applications for its Hemopurifier® blood filtration system in organ transplantation. The study, published February 28, 2025, shows the device's effectiveness in removing harmful extracellular vesicles (EVs) and microRNAs from renal perfusates of discarded donor kidneys.

The research indicates significant reductions in EVs and microRNAs linked to renal dysfunction, suggesting potential benefits for kidney transplant outcomes. This expands the Hemopurifier's therapeutic potential beyond its current applications in virology and oncology, presenting what the company calls a "pipeline within a device."

While the company's primary focus remains on Australian and India Oncology trials, these findings suggest the technology could potentially be integrated with existing organ preservation systems, though further evaluation and clinical trials would be necessary.

Positive

• Successful preclinical results showing Hemopurifier's effectiveness in removing harmful substances from kidney perfusates
• Potential expansion of product applications beyond current virology and oncology focus
• Possibility of integration with existing organ preservation technology

Negative

• Additional studies and clinical trials required before commercialization in transplantation
• Company resources primarily focused on other trials, limiting immediate development in transplantation

Insights

Biotech Analyst

Aethlon's publication in Transplant Immunology reveals an intriguing expansion of their Hemopurifier's potential applications into organ transplantation. The preclinical data shows the device can effectively remove extracellular vesicles (EVs) and specific microRNAs from kidney perfusion fluid during the controlled oxygenated rewarming process of discarded donor kidneys.

This represents significant scientific validation for what the company calls a "pipeline within a device" - demonstrating therapeutic potential beyond the existing focus areas of virology and oncology. The ability to potentially improve kidney transplant outcomes addresses a real medical need, as thousands of patients await kidney transplants with organ availability.

However, investors should note several key factors: 1) This remains preclinical research requiring substantial additional validation, 2) The company explicitly states their "funding and focus" remains on their Australian and India oncology trials, not this new application, and 3) Further development would require integration into machine perfusion circuits followed by clinical trials.

The "bolt-on" potential to existing organ preservation technology suggests a partnership approach rather than standalone development would be likely if this application advances. While scientifically promising, the commercial path would likely require significant additional resources and time before potentially reaching market.

Medical Device Expert

Aethlon's Hemopurifier demonstration in kidney perfusion represents a technically elegant expansion of the device's mechanism of action. The company has shown their lectin-based filtration approach can effectively target and remove both extracellular vesicles and microRNAs associated with kidney dysfunction from perfusion fluid.

From a device perspective, this showcases versatility in the Hemopurifier platform beyond its original design parameters. The concept of incorporating the technology into existing organ preservation systems as a "bolt-on" solution is particularly noteworthy, as it suggests potential integration with established technologies rather than requiring an entirely new preservation approach.

The kidney transplantation space presents significant unmet needs with approximately 20% of deceased donor kidneys showing delayed graft function. However, the path from this preclinical proof-of-concept to commercialization would require substantial investment in both engineering refinement and clinical validation. The company acknowledges this by noting the need for "incorporating the Hemopurifier into a machine perfusion circuit with discarded kidneys followed by a clinical trial."

Given the company's stated prioritization of oncology trials, this transplantation application likely represents a longer-term opportunity that would require either redirected internal resources or external partnerships to advance. While scientifically notable, the immediate commercial implications remain without significant additional development investment.

Preclinical Data Suggests Expanded Therapeutic Potential of the Hemopurifier® Beyond Virology and Oncology

Results Support Further Evaluation of the Hemopurifier^® as Part of a Machine Perfusion Circuit to Further Assess its Impact on the Function of Retrieved Kidneys

SAN DIEGO, March 10, 2025 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases and for use in organ transplantation, today announced the publication of a pre-clinical study in the peer-reviewed journal Transplant Immunology (https://doi.org/10.1016/j.trim.2025.102215) on February 28, 2025, entitled, " A lectin affinity plasmapheresis device removes extracellular vesicles and microRNAs from renal perfusates following controlled oxygenated rewarming of discarded donor kidneys."

Aethlon Medical's Hemopurifier^® is a therapeutic blood filtration system designed to bind and remove harmful extracellular vesicles and life-threatening viruses from blood and other biological fluids. Its capabilities have potential applications in oncology and infectious diseases, and organ transplantation.

"Kidney transplantation provides the highest quality of life for those afflicted with end stage renal disease, yet there is a shortage of organs available, and for those who do receive organs, complications may include delayed function and organ rejection," stated Steven LaRosa, MD, Senior Author of the publication and Chief Medical Officer of Aethlon Medical. "The use of machine perfusion of recovered organs as opposed to cold storage has helped but there is still room for improvement. The release of extracellular vesicles (EVs) and microRNAs from the donor kidney are hypothesized to play a role in these complications. With that in mind, we specifically examined the ability of the Hemopurifier to remove EVs and noxious microRNAs from the perfusion fluid from discarded kidneys that had undergone Controlled Oxygenated Rewarming. We demonstrated significant reductions in EVs as well as microRNAs implicated in renal dysfunction."

"While the company's funding and focus are dedicated to the Australian and India Oncology trials, the data generated from this pre-clinical study demonstrates that extracellular vesicle removal as a therapeutic target for the Hemopurifier extends beyond virology and oncology. We believe there exists a "pipeline within a device"," added James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. However, we acknowledge that further evaluation is needed, including incorporating the Hemopurifier into a machine perfusion circuit with discarded kidneys followed by a clinical trial. Our technology could be potentially "bolted on" to existing organ preservation technology.

About Aethlon and the Hemopurifier^®
Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

Additional information can be found at www.AethlonMedical.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to raise additional capital and to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility of the Hemopurifier in removing EVs and microRNAs from renal perfusates; the Company's ability to conduct its planned oncology clinical trials in Australia and India; the Company's ability to manage and successfully complete its current and future clinical trials, if initiated; the Company's ability to conduct clinical trial(s) designed to demonstrate benefits of the incorporation of the Hemopurifier^® into renal perfusion; the Company's ability to successfully manufacture the Hemopurifier in sufficient quantities for its clinical trials, and other potential risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2024, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Company Contact:
Jim Frakes
Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com

View original content:https://www.prnewswire.com/news-releases/aethlon-medical-publishes-preclinical-data-on-the-hemopurifier-in-transplant-immunology-journal-302396250.html

SOURCE Aethlon Medical, Inc.

FAQ

What were the key findings of Aethlon Medical's (AEMD) preclinical study published in February 2025?

The study showed the Hemopurifier successfully removed harmful extracellular vesicles and microRNAs from renal perfusates of discarded donor kidneys, demonstrating potential benefits for kidney transplantation.

How could AEMD's Hemopurifier technology impact kidney transplant outcomes?

The technology could potentially improve transplant outcomes by removing harmful EVs and microRNAs from perfusion fluid, which are believed to contribute to delayed function and organ rejection.

What are the current focus areas for AEMD's Hemopurifier development as of March 2025?

The company's primary focus and funding are dedicated to Australian and India Oncology trials, while exploring potential applications in organ transplantation.

What next steps are required for AEMD's Hemopurifier in kidney transplantation?

Further evaluation is needed, including incorporating the Hemopurifier into a machine perfusion circuit with discarded kidneys, followed by clinical trials.