FDA Events for Aethlon Medical (AEMD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Aethlon Medical (AEMD).
Over the past two years, Aethlon Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Hemopurifier. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Hemopurifier - FDA Regulatory Timeline and Events
Hemopurifier is a drug developed by Aethlon Medical for the following indication: Severe COVID-19.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Hemopurifier
- Announced Date:
- June 9, 2025
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc announced that an abstract has been accepted for poster presentation at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes being held at Eldorado Hotel & Spa, Santa Fe, NM, United States, August 10-13,2025
AI Summary
Aethlon Medical, Inc. announced that an abstract on its Hemopurifier® Affinity Resin will be presented as a poster at the upcoming Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes. The event is scheduled to take place at the Eldorado Hotel & Spa in Santa Fe, NM, from August 10 to 13, 2025.
The poster reviews the device’s ability to bind extracellular vesicles in blood samples from individuals suffering from long COVID, a condition with persistent symptoms following acute COVID-19. By using a proprietary lectin-based technology that targets mannosylated markers, the Hemopurifier® aims to remove these vesicles, which may contribute to ongoing health challenges. The presentation, set for August 12, 2025, will provide insights into the potential of this innovative approach to address long COVID symptoms.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- May 14, 2025
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc. announced the publication (https://www.biorxiv.org/cgi/content/short/2025.05.09.652772v1) of a pre-clinical ex vivo study in pre-print vehicle bioRxiv, entitled, "Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical Device containing a Galanthus nivalis agglutinin (GNA) affinity resin."
AI Summary
Aethlon Medical, Inc. recently announced the publication of a pre-clinical ex vivo study on bioRxiv titled "Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical Device containing a Galanthus nivalis agglutinin (GNA) affinity resin." This study tested the Hemopurifier®, a blood filtration device that uses a proprietary GNA affinity resin to bind and remove platelet-derived extracellular vesicles (PD-EVs) from plasma. In the experiment, 200 milliliters of donated healthy human plasma was circulated through the device to simulate a clinical treatment session. The results showed that the Hemopurifier achieved a 98.5% removal of PD-EVs during a period equivalent to a four-hour treatment session. Researchers believe that the successful removal of these PD-EVs, which may contribute to conditions like cancer and other diseases, supports further investigation of the device across multiple medical indications.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- March 10, 2025
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, 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."
AI Summary
Aethlon Medical recently published a pre-clinical study in the peer-reviewed journal Transplant Immunology on February 28, 2025. The study, titled "A lectin affinity plasmapheresis device removes extracellular vesicles and microRNAs from renal perfusates following controlled oxygenated rewarming of discarded donor kidneys," focused on evaluating the Hemopurifier® in organ transplantation. Researchers demonstrated that when integrated into a machine perfusion circuit, the device significantly reduced extracellular vesicles and microRNAs in the perfusion fluid from donor kidneys. These harmful elements are believed to contribute to complications such as delayed function and rejection after kidney transplants. The promising results suggest that the Hemopurifier®, already explored for oncology and virology, may also improve the quality and function of retrieved kidneys. Further evaluation in clinical settings is planned to assess the potential benefits of this approach for enhancing organ preservation and transplant outcomes.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- December 20, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc. today provided a statement of its investigational medical device with respect to H5N1 avian influenza "Bird Flu."
AI Summary
Aethlon Medical, Inc. today issued a statement regarding its investigational Hemopurifier device and its potential application against the H5N1 avian influenza, also known as Bird Flu. The Hemopurifier is an extracorporeal device designed to remove enveloped viruses and harmful particles like extracellular vesicles from the bloodstream. In laboratory tests conducted with Battelle labs, a scaled-down version of the device removed 99% of the H5N1 virus over six hours, suggesting it could provide a new avenue for treating severe influenza cases where standard treatments sometimes fail due to antiviral resistance.
The company emphasized that while the Hemopurifier has been used safely in patients with other life-threatening illnesses such as hepatitis C, HIV, COVID-19, and Ebola, further monitoring and study will determine its effectiveness specifically for H5N1 infections.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- September 19, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc. announced that, on September 9, 2024, the Medanta Institutional Ethics Committee (MIEC) granted full ethics approval for Aethlon's safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study).
AI Summary
Aethlon Medical, Inc. announced that on September 9, 2024, it received full ethics approval from the Medanta Institutional Ethics Committee (MIEC) for its upcoming clinical trial. The study will assess the safety, feasibility, and proper dosing of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease while receiving anti-PD-1 treatments like Keytruda® (pembrolizumab) or Opdivo® (nivolumab).
The trial, approved for one year with annual reviews, aims to determine how effectively the Hemopurifier® can remove tumor-derived extracellular vesicles that are believed to contribute to resistance and metastasis during these immunotherapies. Conducted at Medanta Medicity Hospital in India, the study is an important step in exploring innovative therapeutic options for patients not responding to standard cancer treatments.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- September 16, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc. announced that the Cancer Clinical Trial Unit at Royal Adelaide Hospital was activated on September 10, 2024 to begin screening and enrolling patients in its safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study).
AI Summary
Aethlon Medical, Inc. announced that the Cancer Clinical Trial Unit at Royal Adelaide Hospital in Australia was activated on September 10, 2024. The site has begun screening and enrolling patients for a new clinical trial investigating the safety, feasibility, and proper dosing of the Hemopurifier® device. This trial focuses on patients with solid tumors who are either stable or experiencing disease progression while on anti-PD-1 monotherapy treatments such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab).
Led by Professor Michael Brown and his team, the study aims to determine if the Hemopurifier® can safely bind and remove extracellular vesicles, which are believed to promote cancer spread and resistance to treatment. By monitoring adverse events and changes in safety lab tests, the trial seeks to understand if reducing these vesicles might boost the body’s natural ability to fight tumor cells.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- September 13, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, is pleased to announce that Jim Frakes, interim CEO and CFO and Steve LaRosa, Chief Medical Officer, will present live at the Life Sciences Investor Forum, hosted by VirtualInvestorConferences.com, on September 19th 2024.
AI Summary
Aethlon Medical announced that Jim Frakes, the interim CEO and CFO, along with Steve LaRosa, the Chief Medical Officer, are set to present live at the upcoming Life Sciences Investor Forum on September 19, 2024, at 1:30 PM ET. The event will be hosted by VirtualInvestorConferences.com and will offer an interactive platform where investors can ask questions in real-time. Attendees who are unable to join the live session can later view an archived webcast, and options for one-on-one meetings will be available on September 19 and 20.
This live presentation is part of Aethlon Medical’s efforts to keep the investment community informed about its work on innovative medical therapies. The company’s participation in the forum emphasizes its commitment to transparency and active engagement with investors, making it easier for interested parties to receive updates and ask questions directly during the event.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- August 27, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc. announced the publication in preprint of an in vitro study in bioRxiv on August 24, 2024, entitled, "The Hemopurifier® Removes Extracellular Vesicles and microRNAs From Renal Perfusates Following Controlled Oxygenated Rewarming of Discarded Donor Kidneys."
AI Summary
Aethlon Medical announced the publication of an in vitro study in bioRxiv on August 24, 2024, titled “The Hemopurifier® Removes Extracellular Vesicles and microRNAs From Renal Perfusates Following Controlled Oxygenated Rewarming of Discarded Donor Kidneys.” This preprint details a proof-of-concept experiment using the Hemopurifier®, a blood filtration system designed to remove harmful exosomes and microRNAs from biological fluids.
The study involved processing perfusates from discarded donor kidneys that underwent controlled oxygenated rewarming—a type of machine perfusion. Results showed that the device successfully removed both small and larger extracellular vesicles and significantly reduced microRNA levels. These promising findings suggest that integrating the Hemopurifier® into renal perfusion circuits could improve the function of retrieved kidneys, potentially leading to fewer complications in transplant recipients. Further preclinical and clinical studies are planned to assess these potential benefits in real-world settings.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- August 12, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc. announced that, on August 6, 2024, the Bellberry Human Research Ethics Committee (BHREC) granted full ethics approval to the Pindara Private Hospital for a safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Keytruda® (pembrolizumab) or Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study).
AI Summary
Aethlon Medical, Inc. announced that on August 6, 2024, the Bellberry Human Research Ethics Committee granted full ethics approval to the Pindara Private Hospital to begin a clinical trial. This study will test the safety, feasibility, and proper dosing of the Hemopurifier® in patients with solid tumors experiencing stable or progressive disease during anti-PD-1 monotherapy treatment, such as with Keytruda® or Opdivo®.
The trial, known as AEMD-2022-06 Hemopurifier Study, will be led by Dr. Marco Matos and his team in Queensland, Australia. It aims to enroll approximately nine to 18 patients. The Hemopurifier is designed to remove harmful extracellular vesicles that may hinder treatment efficacy by assisting the body’s natural response to tumor cells. This ethics approval, valid until August 6, 2025, marks an important step towards advancing innovative cancer treatment solutions.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- June 18, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc. announced that, on June, 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for Aethlon's safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study).
AI Summary
Aethlon Medical announced that on June 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network granted full ethics approval for its clinical trial of the Hemopurifier®. This study will explore the safety, feasibility, and optimal dose of the device in cancer patients with solid tumors that are stable or progressing during anti-PD-1 monotherapy treatments, such as Keytruda® or Opdivo®. The approval, valid until June 13, 2027, marks an important milestone as the trial, led by Prof. Michael Brown at the Royal Adelaide Hospital’s Cancer Clinical Trials Unit, will assess adverse events and laboratory changes throughout the treatment process.
Researchers expect that by reducing tumor-derived extracellular vesicles with the Hemopurifier, patients might see better responses to their immunotherapy. This significant progress supports further steps, including additional regulatory submissions and study site approvals in Australia and India.
Read Announcement- Drug:
- Hemopurifier
- Announced Date:
- May 10, 2024
- Indication:
- Severe COVID-19
Announcement
Aethlon Medical, Inc announced positive results from an in vitro binding study of its Hemopurifier® in removing extracellular vesicles (EVs) from plasma.
AI Summary
Aethlon Medical, Inc recently announced positive results from an in vitro binding study of its Hemopurifier®. The study showed that the device effectively removes extracellular vesicles (EVs) from plasma. EVs play a role in cell communication and have been linked to various diseases, making their removal a promising step in treatment. These findings indicate that the Hemopurifier® may help reduce harmful particles in the blood, potentially leading to better patient outcomes in future clinical settings.
The successful in vitro binding study suggests that this technology could advance treatment options for patients. By targeting extracellular vesicles, Aethlon Medical hopes to improve the effectiveness of therapies aimed at diseases where these vesicles are a major factor. This breakthrough reflects the company’s ongoing commitment to developing innovative medical treatments, with the Hemopurifier® serving as a promising tool in the fight against complex health conditions.
Read Announcement
Aethlon Medical FDA Events - Frequently Asked Questions
As of now, Aethlon Medical (AEMD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Aethlon Medical (AEMD) has reported FDA regulatory activity for Hemopurifier.
The most recent FDA-related event for Aethlon Medical occurred on June 9, 2025, involving Hemopurifier. The update was categorized as "Abstract Presentation," with the company reporting: "Aethlon Medical, Inc announced that an abstract has been accepted for poster presentation at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes being held at Eldorado Hotel & Spa, Santa Fe, NM, United States, August 10-13,2025"
Currently, Aethlon Medical has one therapy (Hemopurifier) targeting the following condition: Severe COVID-19.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:AEMD) was last updated on 7/11/2025 by MarketBeat.com Staff
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