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Aethlon Medical(AEMD) - 2025 Q4 - Annual Results
2025-06-27 17:04
[Key Fiscal 2025 Highlights](index=1&type=section&id=Key%20Fiscal%202025%20Highlights) Aethlon Medical achieved significant milestones in FY2025, including advancing its Hemopurifier® cancer trials and reducing operating expenses - Treated the first three patients in the Hemopurifier® cancer trial at Australian sites[7](index=7&type=chunk) - Received Indian regulatory approval for a similar oncology study[7](index=7&type=chunk) - Expanded the study protocol to align with current immunotherapy standards[7](index=7&type=chunk) - Demonstrated **98.5%** removal of platelet-derived EVs in a preclinical simulated treatment[7](index=7&type=chunk) - Collaborated with UCSF on Long COVID research, with findings to be presented at the Keystone Symposium[7](index=7&type=chunk) - Significantly reduced operating expenses through streamlined operations[7](index=7&type=chunk) [Clinical and R&D Updates](index=1&type=section&id=Clinical%20and%20R%26D%20Updates) Aethlon advanced its Hemopurifier® clinical trials in Australia and India, with preclinical data supporting broader applications including Long COVID [Clinical Progress in Cancer Trial](index=1&type=section&id=Clinical%20Progress%20in%20Cancer%20Trial) - The first three participants in the safety, feasibility, and dose-finding study for solid tumors have been treated with the Hemopurifier® in Australia, completing the 4-hour treatment without immediate complications[5](index=5&type=chunk) - This milestone triggers a Data Safety Monitoring Board (DSMB) review to assess safety and recommend advancing to the second cohort, where patients will receive two Hemopurifier treatments in one week[6](index=6&type=chunk) - The primary endpoint of the 9-18 patient study is safety, with exploratory analyses evaluating the impact on EV concentrations and the body's anti-tumor response to guide future trials[10](index=10&type=chunk)[11](index=11&type=chunk) - The trial protocol was amended to include patients receiving combination therapies with Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®), reflecting current standards of care[8](index=8&type=chunk) [Regulatory Approval in India](index=2&type=section&id=Regulatory%20Approval%20India) - On June 19, 2025, Aethlon received formal approval from India's Central Drugs Standard Control Organization (CDSCO) to initiate a similar oncology trial[12](index=12&type=chunk) - The trial will be conducted at Medanta Medicity Hospital and will commence after a Site Initiation Visit (SIV)[12](index=12&type=chunk) [Preclinical Study and Broader Applications](index=2&type=section&id=Preclinical%20Study%20Supports%20Broader%20Applications) - A preclinical ex vivo study demonstrated that the Hemopurifier® removed **98.5%** of platelet-derived extracellular vesicles (PD-EVs) from human plasma[13](index=13&type=chunk) - These results suggest potential applications for the Hemopurifier® in other EV-associated diseases, including cancer, lupus, multiple sclerosis, Alzheimer's, sepsis, and Long COVID[13](index=13&type=chunk) [Scientific Collaboration in Long COVID Research](index=3&type=section&id=Scientific%20Collaboration%20in%20Long%20COVID%20Research) - Aethlon's collaborative research with the UCSF Long COVID Clinic was accepted for a poster presentation at the Keystone Symposium on Long COVID (August 10-13, 2025)[15](index=15&type=chunk) - The study analyzed the binding of extracellular vesicles from Long COVID patients to the Hemopurifier's resin, supporting further investigation into this unmet medical need affecting millions in the U.S[15](index=15&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) Aethlon significantly reduced operating expenses by **26%** to **$9.3 million** in FY2025, ending with **$5.5 million** cash, despite an increased net loss of **$13.4 million** due to a non-cash charge [Fiscal 2025 Financial Summary](index=3&type=section&id=Fiscal%202025%20Financial%20Summary) | Metric | FY 2025 | FY 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $5.5 million | $5.4 million | +$0.1M | | Consolidated operating expenses | $9.3 million | $12.6 million | -$3.3M (-26%) | | Operating loss | ($9.3 million) | ($12.6 million) | +$3.3M | | Net loss | ($13.4 million) | ($12.2 million) | -$1.2M | [Detailed Operating Expense Analysis](index=3&type=section&id=Detailed%20Operating%20Expense%20Analysis) - Total operating expenses decreased by approximately **$3.3 million (26%)** year-over-year, from **$12.6 million** to **$9.3 million**[18](index=18&type=chunk) - **Payroll and related expenses** declined by **$1.3 million** due to executive terminations and workforce reductions[19](index=19&type=chunk) - **Professional fees** decreased by **$1.3 million**, driven by savings in legal, contract manufacturing, and consulting costs[20](index=20&type=chunk) - **General and administrative expenses** fell by **$660,000** due to lower raw material, lab supply, and insurance costs, partially offset by a **$467,000** increase in clinical trial expenses for the Australian study[21](index=21&type=chunk) [Other Income and Expense](index=4&type=section&id=Other%20Income%20%28Expense%29) - A non-cash charge of approximately **$4.6 million** was recorded related to a warrant inducement offer in March 2025, which did not impact operating cash flows[23](index=23&type=chunk) - The company recognized approximately **$324,450** in other income from the Employee Retention Tax Credit (ERTC) under the CARES Act[24](index=24&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Aethlon's FY2025 financial statements show total assets of **$7.4 million**, total liabilities of **$2.2 million**, and a net loss of **$13.4 million** or **($8.58)** per share [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | (in thousands) | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $5,501 | $5,442 | | TOTAL CURRENT ASSETS | $5,950 | $6,226 | | TOTAL ASSETS | $7,360 | $8,246 | | **LIABILITIES & EQUITY** | | | | TOTAL CURRENT LIABILITIES | $1,899 | $1,830 | | TOTAL LIABILITIES | $2,236 | $2,480 | | TOTAL STOCKHOLDERS' EQUITY | $5,124 | $5,766 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $7,360 | $8,246 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | (in thousands) | Fiscal Year Ended 3/31/25 | Fiscal Year Ended 3/31/24 | | :--- | :--- | :--- | | Total operating expenses | $9,341 | $12,637 | | **OPERATING LOSS** | **($9,341)** | **($12,637)** | | Total other expense (income) | $4,047 | ($428) | | **NET LOSS** | **($13,388)** | **($12,208)** | | Basic and diluted net loss per share | ($8.58) | ($38.87) | | Weighted average shares outstanding | 1,561 | 314 | [Corporate Information and Forward-Looking Statements](index=4&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) Aethlon Medical, developer of the FDA Breakthrough Device Hemopurifier®, provided corporate updates and cautioned on forward-looking statements subject to inherent risks [About Aethlon and the Hemopurifier®](index=5&type=section&id=About%20Aethlon%20and%20the%20Hemopurifier%C2%AE) - Aethlon Medical is focused on developing the Hemopurifier®, a clinical-stage immunotherapeutic device designed to combat cancer, life-threatening viral infections, and be used in organ transplantation[29](index=29&type=chunk) - The Hemopurifier® holds two FDA Breakthrough Device designations: one for advanced or metastatic cancer and another for life-threatening viruses not addressed by approved therapies[29](index=29&type=chunk) [Conference Call Information](index=4&type=section&id=Conference%20Call) - Management hosted a conference call on June 26, 2025, at 4:30 p.m. ET to review financial results and corporate developments[26](index=26&type=chunk) - A replay of the call is available through July 26, 2025, with replay ID number **4903201**[28](index=28&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) - This press release contains forward-looking statements that involve risks and uncertainties, where actual results may differ materially from expectations[31](index=31&type=chunk) - Key risks include the ability to raise capital, successfully complete clinical trials, obtain regulatory approvals, and manage manufacturing and research collaborations[31](index=31&type=chunk)
Aethlon Medical(AEMD) - 2025 Q4 - Earnings Call Transcript
2025-06-26 21:32
Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17][18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22][24] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15][16] - Future exploration of the Hemopurifier's applications beyond oncology is being considered, particularly in conditions like lupus and Alzheimer's disease [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical trials and the potential for future partnerships based on safety data [62] - The company anticipates needing to raise additional funds until it can secure government grants or partnerships with larger companies [61] - Management does not expect further nonrecurring expenses related to terminated executives [32][33] Other Important Information - The company has published results of a preclinical study showing a 98.5% removal of platelet-derived extracellular vesicles during Hemopurifier treatments [13] - The next earnings call is scheduled for August 2025, coinciding with the filing of the quarterly report [19] Q&A Session Summary Question: What are the focus areas for the company? - The primary focus remains on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are nonrecurring expenses finished? - Management does not anticipate further nonrecurring expenses following the termination of three senior executives [32][33] Question: Will patient recruitment in India be faster than in Australia? - There is potential for faster recruitment in India due to the larger population and the hospital's capabilities [70][72] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [78][80]
Aethlon Medical(AEMD) - 2025 Q4 - Earnings Call Transcript
2025-06-26 21:30
Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17] - The company recorded approximately $324,000 in other income related to the employee retention tax credit under the CARES Act [18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15] - Future exploration of the Hemopurifier in addressing long COVID is being considered, but oncology remains the main priority [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical and laboratory settings, noting it as the most significant advancement since joining the company [16] - The company is preparing for potential partnerships and government grants to support ongoing research and development [57] Other Important Information - The company plans to file its annual report on Form 10-K following the call and will hold its next earnings call in August 2025 [19] Q&A Session Summary Question: What are the focus areas for the company? - The focus remains primarily on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for delivering more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are there any nonrecurring costs expected in the future? - Management does not anticipate additional nonrecurring expenses following the termination of senior executives [32][33] Question: How quickly can patient recruitment be expected in India? - Recruitment in India may proceed faster than one patient per month, depending on oncologists' comfort levels [66][68] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [72][74] Question: What is the current expense run rate? - The company is operating at a level that is necessary to continue operations, with potential increases in expenses as clinical activities ramp up [76][78]
Aethlon Medical(AEMD) - 2025 Q4 - Annual Report
2025-06-26 21:10
Financial Performance - The consolidated operating expenses for the fiscal year ended March 31, 2025, were $9,341,364, a decrease of $3,295,203 from $12,636,568 in the prior year[300]. - Payroll and related expenses decreased by $1,332,359, driven by a reduction in salaries and related expenses and stock-based compensation[301]. - Professional fees decreased by $1,302,834, primarily due to a reduction in legal fees and the termination of services with a contract manufacturing organization[302]. - General and administrative expenses decreased by $660,010, with significant reductions in raw material purchases and laboratory supplies[303]. - The operating loss decreased to $9,341,364 for the fiscal year ended March 31, 2025, from $12,636,568 in the prior year[304]. - Other expense included a non-cash charge of $4,612,862 related to a warrant inducement offer[305]. - The company recognized $324,450 in other income related to the Employee Retention Tax Credit during the fiscal year ended March 31, 2025[306]. Cash and Capital Management - As of March 31, 2025, the company had a cash balance of $5,501,261 and working capital of $4,050,514, compared to $5,441,978 and $4,395,889, respectively, at March 31, 2024[307]. - The company raised capital through a warrant inducement offer and a public offering during the fiscal year ended March 31, 2025[309]. - The company raised aggregate net proceeds of $7,746,311 during the fiscal year ended March 31, 2025, after deducting $405,002 in commissions and legal expenses[310]. - The company raised approximately $3,540,000 from the issuance of common stock and approximately $2,316,000 from the exercise of warrants under induced terms in the fiscal year ended March 31, 2025[335]. - Net cash used in operating activities was approximately $7,646,000 in fiscal 2025, a decrease of approximately $2,484,000 compared to $10,130,000 in fiscal 2024[332]. - The company intends to use the net proceeds from the warrant exercise for working capital and general corporate purposes[312]. - The company generated approximately $7,727,000 from financing activities in the fiscal year ended March 31, 2025, compared to $1,288,000 in the previous fiscal year[334]. - The company may face challenges in accessing additional capital due to potential worsening global economic conditions and market volatility[330]. Clinical Trials and Product Development - The Hemopurifier has demonstrated a 98.5% removal of platelet-derived extracellular vesicles in a pre-clinical study, supporting its ongoing clinical trials[293]. - The company expects clinical trial expenses for planned oncology trials to increase for the foreseeable future, along with rent payments for headquarters and manufacturing facilities[325]. - The company anticipates continuing to incur increasing negative cash flows and net losses for the foreseeable future, necessitating additional capital raises[326]. - A second patient was treated with the Hemopurifier at GenesisCare North Shore Hospital in Sydney, Australia, with the procedure lasting 4 hours[346]. Stock and Compensation - The Company granted 4,112 RSUs to each of the four non-employee directors in April 2024, with each RSU priced at $12.16 per share[343]. - In April 2025, the Company granted 17,858 RSUs to each of the four non-employee directors, with each RSU priced at $2.80 per share[347]. - A reverse stock split of 1-for-8 was approved, effective June 6, 2023, combining every 8 shares of common stock into one share[345]. - The Company's authorized common stock remained at 60,000,000 shares following the reverse stock split[345]. - As of March 31, 2025, there were no vested RSUs outstanding[344]. - The RSUs granted in April 2024 are subject to vesting in four equal installments, with 25% vesting on June 30, September 30, December 31, 2024, and March 31, 2025[343]. - The RSUs granted in April 2025 are also subject to vesting in four equal installments, with 25% vesting on June 30, September 30, December 31, 2025, and March 31, 2026[347]. - The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs for current non-employee directors at the beginning of each fiscal year[343]. - Newly elected non-employee directors receive stock options or $75,000 worth of RSUs upon election[343].
Aethlon Medical Announces Financial Results for the Fiscal Fourth Quarter Ended March 31, 2025, and Provides Corporate Update
Prnewswire· 2025-06-26 20:15
Core Insights - Aethlon Medical, Inc. has made significant progress in its Hemopurifier® cancer trial, having treated three patients and received regulatory approval in India for a similar study [1][9][11] - The company has successfully reduced operating expenses by approximately 26% year-over-year, positioning itself for sustained focus on clinical and regulatory goals [14][16] - Preliminary data from the ongoing trials is expected to provide insights into the efficacy of the Hemopurifier in treating solid tumors and potentially Long COVID [4][10][13] Clinical Progress in Cancer Trial - The first three participants in the Hemopurifier trial completed treatment without complications, and safety follow-ups have been conducted [3][4] - An independent Data Safety Monitoring Board (DSMB) will review safety data and recommend advancement to the next treatment cohort [4] - The trial protocol has been amended to include patients receiving combination therapies with Pembrolizumab or Nivolumab, reflecting current treatment practices [5][6] Regulatory Approval India - Aethlon received approval from India's CDSCO to initiate a similar trial at Medanta Medicity Hospital, following necessary ethical clearances [9] Preclinical Study Supports Broader Applications - A preclinical study demonstrated that the Hemopurifier can remove 98.5% of platelet-derived extracellular vesicles (PD-EVs) from human plasma, indicating potential applications in various diseases [10][11] Scientific Collaboration in Long COVID Research - Aethlon is collaborating with UCSF to investigate the Hemopurifier's potential in treating Long COVID, with findings to be presented at an upcoming symposium [13] Operational Achievements - The company streamlined operations, resulting in a significant reduction in operating expenses, which decreased from approximately $12.6 million in fiscal 2024 to $9.3 million in fiscal 2025 [16][20] Financial Results for the Fiscal Fourth Quarter Ended March 31, 2025 - As of March 31, 2025, Aethlon had a cash balance of approximately $5.5 million [15] - The operating loss for the fiscal year ended March 31, 2025, was $9.3 million, down from $12.6 million the previous year [20][32]
Aethlon Medical to Release Fiscal Fourth Quarter Financial Results and Host Conference Call on June 26, 2025
Prnewswire· 2025-06-20 12:01
Core Viewpoint - Aethlon Medical, Inc. is set to release its financial results for the fiscal fourth quarter ended March 31, 2025, on June 26, 2025, at 4:15 p.m. ET [1] Financial Results Announcement - The financial results will be followed by a conference call hosted by management on June 26, 2025, at 4:30 p.m. ET to discuss the results and recent corporate developments [2] - Interested parties can register for the conference call online, and registered participants will receive their dial-in number upon registration [2] Conference Call Details - For those without internet access, a toll-free participant dial-in number is available at 1-844-836-8741, with an international dial-in option at 1-412-317-5442 [3] - A replay of the call will be accessible approximately one hour after the call ends and will be available until July 26, 2025 [4] Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an immunotherapeutic device aimed at treating cancer and life-threatening viral infections [5] - The Hemopurifier has shown promise in human studies for removing life-threatening viruses and harmful exosomes, which may contribute to immune suppression and cancer metastasis [5] - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses not addressed by approved therapies [5]
Aethlon Medical Treats Second Patient in Australian Hemopurifier® Cancer Trial
Prnewswire· 2025-06-18 12:01
Core Insights - Aethlon Medical has achieved a significant milestone by treating the second patient with the Hemopurifier in its clinical trial for solid tumors not responding to anti-PD-1 antibodies [1][2] - The trial aims to assess the safety and feasibility of the Hemopurifier, with the first cohort consisting of approximately 18 patients [6] - The Hemopurifier is designed to remove tumor-derived extracellular vesicles (EVs) from the bloodstream, potentially improving responses to anti-PD-1 therapies [5][7] Group 1: Clinical Trial Progress - The second patient was treated on June 11, 2025, at the Royal North Shore Hospital/University of Sydney, following the first patient treated on January 29, 2025 [1][2] - Both patients completed the 4-hour Hemopurifier treatment without device deficiencies or immediate complications, and have finished the 7-day safety follow-up period [2][4] - The Data Safety Monitoring Board (DSMB) will review the safety data after the third patient is enrolled, which is expected to occur soon [3][4] Group 2: Device and Mechanism - The Hemopurifier is an investigational device that utilizes plasma separation and affinity binding to remove enveloped viruses and EVs from circulation [7][8] - Preclinical studies indicate that the Hemopurifier can reduce the number of exosomes in cancer patient plasma, which may enhance the effectiveness of anti-PD-1 therapies [5][6] - The device holds FDA Breakthrough Device designation for treating advanced or metastatic cancer patients who are unresponsive to standard therapies [8] Group 3: Future Directions - The primary endpoint of the trial is to monitor adverse events and significant changes in safety lab tests among treated patients [6] - The study will also explore the number of Hemopurifier treatments required to decrease EV concentrations and whether this improves the immune response against tumor cells [6] - Data on the effects of the Hemopurifier on anti-tumor T cell activity is anticipated approximately three months after the enrollment of the third patient [3]
Aethlon Medical (AEMD) Conference Transcript
2025-06-17 20:40
Aethlon Medical (AEMD) Conference Summary Company Overview - Aethlon Medical Inc. is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases [1][2]. Key Points and Arguments Long COVID Research - Aethlon Medical is collaborating with the University of California in San Francisco to explore the potential utility of their Hemopurifiers in treating long COVID [3]. - Preliminary research indicates that the Hemopurifiers can bind extracellular vesicles and the spike protein associated with long COVID [3][4]. - The CDC estimates that 6-7% of the U.S. population, approximately 44-48 million people, suffer from long COVID, highlighting a significant market opportunity [6]. - The U.S. government has invested $1 billion in long COVID research without finding effective therapies, indicating a gap in the market that Aethlon aims to address [7]. Oncology Trials - Aethlon's primary focus remains on oncology, with ongoing trials in India and Australia [4][12]. - Regulatory changes in India have delayed the start of trials, but the company is optimistic about beginning soon [12][13]. - In Australia, three hospitals are involved in the clinical trial, with the first patient treated in January [14][16]. - The trial is a safety study for patients with solid tumors undergoing anti-PD-1 monotherapy, with a structured cohort design to assess treatment safety and efficacy [17][18]. Product Development - The Hemopurifier is an extracorporeal device that can be integrated with blood pumping machines, targeting extracellular vesicles emitted by tumors and other diseases [9][10]. - Aethlon is applying for patent protection related to their work on extracellular vesicles, which connects to their oncology research [11]. Additional Important Information - Aethlon Medical has been accepted to present preliminary findings at the Keystone Conference in August, which may provide further validation of their research [5]. - The company is hopeful about potential government grant opportunities related to their long COVID research [7]. - The upcoming milestones in the oncology trials are critical for the company's future, with expectations for significant developments soon [20]. This summary encapsulates the key aspects of Aethlon Medical's recent conference, focusing on their research initiatives, product development, and ongoing clinical trials.
Aethlon Medical to Present New Pre-Clinical Data at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes
Prnewswire· 2025-06-09 12:01
Core Insights - Aethlon Medical, Inc. is presenting research on the Hemopurifier® device's ability to bind extracellular vesicles (EVs) in Long COVID samples at an upcoming symposium [1][6] - Long COVID affects an estimated 44 to 48 million people in the U.S., with a significant economic burden projected at $2 billion for those experiencing symptoms for a year [2] - The Hemopurifier is designed to remove harmful EVs from the blood, which are implicated in the pathogenesis of Long COVID [4][8] Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an investigational device aimed at treating cancer and life-threatening infectious diseases [8] - The Hemopurifier has shown efficacy in removing life-threatening viruses and harmful EVs in pre-clinical studies [8] - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [10] Research Details - The research presented will evaluate the binding of EVs from Long COVID patients to the Hemopurifier's affinity resin, which targets the sugar mannose [5][6] - The study involves collaboration with the University of California San Francisco Medical Center Long COVID clinic [5] - The poster presentation is scheduled for August 12, 2025, and will be available on Aethlon's corporate website afterward [6][7]
Aethlon Medical Announces Publication of Preclinical Data Showing Ability of the Hemopurifier® to Remove Platelet-Derived Extracellular Vesicles from Plasma
Prnewswire· 2025-05-14 12:01
Core Insights - Aethlon Medical, Inc. announced the publication of a pre-clinical ex vivo study demonstrating the effectiveness of its Hemopurifier in removing platelet-derived extracellular vesicles (PD-EVs) from plasma, which supports ongoing oncology clinical trials in Australia [1][4][6] Group 1: Study Findings - The study showed a 98.5% removal of PD-EVs from 200 milliliters of healthy human plasma, simulating a 4-hour treatment session with the Hemopurifier [3][4] - The results indicate the potential of the Hemopurifier to address various diseases where PD-EVs are implicated, including cancer and other serious conditions [5][6] Group 2: Clinical Implications - The findings are expected to enhance the ongoing oncology clinical trial in Australia, where the focus will be on PD-EV removal in enrolled subjects [4][5] - The Hemopurifier is recognized as a Breakthrough Device by the FDA, aimed at treating advanced or metastatic cancer and life-threatening viral infections [6] Group 3: Future Directions - The company plans to submit the study findings for peer review and further investigate PD-EV removal in plasma samples from various diseases [5] - There is potential for the Hemopurifier to serve multiple therapeutic indications beyond oncology, suggesting a "pipeline within a device" concept [5]