The Hemopurifier holds a U.S. Food and Drug Breakthrough Device designation for treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy. The company advanced to the final cohort in its oncology clinical trial in March 2026 following positive Data Safety Monitoring Board review, with focus on patients receiving anti-PD-1 immunotherapy.
Cyborg Score Rationale
No safety concerns were noted with the Hemopurifier device/procedure through the first two cohorts, and the company has FDA Breakthrough Device designation. However, as a clinical-stage company with limited revenue visibility, execution risk remains elevated pending final trial completion and regulatory approval.
Top Insights
Hemopurifier oncology trial advanced to final cohort (March 2026) following positive safety review, with enrollment now open at three Australian clinical sites
Extracellular vesicles released by solid tumors are believed to play a role in metastasis and resistance to immunotherapies and chemotherapy, representing the therapeutic rationale
Company raised $3.3 million in December 2025 through private placement priced at $4.03 per share
Clinical program focuses on patients with stable or progressive disease on pembrolizumab (Keytruda) or nivolumab (Opdivo), targeting the ~60-70% who don't respond to anti-PD-1 monotherapy
Named Competitors
Keytruda — Anti-PD-1 checkpoint inhibitor
Opdivo — Anti-PD-1 checkpoint inhibitor
Recent Developments
(March 2026) Advanced to final patient cohort in oncology clinical trial with positive safety data; three participants completed treatment without safety concerns
(December 2025) Completed private placement financing of $3.3 million
(July 2025) Data Safety Monitoring Board approved advancement from first to second cohort with favorable safety profile
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