ExThera Medical Executive Charged in Blood Filter Scheme

A former chief regulatory officer at ExThera Medical has been charged with concealing adverse events, including patient deaths, related to the company’s Seraph 100 Microbind Affinity Blood Filter. The Justice Department announced the charges on March 5, 2026, alleging a deliberate effort to mislead the Food and Drug Administration (FDA) [Source: Department of Justice].

The Allegations

According to the Department of Justice, the defendant and ExThera Medical failed to report adverse events linked to the Seraph 100 device. These events included the deaths of two patients. The charges suggest a pattern of concealing critical safety information from the FDA, potentially jeopardizing patient safety. The executive faces up to three years in prison if convicted.

What is the Seraph 100?

The Seraph 100 is a blood filtration device designed to remove pathogens from the bloodstream. [Source: ExThera Medical] It utilizes microbead adsorption media with chemically-bonded modified heparin, initially developed to target and remove COVID-19 from the blood. [Source: ExThera Medical] The device has also been investigated for its potential in treating bloodstream infections and, more recently, in cancer treatment, with a Phase I trial for pancreatic cancer completed in September 2024. [Source: ExThera Medical]

Controversial Cancer Treatments in Antigua

Recent reports indicate that ExThera Medical attracted cancer patients to Antigua with promises of curative treatments using its devices. [Source: The New York Times] This practice has raised ethical concerns, particularly given the allegations of concealed adverse events and the experimental nature of the treatments.

A Device That “Seems to Work”

Despite the current legal challenges, a January 2025 article in Science noted that ExThera’s device “actually seems to work.” [Source: Science/AAAS] This highlights the complex nature of the situation, as the technology itself may hold promise, while the company’s practices are under scrutiny.

Looking Ahead

The charges against the former chief regulatory officer represent a significant setback for ExThera Medical. The outcome of the legal proceedings will likely have a substantial impact on the company’s future and the availability of the Seraph 100 device. Further investigation is expected to reveal the full extent of the alleged misconduct and its consequences for patients.