The Dark Side of Medical Startups: Lessons from the ExThera Controversy

Written by Sophia Ly, PharmD 2027

January 27, 2025

The Dark Side of Medical Startups: Lessons from the ExThera Controversy

In the rapidly evolving field of digital health, the promise of cutting-edge medical technologies often captivates both patients and investors. However, the story of ExThera Medical Corporation and its blood-filtering device is a stark reminder of the ethical and regulatory challenges that can arise when experimental treatments are marketed to vulnerable populations. This case highlights the fine line between innovation and exploitation in cancer care.

ExThera, a U.S.-based medical startup, developed a blood-filtering device initially approved by the FDA for emergency use in treating severe COVID-19 cases. The device, the Seraph 100 Microbind Affinity Blood Filter, was designed to remove pathogens and inflammatory mediators from the bloodstream, showing promise in treating critically ill COVID-19 patients. However, as the pandemic waned, ExThera sought new applications for its technology, turning its attention to cancer treatment. The company hypothesized that the device could filter circulating tumor cells (CTCs), which play a key role in cancer metastasis.

Encouraged by preliminary results from a small, non-peer-reviewed study in Croatia, ExThera partnered with billionaire investor Alan Quasha to offer the experimental treatment at a clinic in Antigua, where U.S. regulatory oversight did not apply. For $45,000 per treatment, terminally ill cancer patients were lured by the promise of a miracle cure. However, the reality was far from the hopeful narrative presented by ExThera and its partners.

Reports from the Antigua clinic revealed alarming conditions, including inadequate medical oversight, unsanitary practices, and patients subjected to painful procedures without proper anesthesia. ExThera’s own director of medical affairs, Jonathan Chow, warned company leadership about the unethical and unsafe nature of the operation, but his concerns were ignored. Tragically, of the roughly two dozen patients treated in Antigua, at least six died, with some families alleging that the treatment accelerated their loved ones’ decline.

The case raises critical questions about the ethical responsibilities of companies operating in the digital health space. While ExThera’s device showed potential in treating COVID-19, its application to cancer care was premature and inadequately supported by scientific evidence. The lack of rigorous clinical trials, combined with the exploitation of desperate patients, highlights the need for regulatory frameworks to prevent such abuses. This cautionary tale serves as a reminder that innovation in digital health must be balanced with ethical considerations and rigorous scientific validation. As the industry continues to advance, stakeholders must prioritize patient safety and transparency to ensure that groundbreaking technologies fulfill their promise without causing harm.

References:

1. Carreyrou J. ExThera Claimed Its Device Could Cure Cancer. But Patients Died. The New York Times. https://www.nytimes.com/2025/01/23/business/exthera-cancer-blood-filtering-device.html. Published January 23, 2025.

2. Landymore F. Patients Are Dying After a Strange Cancer Treatment on a Remote Island. Futurism. Published January 23, 2025. Accessed January 27, 2025. https://futurism.com/neoscope/patients-dying-cancer-treatment-island

3. ExThera Announces Completion of Phase I OSCAR I Trial. BioSpace. Published September 25, 2024. Accessed January 27, 2025. https://www.biospace.com/drug-development/exthera-announces-completion-of-phase-i-oscar-i-trial

4. Hinton D. To: Erdie De Peralta of ExThera Medical Corporation, Response to ExThera Medical Corporation’s request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA). US Food & Drug Administration. Published online April 2020