FDA WARNING_LETTER - ExThera Medical Corporation - June 04, 2025

The FDA issued a Warning Letter to ExThera Medical Corporation on February 6, 2026, following an inspection from May 27 to June 4, 2025. The inspection uncovered serious violations concerning the investigational Seraph 100 Microbind Affinity Blood Filter and Onco-Seraph 100 devices, falling under Title 21, Code of Federal Regulations Part 812 – Investigational Device Exemptions, and sections of the Federal Food, Drug, and Cosmetic Act.

Key issues included the company"s failure to obtain prior FDA approval for changes to investigational plans, specifically regarding the distribution of devices for compassionate use without authorization. Additionally, ExThera failed to properly monitor clinical investigations, evidenced by its inability to verify informed consent for enrolled subjects.

Most critically, ExThera engaged in unapproved device violations, misbranding, and adulteration. The company and its Chief Medical Officer promoted the Seraph 100 as approved, safe, and effective for various conditions, including COVID-19, Long COVID, cancer, and chronic viremia, despite lacking FDA approval or clearance for any indication. This involved making false and misleading statements about the device"s regulatory status and safety profile on its website and in public statements, contradicting previous commitments made to the FDA.

The FDA requires ExThera to immediately cease all activities that result in the misbranding or adulteration of the Seraph 100. The company must provide a detailed plan within 15 working days, outlining corrective and preventative actions. This includes a complete accounting and proper disposition of all distributed investigational devices, revisions to clinical monitoring procedures, and measures to ensure distributors do not make unapproved claims. Failure to comply may lead to further regulatory action.