ExThera Has Reached a Resolution with the U.S. Department of Justice, with Substantial Recognition for Cooperating in the Investigation and Implementing Remedial Measures
MARTINEZ, Calif., March 5, 2026 /PRNewswire/ -- ExThera Medical has resolved a United States Department of Justice investigation into the company's involvement with a Caribbean distributor.
Following the Department of Justice's investigation, the Company acknowledged that a former ExThera employee, who was fired prior to the Department's year-long investigation, intentionally failed to adequately investigate and report certain adverse events to the U.S. Food and Drug Administration. ExThera has recognized that, as a matter of law, the company is responsible for the conduct of its former employee.
As part of the resolution, the Justice Department fined ExThera $750,000, noting the company's cooperation in the investigation. The Department of Justice has agreed that if ExThera fulfills its obligations in the resolution the charge will be dismissed in its entirety.
'The DOJ's thorough investigation and resolution allows the company to move forward in its effort to save lives,'' said a spokesman for ExThera. 'We hope that the resolution helps clear up what ExThera believes were prejudicial characterizations of our company in the media."Â
During the government's investigation, ExThera cooperated fully and took decisive corrective action. In the resolution, the Department of Justice credited ExThera for this cooperation, which included (1) providing expedited, detailed factual disclosures, (2) conducting an internal investigation, (3) making numerous, thorough factual presentations, (4) reporting results of the company's investigation to the government, and (5) identifying and disclosing additional relevant information beyond what the Department of Justice required.
The Department of Justice also acknowledged that the company remediated the conduct by (1) hiring new personnel, including experienced regulatory compliance and legal leadership, (2) enhancing and standardizing training, documentation, and adverse event reporting, and (3) establishing regular third-party audits and other internal monitoring procedures. ExThera also has committed to implementing compliance functions commensurate with its operations going forward.
ExThera is pleased to have resolved this matter, and appreciative of the DOJ's recognition of its cooperation. ExThera looks forward to resuming its operations and the continued development of its life-saving technologies that are becoming more important with the creation of AI pathogens and biological weapons.
More information can be found at www.extheramedical.com
About ExThera Medical Corporation
ExThera Medical Corporation developed extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 can be used in hospitals, clinics, on battlefields and in other austere environments.
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SOURCE ExThera Medical Corporation
