The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling its Seraph 100 blood filter device to treat cancer patients under specious conditions.
The warning letter, posted on the agency’s website and dated Feb. 6, was the result of an inspection conducted at the company’s California headquarters last May 27 through June 4.
It also comes a year after a New York Times article documented how the device was being used without FDA approval by another company (Quadrant Clinical Care) in Antigua to treat cancer patients for $45,000 a round.
The device first garnered widespread notice when the FDA cleared it for emergency use in April 2020 to reduce pathogens in the blood of adult COVID-19 patients in intensive care with confirmed or imminent respiratory failure. It had been approved in the EU the year before for severe bloodstream infections.
The inspection last year was conducted by the Bioresearch Monitoring Inspectorate (OBMI) to determine whether ExThera’s activities and procedures as a sponsor in the significant risk clinical studies complied with federal regulations.
The OBMI focuses on data related to investigational device exemptions and premarket approvals with an objective of protecting clinical trial subjects from hazards and risks during scientific investigations.
The FDA found the company failed to obtain approval before it changed its investigational plan.
“Your firm’s email communications with (redacted hospital name) dated April 27-28, 2024, indicate that these devices were shipped for treatment of a patient under the CU (compassionate use) pathway,” the agency said in its letter. “However, FDA approval for CU was not obtained prior to the devices being distributed.”
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Additionally, the FDA said a second request for CU was received in November 2024, however, a report was never submitted to the agency that documents the distribution of devices for use in treating the identified patient.
The company was also cited for not properly monitoring the investigation and failing to achieve compliance with investigational plans.
“ExThera failed to properly monitor its clinical investigations and failed to provide evidence for verification and attestation that informed consent was signed for enrolled subjects,” the agency said.
The FDA also rebuked ExThera for a number of unapproved device violations that included claims made on the company’s website and by Lakhmir Chawla, M.D., its chief medical officer.
In closing, the FDA said ExThera should cease activities that result in the misbranding or adulteration of the Seraph 100 Microbind Affinity Blood Filter.
