Former ExThera Executive Admits Hiding Patient Deaths From U.S. Regulators

A former executive of a California-based medical technology company has admitted to hiding critical patient safety information from U.S. regulators while the company has entered into a legal agreement with federal prosecutors to resolve related criminal charges.

According to U.S. authorities, Sanja Ilic, 58, who previously served as Chief Regulatory Officer of ExThera Medical Corporation, has agreed to plead guilty to charges connected to the failure to report serious medical incidents linked to a blood filtration device used on cancer patients outside the United States.

Prosecutors say the device was designed to filter pathogens from a patient’s bloodstream and was used in treatments at a clinic in Antigua that treated cancer patients who traveled abroad for specialized care.

Court documents state that in 2024 Ilic allegedly concealed important safety reports that should have been submitted to the U.S. Food and Drug Administration. Among the incidents that were not reported were the deaths of two patients who had received treatment using the company’s blood filtration technology.

Before the treatments began at the Antigua clinic, Ilic had reportedly warned company leadership and regulatory staff about possible risks associated with the device, including life-threatening complications. Medical professionals later reported that several patients experienced severe medical problems following treatment.

In early 2024, Ilic became aware that at least two patients treated at the clinic died within days of each other. Prosecutors allege that she chose not to disclose these incidents to regulators because doing so could have triggered a regulatory investigation and potentially damaged the company’s business prospects.

At the time, the company had recently secured approximately $10 million in funding and was preparing for further commercial agreements related to the device. Officials say the company was also planning clinical trials in the United States focused on cancer treatment.

Authorities allege that reporting the deaths could have jeopardized those business plans, leading Ilic to suppress the information rather than comply with federal reporting requirements.

After media coverage raised concerns about the medical device and Ilic was later removed from the company, ExThera filed several delayed reports with the FDA regarding medical incidents connected to the treatment of cancer patients outside the United States.

Federal prosecutors also announced that ExThera Medical Corporation has entered into a three-year deferred prosecution agreement with the U.S. Department of Justice. Under the agreement, the company acknowledged that it failed to properly report serious safety events connected to the device.

The agreement requires the company to cooperate with investigators, implement new compliance and ethics programs, and strengthen procedures designed to ensure accurate reporting of patient safety incidents.

As part of the settlement, the company agreed to pay a criminal penalty of $750,000 and place the funds in an escrow account. Prosecutors also said the company has agreed to forfeit more than $5.6 million linked to the conduct described in the case.

Officials noted that the company received some credit for cooperating with the investigation and accepting responsibility for the violations, although it did not voluntarily report the misconduct when it first occurred.

Ilic faces a federal charge related to failing to report adverse medical events with the intent to mislead regulators. If convicted, she could face up to three years in prison along with financial penalties and other court-ordered consequences.

Federal investigators from several agencies are involved in the case, including authorities responsible for monitoring medical safety and combating health care fraud.

The case is part of broader efforts by U.S. law enforcement to investigate fraud and safety violations in the health care industry and to hold companies accountable when medical risks to patients are concealed.

Under federal law, the charges remain allegations until proven in court.