<ul>
<li>ExThera Medical agrees to $750,000 fine and $5.69 million forfeiture</li>
<li>Former executive to plead guilty, faces 34-month prison recommendation</li>
<li>Prosecutors said executive concealed from FDA deaths of patients treated with device</li>
</ul>
By Nate Raymond
BOSTON, March 6 (Reuters) - A California medical technology start-up and one of its former executives have agreed to resolve criminal charges that they concealed reports of complications and deaths involving cancer patients who traveled to Antigua to be treated with its blood filtration device.
Federal prosecutors in Boston on Thursday filed charges against ExThera Medical Corp and its ex-chief regulatory officer, Sanja Ilic, who has agreed to plead guilty to failing to report adverse events to the U.S. Food and Drug Administration. ExThera, which was founded in 2007, entered into a three-year deferred prosecution agreement under which it admitted wrongdoing, agreed to pay a $750,000 fine and to the entry of a $5.69 million forfeiture judgment against the company. Prosecutors have agreed to recommend that Ilic, 58, be sentenced to 34 months in prison, according to her plea deal. A date for her plea hearing has not been scheduled.
Ilic’s lawyer, Nicholas Johnson of Oberheiden, did not respond to a request for comment. Seth DuCharme, ExThera’s attorney at Bracewell LLP, also did not respond to a request for comment.
Prosecutors said the small size of ExThera’s fine was due to its current financial condition. The agreement includes terms contemplating the prospect that ExThera files for bankruptcy, but the $750,000 would be held in escrow to pay any amounts owed in related civil litigation. A group of cancer patients and relatives of people who died after having their blood filtered have sued the company and the New York-based private equity firm that backed it, billionaire investor Alan Quasha’s Quadrant Management, in San Francisco federal court. Among the plaintiffs are relatives of David Hudlow of Panama City, Florida, and Kyle Chupp of Orillia, Ontario, who died just a day apart in April 2024 after returning home from Antigua, where they had undergone a blood-filtering procedure.
ExThera’s main product was the Seraph 100 blood filter, a device designed to remove pathogens from the blood. The device was initially granted an emergency use authorization to treat COVID-19 patients in 2020.
The company in court papers in the civil case has said that its testing of the device to extract tumor cells showed “encouraging” results, which led to Quasha approaching ExThera about supplying its filters for use in treating patients in Antigua at a clinic there.
Quadrant Management’s lawyer did not respond to a request for comment.
Prosecutors said cancer patients paid $45,000 to travel there believing ExThera’s device could help them, with some even suspending or delaying chemotherapy to undergo treatment. Just prior to starting treatments there, Ilic in December 2023 had circulated an email internally that described potentially “life-threatening” complications patients could experience, according to charging documents. As treatments began, Ilic learned about patients developing serious health conditions, including two patients who later died, but concealed that information from the FDA in order to defraud and mislead it, prosecutors said.
In January 2025, the New York Times published an article documenting what had been occurring in Antigua written by John Carreyrou, an investigative journalist best-known for having brought to light fraudulent practices at Theranos while reporting at the Wall Street Journal.
Ilic was fired that same month, according to court papers. Prosecutors said only after public reporting on ExThera’s device did the company file adverse reports with the FDA about the two deaths.
The cases in the U.S. District Court for the District of Massachusetts are U.S. v. Ilic, No. 26-cr-10055, and U.S. v. ExThera Medical Corporation, No. 26-cr-10056.
For the United States: Mackenzie Queenin and William Abely II of the U.S. Attorney’s Office for the District of Massachusetts
For Ilic: Nicholas Johnson of Oberheiden
For ExThera: Seth DuCharme of Bracewell LLP

Reuters

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Blood filter start-up, ex-executive face US charges for concealing deaths