A group of former patients and their spouses has sued a Bay Area medical device company in federal court in San Francisco in connection with an offshore clinic that treated their cancer by filtering cancer cells from their blood.
The lawsuit filed Wednesday alleges that Martinez-based ExThera Medical Corporation was part of a fraudulent scheme that preyed on patients with metastatic cancer by touting an unproven technology for treating cancer patients. Three of the patients have since died and the others have allegedly seen their cancers worsen.
The story begins with ExThera’s Seraph 100 blood filter that was used by the military to treat sepsis during the COVID-19 pandemic. The device worked in connection with dialysis to run a person’s blood through an external filter, removing toxins before the blood was returned to the body.
The company allegedly decided to pivot to other markets as COVID receded, and in the fall of 2023 tried using the filter to remove “circulating tumor cells” from the bloodstream.
The test was run on a small group — a dozen or less — in Zagreb, Croatia. The lawsuit alleges that the “location (was) presumably chosen because such human experimentation would have been forbidden in the United States.”
The procedure was branded “ONCObind.” The company claimed that for multiple users it reduced tumor size, alleviated pain, and “rendered their cancers undetectable.”
The lawsuit describes a rapid push to exploit the technology.
Private equity investor takes a stake
Before the end of 2023 — only months after the test in Croatia — Quadrant Management LLC, a private equity firm associated with a wealthy investor named Alan Quasha, allegedly invested $3 million in ExThera.
Quadrant’s website describes itself as “a value-added investor, seeking opportunities where the skills and network of the Quadrant team can modify the business strategy to greatly accelerate value creation.”
Quadrant allegedly licensed the ONCObind technology from ExThera and created a subsidiary to run a medical clinic on the island of Antigua to use the filtering device to provide treatment to cancer patients. The complaint says that Quadrant’s goal was to establish a chain of clinics employing the filters and the ONCObind treatment.
Potential patients were allegedly told that the results from the Croatia trial were extremely positive and that tumors of the patients in the trial were eliminated or dramatically reduced.
The complaint says these claims and many others like them were unproven or completely untrue. “Victims were told there were no potential adverse effects and were not informed they were taking part in what was amounted to a medical experiment,” the lawsuit says.
The complaint says that the Quadrant clinic began using the ONCObind procedure in Antigua as early as January 2024, charging patients $45,000 for the treatment.
When it began operations, the Antigua clinic was not appropriately set up for treatment of cancer patients, lacked basic equipment, and did not have an oncologist on site, according to the complaint.
David Hudlow, the first of the plaintiffs to receive treatment in Antigua, had stage 4 esophageal cancer, first diagnosed in 2022. He arrived in Antigua in late February 2024 and had a round of filtrations that allegedly caused him great pain and created a series of debilitating side effects. After he returned home to Florida, his conditions worsened.
He returned to Antigua for another round of treatment in early April and his adverse conditions worsened. His wife brought him back to the U.S. where he died April 12.
Throughout the process, the complaint alleges that Hudlow’s wife was advised that the treatment was working and that a patient from the “European trial” who had been “even sicker than Mr. Hudlow … now was training for a marathon.”
A familiar refrain
The 61-page complaint tells similar stories for the other five plaintiffs who had the procedure. Two are deceased and the other three allegedly have had their cancers worsen. Some of the plaintiffs were told to stop or refrain from chemotherapy treatment because they were told it would interfere with the beneficial effects of the ONCObind procedure.
The complaint asserts claims against ExThera, Quadrant, Quasha and others for their role in the treatment. In addition to fraud, the lawsuit raises claims for negligence, assault, battery and wrongful death.
The complaint contains a footnote that references a Jan. 23, 2025, New York Times article about the ExThera device, the ONCObind procedure and the Antigua clinic, raising many of the same issues described in the complaint.
The reporter who wrote the story, John Carreyrou, is widely credited for the stories he wrote about Theranos Inc. and its claim to have created a device that could test blood for many medical conditions from a single blood prick.
Theranos later collapsed and its founder Elizabeth Holmes, and her partner Ramesh “Sunny” Balwani, were convicted of fraud and other charges and are both currently in prison serving their sentences.
Lieff Cabraser Heimann & Bernstein LLP, the San Francisco law firm representing the plaintiffs in the ExThera case, was co-lead counsel in a civil class action suit against Theranos and the pharmacy chain that marketed Theranos tests to its customers.
ExThera’s website contains a July 18, 2024, news release that says, “in a groundbreaking advancement of a novel cancer treatment, researchers have successfully deployed Seraph … blood filtration media to demonstrate removal of (cancer cells) from the blood of patients suffering from advanced pancreatic cancer.”
The release cites a June 2024 study published in a medical journal by research scientists. While the study did not examine patient health outcomes, it said that ExThera’s blood purification treatment “shows promise” as a potential treatment strategy for patients with pancreatic cancer and that “the results of this study could be relevant for other carcinomas as well.”
A request to Quadrant for comment on the suit was not immediately returned.
Attorneys for ExThera stated that the plaintiffs’ complaint was “rife with factual errors, misstatements, and omissions.” They sent links to dozens of articles and studies, including the one noted above, that they contend show that “the Seraph 100 is a proven and safe technology. It has helped thousands of patients with a range of blood-borne illnesses and has shown early promise in cancer therapy in clinical studies.”
The attorneys said they “look forward to addressing the Plaintiffs’ claims in court.”
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