SERAPH 100

Additional Manufacturer Narrative

THIS WAS STATED IN THE NYT, SEE CARREYROU, JOHN. "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. THE MANUFACTURER FOLLOWED UP WITH THE FACILITY IN ANTIGUA WHERE THE CLAIMED ADVERSE EVENTS TOOK PLACE AND WITH THE TREATING PHYSICIAN. THE FACILITY HAS STATED THAT IT WAS NOT AWARE OF ANY ADVERSE EVENTS. THE PHYSICIAN HAS NOT RESPONDED.

Description of Event or Problem

THIS INFORMATION WAS REPORTED PUBLICLY BY THE NEW YORK TIMES. SEE CARRERAI, JOHN. "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. PATIENT P6, NOT OTHERWISE IDENTIFIED, DIED FOLLOWING TREATMENT. OVERALL THE ARTICLE INDICATES THAT P6 WAS ONE OF SEVERAL PATIENTS SEEKING OFF-LABEL TREATMENT FOR CANCER. THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN ANTIGUA. FURTHER INVESTIGATION INDICATES THAT TREATMENT AND ANY SUBSEQUENT ADVERSE EVENT WOULD HAVE OCCURRED SOME TIME IN 2024, DUE TO THE TIMING OF THE ARTICLE AND THE AVAILABILITY OF TREATMENT IN ANTIGUA.