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, JANUARY 23, 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 CARREYROU, JOHN. "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, JANUARY 23, 2025. AS REPORTED IN NYT ARTICLE, PATIENT P1 (IDENTIFIED AS MALE, 55, DIAGNOSED WITH LATE-STAGE METASTATIC ESOPHAGEAL CANCER) SAW PROGRESSION OF HIS CANCER AFTER TREATMENT. PER THE ARTICLE, "TUMORS IN HIS LIVER, ADRENAL GLANDS, BONES, AND SOFT TISSUES HAD MULTIPLIED AND GROWN." HIS WIFE CLAIMED THAT THE TREATMENT ACCELERATED MR. HUDLOW'S CANCER PROGRESSION. DAY OF INCIDENT UNKNOWN BUT ASSUMED TO BE BETWEEN THE DAY HE ARRIVED AT THE MAYO CLINIC AND THE DAY THE HE LEFT TO GO HOME (APRIL 10TH TO APRIL 16TH 2024). HE DIED ON APRIL 18TH 2024, APPROXIMATELY 1-2 WEEKS AFTER HIS LAST TREATMENT. THE ARTICLE STATES THAT SERAPH 100 TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN ANTIGUA.