SERAPH 100

Additional Manufacturer Narrative

THIS WAS STATED IN THE NYT, SEE (B)(6). "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 (B)(6) 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 (B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. PATIENT P3 (MALE, 47, DIAGNOSED WITH METASTATIC RECTAL AND LIVER CANCER) WAS DESCRIBED AS "WHITE AS A SHEET" SHORTLY AFTER TREATMENT AND AFTER STANDING AND WALKING "SLUMPED TO THE FLOOR UNCONSCIOUS AND BEGAN SHAKING". PER THE ARTICLE, A PHYSICIAN INITIALLY CLAIMED THAT PATIENT P3 WAS EXPERIENCING HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), BUT LAB TESTS LATER INDICATED THAT HIT WAS "NOT THE CULPRIT," AND THE PATIENT'S WIFE BELIEVES HE SUFFERED BLOOD LOSS DUE TOO FREQUENT CHANGES OF CLOGGED FILTERS. PATIENT P3 RECEIVED A BLOOD TRANSFUSION AND WAS ADMITTED TO THE ICU TO RECOVER. THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN (B)(6). THE DEVICE WAS BEING USED OFF-LABEL FOR THE TREATMENT OF CANCER, OUTSIDE OF THE UNITED STATES IN (B)(6).