FDA Adverse Event Injury Summary report: N

SERAPH 100

MDR report key: 22024600 · Received May 15, 2025

Report

Report Number: 3014015528-2025-00013
Event Type: Injury
Date Received: May 15, 2025
Date of Event: April 24, 2024
Report Date: February 21, 2025
Manufacturer: EXTHERA MEDICAL CORPORATION
Product Code: QLO
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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 · 0

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) EXPERIENCED AN INITIAL REGRESSION OF HIS CANCER IN THE FIRST FEW WEEKS AFTER TREATMENT, THEN HIS TUMOR CELL COUNTS ROSE AS MUCH AS 5 TIMES THEIR PRE-TREATMENT LEVELS. SCANS ALSO SHOWED GROWTH IN THE PREEXISTING TUMORS IN HIS LIVER. THE PATIENT'S WIFE BELIEVES THAT THE DEVICE "SUPERCHARGED HER HUSBAND'S CANCER" BUT ACKNOWLEDGES "THAT MAY BE IN PART BECAUSE IT LED HIM TO STOP UNDERGOING CHEMOTHERAPY, BUT IT IS IMPOSSIBLE TO KNOW FOR SURE." THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
370857	SERAPH 100	SERAPH 100	QLO	EXTHERA MEDICAL CORPORATION	50001-EUA	K007121

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR	Male	Required Intervention\| L