Arctx Medical Receives FDA Marketing Authorization for its Arctx Cool Catheter™ Set for Body Temperature Regulation, Releases Initial Clinical Results in Acute Pancreatitis

RALEIGH, N.C., Nov. 17, 2025 /PRNewswire/ -- Arctx Medical, Inc. ("Arctx," "the Company"), a clinical-stage medical device company, announced today that it has achieved two additional significant milestones:

Arctx was granted FDA 510(k) clearance to market its flagship product, the Arctx Cool Catheter™ Set ("ACC," "the Device"), for use in body temperature regulation. The ACC provides internal temperature management without requiring general anesthesia or vascular access. The Device includes a non-surgical, nasogastrically placed catheter within which either cold or warm water can be circulated in a closed circuit to provide patient cooling or warming. This marketing authorization represents another key milestone for Arctx Medical.

Arctx was also honored to have the results of its First-in-Human (FIH) clinical trial of the ACC for the treatment of Acute Pancreatitis (AP) selected for oral presentation as a Late Breaker during the 2025 American College of Gastroenterology annual conference. The Late Breaker results were presented by Dr. Walter Park of Stanford University, who remarked that "the initial results were encouraging and set the stage for CHILL-AP, the upcoming randomized, controlled pivotal trial of ACC therapy for AP." Dr. Bernardo Goecke, the leading enroller in the FIH study, added that "The Cool Catheter performed reliably for patients and did not pose any safety concerns for us. Based on our positive experience with this therapy, we look forward to participating in the upcoming pivotal clinical trial." Arctx was recently granted Investigational Device Exemption (IDE) approval by the FDA to conduct CHILL-AP at multiple leading US clinical investigation sites for patients presenting with AP.

"These two additional milestones, of which we're incredibly proud, are great successes for the entire Arctx team. We're excited about the promise that our ACC technology holds to become a first-of-its-kind treatment option for patients suffering from acute pancreatitis. We're also gratified to now be able to offer a new alternative for patients in need of general thermal management," said Arctx CEO Robert Kieval.

About Acute Pancreatitis

AP, or acute inflammation of the pancreas, is a leading cause of hospitalization for gastrointestinal disorders. Its causes include gallstones, alcohol use disorder, high triglyceride levels, infections, and other medical conditions. A possible association between the use of popular GLP-1 receptor agonists and AP has also been reported. AP causes significant and prolonged patient discomfort, can lead to serious systemic illness, and in advanced cases can cause death. With no dedicated therapies for AP available, treatment is limited to supportive care that typically includes intravenous hydration and administration of pain-relieving medications. The incidence of AP is increasing, with several hundred thousand patient hospitalizations per year. Consequently, annual US health care costs for managing the disease exceed $3 billion.

About Arctx Cool Catheter Technology

The proprietary Arctx cooling technology was initially developed and tested at Mayo Clinic. Through an exclusive license and further development by Arctx Medical, the Arctx Cool Catheter is designed to reduce the temperature of the inflamed pancreas from within the stomach, and to reduce the severity and progression of the inflammatory process. Cold water is circulated within the catheter in a closed circuit, which is designed to cool the stomach wall and its contents, and by extension, the immediately adjacent pancreas. Nasogastric placement of the catheter does not require anesthesia, and the therapy is intended to cool the pancreas without inducing patient hypothermia. Arctx has now also received FDA marketing authorization for the Arctx Cool Catheter Set as a thermal regulating device, intended to control patient temperature, allow enteral administration of fluids, and provide gastric decompression and suctioning.

About Arctx Medical

Headquartered in Raleigh NC, privately held Arctx Medical, Inc. has been pioneering the development of treatments for Acute Pancreatitis and for body temperature regulation since 2021. Its mission is to reduce patient illness and pain, speed patient recovery, reduce hospital stays, and decrease health care costs associated with AP and other body temperature management needs. The Arctx Medical Advisory Board, which guides therapy and clinical development, is led by world-renowned gastroenterologist and pancreatic specialist Walter Park, MD at Stanford University. The Company's investors include Scientific Health Development, Mayo Clinic and Solas BioVentures.

For more information about Arctx Medical and Cool Catheter therapy for AP, please visit the Arctx website or contact the Company at [email protected].

SOURCE Arctx