Arctx Medical Receives FDA IDE Approval for Pivotal Trial of Novel Cooling Therapy for Acute Pancreatitis
Key Insights
Arctx Medical (search) received FDA Investigational Device Exemption approval to conduct a pivotal clinical trial of its Cool Catheter Kit in approximately 200 acute pancreatitis patients at up to 25 US hospitals.
The company successfully completed a first-in-human trial with 21 acute pancreatitis patients treated with pancreatic cooling therapy, with results being prepared for peer-review publication.
The novel therapy addresses a significant unmet medical need, as acute pancreatitis has no dedicated treatments available and causes over $3 billion in annual US healthcare costs.
Arctx Medical (search) has achieved a significant regulatory milestone with FDA approval to advance its innovative cooling therapy for acute pancreatitis into pivotal clinical testing. The clinical-stage medical device company announced it received Investigational Device Exemption (IDE) approval to conduct a pivotal trial of its Arctx Cool Catheter Kit (search) in approximately 200 patients with acute pancreatitis at up to 25 US hospitals.
The approval follows successful completion of a first-in-human clinical trial that evaluated the flagship device in 21 acute pancreatitis patients who received pancreatic cooling therapy. Results from this initial study are currently being prepared for peer-review publication, marking a crucial step toward establishing clinical evidence for this novel therapeutic approach.
Novel Cooling Technology Addresses Critical Unmet Need
The Arctx Cool Catheter Kit (search) represents a first-of-its-kind treatment approach for acute pancreatitis, a condition that currently has no dedicated therapies available. The proprietary technology, initially developed and tested at Mayo Clinic, is designed to reduce the temperature of the inflamed pancreas from within the stomach through nasogastric catheter placement.
The device operates by circulating cold water within the catheter in a closed circuit, cooling the stomach wall and its contents, and by extension, the immediately adjacent pancreas. The therapy is designed to avoid inducing patient hypothermia while providing targeted cooling to the inflamed organ. Importantly, the nasogastric placement does not require anesthesia, potentially making it accessible for widespread clinical use.
Significant Disease Burden Drives Development
Acute pancreatitis represents a substantial healthcare challenge, serving as a leading cause of hospitalization for gastrointestinal disorders. The condition causes significant and prolonged patient discomfort, can lead to serious systemic illness, and in advanced cases can cause death. With several hundred thousand patient hospitalizations per year, the incidence of acute pancreatitis is increasing, resulting in annual US healthcare costs exceeding $3 billion.
Current treatment remains limited to supportive care, typically including intravenous hydration and administration of pain-relieving medications. The condition has multiple causes, including 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 acute pancreatitis has also been reported.
Leadership Transition Positions Company for Growth
In July 2025, Arctx Medical (search) appointed Dr. Robert Kieval as Chief Executive Officer, succeeding cofounder Don Gurskis, who will continue as Chief Technology Officer. Dr. Kieval brings over 20 years of CEO and C-level leadership experience at the intersection of healthcare, technology and business, with a proven track record in innovating, financing and commercializing sophisticated medical technology.
"I'm honored and excited to join the Arctx team. We're poised to be able to offer a desperately needed therapy to patients with a devastating condition that has no established treatments available for it," said Kieval. "We believe that the Arctx Cool Catheter provides an elegant solution that could establish a new standard of care for treating patients with Acute Pancreatitis."
Arctx cofounder and Executive Chairman Steve Bacich added, "The Arctx team is delighted to have Rob on board. He joins an experienced group of medical device professionals, and his leadership will further strengthen the company."
Clinical Development Timeline and Regulatory Strategy
The company expects to launch its pivotal clinical trial in early 2026, with the study designed to support marketing authorization for the Arctx Cool Catheter Kit (search) in the US. Separately, Arctx is pursuing FDA 510(k) market authorization for the device for a body temperature management indication, potentially providing an additional regulatory pathway.
The Raleigh, North Carolina-based company has been pioneering acute pancreatitis treatments since 2021, with a mission to reduce patient illness and pain, speed patient recovery, reduce hospital stays, and decrease healthcare costs associated with the condition. The company's Medical Advisory Board is led by world-renowned gastroenterologist and pancreatic specialist Walter Park, MD at Stanford University.
Arctx Medical (search)'s investor base includes Solas BioVentures, Mayo Clinic Ventures, and Scientific Health Development Partners, providing the financial foundation to advance this potentially transformative therapy through clinical development and toward commercialization.