Arctx Medical Receives IDE approval from FDA for a Pivotal Clinical Trial of its ACC Kit for the Treatment of Acute Pancreatitis, Announces New Leadership

RALEIGH, N.C., Aug. 26, 2025 /PRNewswire/ -- Arctx Medical, Inc. ("Arctx", "the Company"), a clinical-stage medical device company, announced today that it has achieved three significant milestones:

• The Company successfully completed a First-in-Human clinical trial evaluating its flagship product, the Arctx Cool Catheter™ Kit, as a treatment for patients suffering with Acute Pancreatitis (AP). The study included 21 AP patients who were treated with pancreatic cooling therapy provided by the Arctx device. Results of the study are being prepared for peer-review publication.
  
  
• Arctx was granted approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to conduct a pivotal clinical trial of its novel therapy in approximately 200 patients with AP at up to 25 US hospitals. The clinical trial is being conducted to support marketing authorization for the Arctx Cool Catheter Kit in the US for a first-of-its-kind treatment of AP.
  
  
• In July 2025, the Company hired Dr. Robert Kieval, a successful medical device industry veteran, as its new Chief Executive Officer. Dr. Kieval will succeed Cofounder Don Gurskis, who will continue with Arctx as the Company's Chief Technology Officer. Dr. Kieval brings over 20 years of CEO and C-level leadership experience at the intersection of health care, technology and business, with a track record of success 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."

These accomplishments will propel Arctx toward commercializing the Cool Catheter Kit and providing a needed new therapeutic option for patients with AP. The Company expects to launch its pivotal clinical trial in early 2026.

About Acute Pancreatitis 
Acute Pancreatitis, or 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 Therapy
The proprietary Arctx Cool Catheter Kit 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. 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 is separately seeking FDA 510(k) market authorization for the Arctx Cool Catheter Kit for a body temperature management indication.

About Arctx Medical
Headquartered in Raleigh NC, privately held Arctx Medical, Inc. has been pioneering the development of treatments for Acute Pancreatitis 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. 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 Solas BioVentures, Mayo Clinic Ventures, and Scientific Health Development Partners.

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