Arctx Medical, Inc, 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.

 

Source: prnewswire.com

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