#United States #Raleigh #Arctx Medical #Cool Catheter #Acute Pancreatitis

Arctx Medical Achieves FDA Approval and Welcomes New Leadership

In a significant development for the field of medical devices, Arctx Medical, Inc. has secured FDA approval for its Investigational Device Exemption (IDE) application, paving the way for a pivotal clinical trial of its innovative ACC Kit designed for the treatment of Acute Pancreatitis (AP). This initial step marks a substantial milestone for the clinical-stage enterprise specializing in advanced therapeutic solutions.

The recently approved trial will recruit around 200 participants across 25 hospitals in the United States, aiming to evaluate the effectiveness of the Arctx Cool Catheter™ Kit. The technology, which allows for pancreatic cooling therapy, addresses a pressing medical need since no established treatments currently exist for AP, a condition characterized by intense inflammation of the pancreas associated with severe pain and potential complications.

Background and Current Milestones

Arctx Medical's achievements are bolstered by the positive outcomes from a First-in-Human clinical trial involving 21 patients who were treated using the Arctx device. This initial study analyzed its effectiveness in providing relief through pancreatic cooling therapy. The results are being prepared for publication in a peer-reviewed medical journal, signaling the company’s commitment to transparency and scientific validation.

In an effort to steer the company towards future success, Arctx recently appointed Dr. Robert Kieval as its new Chief Executive Officer. Dr. Kieval, known for his extensive experience in the medical device sector, will succeed co-founder Don Gurskis, who will take on the role of Chief Technology Officer. Dr. Kieval’s proven track record in innovating and commercializing medical technologies aligns perfectly with Arctx’s vision of delivering much-needed therapeutic options for patients.

“I’m honored and excited to join the Arctx team,” Dr. Kieval commented, reflecting on his new position. “We’re poised to offer a desperately needed therapy to patients dealing with a debilitating condition that currently has no established treatments available.” His appointment is expected to further galvanize the company’s experienced team of professionals dedicated to revolutionizing healthcare for acute pancreatitis patients.

Understanding Acute Pancreatitis

Acute Pancreatitis is increasingly recognized as a critical health issue, being a leading cause of hospitalization related to gastrointestinal disorders. The condition can arise from various factors such as gallstones, alcohol use, and other medical conditions, leading to severe patient complications. Given its rising incidence, estimated annual hospitalizations for AP exceed several hundred thousand in the United States alone, accumulating healthcare costs of more than $3 billion per year.

The absence of dedicated therapies means current treatments predominantly focus on supportive care, including hydration and pain management. Thus, the Arctx Cool Catheter aims to fill this gap by utilizing a non-invasive method that cools the inflamed pancreas through a closed circuit of cold water circulated within the catheter.

The Future Ahead

With the pivotal clinical trial expected to commence in early 2026, Arctx Medical is set to take significant steps towards commercializing the Cool Catheter Kit and potentially establishing it as the new standard of care for acute pancreatitis treatment. The company, guided by a renowned advisory board led by gastroenterology expert Walter Park, MD, from Stanford University, clearly aims to transform treatment paradigms and enhance the quality of life for patients suffering from this painful and potentially life-threatening condition.

The pioneering efforts of Arctx Medical not only showcase innovation in the field of medical devices but also emphasize the company’s dedication to making a positive impact on healthcare outcomes for those afflicted with Acute Pancreatitis. For more detailed information regarding Arctx Medical and its transformative technologies, interested parties are encouraged to visit the company's website.