Cooling the Pancreas to Save Lives with Robert Kieval, CEO of Arctics

In this episode, Henry Norton sits down with Robert Kieval, CEO of Arctx Medical Inc, to talk about a condition that sends 300,000 Americans to the ER every year with no approved treatment options waiting for them.Robert shares how Arctx is developing a deceptively simple solution: a cooling catheter that targets pancreatic inflammation from inside the stomach. He also opens up about the hard lessons from his previous venture, including why he wishes he'd hired a marketing lead much earlier.Key Topics:- How Arctx's gastric cooling catheter targets pancreatic inflammation- The regulatory pathway: 510(k) clearance for temperature management, de novo for pancreatitis- Designing a 200-patient randomised controlled trial with FDA IDE approval- Why market development and reimbursement strategy need to start earlyRelated Insights:- The importance of building clinical champions before commercialisation- Why new technologies must fit into existing clinical workflows to gain adoption- Navigating the current medtech funding environmentCore Challenges:- Acute pancreatitis affects 300,000 US patients annually with no targeted therapies only supportive care- Arctx's cooling catheter aims to reduce inflammation, shorten hospital stays, and become a new first-line treatment option🎧 Tune in now to hear how Arctx is turning cooling into a therapeutic platform.The Crux of MedTech podcast is brought to you by Cruxx, a specialist surgical robotics recruitment agency. To learn more about Cruxx,⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠click here.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠A big thank you to our sponsors on this season of the podcast; ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP plc⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ With a 35-year track record, TTP excels in turning innovative ideas into market-ready solutions. Their team of 300+ experts deliver breakthrough solutions in areas ranging from endoluminal robotics and navigation systems to ultrasound imaging. Whether you're a startup or a multinational, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP plc⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ can accelerate your development with the latest technologies. Learn more at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TTP.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠&⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠KUKA⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ is a global leader in robotics with over 25 years of experience partnering with medtech companies on their journey to market. Their reputation is built on robust technology, reliability and long term collaboration and being more than just a supplier.KUKA provides trusted support throughout the product life cycle, from development to integration and beyond. Find out more at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠kuka.com/healthcare⁠⁠⁠⁠⁠