Hallstat, a nurse-founded medical-device company focused on reducing catheter-associated urinary tract infections (CAUTIs), announced plans to move manufacturing of its Hallstat Foley System to the United States or nearby countries. The Miami-based company said the move is intended to lower manufacturing costs and shorten shipping times ahead of a U.S. market introduction. Hallstat is in active discussions with several manufacturers and is reviewing their capabilities to confirm they meet the company's quality control standards. No manufacturing agreement has been finalized.
The decision matters for hospitals and clinicians because CAUTIs are a persistent and costly complication of catheter use, and supply-chain disruptions have exposed vulnerabilities in medical-device procurement. By bringing production closer to U.S. customers, Hallstat aims to strengthen supply-chain resilience, improve oversight and transparency, and ensure faster delivery to hospitals that need the product. The company said it will share updates as it selects a partner, establishes its facility, and prepares for U.S. market introduction.
"Our priority has always been patients and the nurses who care for them," said Bruce Huici, Founder, President and CEO of Hallstat, and inventor of the Hallstat Foley System. "Bringing production closer to home is about building a supply chain we can stand behind—one that delivers consistent quality, lower costs, and faster delivery to the hospitals that need it."
The Hallstat Foley System combines several design features into one product, each designed to address a known contributor to CAUTI risk. These include MicroTip™, a catheter tip less than one-third the size of a standard tip, designed to reduce bladder irritation during drainage; BACTIStat™ Tubing, drainage tubing infused with BactiStat technology, designed to reduce bacterial development as urine settles in the line; BermeoValve™, a valve designed to reduce urine backflow; and CallisterCath™, a catheter made of 100% medical-grade silicone, a material chosen as an alternative to latex.
Huici, a nurse with experience in cardiac catheterization and interventional radiology, invented the system after seeing firsthand the challenges that urinary catheters can create for patients and care teams. "As a nurse, I saw how often catheter-related infections complicated a patient's recovery," Huici said. "I designed this system to tackle the problem at its source. Every feature exists because someone at the bedside needed it."
Hallstat is evaluating potential manufacturing partners using a structured review of their capabilities, including quality management systems and compliance with recognized medical-device standards such as ISO 13485; experience producing medical-grade silicone and urological devices; capacity to scale production reliably as demand grows; and proximity to U.S. customers to shorten shipping times and strengthen supply-chain resilience.
"We won't trade quality for speed," Huici said. "Any partner we choose has to meet our standards, not the other way around. We're taking the time to get this right, because hospitals and patients deserve a product they can trust every time."
"This is a decision about accountability," Huici added. "Moving manufacturing closer to our customers gives us more oversight, more transparency, and a stronger foundation for the next chapter of Hallstat." Hallstat is a certified Minority Business Enterprise, and more information is available at www.hallstat.com.
