Hallstat Shifts Foley Catheter Manufacturing Closer to U.S. Ahead of Market Launch

Hallstat, a nurse-founded medical-device company focused on reducing catheter-associated urinary tract infections (CAUTIs), announced plans to move manufacturing of the Hallstat Foley System to the United States or nearby countries. The company said the move is intended to lower manufacturing costs and shorten shipping times as it prepares to introduce the system to the U.S. market.

The announcement matters beyond a single product line. Hallstat is in active discussions with several manufacturers and is reviewing their capabilities against its quality control standards. For Texas, a state with a growing medical-device and advanced manufacturing base, the decision signals where a small, clinically driven company sees supply-chain value: proximity to U.S. hospital customers, shorter delivery windows, and tighter oversight of production. Any partner selected would need to demonstrate 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 reliably, and proximity to U.S. customers.

"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."

Huici, a nurse with experience in cardiac catheterization and interventional radiology, invented the system after seeing firsthand the challenges urinary catheters can create for patients and care teams. The product combines several design features into one system, each aimed at a known contributor to CAUTI risk: 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 in the drainage tubing; and CallisterCath™, a catheter made of 100% medical-grade silicone as an alternative to latex.

"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."

The company emphasized that no manufacturing agreement has been finalized and that it will share updates as it selects a partner, establishes its facility, and prepares for U.S. market introduction. "We won't trade quality for speed," Huici said. "Any partner we choose has to meet our standards, not the other way around." Hallstat is a certified Minority Business Enterprise, and additional information about the company is available at www.hallstat.com.

For readers in Texas' medical supply chain and hospital sector, the plan is worth watching. A domestic or nearshore manufacturing footprint could reduce lead times for hospitals managing infection-prevention budgets, while the partner-selection process creates an opening for manufacturers with silicone and urological device expertise. Huici framed the move as a matter of accountability: "Moving manufacturing closer to our customers gives us more oversight, more transparency, and a stronger foundation for the next chapter of Hallstat."