MIAMI, FL, October 29, 2026 /24-7PressRelease/ -- Hallstat, a nurse-founded medical-device company focused on reducing catheter-associated urinary tract infections (CAUTIs), today announced its plan to move manufacturing of the Hallstat Foley System to the United States or nearby countries. The move is intended to lower manufacturing costs and shorten shipping times. Hallstat is in active discussions with several manufacturers and is reviewing their capabilities to confirm they meet the company's quality control standards.
Once Hallstat has established its new manufacturing facility and partnership, the company plans to introduce the Hallstat Foley System to the U.S. market.
"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."
About the Hallstat Foley System
Huici, a nurse with experience in cardiac catheterization and interventional radiology, invented the Hallstat Foley System after seeing firsthand the challenges that urinary catheters can create for patients and care teams. The system combines several design features into one product, each designed to address 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.
- CallisterCath™ — a catheter made of 100% medical-grade silicone, a material chosen as an alternative to latex.
"As a nurse, I saw how often catheter-related infections complicated a patient's recovery," said Huici. "I designed this system to tackle the problem at its source. Every feature exists because someone at the bedside needed it."
A Quality-First Manufacturing Strategy
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.
- Proximity to U.S. customers, to shorten shipping times and strengthen supply-chain resilience.
"We won't trade quality for speed," said Huici. "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."
No manufacturing agreement has been finalized. Hallstat will share updates as it selects a partner, establishes its facility, and prepares for U.S. market introduction.
"This is a decision about accountability," said Huici. "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 medical-device company founded by nurses and dedicated to fighting hospital-acquired infections and improving patients' quality of life. Its products are designed by nurses and the medical professionals who use them. Hallstat is a certified Minority Business Enterprise. Learn more at www.hallstat.com.
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