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Paragonix Technologies Announces First Pediatric Use of BAROguard Lung Preservation System

UF Shands Children’s Hospital Leads the Way in Life-Saving Pediatric Transplant with Innovative Donor Lung Preservation System

Paragonix Technologies, a leading organ transplant company, today announced the first lung transplant case in which a set of pediatric donor lungs were preserved using its BAROguard® Donor Lung Preservation System. The donor lungs were procured by Dr. Yuriy Stukov and Dr. Mohamad Aladaileah, and successfully transplanted by Dr. Mindaugas Rackauskas and Dr. Mark Bleiweis at UF Shands Children’s Hospital in Gainesville, Florida. BAROguard® received FDA 510(k) clearance in August 2023 and launched commercially in April 2024. This groundbreaking case was the innovative device’s first use in a pediatric setting.

Unlike any other organ, lungs must always contain air, making them vulnerable to both thermal damage and injury from over or under inflation during transport. The BAROguard® system addresses these challenges by combining clinically proven hypothermic preservation techniques with active airway management control, ensuring optimal air pressure is maintained throughout transport. This ensures donor lungs remain in optimal condition during transport for maximum protection. Additionally, the device is equipped with built-in Bluetooth® tracking and real-time reporting, providing surgeons and transplant teams with continuous data on the organ's condition throughout transit.

“UF Shands Children’s Hospital is committed to providing leading-edge and high-quality care to children and their families, and we are proud to do so by utilizing innovative technologies like advanced organ preservation,” said Mindaugas Rackauskas, MD, Surgical Director of Pediatric Lung Transplant Program at UF Health Shands Hospital. “The ability to actively manage airway pressure and internal temperature is an advancement that is increasing the availability of high-quality donor lungs nationwide. Introducing this technology to the pediatric field will significantly impact the many children on the pediatric donor waiting list.”

“We are thrilled to see BAROguard technology making a difference in the pediatric setting, enhancing preservation techniques and outcomes for pediatric lung transplant recipients,” said Lisa Anderson, Ph.D., President of Paragonix Technologies. “Our advanced preservation system, which has consistently proven successful in previous pediatric transplant cases, offers young recipients a vital second chance at life and reinforces our commitment to continued innovation in organ transplantation.”

For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

About Paragonix Technologies

Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation.

Paragonix Technologies provides Advanced Organ Preservation (“AOP”) devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.

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