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Paragonix Technologies Announces Nationwide Commercial Availability of FDA-Cleared BAROguard™ Donor Lung Preservation System

By: Paragonix Technologies, Inc. via Business Wire

April 04, 2024 at 09:00 AM EDT

The innovative airway management device for donor lungs is now commercially available for use in clinical transplantation across the United States to promote maximum control over preservation conditions throughout procurement.

Paragonix Technologies, Inc., a pioneer in organ transplant technologies and procurement services, announces the full commercial launch of its next-generation transport device, the BAROguard™ Donor Lung Preservation System. After an overwhelmingly positive response and demand during its limited market release, the technology is now available to transplant centers and Organ Procurement Organizations across the United States.

First-of-its-kind, the novel BAROguard system combines clinically proven hypothermic preservation techniques alongside active airway management control to ensure that donor lungs maintain optimal conditions during transport for maximum protection. Equipped with built-in tracking and real-time reporting, the device provides surgeons and transplant teams with continuous data on the organ's condition throughout transit. Paragonix Technologies received FDA 510(k) clearance for the device in August 2023, and conducted its first-in-human case at Duke University Medical Center in November 2023. Throughout its limited market release, five of the country’s top thoracic transplant centers (Duke Health, Massachusetts General Hospital, Johns Hopkins Medicine, UCSF Health, UCLA Health) deployed the BAROguard System to safely place donor lungs for lung transplantation.

“Traditional lung preservation does not provide transplant teams with any information about the actual conditions experienced by the organ,” explained Dr. Nathaniel Langer, MD, MSC, Surgical Director, Lung Transplantation at Massachusetts General Hospital. “Unlike any other organ, lungs must hold air, so they are susceptible to damage from both over and under inflation during transport. The introduction of a device that both actively manages airway pressure and provides real-time data on internal temperature+- conditions during transport is an exciting advance that I hope will increase the availability of quality donor lungs to transplant programs around the country.”

The highly anticipated device launches in advance of the 44^th ISHLT (International Society for Heart and Lung Transplantation) Annual Meeting and Scientific Sessions, where it is available for demonstrations at the Paragonix exhibit at the Prague Congress Centre in Prague, Czech Republic, from April 10th to April 13th. Attendees will have the opportunity to examine the new technology and hear from leading clinical experts who participated in the limited market release, such as Dr. Jasleen Kukreja, director of the Lung Transplant Program at UCSF Medical Center. Dr. Kukreja joins a panel of esteemed preservation experts on Friday, April 12^th, to lead an industry symposium entitled “Reimagined Clinical Standards: Transformative Innovations in Organ Preservation,” which will feature research showcasing the impact of the BAROguard System’s active pressure control.

“The commercial launch of BAROguard represents a significant breakthrough for the organ transplantation industry,” said Dr. Lisa Anderson, CEO and President of Paragonix Technologies. "We are immensely pleased with the success it has already achieved, and we are excited to offer this game-changing technology nationwide to help transplant surgeons and their teams to innovate the standard of care in transplantation."

The valuable data collected from the commercial use of the BAROguard device will contribute to the renowned GUARDIAN-Lung study, a post-market observational registry intended to evaluate the clinical outcomes of patients who have donor lungs preserved with Paragonix lung preservation devices versus other storage methods.

The BAROguard System is available for clinical use across the United States. 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 provide 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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