Paragonix Unveils PancreasPak™: The World’s First FDA-Cleared Preservation Device for Donor Pancreas Transplantation

Industry-leading transplantation company pioneers the PancreasPak™ Organ Preservation System to protect and monitor donor pancreases during transportation


WALTHAM, Mass.–(BUSINESS WIRE)–Paragonix Technologies, a leader in organ transplant technology, proudly announces the PancreasPak™ Organ Preservation System, the first FDA-cleared device designed to protect and monitor donor pancreases during transportation. Pre-orders for this groundbreaking technology begin on June 27, 2024, with full availability slated for September 1, 2024.

The PancreasPak™ System is set to transform the pancreatic transplant field, a market that has long been overlooked. Leveraging the proven principles of Paragonix’s SherpaPak® Cardiac Transport System, used in 1 of every 3 cases across the US, the new device promises to deliver unprecedented levels of tracking and control in pancreatic transplantation. By establishing a controlled environment, the preservation digitally monitors the pancreas at an optimal thermal range of 4-8°C for up to 21 hours. This recommended temperature standard follows the footsteps of the SherpaPak®, which has been shown to safely extend ischemic times, minimize post-transplant outcomes, and improve 2-year patient survival.1,2 This strategic move underscores the Paragonix’s commitment to improving and redefining the standard of care across all of transplant medicine.

The pancreas, unlike other solid organs, is extremely delicate and vulnerable to damage during transport. Traditional methods involving plastic coolers and crushed ice expose the organ to harmful freezing temperatures.

“This is an incredibly exciting time for pancreas transplantation. Preservation impacts organ function, and better preservation would allow us to help more patients. Until now, there has been a distinct lack of innovation within the pancreatic market specifically,” said Dr. Joseph Scalea, Vice Chair of Innovation, Department of Surgery, from Medical University of South Carolina. “An advanced preservation device has the potential to change everything. In just a few short months, we will finally have a tool tailored specifically to our needs, that aligns with our goal to substantially enhance organ viability and patient outcomes.”

“Our team is thrilled to introduce this advanced technology to the pancreatic transplant community,” said Dr. Lisa Anderson, CEO and President of Paragonix. “This milestone demonstrates our dedication to advancing the boundaries of organ transplantation excellence. We are honored to stand at the forefront of preservation and provide unparalleled support to countless patients in need of a heart, lung, liver, and now, pancreas. To be at the forefront and be the first company to provide pancreas preservation technology is a tremendous achievement and consistent with our commitment to service all transplant and donor patients.“

PancreasPak, which has already received FDA 510(k) clearance, will be available for commercial pre-order starting in late June. Questions and requested pre-orders can be received by reaching out to info@paragonixtechnologies.com.

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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References

D’Allesandro et al. Impact of controlled hypothermic preservation on outcomes following heart transplantation. JHLT March 2024

Haney et al, 2024 ISHLT Presentation

Contacts

Media: Adam Lafreniere, Sr. Director, Marketing

marketing@paragonixtechnologies.com