#USA #FDA Approval #Duluth #VitaSmart #Bridge to Life

Bridge to Life Achieves Groundbreaking FDA Approval for VitaSmart® System

In a significant advancement for liver transplantation, Bridge to Life™ Ltd. has secured De Novo approval from the U.S. Food and Drug Administration (FDA) for its innovative hypothermic oxygenated perfusion (HOPE) system named VitaSmart™. This groundbreaking decision marks the first-ever FDA approval for a hypothermic perfusion machine aimed at enhancing liver preservation for transplantation in the United States.

A Milestone in Organ Preservation

The FDA's endorsement permits commercial utilization of VitaSmart™ specifically for the perfusion of livers from donors after static cold storage, paving the way for U.S. transplant centers to incorporate HOPE protocols into their clinical practices. According to Don Webber, CEO of Bridge to Life™ Ltd., "This authorization represents a transformative milestone for both our company and the field of liver transplantation in the U.S. VitaSmart™ is not only the first FDA-approved hypothermic oxygenated perfusion system for liver transplants but also aligns with established clinical practices regarding safety and efficacy. We believe this will drive adoption, enhance organ utilization, and provide substantial clinical and economic value to transplant programs."

Expanding Opportunities in Liver Donation

One of the pivotal aspects of the FDA’s approval is its focus on organs from donors after cardiac death (DCD), which are increasingly crucial in contemporary liver transplants. The inclusion of DCD grafts in the VitaSmart™ labeling underscores the growing clinical interest in preservation strategies that support grafts prior to implantation. Dr. Kristopher Croome, a transplant surgeon at Mayo Clinic Florida, emphasized, "Having an FDA-approved hypothermic oxygenated perfusion system commercially available is a significant advancement for transplantation programs. The introduction of VitaSmart's HOPE technology provides flexibility to optimize preservation strategies, especially with DCD liver grafts, ensuring the best care for patients in need of transplants."

Practical Application of FDA Approval

The approved labeling for VitaSmart™ supports hypothermic oxygenated perfusion in liver transplantation from both brain-dead donors (DBD) and donors after cardiac death (DCD), thus broadening the scope for potential grafts. Notably, the FDA’s indicatory labeling does not stipulate a maximum duration for perfusion, allowing medical professionals to leverage their clinical judgment and established protocols. Extended HOPE duration offers numerous operational and patient safety benefits, including improved transplant logistics, reduced risk of rushed surgeries, and diminished likelihood of reverting to cold static ischemia.

Clinical Evidence and Economic Considerations

The FDA’s approval was bolstered by data from the pivotal Bridge to HOPE clinical trial, a randomized controlled multicenter study conducted across 15 U.S. transplant centers. The study involved 219 recipients, including those receiving extended criteria grafts from both DBD and DCD populations. Statistically significant clinical outcomes demonstrated enhanced early graft function alongside a strong safety profile, providing a solid foundation for the FDA's De Novo determination.

VitaSmart™ is designed not only to facilitate optimal organ utilization but also to streamline post-transplant resource use and simplify workflow integration without reliance on transport-based perfusion. This system represents a scalable, capital-efficient approach to advanced organ preservation, resonating with the ongoing need for transplantation programs to balance clinical outcomes with operational complexities and resource limitations.

Launch Plans for VitaSmart™

As Bridge to Life gears up for the commercial launch of VitaSmart™ in the first quarter of 2026, David Castiglioni has been appointed as Chief Commercial Officer to spearhead this initiative. With a vast background in transplant services, Castiglioni is tasked with navigating the commercial landscape while maintaining the company's strong relationships within the transplant community.

The innovative HOPE technology embedded in VitaSmart™ regulates donor livers at controlled hypothermic temperatures while supplying oxygenated perfusion prior to transplantation. Designed for reliability and ease of use, VitaSmart™ aims for a seamless adoption in various transplant centers across the United States following its FDA approval.

Acknowledgment of Collaborative Efforts

Webber expressed gratitude towards the contributing researchers, transplant teams, and clinical staff at the involved transplant centers, acknowledging their commitment to rigorous scientific execution which culminated in this milestone. Bridge to Life™ Ltd. remains dedicated to furthering organ preservation sciences and enhancing life-saving transplant solutions globally. For further information, visit Bridge to Life.