DULUTH, Ga., Oct. 7, 2025 — Bridge to Life Ltd. has received FDA 510(k) clearance for its multi-sourced Belzer UW® and MPS® organ preservation solutions, including expanded labeling for Belzer MPS® UW Machine Perfusion Solution across all abdominal organs. This marks the first clearance of its kind in transplantation, enhancing clinical flexibility and access for transplant centers nationwide.
Science Significance
The clearance validates Bridge to Life’s leadership in organ preservation science, ensuring high-quality solutions that maintain organ viability during transport and storage. The expanded indication for Belzer MPS® UW Machine Perfusion Solution supports liver, kidney, pancreas, and intestinal transplants, offering greater consistency in perfusion outcomes and extending organ preservation times — a vital innovation in transplant medicine.
Regulatory Significance
The FDA 510(k) clearance confirms full compliance with U.S. medical device and biologic preservation standards, setting a new precedent for perfusion technology. Bridge to Life is also pursuing CE Mark approval in 2026 to expand global availability. This achievement underscores the company’s adherence to evolving U.S. and international regulatory frameworks governing cGxP-compliant device manufacturing and labeling.
Business Significance
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Bridge to Life’s regulatory win strengthens its commercial standing as a global supplier of preservation and perfusion systems. With multiple supplier agreements and a 60-day global inventory buffer, the company ensures uninterrupted access and supply-chain resilience for organ procurement organizations (OPOs). The clearance reinforces Bridge to Life’s transition from distributor to full-scale MedTech innovator, supporting its growing product ecosystem that includes EasiSlush® and VitaSmart™ Perfusion Systems.
Patients’ Significance
The ability to preserve organs across all abdominal types directly benefits patients awaiting life-saving transplants. Expanded labeling for Belzer MPS® UW enables more efficient donor-organ utilization and reduces organ discard rates, potentially increasing the number of viable transplants performed annually. Patients and clinicians alike gain from improved preservation, enhanced graft survival, and reduced ischemic injury.
Policy Significance
This clearance aligns with federal and global healthcare initiatives to expand transplant capacity and improve organ preservation standards. It supports broader public health goals by promoting innovation in perfusion and cold storage technologies, essential for reducing transplant waiting lists and mortality.
Bridge to Life’s FDA 510(k) clearance for multi-sourced Belzer UW® and MPS® solutions marks a breakthrough in organ preservation. By combining regulatory excellence, scientific precision, and operational resilience, the company continues to advance MedTech innovation and redefine transplantation quality worldwide.
Source: Bridge to Life™ Ltd. press release
