Bridge to Life Receives FDA 510(k) Clearance for Multi-Sourced Belzer UW® and MPS® Solutions with Expanded Labeling for MPS® Across All Abdominal Organs

DULUTH, Ga., Oct. 7, 2025 /PRNewswire/ -- Bridge to Life, Ltd. (BTL), a global leader in organ preservation and perfusion, today announced it has received FDA 510(k) clearance for its multi-sourced Belzer UW^® and MPS^® organ preservation solutions. Notably, this clearance includes expanded labeling for Belzer MPS^® UW Machine Perfusion Solution to cover all abdominal organs — a first-of-its-kind milestone in the field of transplantation.

Customer Assurance and Supply Continuity
Bridge to Life's solutions are utilized daily by Organ Procurement Organizations (OPOs) and transplant centers throughout the United States and internationally. To ensure uninterrupted access, the company maintains a minimum 60-day global inventory buffer and has established multiple exclusive supplier agreements across key regions. This approach enhances operational resilience and mitigates supply chain risks, while also enabling the delivery of highly customizable solutions to meet the evolving needs of our customers.

Advancing Global Regulatory Approvals
In parallel, Bridge to Life is pursuing CE Marks for its preservation solutions, with approvals anticipated in 2026. These efforts highlight BTL's commitment to global access and compliance with evolving regulatory standards.

From Distributor to Industry Leader
With longstanding exclusive rights to Belzer UW^® and MPS^® from the University of Wisconsin and the addition of BTL-owned EasiSlush^®, the company has built a portfolio of trusted brands that have supported transplants for more than a decade. In addition to solutions, Bridge to Life continues to invest in engineering and next-generation product development, positioning itself as the only company offering both foundational preservation solutions and innovative perfusion technologies.

About Bridge to Life^™ Ltd.

Bridge to Life^™ Ltd. is a global leader in organ preservation solutions, offering premier products including Belzer UW^®, EasiSlush^®, and the VitaSmart^™ Hypothermic Oxygenated Perfusion System. With a strong focus on product quality, innovation, and accessibility, Bridge to Life partners with leading Transplant Centers and Organ Procurement Organizations worldwide.

For more information about Belzer UW^® Cold Storage Solution, Belzer MPS^® Machine Perfusion Solution, and other Bridge to Life products, please visit https://bridgetolife.com.

VitaSmart^™ is CE Marked and available for sale in several markets outside of the United States. VitaSmart^™ is an investigational device in the U.S. and currently pending FDA review and clearance; not approved for sale in the U.S.

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SOURCE Bridge to Life, Ltd.