#United States #Duluth #Bridge to Life #FDA 510(k) #Belzer UW

Bridge to Life Achieves FDA Clearance for Innovative Organ Preservation Solutions

On October 7, 2025, Bridge to Life, Ltd. (BTL), a recognized pioneer in organ preservation and perfusion technology, announced significant news within the medical community. The company has obtained FDA 510(k) clearance for its multi-sourced organ preservation solutions, namely the Belzer UW® and MPS® solutions. This achievement not only reinforces the company’s commitment to advancing healthcare but also introduces expanded labeling for the Belzer MPS® UW Machine Perfusion Solution to encompass all abdominal organs, marking a groundbreaking development in the transplantation field.

Commitment to Excellence and Supply Reliability

Bridge to Life's solutions play an integral role in the daily operations of Organ Procurement Organizations (OPOs) and transplant centers, both in the United States and abroad. To maintain a steady and reliable supply of its products, the company has instituted a minimum 60-day global inventory buffer and secured multiple exclusive supplier agreements across diverse regions. This proactive approach aims to enhance operational resilience while minimizing supply chain disruptions. Furthermore, it allows the company to deliver tailored solutions that cater to the dynamic needs of healthcare professionals and institutions.

Pursuing Global Regulatory Approvals

In addition to the latest FDA clearance, Bridge to Life is actively pursuing CE Marks for its preservation solutions, which are anticipated to receive approval in 2026. This initiative signifies the company's dedication to providing global access to its innovative products while adhering to evolving regulatory frameworks. The pursuit of international approvals reflects Bridge to Life's drive for compliance and innovation within the global market.

Transitioning from Distributor to Industry Leader

Having held exclusive rights to the Belzer UW® and MPS® from the University of Wisconsin for several years, Bridge to Life has solidified its standing as a leader in organ preservation solutions. Together with its proprietary EasiSlush® solution, the company boasts a comprehensive portfolio that has been instrumental in facilitating successful transplants for over a decade. Beyond providing quality solutions, Bridge to Life is committed to continuous investment in engineering and the development of next-generation products. This unique strategy positions the company distinctively as the only organization that combines foundational preservation solutions with cutting-edge perfusion technologies.

About Bridge to Life™ Ltd.

Bridge to Life™ Ltd. is dedicated to advancing the field of organ preservation, delivering premier products that include the Belzer UW®, EasiSlush®, and the VitaSmart™ Hypothermic Oxygenated Perfusion System. The company is steadfast in its commitment to product quality, innovative solutions, and global accessibility. Collaborating with leading transplant centers and organ procurement organizations worldwide, Bridge to Life emphasizes the importance of improving patient outcomes through advanced organ preservation techniques. For those interested in learning more about their products, including the Belzer UW® Cold Storage Solution and Belzer MPS® Machine Perfusion Solution, further information can be found on their official website: Bridge to Life.

Conclusion

The FDA clearance achieved by Bridge to Life not only reaffirms the company’s dedication to innovation in organ preservation but sets a new standard in the transplantation industry. With responsive solutions tailored for abdominal organ preservation, Bridge to Life continues to enhance the quality of care in organ transplantation, ultimately contributing to improved patient outcomes and a brighter future for the field.