Apersys granted Breakthrough Device Designation from the FDA

Thursday, 20.03.2024

 Apersys has achieved a significant milestone with the recent Breakthrough Device Designation granted for its perfusion device by the U.S. Food and Drug Administration (FDA). This designation recognizes the device’s innovative technology, tailored for long-term ex-vivo normothermic machine perfusion to improve liver organ recovery and transplantation procedures. The FDA’s Breakthrough Device Program is dedicated to supporting the development and prioritizing the regulatory assessment of medical devices that promise more effective treatment compared to currently available medical practice [1]. 

 The United States stands as the predominant liver transplant market globally, witnessing over 9,000 liver transplants in 2022 [2]. Projections indicate that the entire U.S. liver transplant market is poised to expand at an annual rate of 7 percent until 2030 in face of a growing request for organ donation [3].

At the core of the Breakthrough Devices Program lies the commitment to provide patients and healthcare providers with timely access to new life-saving technologies. This entails expediting the development, evaluation, and review processes through the FDA. In line with this initiative, Apersys AG has been granted priority review status, facilitating interactive communication with the FDA and expediting the path to market access. The Breakthrough Devices Program also enables closer interaction with reimbursement bodies and can facilitate coverage benefits. 


[1] Breakthrough Devices Program
[2] OPTN (Organ procurement and transplantation network)
[3] Apersys Market Intelligence

Apersys AG

Apersys AG

c/o ETH Zürich

Weinbergstrasse 35

WEH F, 8092 Zürich


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