Organ Assist, a leading medical technology company in donor organ perfusion, is preparing to enter the USA market. To do so, the existing technology platform and the disposable sets will need to be adjusted to adhere to the Food and Drug Administration (FDA) regulations. Organ Assist has been awarded a subsidy of €200 thousand by the Groningen Province to support this market introduction.
Wilfred den Hartog, CEO of Organ Assist, commented: “Donor organ shortage is a world wide issue. We have received a lot of requests from USA based healthcare providers concerning our products and services. To enter the USA market we need to invest in making our products and services compliant to the FDA regulations. We are grateful to receive this subsidy from Groningen Province to support our development and USA market introduction, as it enables us to supply the USA healthcare providers with the tools to make more and better quality donor organs available for patients in need of a transplantation.”
Organ Assist will start the FDA regulatory process in the course of 2019, with the aim to clinically treat the first donor organs in the USA in 2020.