24 june 2019
Groningen, The Netherlands, June 24th 2019
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.
For more information please contact:
W.F. den Hartog – CEO
T: +31 50 3131905
Notes to editors:
About Organ Assist
Organ Assist is a medical technology company with an unique versatile platform to perfuse donor organs. The company develops, manufactures and commercializes innovative medical devices, disposables and services which improves the quality and increases the number of donor organs.
The portfolio is developed in-house in collaboration with leading academic centers around the world. It consists of dedicated organ perfusion solutions for liver (Liver Assist), kidney (Kidney Assist-transport and Kidney Assist), lungs (Lung Assist) and donor perfusion (Donor Assist). To date, more than 100 devices have been installed and more than 1200 organs have been successfully perfused.
Organ Assist is a privately held company based in Groningen, The Netherlands. The company is a center of excellence in donor organ perfusion, conditioning and testing and is ISO 13485-certified. The technology platform and clinical application are protected by a broad portfolio of patents and the company’s products are CE certified and have received clearance from other international authorities.
For more information, visit: www.organ-assist.nl
Our devices are all CE marked
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9723 AZ Groningen
+31 50 313 1905