The FDA’s Breakthrough Device status will enable the firm to speed up the development, evaluation, and review procedures of XT-ViVo and TimeSeal
US-based biotechnology firm X-Therma has received Breakthrough Device status from the US Food and Drug Administration (FDA) for its XT-ViVo preservation solution and TimeSeal organ transport device.
XT-ViVo is used to perfuse and cleanse a donor’s kidney before or soon after it is removed from the donor. During hypothermic storage and transportation to the recipient, the solution is left in the organ vasculature.
The TimeSeal Organ Transport Device is designed to keep adult donor kidneys static hypothermic during transit and subsequent transplantation into a recipient leveraging XT-ViVo.
X-Therma CEO and co-founder Dr Xiaoxi Wei said: “This milestone moves us as a company, and more broadly as an industry, one step closer to tackling the organ shortage problem.
“With less than 10% of the worldwide demand met for transplantable organs, being able to remove time barriers for safe and reliable organ preservation, without changing the peri-transplant workflow, is a game-changer and, we envision, will prove to be a lifesaver for all of those in need.”
X-Therma is planning to launch the technology in the market that has the potential to give up to 120 hours of organ storage time.
The company said that donor kidneys that have beyond the clinically acceptable static hypothermic preservation durations should be examined by a transplant surgeon to determine transplantability as per the established clinical criteria and the best medical interest of the intended recipient.
X-Therma CTO and co-founder Dr Mark Kline said: “Paired together, our technology will extend the time for organ transport while minimising ischemic damage and consequently increase the global availability of organs, expand the organ pool, and improve donor-recipient matching as well as elective surgery scheduling.”
The Breakthrough Device status is granted to speed up the development, evaluation, and review procedures in order to give patients faster access to breakthrough technology or devices.