X-Therma receives FDA Breakthrough Device designation for organ preservation and transport solutions


X-Therma has announced that the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted its proprietary XT-ViVo organ preservation solution and TimeSeal organ transport device Breakthrough Device status.

“This milestone moves us as a company, and more broadly as an industry, one step closer to tackling the organ shortage problem,” said Xiaoxi Wei, CEO and co-founder of X-Therma. “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 gamechanger and, we envision, will prove to be a lifesaver for all of those in need.”

XT-ViVo is a novel organ preservation solution indicated for perfusion and flushing of a donor’s kidney prior to removal from the donor, or immediately after removal from the donor, according to X-Therma. The solution is left in the organ vasculature during hypothermic storage and transportation to the recipient.

The TimeSeal organ transport device is designed for static hypothermic preservation of adult donor kidneys during transportation and subsequent transplantation into a recipient using XT-ViVo. The anticipated debut of this device into the market has the potential to provide extended organ storage time for up to 120 hours, an X-Therma press release states.

Donor kidneys that exceed clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient, the release adds.

“Paired together, our technology will extend the time for organ transport while minimising ischaemic damage and consequently increase the global availability of organs, expand the organ pool, and improve donor-recipient matching as well as elective surgery scheduling,” said Mark Kline, CTO and co-founder of X-Therma.


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