X-Therma Inc., a biotechnology company developing breakthrough technology for regenerative medicine and organ preservation – announced today that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted its proprietary organ preservation solution, XT-ViVo®, and TimeSeal® Organ Transport Device, Breakthrough Device status. This designation is granted to products that have the potential to offer more effective diagnosis or treatment of life-threatening diseases with an unmet medical need.

“This milestone moves us as a company, and more broadly as an industry, one step closer to tackling the organ shortage problem,” says Dr. Xiaoxi Wei, CEO & Co-Founder of X-Therma. “With less than 10 percent 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.”

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. The solution is left in the organ vasculature during hypothermic storage and transportation to the recipient.