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.
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. 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.
“Paired together, our technology will extend the time for organ transport while minimizing 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,” says Dr. Mark Kline, CTO & Co-Founder of X-Therma.
The Breakthrough Device program is designed to enable accelerated development, assessment, and review processes, with the intention to provide patients with more timely access to breakthrough technologies or devices. This program also offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way.