Overview
X-Therma develops a proprietary biopreservation platform using peptoid-based solutions to enable long-term subzero storage of cells, tissues, organs, and biologics. Their XT-ViVo organ preservation solution and XT-Thrive cryopreservation media extend preservation times beyond traditional cold storage limits, addressing critical gaps in transplantation and regenerative medicine. The company's FDA Breakthrough Device-designated technology has demonstrated successful transatlantic organ transport and maintains organ functionality post-transplant.
Frequently asked questions
- What regulatory approvals has X-Therma obtained?
- X-Therma's XT-ViVo and TimeSeal organ transport system received FDA Breakthrough Device Designation in late 2021 for preserving human kidneys for up to 120 hours (5 days), compared to the traditional 24-hour limit.
- What are the key differences between X-Therma's solutions and conventional preservation methods?
- X-Therma's peptoid-based technology enables ice-free subzero preservation at temperatures between 0°C and -20°C, preventing damaging ice crystal formation. Unlike traditional static cold storage at 2-8°C using ice coolers, X-Therma requires no additional perfusion instruments, blood, or oxygen, and offers DMSO-free, serum-free, and protein-free formulations.
- What clinical evidence supports X-Therma's technology?
- X-Therma has successfully completed five transatlantic pig kidney transports with preservation times of 48-72 hours. A transplanted kidney maintained normal renal function for 200 days post-transplant after 72 hours of ice-free subzero preservation, demonstrating proof of concept for the technology.
- Which cell and tissue types can X-Therma preserve?
- XT-Thrive supports preservation of PBMCs, T cells, CAR-T cells, B cells, iPSCs, iPSC-derived cardiomyocytes, bone marrow and bone marrow-derived HSCs and MSCs, cord blood, organoids, spheroids, beta islet cells, and liver clusters at ultra-low temperatures (-70°C to -196°C).
- What is X-Therma's biopreservation technology based on?
- X-Therma's technology is inspired by naturally occurring anti-freeze proteins found in Arctic species. The company developed proprietary biomimetic peptoid molecules that prevent ice crystal formation, enabling safe long-term subzero storage while maintaining cell and tissue functionality and viability.