X-Therma’s XT-ViVo and TimeSeal were granted the breakthrough device status by the US Food and Drug Administration (FDA) in May 2022. Image Credit: pathdoc / Shutterstock.

US-based X Therma has closed $22.4m in an oversubscribed Series B funding round.

The company plans to use the funds to scale its global commercial operations and facilitate the clinical progression of its medicine and organ preservation devices.

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The Series B financiers included a new investor, Starling Locke Capital, along with a previous investor LOREA AG.

X-Therma’s XT-ViVo organ preservation solution and TimeSeal organ transport device are being developed for the storage and transport of transplant organs.

XT-ViVo is indicated for perfusion and flushing of a donor’s kidney before or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the recipient. It allows organ preservation at sub-zero temperatures while preventing the formation of ice crystals, thereby, reducing ischaemic damage to the organ.

XT-ViVo and TimeSeal were granted the breakthrough device status by the US Food and Drug Administration (FDA) in May 2022. The solution and device can extend the organ storage time for up to 120 hours, compared to the classic method of using ice and a cooler box.

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The company’s portfolio also includes a cryopreservation device, XT-Thrive, for the cryopreservation of various therapies, including vaccines, cell and gene therapies, and engineered tissues. The device contains a non-toxic cryopreservation media that allows for the preservation of mammalian cells at ultra-low temperatures of -70°C to -196°C.

X-Therma’s XT-NoVo, a cell product preservation solution; and TimeSeal, a tissue and cell transporter device, can be used to store and transport cell-based materials and products at sub-zero temperatures of -5°C without freezing. The storage solution increased the shelf life of biologics from one to two days to up to seven days.

Multiple companies are developing organ preservation devices. In September 2023, US-based Paragonix debuted its organ preservation system, LIVERguard. The US FDA-cleared device was used to successfully transport a liver 1,200 miles from Puerto Rico to Florida.

In July 2023, OrganOx raised £25m ($32m) to develop its normothermic machine perfusion (NMP) device that preserves donor livers in a functioning state for up to 24 hours before transplantation. In December 2023, Vascular Perfusion Solutions received a $25,000 grant from the Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC) to develop its VP.S Encore cardiac preservation technology into a portable paediatric device.