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Preserving Life by Emulating Nature

X-Therma pioneers a breakthrough biopreservation platform, transforming “living” medicines into on demand treatments. We empower patients with access to safe, reliable organs, engineered tissues, and advanced cell & gene therapies, dismantling the obstacles of time and distance.

Products

For Cell and Tissue Cryopreservation

XT-Thrive®

cGMP grade, DMSO-free and non-toxic cryopreservation media perfected for clinical & commercial translation at ultra-low temperatures (-70°C to -196°C).

For Organ Preservation

XT-Vivo® and TimeSeal®

XT-ViVo® and TimeSeal® received FDA Breakthrough Device Designation in 2022. This turnkey solution for organ transplantation preserves organs up to 5 days at high subzero temperatures (0 to -20°C).
X-Therma’s biopreservation breakthroughs are solving these problems.
Organ Transplant

The Problem

Not Enough Time

90% Unmet Needs

80% Transplantable Organs Left Unused

Just Hours to Keep Organs Alive

1 Per Hour Die on Waitlist

Did you know that 80% of transplantable organs are NOT being transplanted, especially hearts and lungs?

In organ transplantation, we are racing against TIME on Ice every day, battling an extremely slim window where every minute matters. We currently perfuse and store an organ in preservation solution that is kept between 2-8°C in an igloo cooler on wet-ice. This only allows organ survival for less than a day. For the heart, that is an ephemeral 4 hrs. This extremely tight race severely hinders organ accessibility, breeds extreme risk, creates a logistics nightmare for the transplant team and significantly impacts patient survival. To win such a race, we MUST remove TIME from the equation.

The Problem

For Cell Manufacturing, DMSO and Serum No Longer Meet Integrated Demands

Poor Performance

• Poor post-thaw cell survival as low as 15-20%
• Cell functionality impaired

Toxic*

• Profound in vivo toxicity
• Severe injection site pain/neurotoxicity
• Adverse Genotoxicity

Hindered Scalability

• Processing nightmare
• Limited scale-up production
• Batch variation

Biopreservation is the key for commercial cell manufacturing & processing, which happens 3-5 times throughout the process. However, preservation has seen little improvement. Existing standards use 5-10% dimethyl sulfoxide (DMSO) with serum. A new solution is needed to enable “off-the-shelf” living medicines.

*Nature, Scientific Reports volume 9, Article number: 4641 (2019)

The Problem

Toxicity of In Vitro Materials

DMSO Adverse Toxicity and Genotoxicity

Poor Functional Recovery <10% (human eggs)

In Vitro Fertilization uses a high concentration of toxic vitrification media to freeze eggs or embryos that can kill a cat just in one teaspoon taken orally. This causes severe cell shrinkage and damage to the cell membrane, ultimately leading to a negative impact on the viability of the eggs, giving less than 10% with functional recovery.

The extreme changes in microRNAs and alterations in the epigenetic landscape indicate that DMSO is not inert. Its use should be reconsidered, especially for preservation of embryos and oocytes, since it may impact embryonic development.

*Nature, Scientific Reports volume 9, Article number: 4641 (2019)

XTherma-Design-Elements-44.png

"Look deep into nature, and then you will understand everything better. "

- Albert Einstein

As a fundamental principle of nature, reducing temperature extends time, but we had to find a way around the detrimental impact of ice crystals. Inspired by antifreeze proteins (AFPs) produced by arctic species who thrive in sub-zero environments, we developed a chemically defined antifreeze molecule that is hyper effective, non-toxic, biocompatible, and scalable.

News
X-Therma Achieves World’s First Subzero Organ Transports: Multiple 48-Hour Transatlantic Journeys Support First Steps Toward Tackling Organ Waitlist
Surgeons successfully transported pig kidneys between Baltimore and Innsbruck five times using X-Therma's FDA Breakthrough-designated subzero preservation technology
X-Therma Achieves GMP Commercial Readiness with XT-Thrive®
X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, has achieved GMP (Good Manufacturing Practice) commercial readiness with its flagship product, XT-Thrive®.
X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)
X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®.
NORTH AMERICA

625 Alfred Nobel Drive
Suite B
Hercules, CA 94547
USA

EUROPE

X-Therma GmbH
Langer Weg 11 
6020 Innsbruck
Austria