XT-VIVO® & TIMESEAL®
Multi-Day Preservation of Organs, Tissues and Cells
The global shortage of transplantable organs is considered one of the greatest modern medical crises. Only 10% of the worldwide transplantation needs are being met. Every hour in the US, at least one patient dies while waiting for a life-saving organ. Donor availability is one part of the equation… the other is time.
XT-ViVo® & TimeSeal® will enable multi-day preservation and remove time from the equation. Check out our white paper on organ ischemia to learn more!
Organ Transplant
Not Enough Time
Do you know 80% of transplantable organs end up NOT being transplanted today, especially for hearts and lungs?
90%
1/hour
Die on waitlist
80%
transplantable organs wasted
Just hours
to keep organs alive
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.
cGMP CELL & GENE THERAPY
DMSO and Serum No Longer Meet Integrated Demands
- Poor post-thaw cell survival as low as 15-20%
- Cell functionality impaired
- Profound in vivo toxicity
- Severe injection site pain/neurotoxicity
- Adverse Genotoxicity
Nature, Scientific Reports volume 9, Article number: 4641 (2019)
- 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.
In Vitro Fertilization
Can we say “No” to toxins for healthy babies?
DMSO
Adverse Toxicity & 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)
Organ Transplant
Not Enough Time
Do you know 80% of transplantable organs end up NOT being transplanted today, especially for hearts and lungs?
90%
1/hour
Die on waitlist
80%
transplantable organs wasted
Just hours
to keep organs alive
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.
You Have Time
Our solutions provide significantly longer preservation of organs, cells, and tissues.
FDA Breakthrough Designation
The FDA has granted XT-ViVo® & TimeSeal® Breakthrough Device Designation for an intended kidney preservation and storage time of up to 120 hours. The products also have the potential to be used in other organ and tissue applications.
XT-ViVo® Biopreservation
XT-ViVo® is a preservation solution powered by our novel peptoid technology. The preservation solution is ice-free at high subzero temperatures, preventing damaging ice crystal formation. Lower storage temperatures reduce metabolism and the risk of ischemic damage, greatly extending preservation time.
TimeSeal® Transport Device
TimeSeal® is an innovative, lightweight, and easy-to-use transport device for organs, tissues, cells, and regenerative medicine. Organs, tissues and cells can be stored for 3-7 days with the highest temperature stability while maintaining functionality and viability. External power, oxygen, or blood is not required to keep the organ or tissue alive. The container is built with smart sensor technology to monitor transport.
Benefits of XT-ViVo® & TimeSeal®
Extension of Time
XT-ViVo® will enable subzero preservation for 3-7 days compared to the 4-24 hours we have today.
TimeSeal® will provide a stable subzero environment.
Increased Transplant Availability
XT-ViVo® & TimeSeal® will eliminate geographic restriction, enabling organs, tissues, and cells to be shared around the world.
Better Transplant Quality
Subzero preservation is the most effective way to slow down metabolism and extend the life of an organ. XT-ViVo® eliminates ice phase transitions and reduces the risk of shock-induced ice damage during organ transport.
Smart & Easy Transportation
The TimeSeal® transport system contains an integrated intelligent sensor system that transmits real-time logistics data to the receiving team during transport. Simplicity and effectiveness in one platform. No supporting accessories such as blood, oxygen, or external power supply are required.
Medical Cost Reduction
Improved organ matching can shorten postoperative treatment time and reduce medication use.
Organ transplants can be scheduled in advance, eliminating middle-of-the-night and weekend procedures.
