This company is not hyper-growth at this point, but I believe it will be in the next year or 2 (assuming they get some key FDA approvals). I have posted on them several times in the past if you want to get more background.
There are different Heart related trials from TMDX:
Donor after Brain Death (DBD) - this is the “standard” type of donor and transplant. TMDX has completed this trial and is waiting for FDA review.
Donor after Circulatory Death (DCD) - these hearts are rarely/never used in the US without the TMDX device. TMDX is finishing up a trial for this group and will submit for approval next year.
Expanded Criteria Hearts - these are hearts that normally would not be used for a variety of reasons, but now CAN be used with the TMDX device. The video in the link goes in depth on the trial for this type of heart. The video also touches on the other criteria hearts in different places.
It may be a little hard to follow for those that don’t have a medical background, but it’s still worth a watch if you are one of the few that have invested in this company. It is one of the lead investigators in the trial presenting, and he gives a very balanced assessment - touching on both the good and bad aspects of the trial.
The stock has been doing well in the last couple weeks, and there are many catalysts coming in 2021. If the FDA approvals come in as expected, it is very realistic for them to have 100% growth the next 2 years - with very high gross margins.
AK,
What is your take on the competition from XVIVO? https://www.xvivoperfusion.com/
XVIVO seems to be the leader in lung transplants. They trade on the Swedish market and they seem to be larger than TMDX.
AK, What is your take on the competition from XVIVO? https://www.xvivoperfusion.com/ XVIVO seems to be the leader in lung transplants. They trade on the Swedish market and they seem to be larger than TMDX.
I have not looked into XVIVO in a while, but here is what I had written about them in my research notes:
o Competitor XVIVO has a system for lung perfusion, but it is not portable (it’s a big stationary machine). It was designed to be used for evaluating lungs in the transplant hospital after they were collected and retrieved using the cold storage process. It is not really a direct competitor to TMDX. Once TMDX OCS is fully deployed in lungs, the XVIVO system will be obsolete in my opinion.
? The intention of the XVIVO system was to evaluate “questionable” quality lungs after they had been transported and delivered to the transplant hospital. The lungs are still transported with regular cold storage and then they are warmed up and tested in the XVIVO device. The potential damage from cold storage is still an issue.
The TMDX system is a much better option IMO because it keeps the lungs warm during the entire transport time and also enables evaluation of the lungs in much the same way that the XVIVO system does.
The other HUGE advantage of the TMDX system is the ability to keep lungs viable for a much longer time - which enables transport over long distances. XVIVO is limited by the amount of time lungs can be kept viable when stored on ice - about 6 hours if I’m remembering correctly.
The portable nature of the TMDX device enables donor lungs to be put directly into the TMDX device after removal from the donor. They are then perfused (warm, oxygenated blood is pumped through them) during the ENTIRE TRANSPORT PROCESS. TMDX has successfully transported donor lungs from Hawaii to hospitals in the eastern US which were then successfully transplanted. The donor lungs were in-transit over 20 hours. This is impossible with XVIVO.
The 2 competing systems will co-exist in the short term, but I think TMDX will eventually take most of the market. NOTE - I’m no expert, and I don’t work in the field, so these are just my opinions based on what I’ve read.
I’m no expert either, but my take is the same based on what I read. They are just a bit better cold storage process. TMDX is in a different league. Plus, I didn’t see anything for XVIVO for transplanting livers or hearts. TMDX has units that provide for those as well (US use in final stages of approval). My recollection is livers and heart transplants are higher margin and have less competition.
I’m no expert either, but my take is the same based on what I read. They are just a bit better cold storage process. TMDX is in a different league. Plus, I didn’t see anything for XVIVO for transplanting livers or hearts. TMDX has units that provide for those as well (US use in final stages of approval). My recollection is livers and heart transplants are higher margin and have less competition.
Mike
Correct that TMDX has devices for all 3 organs - with future plans to develop a device for kidneys. The other big advantage that TMDX will have is the service organization they are developing. They will have TMDX technicians regionally located that will be trained on using all 3 organ devices to assist with organ retrieval, transportation, and delivery - XVIVO has nothing like that. My opinion has been that the success (or failure) of the service organization will be the determining factor in how big and fast TMDX grows.
I’m not sure on margins, but I do know the number of transplants is much higher for liver and heart than it is for lungs.
2019 total transplants for lung = 2,700; heart = 3,500; liver = 8,900; kidney = 15,500.
NOTE - the kidney number is only for deceased donors. It’s much higher for live donor kidney transplants.
Here is another great video regarding the TMDX OCS system. This one is specific to the DCD Heart Trial (this is a different trial than the last video link I sent). It is a surgeon from Mass General Hospital providing an overview to a group of people representing different Organ Procurement Organizations. Overall very positive on the TMDX system IMO.
During the Q&A at the end he talks about the challenges of sending organ procurement teams out around the country to get the donated organs. He envisions “local” teams in the future that would collect the organ and ship it to the receiving hospital - this is exactly what TMDX is working on implementing with their service organization.
The presenter also says at the end that the TMDX system adds a lot of expense, but that in his opinion hospitals are going to pay for it because people are going to want it.