1/ We've mentioned before that extra utilization for DBD Hearts is 81% when using $TMDX.

The comparison between OCS and UNOS SRTR in the tables below is pretty powerful. Look at % in p. 36.

OCS can expand pool into donors w/ various risk factors (previously unused organs). ImageImage
2/ 19% of 93 hearts in study turned down.

Main reason being lactate rising, which is a biomarker mentioned by Dr. Schroder in presentation earlier.

Out of 75 hearts used...
24% age >65%
64% history of mechanical circ support
16% F-to-M mismatch
15% renal dysfunction
... ImageImageImage
3/ 6.3hr cross-clamp (while w/ cold storage, 85% of hearts transplanted are <4hr, so major UPLIFT)
*Highest cross-clamp time in study of 11.4hr... wow
while minimizing cold ischemic time

Primary effectiveness (on 30-day survival and no severe ISHLT PGD): 88% vs. 65% perf goal ImageImage
4/ From the study, can see only 10.7% in severe Primary Graft Dysfunction (first 24 hr.), lower than other studies.

Again, lots of recipients are already unhealthy to begin with, so overall survival trends down post-Tx. Should focus on cardiac survival made possible by $TMDX. ImageImageImageImage
5/ 4 deaths in EXPAND trial
(70/74 survived; 75th needed retransplant)
Death from defects in liver, lung, and even car accident

With EXPAND Cap, even higher survival than EXPAND at 100%. 2.4% of severe PGD.

Same trend goes for overall vs. cardiac survival in EXPAND + CAP. ImageImageImage
P.S. Want to clarify that 24% in 2nd tweet in thread is RECIPIENT age >65 i.e. 18/75. If you look at screenshot, it’s clearly labeled.

For the trial, DONOR age >55 is 11.8% (11/93) per 1st message in thread.

Suggest you look at actual screenshots along with commentary.
Re: tweet 5 of the thread, 70/74 survived as of 30 DAYS POST-TRANSPLANT, which is the secondary endpoint measured.

In total trial timeframe, there are indeed more deaths:
PGD: 4
Multiorgan Failure: 2
Pneumonia: 1
Pulmonary Embolus: 1
Severe AB & Cellular Rejection: 1
The 4 acute severe PGD cases happened very soon after actual Transplant.
3 cases within 24hrs.
1 case within 48hrs.

Believe this means the rest of the deaths came from completely other sources and were after 30-day mark.

Again, Recipients were not the most healthy lot. Image

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More from @genghis_pon

5 Apr
1/ $TMDX results are positive, but FDA's job is to question things every step of the way.

In spirit of being informed / keeping a balanced view, below are some FDA concerns:

- Trial design (single-arm study)
- $TMDX's subjective definition of extended-criteria hearts
... ImageImage
2/ - Extended-criteria hearts in EXPAND also include single-criterion >=4hr cross-clamp time, which actually make it somewhat overlap w/ PROCEED group

(i.e. imperfect definition extended-criteria heart) ImageImageImageImage
3/ - 65% as questionable performance goal (b/c $TMDX defined goal after benchmarking w/ old studies that achieved 22.6%-32.0%, but those studies didn't use standard definition of PGD and don't know proportion of extended-criteria pop in those studies)
... ImageImage
Read 10 tweets
19 Mar
[THREAD] Detailed thoughts on $TMDX below

- "Key Geographies" Supply-Driven TAM
- U.S. Supply-Driven TAM
- Demand for Organ Transplants (Lung/Heart/Liver)
- Larger donor list --> larger recipient list
- Quick revenue sizing based on current demand
- More positive catalysts
1/ Company-provided TAM from $TMDX's 10K of $8.02Bn for lung, heart and liver.

This is supply-driven i.e., sizing opp by unlocking utilization of previously unused organs.

"Key Geographies" per $TMDX include US, Canada, EU and Australia.
2/ We extrapolate $TMDX's TAM for U.S. by applying utilization assumptions from above to Company-provided U.S. figures.

We get U.S. TAM of approx $3.65Bn.

Important to know b/c a successful FDA panel will first benefit U.S. commercial efforts, then trickle over to int'l after.
Read 13 tweets
18 Mar
1/ Senator Bill Frist, MD ($TDOC Board Member for 7 years) on CEO Jason Gorevic:
“One thing that obviously impressed me about your leadership is your ability to say where you’re going based on, as you've said, a plan from 7 years ago - the pyramid that you’ve always presented...
2/ ...that this is where we’re going to be someday. Everybody presents that, but you made it real block by block. I still have those initial slides of your presentation. As you’ve said, none of this is new in your mind.”
Link >>
3/ Am confident in $TDOC. Despite recent events: (i) MDLive acquired by $CI in Feb '21, and (ii) Dr. on Demand merging with Grand Rounds in Mar '21, and (iii) $AMZN Care offering services to employers across the nation by summer '21...
Read 10 tweets

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