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)
...
4/ - PROCEED II's LT survival results (not homerun overall outcomes, but I guess $TMDX shows low cardiac death)
Side note:
PROCEED is supplemental. Panel on EXPAND.
Good thing EXPAND is doing better than OCS PROCEED. Also, there are arguably worse-condition hearts in EXPAND.
5/ - Using FDA's Piecewise exponential model, FDA thinks EXPAND survival rate might drop to rates similar to PROCEED
- (i) Use of MCS (Mechanical Circulatory Support) & (ii) ICU stay length both higher in EXPAND than PROCEED's OCS / Control
*but again, these are worse hearts
6/ Ultimately, $TMDX beat the 65% benchmark in primary endpoint, but MUST keep balanced view.
FDA can question how data came about / whether it is valid.
This will ultimately depend on Panel. Waleed, Schroder and others at meeting need to be on A-game and crush it.
7/ I think it is crucial to emphasize that FDA Panel was never meant to be easy. This is normal.
As a rebuttal regarding single-arm trials, believe $TMDX will argue that it is unethical to randomize and use extended-criteria hearts w/ cold storage (can lead to death).
8/ PROCEED II should in theory also be supplemental information, given there is no control group for EXPAND.
Main focus is on EXPAND results, not PROCEED II, which used a different OCS Solution (HTK Custodiol, which is extracellular i.e., low potassium)
9/ Personally not my job to guess FDA decision (even CEO Waleed keeps repeating that he's not in the position to do so).
However, $TMDX's OCS Heart should bridge well into DCD Hearts which is a revolutionary unlock in supply.
10/ Leaving off w/ screenshot below. FDA mentions structure / setup of the trial, but let's not forget the worst survival rate is for unattended people on waitlists.
Believe $TMDX will give Tx surgeons more tools.
It will also give dying patients more options.
• • •
Missing some Tweet in this thread? You can try to
force a refresh
[THREAD]
Update on rest of $PAVM's biz segments.
- Minimally Invasive Surgery (CarpX)
- Infusion Therapy (PortIO + NextFlo)
- Emerging Innovations (DisappEAR + Solys)
Exercise is to discuss product/potential but also analyze changes in Mgmt commentary over time.
Please DYODD.
1/ Minimally Invasive Surgery...
Carpal Tunnel Syndrome ("CTS")
- Median nerve compression
- Numbness/weakness/pain
- >50% of occupational injuries
- 5mm U.S. adults
- 2mm visits but 600K procedures/yr
- Typical sol'n is open surgery (long recovery time)
- 1mm+ silent patients
2/ $PAVM's solution: CarpX
- Minimally invasive / fast recovery
- Balloon catheter inserted under scarred ligament, tensioning it while pushing nerve & tendons away
- Once activated, bipolar radio-frequency electrodes precisely cut ligaments from inside out
- Fast recovery time
[THREAD]
Couple more thoughts on Lucid before we move on.
- What a Binary EsoGuard Test Means
- Revisiting Treatable Population + Test Frequency
- Is EsoCheck Uncomfortable?
- Learning Curve for NPs
- Highlighted by NCI as Advance in Cancer Prevention
Enjoy!
1/ One of the most bullish arguments that I believe strongly applies to $PAVM is that GI physicians will be supportive of the technology.
EsoGuard Test is binary. What this means is that results literally just show "Positive" or "Negative".
What does this mean?
2/ Positive means you either have: 1) Non-Dysplasia BE; 2) Dysplasia BE (Low-Grade) 3) Dysplasia BE (High-Grade); or 4) Full blown esophageal cancer
It is 90%+ in telling if you have ANY of the above.
BUT it doesn't tell you which one.
Schroder crushed it with his closing sentence for his segment saying OCS technology not only solves current quantity in the waitlist but can also allow an increase in waitlist size.
He literally said that there are plenty of good hearts out there - - just need to use OCS.
Chris Mullin (Independent Advisor) brought on by $TMDX reiterated the Piecewise FDA model is not valid nor reliable for long-term death extrapolation.
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).
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
...
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