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
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.
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.
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.
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[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.
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)
...