1. Getting the most out of the Ross report
Opportunity
The study
The products
Results
Why we win?
Overcoming reservations.
Plan - discussion.

2. The opportunity
A step change in the US military and government purchasing of hemostats is likely.
Celox is perfectly placed to make a huge step change in sales but only if we get our voice heard and influence the debate.

3. Today: how do we...
Make sure that everyone sees Celox as the “winner” and best product from the Ross study?
Prevent competitors from getting their spin across?
Drive an open market for hemostats with performance –based purchasing?
Grow sales.

4. The key study for the TCCC
A swine model of lethal arterial injury
Carried out by US Navy medical research unit.
Used D of D consensus swine model of uncontrolled hemorrhage with input from Army ISR scientists .
Compared 4 products including Celox Gauze to the incumbent Combat Gauze.
All used 3 minutes compression time.
Ten animals used on each product.
Several measures of success were used.
So what?
This is not just another test, it is a landmark study:
With support of TCCCC they tested all of the gauze products they saw as candidates. They have to take the results seriously.
The test was done so that the TCCC can review the recommendation to use Combat Gauze

5. The products Celox Gauze 10 ft x 3 in Roll. Combat Gauze 12 ft x 3 in
Z-fold.
Combat Gauze XL
12 ft x 4in
Double ply, Z fold.
Discuss:
1) Pack size : the two largest heaviest products ; Celox Gauze and Combat Gauze XL have similar volumes and weight.
2) Mechanism – all Chitosan except for Combat gauze and Combat gauze XL (kaolin)
Celox Trauma Gauze
6 ft x 3 in
Roll.
Chitogauze
12 ft x 3 in
Z-fold.

6. What results they measured
Lots....
Time taken to pack.
Stopping bleeding (hemostasis).
Re-bleeding after stopping bleeding.
Total amount of time bleeding was stopped.
Blood loss at three time points after treatment.
Amount of resuscitation fluid.
Various measures of the blood’s ability to clot at different times.
Survival.
Re-bleeding after pulling leg.
Material in the body at the end.
State of the tissues at the end.
So which are important?
Survival.
Achieving hemostasis
Total blood loss.
The state of tissues and material can also be important for safety.
Survival has got to be number one.
Total blood loss: this pretty much tells you what condition the casualty is in when they get to the OR
Hemostasis: stopping bleeding is the main point.

7. Hemostasis
Measured at 3 minutes after compression (“immediate”) and at study end (“eventual”).
For each product the first column is “immediate” the second column is “eventual”.
QCG: QuikClot Combat Gauze
QCX: QuikClot XL
CTG: Celox Trauma Gauze
CEL: Celox Gauze
HCG: Chitogauze

8. Results: Hemostasis
Celox Gauze 70 % at 3 minutes and 90 % at end of study.
Celarly outperforming Combat Gauze throughout.
Outperforms Chitogauze throughout.
Celox Gauze is #1 at study end with 90 %.

9. Blood loss
Measured pre-treatment just to show that the trial is fair to all.
Measured at 10 minutes, 30 minutes and study end (150 minutes). These measures are any pooled blood.
Reported in ml / kg. Figures look low, but animals weighed 36 kg. So for example 30 ml/kg is about two pints per animal.

10. Blood loss results Celox lowest blood loss overall
1,200 ml less than Combat Gauze, 400 ml less than Chitogauze (in a 36 kg animal).
#2 at 10 minutes and 30 minutes. Significantly better than CG at 10 minutes.
Celox lowest blood loss overall.

11. Survival
CELOX
Everyone else
Celox is the clear winner: 90 % survival - matching the 90 % hemostasis.

12. Histology – body tissue reaction
No difference between body response to products.
They did find Celox granules outside artery walls, but reported that none was found inside the walls.
Why is this important?
Outside walls is normal – this is the same as treating with Celox granules. Regardless of which product, casualties will always get wounds cleaned / debrided at damage control surgery.
We know particles of kaolin are released from Combat gauze, but these are nano-particles and may not be seen on histology.
Remember: residual Celox is metabolised. The kaolin in Combat Gauze has no known metabolic pathway.

13. Why we win Consistently #1 in the important end results:
Best survival
Lowest blood loss
Highest hemostasis.
Add to this, Celox Gauze is a product proven in real world use today.

14. Overcoming reservations

15. “Surely it is just “bigger is better”. XL was nearly as good as Celox
The bigger is better argument only works for Combat Gauze (works in a different way to us).
Our results show a smaller (5 foot) Celox gauze just as successful in a similar model as the 10 foot.

16. Compare 90 % survival for Celox with 70 % for “XL”....
“Combat Gauze worked for us – maybe we will switch to XL, it is the only one with two results statistically better than CG”
Let’s look at Combat Gauze XL. 8 achieved hemostasis, but only 7 survived – how does that happen?
Three XL animals died between 60 and 100 minutes: can the absorbency of XL hide ongoing bleeding in the wound?
Compare 90 % survival for Celox with 70 % for “XL”....

17. Celox beat Chitogauze on
“ I haven’t got room for the bigger products, I am going to use Chitogauze, it works and it fits in my IFAK – and it is antimicrobial.”
We can offer a 5 ft product with equal performance to the 10 foot roll Celox and fits in IFAK the same as Chitogauze.
Celox beat Chitogauze on
Superior hemostasis
Superior survival
Less blood loss.

18. Celox compared to Chitogauze

19. superior performance Celox had higher survival. Better haemostasis
90 %
Celox had higher survival.
Better haemostasis
Initial
Final.
How did Chitogauze get 80 % haemostasis and only 70 % survived?

20. Significantly less than control
Less blood loss
Lower blood loss at 10 minutes after treatment and at study end.
Celox significantly lower than Combat Gauze.
Significantly less than control *

21. Chitogauze performance
Limited published testing:
63 % haemostasis on first application, (Xie, ATACCC 2009).
“No significant difference compared to Combat Gauze” (Schwartz, 2011).
Celox gauze has been shown 100 % effective in tests in stopping bleeding.

22. Evidence Celox Gauze has published success, unlike Chitogauze
They rely on old Hemcon wafer data.
Article reporting 100 % success used on 21 gunshot wounds in Afghanistan1.
Gauze cases series in air ambulance
and military3.
1: Pozza M, Millner R, Eur J Emerg Med. 18:31-33 (2011)
2: Pozza M, presented at Italian resuscitation council, April 2011.
3: Tan, Bleeker, MCI Forum 3, September 2011.

23. Antimicrobial claims:
Chitogauze claim “effective against a wide range of micro-organisms”.
It is not as a treatment for infection.
It is not a claim based on clinical use. They cannot claim that it will stop infection.
The purpose of the haemostat is to stop bleeding and then transport the patient to surgical care.

24. Celox Gauze compared to Chitogauze.
Celox gauze has superior performance from the direct comparable test results.
Celox has clinical evidence, unlike Chitogauze.
Celox has more chitosan available at the site of bleeding.
The robust Celox Gauze allows faster packing speed than Chitogauze.
Celox Gauze maintains it s volume under pressure and expands when wet, keeping pressure on the bleeding site.

25. Back-up slides

26. “ Celox releases particles – it could cause thrombo-embolic events.”
No Celox found inside the arteries.
Combat Gauze also releases microscopic particles (of a pro-thrombotic, non-degradable material).
Celox is proven in field use (reference) and chosen by multiple NATO countries with no reported complications.

27. “ Celox took longer to pack.”
Celox was quicker than Combat Gauze XL.
The pack time difference with CG or Chitogauze was around 5 seconds – insignificant when you compare it to the higher survival that Celox has.
5 seconds to save a life!

28. Finally the “ I’m happy with Combat Gauze” customer.
Look at the results – Celox gauze compared to Combat Gauze
Celox Gauze has beaten Combat Gauze in all the three head-to-head independent tests published.

29. Some criticisms of the study
10 models for each product will not generally allow statistical proof in this type of work.
There are several measures of success, but not single main outcome measure. This may allow confusion if not dealt with.
Although any study can be criticised, this was set up with the input of the TCCC and key opinion leaders in this field – it was not done by some researchers in isolation.

30. Results: packing time
Pack time included the time to fill any dead space with Kerlix.
Exact figures were not given for Celox, Combat Gauze or Chitogauze – just the graph.
Celox Gauze faster than Combat Gauze XL, slightly slower than regular Combat Gauze or Chitogauze.
QCG: QuikClot Combat Gauze
QCX: QuikClot XL
CTG: Celox Trauma Gauze
CEL: Celox Gauze
HCG: Chitogauze

31. Re-bleeding Measures any bleeding after initial hemostasis achieved.
Combat Gauze and Trauma Gauze appear to do well but.....
Only 3 animals in those groups got initial hemostasis, so a very small sample.
None of the Celox rebleeds were fatal.
One fatal re-bleed for Combat Gauze XL and for Chitogauze.
You cannot re-bleed if you did not stop bleeding in the first place..

32. Total time bleeding controlled
Average time from treatment that the animal maintained hemostasis.
Long is good!
Celox #1 (120 minutes).
Implies that hemostasis was achieved quickly and then maintained.

33. Other results Resuscitation: Coagulation Leg pull at study end
Measured the amount of resuscitation fluid needed to get the blood pressure back to a set level. This can indicate how much blood was lost, but is not a direct measure. Celox performed well, with second lowest level.
Coagulation
A lot of factors can alter coagulation measures. Mostly these will be ignored... But for the record, Celox is the only product that shows some of these parameters going back to “normal” (start point) during the test.
Leg pull at study end
Done to simulate walking, but not very rigorous. All products passed this test.