How did we go from this (extracts from TIS ASX ann 11 Nov 2011) ......
********** Clinical data from 44 difficult-to-treat venous ulcer patients treated with VitroGro® ECM for 12 weeks show: • 34% (15 patients) were completely healed. •43% (19 patients) were more than 90% healed. • 82% (36 patients) were improved ie. were partially or completely healed. • Average reduction in venous ulcer area was 56%. • Average ulcer size at the start of the trial was 7.2 cm2. • Average time the treated ulcers had not responded to expert care prior to VitroGro® ECM treatment was 36 months. • Average age of the patients in this study was 74 years. • Treatment twice per week was no more effective than once per week. • No adverse events related to VitroGro® ECM have been reported after a total of more than 750 uses of the VitroGro® ECM device. ........ The internationally respected wound care clinician and researcher, Professor Keith Harding from the Cardiff University Wound Healing Clinic led this study. **********
...... to this ..... TOTAL ABJECT FAILURE!!!
The following is not criticism - just plain fact:
In view of the trials and tribulations of the old TIS, which as I understand it, were mainly procedural, we got together a smart and talented board. They went about setting things straight - doing it properly, dotting every i, crossing every t and leaving no stone unturned, designing the mother of all trials for a product that was obviously effective but managed shoddily. It was a no brainer. We had the added comfort of comparison with the VENUS III study as the trial progressed. It was a double no brainer.
In my shattered state, I can only come to one nonsensical conclusion ..... they picked exactly the wrong cohort, thereby demonstrating that an effective treatment is ineffective.
Last night I would have rated the possibility of this outcome as zilch as there had to be at least some degree of efficacy.
