robust eu final clinical trial results

Robust EU Final Clinical Trial Results
Biomedical company, Tissue Therapies Limited (ASX: TIS) has today released the final report from the 44 patient, five site,
international clinical trial of VitroGro® ECM for the treatment of venous ulcers. The internationally respected wound care
clinician and researcher, Professor Keith Harding from the Cardiff University Wound Healing Clinic led this study.
The objective of this trial was to produce data from a minimum of 40 patients that demonstrated the effectiveness of
VitroGro® ECM in healing chronic, complex, persistent venous ulcers that were unresponsive to a protracted period of expert
care with current state of the art treatment. This study has been successful in achieving these objectives.
This data will be used for submission for EU approval for sale. Detailed planning for the start of VitroGro® ECM sales in the EU
during the second quarter of 2012 is almost complete.
The CEO of Tissue Therapies Ltd, Dr Steven Mercer said, “The Board and management are very pleased with these strong
results, particularly since this group of patients were particularly difficult to treat. Some had not responded to years of expert
care and one of the completely healed patients was 100 years of age.”
Dr Mercer went on to say, “We are confident that this data will be sufficient for EU approval for sale (CE Mark). The final piece
we need for CE Mark is the validation data from our new, larger scale manufacturing process and this will be available during
December 2011.”
He explained, “We already have approval from an EU Notified Body, BSI, for an accelerated review which takes 45 days and so
we have more than enough time for a second quarter 2012 sales launch in the EU.”
“We also anticipate announcing a commercial partnership arrangement this month.”
“This is a strong result and we look forward to the start of sales with great anticipation.”
VitroGro® is a registered trademark of Tissue Therapies Limited © 2011
VitroGro® Delivers Consistent, Convenient, Cost Effective Healing:
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.
•• Expert health economics modelling indicates that VitroGro® ECM offers the opportunity for more cost effective treatment
of wounds than the current standard of care.
ASX Announcement 11 November 2011
For Further information
Dr Steven Mercer
CEO, Tissue Therapies Limited
Telephone: +61 (0)7 3839 9938
Email: [email protected]