mad ramblings - good reasons, page-15

Agree SuperTramp, also CCBM please also consider that VitroGro is classified as a device so looking for authority reimbursement as a handbrake to gaining inroads may be a mute argument. You suggested I use a bit of commercial pragmatism, I can only ask the same of others and ask that they use all facts in front of them as well and read exactly what I have written, this sector is growing rapidly due to patient inflows and is begging for a new Gold Standard of care, so the potential is there.

From the Annual report

Classification of VitroGro as a Device

VitroGro, used as a topical wound healing treatment, has been classified as a device by Health Canada and also by a UK notified body and an EU regulatory consultant. This means that it is only necessary for VitroGro to successfully complete a device clinical test regime instead of the Phase trials that apply to pharmaceutical candidates. Only a single, small clinical trial of new formulation
VitroGro should be required to gain approval for the sale of new VitroGro wound healing products.

Device classification also allows future sales through a far broader range of outlets and partners than would be possible if VitroGro were classified as a pharmaceutical.


Commercial Significance of Clinical Trial Results

Clinical trial results from Canada and Australia confirm that VitroGro can substantially increase the incidence of complete healing and reduce treatment time for diabetic and venous ulcers, as well as being potentially more cost
effective than currently available treatments. It has also been shown that VitroGro is a remarkably stable protein complex that is effective in very low doses and remains active after freeze drying and gamma irradiation, both important for cost effective incorporation into wound dressings.

VitroGro is therefore an exceptional candidate for a new generation of wound healing and consumer products because it can be produced to pharmaceutical standard (already achieved by Tissue Therapies) and because all pre-clinical and human trial data consistently indicates a cost effectiveness that has not previously been available to patients and health care systems worldwide. All data indicates that VitroGro wound dressings have the potential to transform the treatment of diabetic, venous and pressure ulcers a US$4 billion market in the 2007 calendar year with annual compound growth of 11-15%.(1, 2)