SINCE listing on the ASX in 2004 Tissue Therapies (TIS) has recorded around $14 million in tax losses, but successful clinical trial results have boosted the company’s share price more than three-fold since October. With wound-healing technology that is transforming lives, CEO Steven Mercer tells Brisbane Business News that sales could begin in early-2012.
WHAT started as a unique protein formula developed by Dr Zee Upton at the Queensland University of Technology (QUT) is now on the cusp of tapping into the $7 billion global market for diabetic ulcer treatment.
Steven Mercer (pictured) says that apart from TIS’ product VitroGro, a definitive treatment for chronic wounds does not exist anywhere, which is particularly relevant given the 171 million diabetics worldwide who are prone to the condition.
“Chronic wounds are often painful and embarrassing for these patients to leave home and so they often become isolated, depressed and in a potentially fatal spiral of decreasing activity,” he says.
He cites the statistic that only half the patients who undergo amputation for such wounds survive after three years, which is why it was so positive for Mercer to see VitroGro genuinely helping diabetics in pre-trials and clinical testing.
“For example, the first patient in the Canadian human trial of VitroGro had a diabetic ulcer on his foot that had not responded to expert care for two years. The doctors caring for this man recommended that he consider amputation of his foot as the only option left,” says Mercer.
“After treatment with VitroGro once per week for six weeks, his diabetic ulcer was 29 per cent healed and he continued to heal after the end of the clinical trial. He still has his foot.”
He says the incidence of diabetic ulcers is growing between 11 and 15 per cent worldwide with very few reimbursements available for home treatments, which is the main location where wounds are cared for. It’s a health and cost gap that TIS plans to fill.
VitroGro is now undergoing a multiclinical trial in conjunction with the European Union, with three clinics in Australia and two in the UK. Once these trials are complete, Mercer plans to use the data to apply for sales in the EU, with expectations for the product to hit the shelves there in 2012.
“We’ll then use the data and those agreements to accelerate applications in Canada, Australia and New Zealand and that will then accelerate applications in Asia and South America, while the US application is running parallel,” he says.
“I expect we’ll have sales in Canada, Australia and New Zealand sometime towards the end of 2012 or early 2013 and we should have sales in Asia and South America in 2013.”
“Our total company expenditure so far, including manufacturing, trials and pre-trials has been about $20 million, but we have accounted tax losses and had government funding to offset that.
“We’ve accounted tax losses of $14 million but I expect shareholders should benefit relatively quickly now.”
Mercer highlights that these losses actually equate to a very low cash-burn policy, with ‘mutually beneficial agreement’ with QUT.
“Through the history of Tissue Therapies we have tended to only raise the capital necessary for the next set of essential development steps and then to spend these funds wisely,” he says.
“This has resulted in the situation where today Tissue Therapies only has a little over 138 million shares on issue, a very low figure for a listed biotech company.”
Despite the low number of shares, TIS has now broken the $100 million market capitalisation mark.
Mercer also points to plans to expand VitroGro’s application into other areas, while not all research is directly applied to ‘obvious commercial application’.
“These include potential treatments for scars, a sophisticated multilayer dressing that selectively removes components of wound fluid that prevent healing and potential treatments for cancers of the breast, bowel and prostate,” he says.
“It is also important that we preserve room for basic research that does not necessarily have an obvious commercial application and this has produced some of our most promising pipeline technologies.
“There has been a firm conviction throughout the company that we are engaged in the development of a new generation of wound healing products with the potential to profoundly improve millions of people’s lives, to relieve their suffering
and even to prevent their premature deaths.”
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