Perth-based medical device company, bioMD Ltd, is one step closer to commercialising its acquired cardiovascular patch technology, after years developing its other medical devices.
Perth-based medical device company, bioMD Ltd, is one step closer to commercialising its acquired cardiovascular patch technology, after years developing its other medical devices.
Having invested in research and development for a number of medical devices, which have as yet failed to reach commercialisation, the company has secured ethics approval for a 12-month Phase II human clinical trial of its cardiovascular tissue treatment technology, which is used to repair heart valves.
bioMD acquired the technology after taking a majority shareholding and investing $500,000 of working capital in tissue engineering company, Celxcel Pty Ltd, which developed the technology at Fremantle Hospital.
Following seven years of research, including pre-clinical animal trials at the University of Western Australia, the animal tissue bioimplant will be trialled at a cardiothoracic hospital in South Africa.
The clinical trial will require 50 patients with heart deformities to use a treated biomaterial patch in the surgical reconstruction of their heart valves, followed by a 12-month monitoring period.
According to bioMD managing director Michael Bennett, the receipt of ethics approval is the company’s most significant milestone to date and reflects its transition from a research and development company to a late stage technology developer.
Mr Bennett said the company would most likely pursue a licensing agreement following the conclusion of the human clinical trial.
“We’re going to get the technology in front of the global medical technology companies,” he said.
Mr Bennett said the technology was appealing in a commercial sense because it would have applications in other medical fields, such as orthopedics.
bioMD executive director Rob Towner said the company, which has a market capitalisation of $14 million, was adequately funded for the duration of the Phase II trial.
“At the moment, on our budget, we’ve got sufficient capital for two years,” he said.
However, bioMD is in the process of investigating potential partnership arrangements with pharmaceutical companies.
“That would be the point at which we’d have to consider what our ongoing capital requirements would be, under those partnerships,” Mr Towner said.
“Certainly, things have begun in terms of the commercialisation process, through talking to global participants in the areas we’re moving into.”
Mr Towner told WA Business News the company would prefer to have a joint collaboration with a multinational company.
“The simple fact is, we are going into a global market and will need a lot of capital on both sides,” he said.
“It’s unlikely we’ll be going into production of our potential patches or products on our own, because it’s demonstrated historically that it doesn’t work.”
Established in 2003, bioMD bought the intellectual property rights for a range of needles and syringes prior to listing on the ASX, with one of the devices – a pre-filled syringe – being developed into a final prototype.
Having secured patents for the product in the US, Europe and Australia during the past two and a half years, bioMD is currently exploring potential licensing arrangements for the syringe.
“We have had approaches and have approached pharmaceutical companies that could be interested, and those discussions are preliminary and ongoing,” Mr Towner said.
“We’re not racing around the world selling it, because we’ve really changed the focus of our work. The commercial outcomes, we believe, are a lot better for the [tissue treatment] process.”
bioMD also entered into a research partnership with CSIRO in 2005 to develop an alternative material for intravenous catheters and other vascular access devices.
Under the agreement, CSIRO will own the intellectual property for the device, while bioMD will retain the right to license the product.
Mr Towner said the company was approaching the final decision gate under the original agreement and would meet with CSIRO next week to review progress.
bioMD is about to commence pre-clinical animal trials using its patch treatment technology on ligament and tendon tissue.
The research will be undertaken at UWA.
