Medical device developer OncoSil Medical hopes to receive European Union regulatory approval for its revolutionary pancreatic cancer treatment early in the new year.
OncoSil's treatment involves the injection via endoscope of thousands of radioactive micro-particles made from silica and phosphorous directly into a cancerous tumour.
The micro-particles attack the cancer cells from within the tumour, delivering a higher dose of radioactivity than current treatments using a radioactive beam that attacks the tumour externally.
OncoSil says the injection of the micro-particles directly into the tumour is a more efficient treatment.
Also, the micro-particles do not seep into surrounding tissue, thereby avoiding the damage to healthy tissue that can arise from using an external radioactive beam.
The OncoSil treatment is used in conjunction with chemotherapy.
OncoSil chief executive Daniel Kenny says gaining European Union approval - the CE Mark - for the cancer treatment will be a big milestone for the company.
"We're expecting a determination, which we think will be favourable for us, imminently but most likely in the new year," Mr Kenny told AAP.
"The CE Mark allows us to commercialise in Europe and the rest of the world with the exception of the United States."
OncoSil is set to start a 300-patient, three-year global clinical trial aimed at securing US approval in 2017.
Mr Kenny said having the CE Mark would allow OncoSil to start making sales in Europe, but the company is expecting modest sales in the near term.
Initially, the CE Mark will generate greater market awareness of the OncoSil treatment among physicians, but oncologists will need time to gain experience in using the technology before using it on patients.
Also, data from the global trial as it progresses will help build the knowledge base and, subsequently, sales.
"The CE Mark is really an endorsement of the technology and will lead to commercialisation, but I don't want any investor thinking that we're going to make tens of millions in our first few years," Mr Kenny said.
Mr Kenny says the OncoSil treatment has been found to shrink or stabilise a cancerous tumour in 82 per cent of patients, enabling better disease control, alleviating pain, and extending the patient's life.
OncoSil says that each year, there are more than 85,000 new cases of pancreatic cancer in Europe, 45,000 in the US, and 3,500 in Australia.
Fewer than one in 20 survive the cancer for five years.
Mr Kenny said that at a treatment cost of $US10,000 ($A13,400) per dose, the potential market for OncoSil is worth more than $US1 billion.
