An Australian-invented lung imaging agent has finally been cleared for use in America, decades after it became the standard of care in dozens of other countries.
ASX-listed Cyclopharm announced on Monday it had received Food and Drug Administration (FDA) approval for its Technegas product, a radiopharmaceutical that's been used to help diagnose or rule out pulmonary embolisms in 4.7 million patients in 64 countries since the 1980s.
Cyclopharm chief executive and managing director Dr James McBrayer told AAP that FDA approval would be transformational for the $265 million Sydney-based company.
"It's a game-changer. We're entering the largest healthcare market, certainly the largest nuclear medicine market in the world. We estimate the market potential in the US is upwards of $180 million just in the diagnosis of PE, and that's US dollars.
"Rest of the world, we're doing around 14 million Australian dollars per annum. So it's a big, big jump."
Cyclopharm plans to complete assembly of the first wave of its 200 Technegas generators for air delivery to nuclear medicine departments across the US.
The Technegas generator's crucible uses 2,750-degree heat to aerosolise carbon radioactive isotopes into a nanoparticle gas with a six-hour radioactive life.
A patient suspected of having a pulmonary embolism - a life-threatening blockage in the blood vessels of the lungs - inhales the gas so their lungs can be visualised in three dimensions by a gamma camera during a CT scan.
The technology was first invented in Australia in 1986 by Australian University biomedical engineer Dr Bill Burch, and was approved in Europe back in 1988.
Dr Burch apparently approached the FDA as early as 1991, but the agency wasn't receptive, and in the early 2000s deemed Technegas as a rare "combination product" - both a medical device and a drug - which created a complicated pathway to approval, Dr McBrayer said.
"I joined the company in 2008, and at that point, even though we'd had a few million patients under our belt, they still wanted a clinical trial," he said.
"We had some issues with recruitment, given that the product is primarily used in emergency situations," Dr McBrayer said.
"To get a patient signed up for a clinical trial, when they just want to know if they're going to live or die, it's a bit tricky."
Eventually the US agency gave the company leeway to expand enrolment to other indications beyond pulmonary embolisms, such as lung transplant patients.
There were also other issues that Cyclopharm went back and forth with the FDA over, Dr McBrayer said.
"It's been a long, long way going, and we had to be fluid with changing dynamics - so here we are."
With the FDA's approval, Dr McBrayer said he was confident that Technegas would become the preferred nuclear medicine lung ventilation imaging agent in the US, as it is in Canada and Europe.
Late Monday afternoon, Cyclopharm shares were up 5.3 per cent to a two-and-a-half-year high of $2.98.
