The US FDA has approved Cyclopharm's (ASX:CYC) Technegas for the diagnosis and management of Pulmonary Embolism.
The company said Technegas has been used in 64 countries and 4.7 million patients. It said the technology is now a preferred nuclear medicine lung ventilation imaging agent.
Cyclopharm said the US approval provides access to the single largest market for Technegas. It said the US market could be initially worth approximately US$180 million annually.
The company will now complete the final assembly of its first wave of 200 generators, with plans for the first air shipments to arrive in the US by early November.
Cyclopharm will also execute its planned marketing strategy, leveraging the company’s sales and operational expertise across 64 countries globally where the product is already approved and established.
Under the US sales model, based on anticipated high volumes, Cyclopharm will provide and install Technegas generators to nuclear medicine departments to increase adoption and use of the single patient consumables, which generate recurring annuity-style revenue.
Cyclopharm said it had identified significant pre-existing demand for Technegas in the US.
"US clinicians and their representative bodies have lobbied heavily for Technegas’ approval, and the company has to date received 420 formal expressions of interest in the product," it said.
Cyclopharm managing director James McBrayer said, “USFDA approval for Technegas has been achieved through the persistence and the hard work of our highly skilled global team along with the unwavering support of our Board and shareholders. Importantly, USFDA approval has also established a platform for maximising the clinical use of Technegas across a wide range of respiratory applications going forward.
“While FDA approval for Technegas is a major milestone for Cyclopharm, our ability to now make this technology available to US clinicians and to the patients they serve, is where the key significance lies. I look forward to providing you with regular updates on the US rollout of Technegas as we proceed with this exciting new phase for the company.”