The US Food and Drug Administration has approved Cyclopharm’s lung imagining technology Technegas, opening up a US$180 million market that has the potential to quadruple the size of Cyclopharm’s existing Pulmonary Embolism (PE) market.
Technegas is an ultra-fine dispersion of the radiopharmaceutical Technetium-99m within a gas used in diagnostic functional lung imaging in 64 countries – it has been used in over 4.7 million patient procedures.
Technegas is created using Cyclopharm’s propriety Technegas generator, which is inhaled using a Technegas breathing apparatus and travels through the lung, allowing multiple views and tomographic imaging with a nuclear medicine camera.
It is best known for the diagnosis and management of Pulmonary Embolism (PE), however, it can also be used in the diagnosis and management of respiratory disease states beyond PE, such as Chronic Obstructive Pulmonary Disease (COPD), Asthma, Lung Cancer, Long-COVID and other respiratory disease states, which affect up to 30 times more patients than PE.
Cyclopharm Managing Director James McBrayer said: “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.”
Cyclopharm is initially targeting the 600,000 nuclear medicine imaging procedures for PE, a market which it estimates to be approximately US$90 million per annum.
Based on Cyclopharm’s experience in the Canadian market and globally, the company reiterates expectations it can achieve a 50 percent share of this market over the next two to three years, rising to in excess of an 80 percent share over a three to five-year period.
The USFDA approval covers the complete Technegas product, including its manufacture in and distribution from Australia.
The USFDA deems Technegas as a drug-device Combination Product , an uncommon USFDA evaluation category, collectively covering the Technegas Generator, the single use Technegas Crucible and Patient Administration Set (PAS) as interdependent elements.