Technegas generators produce a gas which is inhaled by patients before taking scans, to assist in the detection of pulmonary embolism.
The U.S. trial was set out to determine inter-reader and intra-reader variability for Xenon-133 gas, the only existing FDA approved nuclear medicine ventilation imaging agent in the U.S.
This step was essential in establishing the number of patients required for the next stage in the clinical trial program.
Cyclopharm will next submit to the FDA by 17 October 2016, a Phase 3 non-inferiority structural ventilation protocol comparing Xenon-133 with Technegas in 240 patients.
The clinical trial program is projected to be completed by mid-2018 at a total cost of less than US$7 million.
Technegas is currently sold in 55 countries around the world, excluding the U.S.
Cyclopharm achieved sales of $6.5 million for the half year ended 30 June 2016, a 27% growth compared to the same period in 2015.
The company earned a net profit after tax of $284,000 in 1H 2016, a 59% increase over 1H 2015.
In June, Cyclopharm received the largest ever single order for Technegas generators from China, worth $1.3 million.
The company’s share price has doubled since the beginning of 2016.