Cyclopharm achieves streamlined reimbursement for Technegas in the US

Cyclopharm’s Technegas radiopharmaceutical imaging system has achieved a streamlined reimbursement approval process in the United States, boosting its prospects in what is the world’s largest market.

The Sydney company has received a Coding Determination for Technegas from the Center for Medicare Medicaid Services (CMS), which means users will have a unique identifier which streamlines their reimbursement process.

Use of Technegas, an ultra-fine dispersion of the radiopharmaceutical Technetium-99m within a gas used in diagnostic functional lung imaging, was approved for sale in the US by the US Food and Drug Administration in October 2023, sparking a major marketing effort with US medical institutions.

Cyclopharm CEO James McBrayer said: “We are pleased to receive this positive notification from CMS which will provide our USA customers a more streamlined reimbursement process.

“There are clear and temporary reasons for a slower than anticipated rate of installations during the first few months since our landmark USFDA approval.

“The company’s view of the total market potential for Technegas therefore remains unaltered.”

Cyclopharm told investors that the timing of market take-up in 2024 had been impacted by sign-off processes in each medical institution as well as the timing of regulatory approvals.

“Levels of clinical demand remain exceptionally strong throughout the US nuclear medicine community.”

The company has issued 136 proposals and contracts in the United States representing over 400 locations.

Five Technegas systems have been installed and are bringing in revenue from US institutions, with a further seven sites under contract and scheduling installations.

McBrayer said: “We continue to be encouraged by excellent clinical support and interest received as we progress our rollout across a range of fronts throughout the US.

“We expect…the conversion from clinical demand to executed contracts.”

The company is also working with facilities that fall outside the reimbursement system which include the 120 nuclear medicine departments in Veterans Administration Hospitals and the 35 US based hospitals run by the Military Hospital Systems.

Further reading:
Cyclopharm’s Technegas approved for US market in sales milestone

Picture: Cyclopharm/Technegas generators