Radiopharmaceutical systems manufacturer Cyclopharm is expanding its manufacturing and storage capacity at Kingsgrove in Sydney to meet US demand, following approval by the USFDA for sale of the system in the big Uited States market.
The Sydney company told investors it was preparing to air freight the first 20 Technegas systems to the USA, with a further 180 systems manufactured to the subassembly level, and now being prepared for export.
Additionally, the first commercial production batch of Technegas patient consumables will be completed within the next few weeks.
Technegas is an ultra-fine dispersion of radio-labelled carbon, produced by using dried Technetium-99m in a carbon crucible, micro furnaced for a few seconds at around 2,750°C.
The resultant gaseous substance is inhaled by the patient via a breathing apparatus, which then allows multiple views and tomographic imaging with a nuclear medicine camera.
Technegas is best known for its use in diagnosing Pulmonary Embolism (PE), but is being developed for conditions including Chronic obstructive pulmonary disease (COPD), asthma and Long Covid.
Following US approval Cyclopharm has initially engaged with 200 priority sites in the US, out of its target US market of 2,000 facilities.
According to a statement, the US represents a US$180 million opportunity for Cyclopharm, where Technegas will be fully reimbursable through medicare at US$225 per patient consumable.
Cyclopharm is also moving to take control of wholesale pharmaceutical state licenses in Georgia and Tennessee that will allow the company to avoid a distributor model and serve US customers directly.
“Responses to US based employment advertisement have been overwhelming with interviews of exceptional candidates already taking place.
“Contracts for all supporting third party providers to include customer service, technical support, logistics, invoicing, accounting, and human resources are being finalised.
“Existing global technical and educational resources will be utilised for both customer fulfillment
training new employees and business partners are ready for deployment for first installations.”
Cyclopharm’s Technegas approved for US market in sales milestone
Picture: University of Newcastle/Trial of Technegas generator