Cyclopharm Limited (ASX: CYC) has received United States Food and Drug Administration (USFDA) approval to commence commercial sales of Technegas in the US market.
The approval opens for Cyclopharm the single largest market for Technegas globally, and one which the company estimates to be initially worth approximately US$180 million annually for the diagnosis and management of Pulmonary Embolism (PE).
Commercial rollout can commence immediately and Cyclopharm will now complete 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 which will leverage the company’s sales and operational expertise across 64 countries globally in which 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. Already in place are agreements for third-party distribution, generator service, installation, and administrative support for Technegas in the US.
Cyclopharm notes significant pre-existing demand for Technegas in the US healthcare market. 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.
Technegas is most commonly used in the diagnosis and management of Pulmonary Embolism (PE). Over the past three decades Technegas has been successfully used in 64 countries worldwide, amassing 4.7 million patient studies.
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% share of this market over the next two to three years, rising to in excess of an 80% share over a 3 to 5-year period.
The second stage involves increasing the total US PE diagnostic market which is imaged through nuclear medicine from 15% to 30%. This target, which equates to a total PE market for Technegas of US$180 million annually, is based on the company’s extensive and successful global track record, the unique properties of Technegas including its ability to enhance 3-D imaging technology and create superior outcomes to CT.