After gaining US FDA approval in September 2023, nuclear medicine company Cyclopharm (ASX: CYC) has made an official entry into the country with the signing of its inaugural commercial contract for Technegas in the United States with Duke University Hospital the first institution to enter into a formal agreement to use Technegas.
Technegas, an imaging agent employed in ventilation–perfusion studies for diagnosing pulmonary embolism and various respiratory pathologies, received USFDA approval. This green light not only opens up a market exceeding $270 million but also helps Cyclopharm, which is entering the United States—the largest individual nuclear medicine market on a global scale.
Lung diseases accounted for a staggering 12% of all deaths worldwide in 2019, totaling 6 million fatalities. With COPD, lower respiratory infections, and lung cancer predicted to become the third, fourth, and sixth leading causes of death by 2030, Technegas represents a potential solution in diagnostic capabilities.
Cyclopharm’s Managing Director James McBrayer said, “I am thrilled that Duke University Hospital, a globally respected centre of healthcare excellence, innovation and a recent clinical trial site for Technegas, will be among the first to offer Technegas to their referring physicians and patients.”
Prior to USFDA approval, Cyclopharm had garnered over 420 expressions of interest, and the company is strategically prioritising this demand for Technegas across US medical facilities. This involves focusing on US clinical trial sites involved in Technegas’ New Drug Application (NDA), key opinion leaders in the NDA process, advocates supporting Technegas during the NDA process, large government and private healthcare groups, and major university-affiliated teaching hospitals.
On the financial implications of this agreement, McBrayer said, “The implementation of Technegas at Duke will be on full commercial terms as previously communicated to the market and will be leveraging off Technegas’ wide indication for use approved by the USFDA”.
In H1 FY23, the Company saw revenues from ordinary activities rise by an impressive 44% to $16,487,618. However, the loss from ordinary activities after tax attributable to members increased by 13%, reaching $2,895,275.
Duke University Hospital, situated in Durham, North Carolina, is an integral part of the Duke University Health System. And it is a top-ranking academic medical center. Affiliated with Duke University, the hospital serves as a vital teaching institution for the Duke University School of Medicine.
What’s more, Duke was one of the ten locations in the United States that actively participated in Cyclopharm’s recent clinical trial, a pivotal component of the New Drug Application for Technegas.
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