Australian medtech company Cyclopharm (ASX: CYC) is set to add the United States to the list of 59 countries which have approved Technegas®, its nuclear functional ventilation imaging agent, having lodged its New Drug Application (NDA) with the Food and Drug Administration (FDA). 

As the world’s largest nuclear medicine market in the world, the opportunity to commercialise Technegas® in the United States would be a major milestone for the Company which has been working towards their NDA submission since 2008. 

As a form of nuclear medicine, Technegas® technology produces a gas-like substance which is inhaled by patients which provides medical professional imaging of functional ventilation through the lungs. The nuclear technology has traditionally been used in the diagnosis of pulmonary embolism, but with medical advancements they can also be used to diagnose other diseases including asthma, pulmonary hypertension and COPD. 

“Over the coming months there is still a great deal of work to do in preparing the  Company for USA commercialization; however, the lodgment of our New Drug Application is the single largest  step the Company has ever made toward attaining USFDA approval,” said Cyclopharm CEO, James McBrayer. 

“We are confident of securing approval within the next twelve months. I look forward to updating our shareholders as each milestone along the way is achieved.” 

The company estimates the pulmonary embolism (PE) diagnostics market to be worth USD $90 million in sales per annum and once they have received FDA approval, anticipate gaining 50% of the market share in the first three years, then rising to 80% over 7 years. 

Included in their NDA submission, Cyclopharm has requested priority review designation which would reduce the approval time from 10 months down to 6 months as well as a fee waiver request to reduce or waive the USD $2.9 million application fee. 

In the year ending 31 December 2019, Cyclopharm reported sales revenue of $14m from sales in the 59 countries where Technegas® has obtained regulatory approval.

Alongside the current coronavirus pandemic where shortness of breath being a key symptom of COVID-19, Cyclopharm has reported an increase in Technegas® to differentiate between COVID-19 and pulmonary embolism where laboratory tests results cannot be attained quickly.

Shares in Cyclopharm were up 9.4% in early morning trade following the news of their NDA submission.