The USA is the world’s largest healthcare market and therefore a dream for ASX health stocks to enter.
This is no easy feat – needing to obtain the approval from the FDA, a regulator renowned as the world’s most sophisticated – but one that if accomplished can lead to an ASX health stock’s share price and revenues going up.
Adherium and Optiscan seeking the FDA’s judgement
This morning three ASX health stocks updated shareholders on their endeavours to enter the USA. One was Adherium (ASX:ADR) which rose by over 12 per cent off the back of the update.
This company helps asthma sufferers with an inhaling device, as well as remote monitoring and data management solutions.
Today Adherium formally submitted its application to the FDA for 510(k) clearance for its latest Hailie sensor.
Adherium’s chief technology officer Geoff Feakes said this one was superior to the previous generation because it captures physiological measures and it would release further sensors over the next 18 months.
While it is now a waiting game for Adherium to see what the FDA said, the company said it continued to receive approaches from health providers and insurers about Hailie in the US and elsewhere.
Another company aspiring to enter the USA is Optiscan (ASX:OIL) which wants the FDA to approve its Invivage device which screens for oral cancer.
The company says it had completed multiple requirements for the application including the clinical run in Melbourne that would form part of the submission. It hopes to complete the study and presumably submit to the FDA in the final quarter of this year.
Shares in both ASX health stocks rose today.
Adherium (ASX:ADR) and Optiscan (ASX:OIL) share price chart
Running a clinical trial
Neuren (ASX:NEU) is another ASX health stock seeking to enter the USA although it is a biotech targeting brain diseases.
The company is seeking Investigational New Drug (IND) status for its NNZ-2591 drug for Phase 2 clinical trials in relation to three rare brain diseases affecting children, namely Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome.
This is a necessary to start human clinical trials regardless of whether the disease is rare or common, although according to Neuren CEO Jon Pilcher it is a simpler process than seeking 510(k) approval.
Today Neuren reported receiving positive guidance from the FDA about its application. Although this was not final approval the FDA did give minor feedback in that regard.
Subject to final approval, the company hopes to begin the trials in the second half of this year and the results will be received in the second half of next year.
The Angelman syndrome trial will be conducted in Australia while the other two will run in the USA and all of them will test between 10 and 20 paediatric patients for 13 weeks.