Perth biotechnology firm Avita Medical has announced major changes to a clinical trial in the US it hopes will improve shareholder confidence.
The company, which was borne out of Fiona Stanley’s spray-on skin development in 1993, has been plagued with shareholder discontent in recent years due to lengthy delays in commercialising its ReCell product.
It culminated with the exit of former chairman Dalton Gooding and former chief executive William Dolphin last year when shareholders voted against the company’s remuneration report.
After entering a trading halt yesterday, Avita has announced it had negotiated new terms for a clinical trial of the ReCell product with the Food and Drug Administration in the US.
The FDA has allowed Avita to broaden the eligibility criteria for study participants as well as the way in which ReCell can be used - previously the product was being trialled in isolation but the FDA has given Avita the green light to trial it in combination with skin grafts.
The company said the combined technique had become the clinical standard in Western Australia and was how US surgeons had used ReCell for individual FDA-approved use cases.
The changes are expected to make it easier to recruit participants for the trial, which had previously held up progress.
Avita vice-president of research and technology, Andrew Quick, said the previous trial terms had significantly hampered the commercialisation process.
“The limitation caused by the previous restrictive trial criteria was a frustrating impediment to gaining ultimate approval to use ReCell in the burns segment of the US market,” he said.
“The revised trial criteria remove that impediment, resulting in a clearer and timelier path to market and the opportunity to highlight the clinical benefits of using ReCell to a greater range of patients.”
Alongside the trial changes, Avita has announced a timeframe for undertaking the trial with completion planned for the end of 2015.
“After years of frustratingly slow progress, there is now a clear timeframe and path forward to achieve regulatory approval for the use of ReCell in a larger segment of the US burns market than was previously being sought,” Mr Quick said.
Earlier this month, Business News reported that Perth’s listed biotechnology companies had burned through $185.5 million during the past five years.
Since 2009, Avita Medical has made cumulative losses totalling $28.5 million.
The company’s share price was up 4.8 per cent to 11 cents each at 12:27PM WST.
