A $4 million international grant will help the Ear Science Institute Australia get a new product to market.
A natural product that created the trade route between China and the Mediterranean almost 2,000 years ago is opening up new market opportunities for a team of researchers at the Ear Science Institute Australia.
Silk may not immediately spring to mind as the material of choice to restore hearing to damaged eardrums, but it is a key component of the Subiaco-based institute’s latest invention, ClearDrum.
The biocompatible silk implant is the result of 10 years’ development by Perth surgeon and scientist Marcus Atlas and his team. It is hoped the device will benefit the 300-plus million people worldwide who suffer from perforated (burst) eardrums, with chronic middle ear disease the most common cause.
Implanted under the eardrum, ClearDrum provides scaffolding for the patient’s own cells to grow over, resulting in a healed eardrum.
The device is similar in size and appearance to a contact lens and requires just one operation, compared with the several needed with current technologies.
The new ClearDrum technology. Photo: Courtesy of the Ear Science Institute Australia
Professor Atlas said treatment for the condition currently involved making grafts for new cells to grow from the patient’s own tissue, such as cartilage.
He said among the limitations of cartilage were its inability to transfer sound and its lack of transparency, which restricted doctors from being able to see disease regrowth.
A decade ago, Professor Atlas and his team started researching new ways of reconstructing the eardrum, backed by funding from the Ear Science Institute and Western Australian philanthropists.
“We tried to replicate some of the properties of cartilage, but to make it better,” Professor Atlas told Business News.
“Rather than taking a material and trying to make it work in the ear, we took a different approach to find out what could work best in the ear.
“We tried to find something that the cells of the eardrum would grow over and effectively heal, a material with acoustic properties as well as mechanical characteristics (strong and flexible) to support cell growth.
“And we needed to be able to see through it, to see what’s going on in the middle ear after the surgery; we didn’t have any material that came close to doing that.”
Professor Atlas said the biggest challenge was sourcing and developing this ideal material.
The team reached out to fibre experts from Deakin University’s Future Fibres Hub, where they found silk, specifically its insoluble protein fibroin, ticked all the boxes.
ClearDrum has emerged from years of testing silk mixed with other materials on a line of human eardrum cells at both the institute and the Ear Science Centre at the University of Western Australia. The product will undergo human clinical trials across Australia next year, thanks to international science body The Wellcome Trust Translation Fund, which awarded the institute $4 million in April.
The grant will be used to finance the trials, which Professor Atlas said would take place in two stages over a three-year period, with the second stage comparing the results of ClearDrum with cartilage.
“These studies will be accepted by the major regulators around the world, such as the FDA and the European CE Mark,” he said.
Ear Science Institute Australia chief executive Sandra Bellekom said the institute was expecting to soon be issued a patent for ClearDrum in the US. It had a patent in China and others were currently under review for Europe and Asia,
The name ClearDrum is trademarked in Australia, with the team now working on securing an international trademark.
“One of the key parts of achieving the Wellcome grant was including commercialisation at the beginning of our development plan,” Ms Bellekom told Business News.
“It’s great to publish a journal article, which is how scientists have traditionally been assessed on their success, but as clinicians we want to have something that can change patient’s lives.”
Ms Bellekom said the institute was planning to create a spin-out company to take the device to market, and had already reached out to potential distributors.
“We’d like to have as much influence as possible in the process, to make sure our device is front of mind,” she said.
“They’ve (Wellcome) shown an interest in getting involved in other projects; we have many in the science and clinical side, which also incorporate new technology.
“We can’t keep that all within the institute.”
Ms Bellekom said many people were initially sceptical of demand for ClearDrum, as market analysis proved difficult, given that many patients gave up after numerous surgeries.
“The level of interest has stunned us,” she said.
“We’ve had unsolicited approaches from venture capital groups, not just in Australia but internationally, for investment.”