Pre-clinical tests buoy silk eardrum inventors

A WA invention using silkworms to cure a prevalent hearing problem in Aboriginal communities is nearing human trials having been buoyed by promising soon-to-be-completed pre-clinical tests.

ClearDrum is an implantable device dubbed the world’s first prosthetic ear drum developed with support of WA’s Ear Science Institute Australia to treat perforated eardrums which affects some 330 million people worldwide.

The product developed over more than a decade uses silk from silkworms to build an implant shaped like a contact lens to sit under the eardrum, providing scaffolding for cells to grow over.

ClearDrum chief technology officer Filippo Valente said the next development stage would lead to production, though clinical trials were still needed before the product could hit the market.

“We have almost finished all the preclinical testing, we have created a very good marketing profile for the product, we have published 31 articles over the length of the project… and we have a clear regulatory reimbursement strategy for how to get into the market first in the US,” he said.

“We have joined forces with a US manufacturer to start producing and scale up production of the product itself… and we have set up the whole scale-up production line to be able to do it.

“We have finished development, tech transfer has gone to the manufacturer and after this, there is product validation (which) will happen this year.”

The product has garnered global backing and was last year spun out into a company which is now focused on capital raising to help bring it to market.

It is hoped ClearDrum can replace existing operations where skin grafts are needed with a single procedure using a better medium for cells to grow on.

Perforated ear drums are commonly caused by chronic middle ear disease which are more prevalent in Aboriginal communities than anywhere else in the world.

Dr Valente said addressing ear health held benefits for Australia’s closing the gap efforts.

“As you can imagine if you have a hole in your ear you just don't hear properly,” he said.

“Hearing loss has a devastating impact in like social interaction, education, employment, all sorts of social economic hurdles along the way.

“The fact this disease has such high prevalence in the Aboriginal population makes this project very much an Australian story which has always been a strong point as to why we’re developing with Ear Science Institute in the first place.”

ClearDrum is nominated for two gongs in WA’s Innovator of the Year Awards, winners for which will be announced in November.