- Toothy white smiles as SDI reports strong initial sales of its company-making Stela fillings
- Trivarx awaits FDA key decision on its trial design
- Compumedics completes its biggest deal to date
Dental products stalwart SDI (ASX:SDI) reports promising initial sales of its new filling product Stela, which has the durability of the grey amalgam material but also a nice aesthetic white finish.
Last year the US Food and Drug Administration (FDA) approved Stela, a tooth-coloured filling that is stronger than amalgam and “able to withstand high mastication forces”.
The local Therapeutic Goods Administration and European and Brazilian regulators followed suit.
Developed by SDI, Stela is a replacement not just for an amalgam job, but for all posterior (back) fillings that account for about half of all fillings.
The company reports Stela sales have exceeded $1 million and the product is on track to be one of its best product launches.
“Stela … was released in some key markets during the year [and] initial sales and feedback from the market are positive,” chairman Jeffery Cheetham told today’s AGM.
While amalgam remains an important revenue source for the company, SDI’s sales mix has shifted to tooth whitening and other aesthetic products.
In any event, amalgam material contains mercury and is being banned in many countries.
All in all, SDI had a decent 2023-24 year – especially with unhelpful changes to European regulations and more difficult registration requirements elsewhere.
Sales grew to a record $111.2 million, up 3%, resulting in a 48% rise in net profit to $10.4 million (also a record).
Formerly Southern Dental Industries, SDI is one of Australia’s longest standing exporters, selling its wares in more than 100 countries despite stiff competition.
Dr Cheetham founded SDI in 1972 and it listed in 1985. Since then, the company has stuck with its dental consumables brief, aside from an ill-fated foray into dental chairs.
The company has been run by Dr Cheetham’s daughter Samantha, since 2016.
SDI is in the throes of moving from its long-standing HQ and manufacturing plant in Bayswater, in eastern Melbourne to an expanded property in Montrose.
Students of Melbourne’s geography would know that’s just down the road.
SDI shares edged up 1% to $1.09, having gained 43% year to date.
Trivarx waits for key date with FDA
TrivarX (ASX:TRI) has circled December 17 in its diary as the day of a crucial FDA meeting to approve the design of a pivotal trial of its algo that analyses the nexus between depression and bad sleep.
At the company’s AGM today, chairman David Trimbole said the regulator was expected to approve the study design on that date, with the trial kicking off early next year.
The study will support an approval submission to the FDA under the de novo (new device) path.
An earlier phase II trial of 400 subjects showed the algo was 87% accurate in detecting depression and had a 72% hit rate in ruling out the condition.
On November 7 Trivarx shares soared 40% after the company said it was working on an updated tool with applicability beyond sleep centres.
Trivarx says the new app will enable it to unlock “large new addressable market opportunities” outside of sleep centres, including cardiology monitoring, sports and performance bodies, treatment monitoring and consumer wearables.
Trivarx shares were steady at 1.5 cents.
Compumedics seals a seminal Chinese deal
Speaking of sleep testing, brain imaging house Compumedics (ASX:CMP) says it has completed installing one of its key tools at a large Chinese university.
The $4.7 million contract is the biggest in Compumedics long history, which dates back almost 40 years.
The device in question is its Orion Lifespan magnetoencephalography (MEG) unit. The client is the Tianjin Normal University’s (TJNU’s) psychology faculty.
The MEG units map brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain using sensitive detectors.
The company says that as a key reference site, TJNU should open the door to the burgeoning Chinese neuroscience market.
One of the MEG’s key selling points is having two helmets – the Marj Simpson hairdryer-style sensor units plonked on the patient’s head – which enables two subjects to be neuroimaged at the same time to study how they interact.
The company says it will now work to delivering two more MEG orders in China in 2025, valued at $9.3 million.
Compumedics managed a record $52 million of revenue in the 2023-24 year, up 23% with an underlying profit of $2.7 million compared with a $2 million loss previously.
The company expects sales of $55 million in the current year.
In 1987 Compumedics installed Australia’s first fully computerised sleep clinic, at Melbourne’s Epworth Hospital. The company has been listed since 2000.
Compumedics shares were unchanged at 26 cents.
Filamon eyes ASX listing ‘in due course’
The private drug developer is girding for an ASX listing and IPO at an unspecified date, having raised $3 million in a seed round.
The pre-clinical stage Filamon aims to treat inflammatory and chronic degenerative diseases associated with ageing – tricky areas for drug developers.
Filamon’s lead molecule, Alpha-003 is designed to preserve microtubules (long, hollow tubes vital for healthy brain function) and protect them from destructive neuroinflammation.
Alpha-003 aims to treat a group of diseases known as tauopathies which include the two major forms of dementia (Alzheimer’s disease, frontotemporal dementia), progressive supranuclear palsy (a form of Parkinson’s) and chronic traumatic encephalopathy (CTE, the result of repeated concussion).
Filamon also has in an interest in wet AMD, the leading cause of blindness.
“Current approaches to dementia treatment have failed to deliver meaningful benefits because they focus on minimising damage after brain cells have already suffered catastrophic structural damage,” the company says.
“Filamon has designed a drug capable of preventing that damage occurring in the first place.”
Alpha-003 was discovered by Western Sydney University oncology associate professor Kieran Scott. The company was co-founded by its CEO, Professor Graham Kelly who has a long and sometimes colourful history in the sector.
The company hopes to be in the clinic by 2026.
At Stockhead, we tell it as it is. While Trivarx and Filamon are Stockhead advertisers, they did not sponsor this article
