Our webinar explores what it takes for ASX-listed companies to get new health care developments – whether that be drugs, apps or other technologies – through the complexities of Australia’s Therapeutic Goods Association approvals process.

The TGA sits under the Federal Department of Health, and regulates the safety, efficacy and quality of everything from sunscreens to vitamin supplements, prescription medicines and medical devices. America’s big brother to the TGA is the US Food and Drug Administration. Some companies target the FDA first – looking to tap into a bigger market from the start.

Our webinar guests are:

We also feature insights from Bioshares editor, Mark Pachacz.

Bioshares is an online investor resource delivering research notes specific to Health Care sector companies. Bioshares also has a Biotech Summit which will be held in Fremantle, July 12-13.

While the TGA did not respond to our invitations to join the webinar panel, you can also look at our special report on the topic – which can be downloaded free from The Market Online here. The report is titled: What it takes to get a new drug to market in Australia – Demystifying the clinical trials and approvals process.

The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.

It’s listing on the ASX next Thursday (April 4) under the code BB1.

BlinkLab’s development is being led by chair Brian Leedman – a founder of ResApp Health – the cough analysis app sold to Pfizer two years ago in a $179 million deal.

Now Brian’s confident that BlinkLab – first developed at Princeton University – could mirror that success, while also fast-tracking detection of Autism and ADHD and improving patient outcomes.

“We’re the only company in the world using computer vision and machine learning to assess brain responses to audio and visual stimulation – delivered via a smartphone – to detect autism and ADHD,” Mr Leedman said.

“It’s easy for a doctor or specialist to use as a diagnostic tool. We can diagnose children from 18 months old, which is years younger than through traditional methods that typically result in children being diagnosed from the age of five,” he said.

“By the time a child reaches five years old, neuronal development in the brain has significantly advanced as have the behavioural patterns that led to the concerns of the parents. If the child is autistic, then they were autistic from birth.

“As in all medicines, the earlier you can diagnose anyone with anything, the better the outcomes for the patient.”

There are lengthy diagnosis delays both here in Australia and abroad, so the demand for such a tool is extensive.

BlinkLab uses AI and machine learning algorithms to predict autism and ADHD and recent clinical trials demonstrated sensitivity of 85% and specificity of 84%, suggesting much higher accuracy comparing to existing FDA approved products.

“Based on clinical trial results to date, we have a very accurate test for autism and we now have to replicate that in a US FDA (Food and Drug Administration) medical device registration study,” Brian Leedman said.

“The NDIS in Australia has come under scrutiny for the tremendous cost to the Australian taxpayer over the fact that ASD (Autism Spectrum Disorder) diagnosis and treatment in children is the single largest expenditure – so the timing for this technology development and ASX listing is spot on.”

Industry data suggests more than a third of those claiming through NDIS report the primary condition of autism. The NDIS paid out $6.73 billion dollars in payments to support those Australians last year alone. What’s also concerning is that the figure was 28 per cent higher than for the previous year, 2022. Autism rates in Australia are among the highest in the world and effect 1 in 25 children.

BlinkLab’s FDA trial will recruit up to 500 people, and to fund it, BB1 is raising $7 million through the IPO process with 20 cent shares. It plans to complete the study by mid-next year with the aim of gaining FDA approval by 2026. The neurometric testing technology is also being developed and studied for its efficacy in screening for schizophrenia and forms of dementia.

BlinkLab has an exclusive global commercial licence agreement with Princeton University, where Founders Dr Henk-Jan Boele, Peter Boele and Bas Koekkoek first created early iterations of the idea. It’s come a long way since then with $4.4 million spent on the Software as a Medical Device development. There’ve been 6000 individual diagnostic tests already carried out throughout the world, including eight studies as far afield as Morocco and Ecuador.

The company has forged numerous partnerships with credible institutions including Princeton University, Penn Medicine, Erasmus MC, Baylor College of Medicine, and many others.

Mr Leedman said another advantage in developing medtech such as BlinkLab was that there could be no safety risks or delays.

“The worst that can happen is the phone is dropped on your foot – literally,” he said.

“That means we don’t face the long and slow process of testing for safety, we just have to prove efficacy.”

Aside from his success with ResApp Health, it’s worth mentioning that Mr Leedman has also chaired Neurotech International (ASX:NTI) which is developing the use of very low THC oral cannabis drug candidate NTI164 for children with autism. During his tenure, the share price had risen over 1,000%.

“This is a natural progression for me,” Brian Leedman said.

“Everything I’ve done is highly relevant to getting BlinkLab to this point and strengthens my belief that we have something truly special here.”

That was the message today as four biotech companies and Life Sciences WA presented to 200 brokers and investors at the Broker Meets Biotech event in Perth.

It was hosted by Brian Leedman, a Healthcare sector leader who drove the development of ResApp Health- the company behind smartphone tech that analyses a cough to diagnose respiratory illnesses including pneumonia, asthma and bronchiolitis. That business, which began as a University of Queensland start-up, was acquired by Pfizer in a $179 million deal in 2022.

Mr Leedman is now chair of Blinklab, which has an app to assist in evaluation and diagnosis of conditions including autism and ADHD through measuring blinking rates and neurobehavior – again using a smart-phone.

Blinklab is listing on the ASX early next month after raising $7 million with 20 cent shares. There have been eight studies since 2020, and a feasibility study including 280 child subjects, found the Software as a Medical Device had sensitivity for identifying autism spectrum disorder at 85 per cent. The company is working towards US Food and Drug Administration approval by early 2026.

Other presenters today included Orthocell (ASX:OCC) chief operating officer Alex McHenry.

Orthocell has collagen-based devices for tissue and tendon healing, but now also for repairing peripheral nerve damage caused by injuries.

Company investors include Chris Ellison of Mineral Resources (ASX:MIN) and the McCusker Family, and the company has Professor Fiona Wood and Kim Beazley on the Board.

Meanwhile, HITIQ (ASX:HIQ) has a smart mouthguard with 15,000 data points to measure the forces experienced in the brain during hard impact and concussion. It’s been developed to support the identification, monitoring and management of sport-related brain injuries.

HITIQ chief commercial officer Damien Hawes discussed the company, which has secured a cornerstone agreement with the AFL. While it’s being adopted across professional contact sports and the military, the company is working to bring the mouthguards and accompanying subscription-based app, to grassroots players.

Also presenting today was Canadian-based clinical-stage psilocin company Tryp Therapeutics which has a Prospectus to raise $6.5 million with 2 cent shares, after being acquired by Exopharm (ASX:EX1).

Tryp MD and CEO Jason Carroll said Tryp was developing an IV infusion of psilocin – a compound from psychedelic mushrooms – to treat pain and anxiety disorders. He said the IV infusion addressed limitations of orally-administered psilocybin used by competitors. It has trialled its treatment for binge eating disorder and is also targeting conditions including anxiety, depression, fibromyalgia and irritable bowel syndrome.

Disclaimer: The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.