• EMvision to progress pre-validation trial ahead of FDA engagement
  • The company has named its Gen 1 portable brain scanner ’emu’
  • MedAdvisor delivers a strong first half FY24 


EMvision completes recruitment for Stage 2 study

$130m capped EMvision Medical Devices (ASX:EMV)  has reached its recruitment goal of 150 suspected stroke patients for Stage 2 of its pre-validation clinical trial.

Earlier, Stage 1 of the trial confirmed that its advanced AI-powered Gen 1 portable brain scanner called ’emu’ had a 100% success rate, with full workflow and brain scan of just 9.2 minutes.

The Stage 2 trial will be conducted at three leading stroke centres in Australia, namely Liverpool Hospital, Royal Melbourne Hospital and Princess Alexandra Hospital, with results anticipated to be reported in Q1 of 2024.

In the meantime, EMV is also preparing for its engagement with the US FDA in early 2024 to achieve alignment for its validation (sensitivity/specificity confirmation) clinical trial phase.

Completion of this phase is anticipated to support the FDA submission.

While all that is happening, EMVision will also activate Stage 3 of the trial (pre-validation) as planned, allowing recruitment to continue in the interim at the three sites.

This will include up to 30 haemorrhagic patients over the coming months, with samples expected to further de-risk and set the validation trial phase up for success.

EMVision will be showcasing its world first point-of-care brain scanners at the RSNA Conference in Chicago from November 26-29, alongside its partner Keysight Technologies (NYSE:KEYS).

“We are on track to commence FDA engagement in early 2024, and will continue to collect data in support of the validation phase, further enhanced by Stage 3 of our multi-site trials as planned,” said EMV CEO, Scott Kirkland.


MedAdvisor had a strong first half

Medication management platform provider, MedAdvisor (ASX:MDR), has delivered a strong first half FY24 trading performance.

In H1, group operating revenue is expected to increase by 10-15% on the prior corresponding period (pcp), with revenue growth expected across ANZ and US.

This came on the back of strong momentum in Q1, which has continued into Q2 across its vaccine and chronic medication health programs.

In addition to strong revenue growth, the company is also benefiting from cash collections during the period and modest cost increases. The cash position at 31 December is projected to be approximately $20m, up from $9.8m reported at September end.

MedAdvisor has re-iterated its guidance for profitable growth being achieved in FY24.

“Most pleasing is that our 2Q FY24 revenue will exceed the exceptionally strong 2Q FY23 results. We are entering 2H FY24 with a solidly contracted and diversified revenue base,” said MDR CEO, Rick Ratliff.

MedAdvisor works with over 33,500 pharmacies in the US to deliver programs to help patients take their medication safely and effectively.

In Australia, the company has connected over 3.7 million patients through more than 95% of Australian pharmacies.

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