EMVision’s AI algorithm shows promise

EMvision Medical Devices (ASX:EMV) has shared an update from its ongoing clinical trials focusing on improving EMVision’s AI algorithms for diagnosing strokes caused by bleeding or blockages in the brain.

In the second stage of the trial, EMV enrolled 180 patients who showed up at the emergency room with stroke-like symptoms. These patients were treated at three different hospitals: Liverpool Hospital, Royal Melbourne, and Princess Alexandra Hospital Brisbane.

Out of these, 75 had confirmed blockages in their brain’s blood vessels (ischaemic strokes), while 105 had other conditions like bleeding strokes, stroke mimics, or transient ischaemic attacks (TIAs).

The interim results from the Stage 2 of the trial showed that the AI algorithm is working well in figuring out if a patient has ischaemia stroke or not (clot or not).

The algorithm was able to spot patterns and features in complex patient data, even in cases of early-onset severe ischaemic stroke, which can be hard to detect on standard brain scans.

This analysis builds on previous positive findings that showed EMV’s AI model performs strongly in identifying if there’s bleeding in the brain (haemorrhage).

Following these latest results, EMV said recruitment for the final Stage 3 of the Pre-Validation clinical trial is going according to plan and should be finished in the next few months.

So far, it has recruited more than half of the target group, including up to 30 cases of bleeding.


Telix submits new application to FDA

Telix Pharma (ASX:TLX) has just submitted a New Drug Application (NDA) to the US FDA for TLX007-CDx.

This is a new and proprietary cold kit designed for preparing PSMA-PET imaging for prostate cancer.

If approved, this kit will allow for the use of a PSMA imaging product with a much wider distribution compared to current gallium-68 (68Ga) PSMA-PET imaging agents.

The kit’s innovative features are designed to enhance production flexibility, utilizing 68Ga from newer high-activity generators and cyclotrons powered by the ARTMS QUANTM Irradiation System and GE FASTlab production system.

The ARTMS QUANTM is technology used in medical imaging to produce radioisotopes, such as gallium-68 (68Ga), while the GE FASTlab system is a platform developed by GE Healthcare for the automated production of radiopharmaceuticals.

Telix believes this will make PSMA-PET imaging more widely available and easier to schedule.

Despite the commercial availability of PSMA-PET imaging agents in the US, access is still severely limited for underserved patient demographics in many regions.

“We believe this is particularly important as demand for PSMA-PET imaging is forecast to grow significantly over the coming decade,” said Telix’s CEO, Dr Christian Behrenbruch.


Dimerix to enter Middle East markets

Dimerix (ASX:DXB) and Taiba Middle East FZ LLC have announced an exclusive licence agreement.

This agreement covers the commercialisation of Dimerix’ Phase 3 drug candidate DMX-200 for treating focal segmental glomerulosclerosis (FSGS) kidney disease in the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain, and Iraq.

Dimerix still holds all rights to sell DMX-200 in other places that aren’t covered by this agreement, like the US and China.

In those Middle Eastern countries mentioned above, healthcare is often provided for free by the government.

Usually, the prices of drugs for rare diseases are set based on the prices in the country where they were developed or the prices in the US or Europe.

So if DMX-200 is approved as an orphan drug in the US, its price would likely be based on the pricing models used by the US FDA or the European Medicines Agency.


GSS abandons plans for respiratory kit in US

Meanwhile, Genetic Signatures (ASX:GSS) has decided not to continue developing its EasyScreen Essentials Respiratory Detection Kit for the US market.

This decision comes after assessing the commercial landscape and seeing that other fully automated respiratory tests have already been cleared by the FDA and are widely used in the US.

Since respiratory pathogen testing has decreased in the last 2-3 years, GSS believes its kit wouldn’t compete well in the market. Instead, the company plans to focus on launching the EasyScreen Gastrointestinal Parasite Detection Kit in the US soon.

GSS’ interim CEO, Neil Gunn, said the company is not sufficiently confident that its US Respiratory product will be able to rapidly win market share from the incumbent products in the increasingly competitive market.

“We remain committed to our respiratory products in our domestic market of Australia where we see increasing use as the winter season arrives,” Gunn added.


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