• 4D Medical surged 15pc after a US FDA clearance
  • TrivarX moves rapidly to progress Phase 2 trial in depression
  • Artrya signs five-year deal in the State of Georgia, USA


4D Medical’s share price jumps on US FDA clearance

Respiratory imaging tech company, 4DMedical (ASX:4DX), jumped by 15% this morning after receiving clearance for its CT-based ventilation product, CT LVAS, from the US FDA.

The clearance will expand and broaden patient accessibility of functional lung imaging in the US, following the recent CT LVAS rollout in Australia.

Australia was chosen as the company’s first market due to the country’s high density of CT scanners per head of population.

According to OECD data, the US install base for CT scanners is also material, with 43 CT scanners per million population (versus Australia at 70, France at 20, and Canada at 15 per million).

Just last week, the US Centres for Medicare & Medicaid Services (CMS) had approved reimbursement for 4DMedical’s XV LVAS at a rate of US$299 per procedure, effective 1 January 2024.

Read more here: 4DX skyrockets 54pc after US update on its XV LVAS scanning device

Following FDA clearance for CT LVAS today, the company says it will adopt a similar reimbursement strategy.

First, it will apply to the American Medical Association (AMA) to establish a new, distinct, Category III CPT code to identify the use of CT LVAS.

The company will then seek to have the procedure reimbursed by public and private health insurance schemes.


TrivarX to onboard patients in depression study

AI-based medical devices company, TrivarX (ASX:TRI), was up 6% in early trading after confirming that it has onboarded 15 sleep centres across the US to accelerate its Phase 2 Sleep Signal Analysis for Current Major Depressive Episode study (SAMDE).

The Phase 2 study aims to validate the company’s algorithm, MEB-001, to assist in the screening and diagnosis of current major depressive episode (cMDE) in test subjects.

Trivarx is seeking to test 400 patients for this Phase 2 trial, which will see clinicians administer a Mini International Neuropsychiatric Interview (MINI) in order to provide an independent assessment and establish ground truth regarding each patient’s cMDE status.

To date, the company has successfully enrolled 132 of the 400 target patients, and says it’s confident to complete Phase 2 testing during the first half of 2024.

“Results will also form the basis on Trivarx’s engagement with the FDA to unlock a regulatory pathway for our product, ahead of commercial roll out,” said TrivarX’s non-executive chairman, David Trimboli.


Artyra enters US market

Another AI-focused medtech company, Artrya (ASX:AYA), has entered the US market after a five-year strategic commercial partnership agreement with Northeast Georgia Health Ventures (NGHV).

Under the agreement, NGHV will work with Artrya to validate Artrya’s Salix Coronary Anatomy (SCA) platform into its workflow and hospital network, while the product goes through the FDA 510(k) clearance process.

The two companies will also develop specific use cases for Artrya’s software products across the five hospitals under the network, in order to validate the detection of coronary artery disease.

Post-FDA pre-market clearances, NGHV will then work with Artrya to roll out and expand its point-of-care SCA solution to clinicians and patients across the Northeast Georgia Health System’s to help 100,000 heart disease patients each year in the US state of Georgia.

Artyra says the market opportunity in the US for its product is driven by the scale of heart disease, which kills one person every 34 seconds in the country.


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