Biotech Daily — Dr Boreham’s Crucible: 4DMedical

19 April 2024

“… About the tech
4D’s patented XV Technology platform enables doctors to understand ‘regional’ airflow in
the lungs, thus identifying illnesses with greater efficacy as patients breathe.
4D’s tools supplement – but do not replace – the images produced by conventional x-rays,
computed tomography (CT), magnetic resonance imaging (MRI) and the relatively crude
spirometry (breathing into a handheld device to measure the amount of air expelled).
The technology underpins XV Lung Ventilation Analysis Software (XV LVAS), which
quantifies lung ventilation. A variant, CT LVAS is – you guessed it – an adjunct to
computed tomography (CT).

“XV LVAS interfaces with current imaging techniques by uploading the images to produce
a “rich high-resolution picture of the lungs”. The fourth dimension (4D) is time. The
technology ‘sees’ what the lung is doing.

“4D’s imaging can detect conditions including emphysema, chronic obstructive pulmonary
disease (COPD), lung cancer, asthma, pulmonary and cystic fibrosis and occupational
diseases such as silicosis.

“In August 2022, 4D announced the results of a study for the burns pit disease constrictive
bronchiolitis, at the Vanderbilt University Medical Center in Nashville, Tennessee.
Preliminary results confirmed 4D’s tech could detect the disease – which affects the lung’s
smallest airways of 1.0mm or less – when CT and pulmonary tests could not.
In May 2020, the US Food and Drug Administration (FDA) granted the XV LVAS
clearance for imaging any lung indication, while Australia’s Therapeutic Goods
Administration (TGA) followed suit in September last year.

“In late November last year, the FDA also ticked off CT-LVAS, thus greatly expanding 4D’s
potential market reach…”

“…It’s all happening
“Last year ended with a flurry of announcements for 4DMedical.
In November, the company won reimbursement for XV LVAS from the Centers of
Medicare and Medicaid Services (CMS) – which is almost as important as FDA approval

“The per-procedure reimbursement of $US299 ($460) provides a benchmark for private
insurers. The reimbursement covers 65 million US citizens aged over 65 years, across
4,000 Medicare certified hospitals.

“A week later, imaging house Precision IR said it would offer outpatient screenings across
its clinics in Detroit and Memphis, from January 1, 2024. This will result in subscription
revenue flowing to 4DMedical.

“The company then signed a memorandum of understanding with Philips, which provides
imaging equipment to almost half of US veterans’ lung screening clinics.
Upgraded to a contract in January this year, the distribution deal provides ‘an accelerated
and expanded pathway for commercialisation of veterans’ lung screening products.’

“In December, the company announced the acquisition of Imbio, a private US outfit
specialising in artificial intelligence-based lung and heart analysis…”

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