The All Ordinaries (ASX: XAO), or All Ords, stock 4DMedical Ltd (ASX: 4DX) jumped 18% today after the ASX healthcare share announced exciting news out of the FDA in the United States.
The respiratory imaging technology business has received clearance from the US Food and Drug Administration (FDA) for its IQ-UIP product. This is an advanced AI-driven lung diagnostic tool to "revolutionise the diagnosis of usual interstitial pneumonia (UIP), the hallmark radiological pattern for diagnosing interstitial pulmonary fibrosis (IPF)."
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What this FDA approval will do for the ASX All Ords stock
The company said its acquisition of Imbio in 2023 enabled it to provide its referrers with a comprehensive portfolio of functional and structural lung analysis tools. 4DMedical said this portfolio, combined with its cardiology analysis suite, was unique to the company and provided a "meaningful current revenue stream as well as the opportunity for significant growth".
According to the company, FDA clearance of IQ-UIP "adds another important component" to the portfolio and will be actively offered to referrers in Australia and the US.
4DMedical explained that this offering, combined with CMS reimbursement in the US, facilitated growth opportunities in various markets, including the VA, private radiology, respiratory, and cardiology specialists.
However, receiving FDA clearance for IQ-UIP is one of the three products that could trigger the obligation to pay US$5 million of consideration in 4DMedical shares to the sellers of Imbio Inc. This was approved at the company's extraordinary general meeting (EGM) on 22 January 2024. Shareholders of the ASX All Ords stock will be updated once the issue of shares is finalised.
CEO comments
The 4DMedical managing director, CEO and founder Andreas Fouras said:
IQ-UIP represents a transformative step forward in addressing the challenges of diagnosing and managing UIP.
Its deployment promises to shift the standard of care from reactive to proactive, improving patient outcomes while offering significant benefits to healthcare providers and pharmaceutical developers.
UIP and IPF are an important and expensive part of healthcare, and there has been strong interest in this offering from both doctors and drug developers since winning FDA Breakthrough Device Designation in 2023.
Why IQ-UIP helps the healthcare industry
There are a number of benefits of utilising this product, according to the company.
Firstly, it's meant to enhance diagnostic accuracy – it "quickly and accurately identifies UIP patterns such as subpleural fibrosis and honeycombing". It also enables earlier intervention and management, potentially extending survival rates and improving the quality of life.
4DXMedical also pointed out that IQ-UIP has the potential to "shorten clinical trial timelines and reduce costs for pharmaceutical companies by providing a reliable imaging biomarker and patient selection tool".
Clinical trials in the sector can reportedly cost more than US$115 million per trial, with the total cost of developing new drugs and taking them to the market potentially being in the billions of dollars.
The ASX All Ords stock said IQ-UIP had the potential to "dramatically reduce the costs and time taken for clinical trials, which will benefit pharmaceutical companies, and also deliver better health outcomes to patients in a faster time frame".
The median survival after diagnosis is between one and two years. The condition affects 140,000 individuals annually in the US, and 50,000 new cases are diagnosed each year. The global IPF treatment market is expected to almost double in the next decade to approximately US$7.81 billion, up from US$4.01 billion in 2024.
4DMedical share price snapshot
Shares in 4DMedical closed at 55 cents today, up 14.7%. Despite today's rise, the ASX All Ords stock has fallen 22% in the last 12 months.
