Category: Uncategorised

10 Mar 2020

Lung imaging software may fast-track coronavirus diagnosis

4DX chief executive and founder Andreas Fouras. Picture: Roy VanDerVegt
4DX chief executive and founder Andreas Fouras. Picture: Roy VanDerVegt

 

Posted on The Australian, 11 March 2020

An Australian medical technology company is hoping to forge the pathway to a fast-tracked coronavirus diagnosis by reducing the ­diagnostic time to three hours.

4DX is seeking to partner with an Australian hospital to conduct clinical trials of its lung imaging analysis software at an Australian hospital. There’s international interest brewing, with Duke University in the US and a Chinese university already wanting to use the technology.

The company’s chief executive and founder, Andreas Fouras, is an Australian aeronautical engineer whose research into wind flow across plane wings expanded into lung health analysis technology.

“It makes for a test that is really fast and completely reliable because there is no opportunity for human error to be included in how our tests are run,” Professor Fouras said. “The way that the virus impacts your lungs is it creates these regions that become inflamed and have reduced airflow and that’s the way in which the virus makes you sick. We’ve been able to prove that we are a very early detector of any disease in the lung.”

Pathology labs in Australia are currently screening for corona­virus using nasal and throat swabs that take 24-48 hours to be read by a specialist.

4DX says its technology has a three-hour turnaround from testing to diagnosis. Doctors would send a lung X-ray to the company which they would run through algorithm to reveal any signs of lung damage or reduced airflow.

 

Author: Adeshola Ore
Adeshola Ore is a reporter at The Australian. She previously reported and produced radio for BBC World Service in London and freelanced for Thomson Reuters Foundation in Melbourne. Adeshola holds an Honours Degree in Sociology from The University of Melbourne.

 

03 Jan 2020

Stockhead article names 4Dx as one of six IPOs to watch for in 2020

A new Stockhead article was posted yesterday naming 4Dx as one of six Australian IPOs to watch for in 2020.

See below for the article text, or click HERE to read directly from Stockhead’s website.

Thank you, Stockhead!

 


4Dx

4Dx is a med-tech with a lung imaging platform. It helps detect diseases such as lung cancer and identify side-effects to disease treatments. It uses no dyes whatsoever, needs no injections and uses 35 times less radiation than the next best scan, according to the ASX hopeful.

Back in October 4DX said the tech passed a 13-month clinical trial showing it was superior. Perfect timing, because CEO Andreas Fouras was seeking broker interest for an IPO that very same week. No date for listing has been set.

He told Stockhead the other major milestone he was targeting in 2020 was FDA approval. While 4DX’s lung imaging tech has not yet been approved in other markets, Fouras said because the FDA was the hardest, if 4Dx could make it in America it could make it anywhere.

READ MORE: 4Dx’s lung imaging technology just passed a clinical trial. Next step – an ASX listing

20 Dec 2019

FDA Acceptance Review Notification – 4Dx 510(k) Accepted

The US Food and Drug Administration (FDA) conducted its administrative acceptance review on 4Dx’s premarket notification (510(k)), and found it contained all of the necessary elements and information needed to proceed with the substantive review.

10 Dec 2019

4Dx $15 million Pre-IPO News Hits News Outlets

New news releases from BioMelbourne Network and Biotech Daily, Dec. 10, 2019:

(https://biotechdispatch.com.au/news/4dx-raises-15m-in-oversubscribed-capital-raise)

 

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10 December 2019

Melbourne, Australia: Australian medical technology company 4Dx Limited has raised $15 million in a heavily oversubscribed pre-IPO.

The funds raised via the unsecured converting note issue will be used to drive 4Dx’s go-to-market strategy by adding to the US sales and distribution capability and augmenting the Software-as-a-Service (Saas) sales platform, as well as continued product research and development.

“The scale of the demand is encouraging as we head toward an initial public offering,” said Chairman and CEO Andreas Fouras. “This shows the market is starting to recognise the significant opportunity presented by our unique four-dimensional lung imaging technology and our well-defined commercial strategy.”

4Dx, which has three respiratory diagnostic software products currently under development with the first product before the FDA, expects to launch an initial public offering within the next 12 months.

The capital raising follows last month’s excellent results in a clinical trial of its patented four-dimensional lung imaging technology.

The confirmatory clinical trial showed that 4Dx’s XV Technology™ gave clinicians much more detailed information than the commonly used pulmonary function test (PFT) and computed tomography (CT) imaging methods. This aligns peer-reviewed preclinical evidence that the unique and non-invasive XV Technology™ enables unprecedented insight into pulmonary function, which is critical in the analysis and treatment of respiratory diseases such as COPD, asthma and cystic fibrosis.

Further information:
Rudi Michelson, Monsoon Communications
Mobile (+61) 411 402 737
rudim@monsoon.com.au

About 4Dx:

4Dx is a software company aiming to deliver the global gold standard in respiratory diagnostics for all lung disorders, including, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis and cancer.

The unique 4Dx technology accurately and quickly scans lung function as the patient breathes, to provide sensitive, early diagnosis and to monitor changes over time. Our Software-as-a-Service (SaaS) scans deliver much more complete results, showing the subtlest variations in lung function down to the finest details, using lower levels of radiation than traditional methods.

Respiratory diagnosis is a $30 billion per annum global industry that 4Dx aims to disrupt and grow through technology that provides clinicians with greater insights into diseases of the lung. 4Dx will bring about a step change in lung health by providing better information to doctors and patients.

Better information means better decisions, and better outcomes.

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15 Nov 2019

4Dx Completes FDA Submission Documentation

FOR IMMEDIATE RELEASE

As of November 10, 2019, 4Dx is proud to announce that all documents required to support an FDA 510(k) application have been handed over to its agent for electronic submission.

After a tremendously successful clinical validation trial, 4Dx founder and CEO, Andreas Fouras, was very happy to announce the trial’s results, which showed that 4Dx’s core platform, XV Technology™ was superior to current modalities in detecting and locating the loss of lung function, either due to disease or side-effects of treatments.

The first commercial product within the XV Technology family being examined by the FDA is the 4Dx Ventilation Report.  It is 4Dx’s first commercial offering to enter into global healthcare markets, with the intent to begin with market-entry in the U.S., China and Australia.

The 4Dx Ventilation Report is an interactive report that is a collection of unique 4Dx test results and outputs that provide highly detailed and unprecedented calculations of the lungs’ ventilation properties.

Each 4Dx output included in the Ventilation Report utilizes 4Dx’s XV Technology™, which is a state-of-the-art lung imaging platform that uniquely images the lungs’ motion, as opposed to their shape.  In doing so, 4Dx’s software is able to take information gathered from a standard cinefluorography sequence and provide back four-dimensional analysis on regional ventilation deficiencies ­­at all locations within the lungs, and at all stages of the breath cycle.

“We’re quite excited,” said Andreas, making the announcement today.  “4Dx’s mission is to give doctors earlier detection of changes in lung function to help doctors diagnosis earlier, provide more sensitive treatment monitoring and deliver much better patient outcomes.  And with our technology giving a complete and unprecedented picture of a patient’s lungs, we believe we’re doing just that.”

Andreas continued, “It’s a very exciting time for us currently.  We think our moment has come now and we’re very proud to announce that all the required documentation is in and our regulatory agent is electronically submitting our application .”

With the average timeframe for FDA approval being 112 days for Class II medical devices, 4Dx is hoping for regulatory clearance sometime in 2020. 

 

About 4Dx

4Dx is a cutting-edge medtech company aiming to deliver the new gold standard in respiratory imaging and ventilation analysis for all lung disorders – including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, and cancer.

The unique 4Dx technology is the first and only modality that images the motion of the lung tissue quickly, during the breath cycle – providing back quantitative regional measurements of ventilation with pinpoint accuracy at every location within the lungs, at each stage of the breath.  Our platform operates with greater sensitivity than any other system to date, is non-invasive, operates using existing hospital equipment, requires no contrast agents, and delivers a radiation dose equal to about two chest X-rays.

4Dx’s Software-as-a-Service (SaaS) reports deliver quantifiable data on the subtlest variations in lung function down to the finest details, providing for earlier diagnosis and intervention, as well as the opportunity to closely monitor ventilation changes that occur over time due to progression of disease or effectiveness of treatment.

4Dx aims to provide clinicians with greater insights into lung disease, and thus bring about a step change in lung health by providing better information to doctors and patients that allows for better decisions and better patient outcomes.

 

 

12 Nov 2019

Dr. Sam Hupert, CEO of Pro Medicus, Joins 4Dx Advisory Board

4Dx is pleased to announce the appointment of Dr. Sam Hupert, co-Founder and CEO of Pro Medicus (ASX: PME) to the 4Dx advisory board.

Dr. Hupert has made a private investment into 4Dx and agreed to sit on 4Dx’s advisory board, bringing with him more than 37 years of success as a leader in the global healthcare medtech and imaging IT community.  Pro Medicus develops Radiology Information Systems (RIS) and Picture and Archiving and Communication Systems (PACS) for radiology departments across the globe and has been one of the best performing med tech companies on the ASX in recent years (ASX: PME).

“Like Pro Medicus, 4Dx will commercialize its XV Technology through the U.S. market” says 4Dx Founder & CEO Andreas Fouras.  “Dr. Hupert’s understanding of this market will be invaluable” says Fouras.

Dr. Hupert will commence his advisory role effective immediately.

 

About 4Dx

4Dx is an innovative software company delivering a new gold standard in respiratory function analysis. The revolutionary four-dimensional technology accurately scans lung function and pulmonary ventilation as the patient breathes, working in combination with traditional x-Ray or CT imaging. The 4Dx technology provides greater sensitivity, resolution and accuracy for respiratory disease quantification and management over the current stand-alone imaging modalities. Our Software-as-a-Service scans enable more comprehensive results by identifying the subtlest variations in lung function while using lower levels of radiation than traditional methods.

 

Respiratory disease diagnosis and monitoring is a $30 billion p.a. global industry that 4Dx is aiming to disrupt and grow through imaging analysis technology that provides clinicians with greater insight into diseases of the lung.  4Dx will bring about a step change in lung health by providing better information to doctors and patients.

 

Better information = better decisions = improved patient outcomes