Category: Uncategorised

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 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

 

 

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

 

05 Nov 2019

Biotech Daily – “4DX: ‘XV BEATS PFT, CT FOR LUNG HEALTH’”

From Biotech Daily – released Friday, November 1, 2019

 

4DX LIMITED

4DX says a 32-patient, 13-month study shows that its XV technology is superior to “gold standard pulmonary diagnostics” to measure lung health.

4DX said the study, titled ‘Novel x-ray velocimetry based quantitative regional lung function analysis to assess risk of radiation-induced pneumonitis and pulmonary fibrosis’, was published in the journal Chest, with an abstract available at: https://journal.chestnet.org/article/S0012-3692(19)31813-6/fulltext.

4DX said the results were presented by principal investigator Dr Stephen Shiao at the American College of Chest Physicians meeting in New Orleans on October 22, 2019.

The company said the trial compared XV Technology to pulmonary function tests (PFT) at four time points and to computed tomography (CT) tests at one time point

4DX said it found that XV had “excellent” reliability and repeatability and correlated with PFT and CT tests.

The company said both ventilation heterogeneity and ventilation defect percent of XV were statistically significant when correlated with forced expiratory volume in one second (FEV1) and forced vital capacity.

4DX said XV was superior to PFT and CT tests in detecting and locating loss of lung function either as a result of disease or as part of off-target effects of treatment.

The company said XV’s increased sensitivity and richer data resulted in increased predictive power, greater certainty than PFT testing and the identification of subtle changes not reflected in PFT data.

4DX said clinicians “unanimously agreed” that XV report data was “clinically meaningful” over CT and PFT data following the results of the trial and an expert clinical panel, which reviewed XV.

4DX chief executive officer and co-author of the article Dr Andreas Fouras said that “exhaustive laboratory testing over the past 10 years has shown the capabilities of XV Technology, and it is extremely exciting to see the same capability borne out in a clinical trial”.

4DX said the results would be incorporated into its 510(k) application to the US Food and Drug Administration for market clearance, which it expected to lodge by the end of 2019.

The company said it submitted a pre-submission enquiry with the FDA for XV in 2018.

4DX is a public unlisted company.

19 May 2019

4Dx Presents First Human Scan Data From XV Technology Clinical Trials

Andreas Fouras, PhD, (founder and CEO of 4Dx) presented this week the first release of the highly anticipated results from 4Dx’s clinical trials at the American Thoracic Society (ATS) 2019 International Conference in Dallas, TX,

4Dx opened Day 1 of the 3-day conference with a newly-designed booth dedicated to showcasing the first of many 4-dimensional human data scans obtained from clinical trials.  Video walls, touchscreen TVs and a high-tech hologram attraction served as focal points for the booth to display XV Technology’s heatmap-coded, single slice ventilation distribution contour maps, identifying normal and abnormal lung function.

Additionally, Andreas was invited to speak at the Respiratory Innovation Summit that took place two days before the start of ATS.  Andreas’ 6-minute presentation included early stage validation data illustrating the efficacy of XV Technology in detecting regional lung function defects in human subjects, as well as quantitative analysis graphics that highlight lung ventilation throughout the course of a full breath.

4Dx is currently presenting at their booth (#3543)  running through May 21.

19 Feb 2017

4Dx TO PUBLICLY ANNOUNCE PRELIMINARY CLINICAL TRIAL DATA AT PRESTIGIOUS WORLD LUNG IMAGING EVENT

Melbourne, Australia, 20 February, 2017: Dr. Andreas Fouras, founder and CEO of medical technology company 4Dx Limited, will present preliminary clinical data at the prestigious World Lung Imaging Workshop on the 2nd of March at the University of Pennsylvania.

The software technology developed by 4Dx provides richer information, allowing for earlier detection of respiratory related disease.  Dr. Fouras, who founded the company in 2012, says that “presenting the first 4Dx in human clinical data is a great milestone for the company and we are excited to share these results to many of the world’s leading lung imaging experts at such a prestigious event”.

4Dx technology enables clinicians to capture images that effectively visualise and quantify motion of airflow at high resolution within the breathing lungs.  Currently more than 162 million respiratory diagnostic procedures are performed each year, at a cost of $25 billion per annum.

4Dx limited currently has a range of formal engagements with some of the leading institutions across the United States and is moving rapidly towards a commercial product in the United States by 2018.