Category: News

20 May 2020

Australian Financial Review: 4D Medical gets nod from FDA, pushes ahead with float plans

Written by Carrie LaFrenz, Senior Reporter
May 21, 2020 – 12.30am

Medical-technology developer 4D Medical is pushing ahead with its ASX float plans despite the market turmoil after getting the nod from the powerful US Food and Drug Administration to market its lung-imaging product.

The FDA clearance comes at a time when there is great focus on respiratory health around the world as countries deal with the COVID-19 pandemic.

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. He moved his family to Los Angeles, where he hopes to tackle the most important healthcare market globally, where 80 million lung scans are done every year.

“We are very keen to take 4DMedical to the world, so by having the key opinion leaders and having the toughest regulator in the devices space [give us the tick], we have showed we are ready to take this to not just the US, but everywhere around the world,” he said.

There is a big opportunity with the respiratory diagnostics market valued at more than $US30 billion ($45.8 billion) a year.

“We see COVID something as additional layer, but we are not pivoting towards COVID, we are looking to cover every single lung disease,” said Mr Fouras.

Current lung-imaging techniques give an overall picture of the amount of air a lung is taking in, but 4D Medical’s technology highlights if there are parts of the lungs which are receiving less air, helping in the early diagnoses of diseases such as asthma, chronic obstructive pulmonary disease (COPD) or lung cancer. More effective treatment can then be offered to the patient.

Mr Fouras is hoping for TGA approval this year for its imaging technology, which has a three-hour turnaround from testing to diagnosis. Doctors send a lung X-ray to the company, which then runs through its software and applies algorithms to identify lung damage or reduced airflow. The hospital pays for each scan sent.

4D Medical, formerly known as 4Dx, in December raised $15 million through EL&C Baillieu. It later named Bell Potter and Evans & Partners as joint lead managers on the IPO after a scandal hit Baillieu.

It is believed that the company is seeking to raise between $30 million and $35 million this time around. Mr Fouras is predicting the company will break even by 2022 after posting an operating loss of $12 million this year.The group has already partnered with prestigious hospitals to conduct clinical trials, including LA-based Cedars Sinai Medical Centre, Cleveland Clinic and John Hopkins. Locally, it has teamed with The Telethon Kids Institute and is in talks with hospitals about partnerships, including The Alfred and The Royal in Melbourne.

Mr Fouras controls about 45 per cent of the company and has no plans to sell down in a possible float that could see his company valued at $200 million to $250 million.Other investors include CEO of Pro Medicus Dr Sam Hubert, Ryder Innovation Fund LP, Perennial Private to Public Opportunities Fund, Regal Emerging Companies Fund and Tall Oaks Asset Management.

4D Medical plans to kick off a non-deal roadshow next week to talk to fund managers. It is estimated the company will list by August.

Original article posting: https://www.afr.com/companies/healthcare-and-fitness/4d-medical-gets-nod-from-fda-pushes-ahead-with-float-plans-20200520-p54uoz

 

02 May 2020

Field Ventilator to Combat Corona

As printed in The Courier Mail, Thursday 30th April 2020
By Charles Miranda

A TEAM of Australian scientists has created a groundbreaking “field ventilator” to help combat coronavirus in remote regions where hospital emergency resources are limited.

And critically they are going into production in Australia and not China meaning no issues with supply lines and can be directly dispatched from here to those most in need including to allies in the Pacific with challenged health care systems.

A consortium of leading doctors, engineers and medical researchers from Melbourne and South Australia had already teamed up as part of the Australian Lung Health Initiative to develop the world’s first lung function scanner.

But the corona pandemic prompted the team to fast-track the development of a low-cost ventilator that does not need a hospital or ICU trained staff to operate and can save lives.

Melbourne-based medical tech group 4Dx founder and biomedical engineer Andreas Fouras developed the device initially as a research tool but COVID-19 and fears of a global shortage of ventilators prompted a rethink.

Together with the SA Health and Medical Research Institute, the University of Adelaide as well as independent testing, the product is now ready for use.

21 Feb 2020

IPO Preparation Update

4Dx has appointed E&P (formerly Evans and Partners) and Bell Potter Securities as joint lead managers of its proposed IPO.

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.

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

 

30 Oct 2019

4Dx Celebrates Confirmatory Clinical Trial Success of it’s XV Lung Imaging Technology

29 October 2019

Melbourne, Australia, 29 October 2019

Australian medical technology company 4Dx Limited has attained excellent results in a major clinical trial of its patented four-dimensional lung imaging technology.

The confirmatory clinical trial showed that XV Technology™ gave clinicians much more detailed information than the commonly used pulmonary function test (PFT) and computed tomography (CT) imaging methods, confirming 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.

The trial examined whether clinical data generated using XV was consistent with current ‘gold-standard’ measures and other clinically available measures; and whether XV was more predictive than other measures in assessing changes to lung function, such as the onset of off-target effects of treatment.

The trial was conducted on patients undergoing treatment for cancer. XV scans were acquired, in combination with PFT, CT and other diagnostics, over a 13-month period following admission.

XV Technology™ showed excellent reliability and repeatability, and demonstrated good correlation with the standard of care tests, PFT and CT. Results showed that XV was superior in detecting and locating loss of lung function either as a result of disease or off target effects of treatment.

The trial showed that XV can be used to identify subtle changes not reflected in PFT data, and delivers increased predictive power and greater certainty than PFT testing through increased sensitivity and richer data.

In an expert clinical panel convened to review XV Technology™ and the results of the trial, clinicians unanimously agreed that the XV report data was “clinically meaningful,” and more so, in fact, than CT or PFT data.

The clinical trial results will be incorporated into 4Dx’s 510(k) application to the United States Food & Drug Administration (FDA) for clearance to market a medical device, which 4Dx expects to lodge by the end of 2019. 4Dx submitted a pre-submission enquiry with the FDA for XV in 2018.

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.

Monsoon Communications
Level 1, 121 Flinders Lane
Melbourne VIC 3000
Ph: 03 9620 3333
www.monsoon.com.au

https://biomelbourne.org/4dx-celebrates-confirmatory-clinical-trial-success-of-its-xv-lung-imaging-technology/

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.

26 Apr 2019

FUNDING FOR GROUND-BREAKING LUNG DIAGNOSTIC TECHNOLOGY

 The Hon. Greg Hunt MP 

Minister for Health 

MEDIA RELEASE 

FUNDING FOR GROUND-BREAKING LUNG DIAGNOSTIC TECHNOLOGY 

The Liberal National Government will provide $960,000 for intensive research into new 4D diagnostic technology to allow accurate assessment of lung function in patients of all ages including the very sick. 

The Australian Lung Health Initiative headed by Professor Andreas Fouras is one of 10 highly promising research projects to be funded under Stage One of the bold Medical Research Future Fund (MRFF) Frontiers initiative. 

The project aims to deliver an original technology that is rapid, easy to use and safe, with less than 10 per cent of the radiation used by X-rays. 

Patients would not have to remain still or follow instructions, making it suitable for infants, children, older people and the very sick who are difficult to assess with current technology. 

In Australia, 7.1 million people—almost one in three—live with a lung disease. 

There are more than 30 types of lung conditions. Lung cancer, for example, is Australia’s biggest killer claiming more than 9,000 lives in 2017—more than breast, prostate and ovarian cancers combined. 

The five-year project will build on Australian company 4Dx Limited’s patented XV Technology™, a four-dimensional lung function imaging analysis, and new lose-dose imaging science. Professor Fouras is founder, chairman, and chief executive of 4Dx. 

The Australian Lung Health Initiative was formed to bring together world-leading Australian scientists, engineers, manufacturers and medical researchers to revolutionise lung screening and treatment. 

As well as 4Dx, it includes medical technology company Micro-X, the University of Adelaide, Monash University, South Australian Health and Medical Research Institute, and Telethon Kids Institute, 

Devices developed from the project could have a substantial health impact here and around the world, as well as huge commercial potential. 

The funding is drawn from the Government’s ground breaking Frontier Health and Medical Research program, which is directing $570 million to Australia’s most innovative and transformational medical research. 

Frontiers creates an opportunity for Australia’s best and brightest to form formidable multidisciplinary teams to transform ideas from concept to outcome. Frontier awardees needed to articulate how their idea was novel and would position Australia as a global leader. 

Frontiers has a unique, two-stage structure developed in consultation with Research Australia. 

In Stage One, 10 selected applicants will receive funding of up to $1 million each over one year to develop detailed planning for their cutting-edge research projects. 

Each of the selected 10, like the Australian Lung Health Initiative, will be able to apply for Frontiers Stage Two with the opportunity to secure up to $50 million or more to realise their ground-breaking research plan. 

Applications were assessed by an International Scientific Peer Review Panel to ensure those recommended for funding would deliver new to world ideas and opportunities. 

This investment has the potential to transform healthcare and stimulate growth in the Australian medical technologies, biomedical and pharmaceutical sector, a vital part of the innovation economy. 

The Coalition Government’s strong economic management ensures we continue to invest record amounts of funding into ground-breaking medical research, Medicare, mental health, life-saving medicines, and hospitals. 

ENDS 

 

To view the original article, please click here

07 Aug 2018

Medical imaging startup takes new approach to viewing lung disease

The company’s algorithms use existing fluoroscopy technology, which captures structures in motion and is commonly used to image the cardiovascular system or direct invasive procedures.

 

Lung diseases, like asthma, cystic fibrosis (CF) and COPD, affect millions of people worldwide. However, current diagnostics don’t necessarily provide enough data to support the best possible care. Spirometry tests how much air a patient can forcefully exhale. They provide good global information but don’t show which lung regions are most affected. CT scans can measure lung damage but are a trailing indicator and expose patients to significant radiation.

Melbourne, Australia-based 4Dx may have a new approach. The company has developed 4DxV, which converts x-ray images into more detailed airflow studies. The founder believes the additional information will improve diagnosis and disease control.

“As a mechanical engineer, the most obvious aspect of function is movement, especially in the heart and the lungs,” said 4Dx founder and CEO Andreas Fouras in a phone interview. “Our technology tries to create the highest resolution image of tissue movement. Once you have a detailed map of tissue motion in the lungs, from there, it’s a pretty simple step of calculating airflow.”

The idea germinated around 15 years ago while Fouras was a research assistant in a wind tunnel lab at Monash University. He was working on new algorithms to improve wind tunnel imaging when colleagues suggested his ideas could be applied to medical diagnostics.

The company’s algorithms leverage existing fluoroscopy technology, which captures structures in motion and is commonly used to image the cardiovascular system or direct invasive procedures. Retasking the existing technology could make it easier for hospitals to adopt the approach without a major capital investment.

“The kind of equipment we need in the hospital is only used about 60 percent of the time, which reduces the barrier to entry,” said Fouras. “Flouro allows us to get the (radiation) dose well below a CT scan.”

From a diagnostic standpoint, this approach could provide much richer information about disease progression. Spirometry measures forced expired volume (how much air a patient can blow out) in one second (FEV1), but this doesn’t necessarily provide the detailed studies pulmonologists need to identify severe regional disease.

“You have a developing problem in your lungs, 20 percent loss of ventilation in a region that covers 20 percent of your lungs,” said Fouras. “Well, 20 percent of 20 percent is only 4 percent. So, the best-case scenario on an FEV1 is a 4 percent reduction. An FEV1 isn’t considered clinical until you get to a 20 percent loss of ventilation.”

As a result, spirometry generally identifies problems after damage has become quite severe, but the 4Dx technology could potentially provide more precise regional data.

“In preclinical studies we’ve shown that we can detect the onset of conditions six or 12 times earlier than the old techniques,” said Fouras.

The 4DxV has generated interest from a variety of hospitals, including Cleveland Clinic and Children’s Hospital Los Angeles. Clinicians could use these studies to quantify a treatments efficacy or direct therapy. For example, for children with CF, treatment could be focused on the mucus plug rather than generalized throughout the lung.

“I think this is the future of trying to maximize getting functional information from your imaging studies,” said Marvin Nelson, who chairs the Department of Radiology at Children’s Hospital Los Angeles, in a phone interview. “It’s not just a structural study, you’re actually being able to use the technology to generate quantitative functional value.”

The company is closing out a Series B round and has been in talks with the FDA to pave the way for a 510(k) submission. They are also working on products to measure blood flow for the heart, as well as the lungs. Ultimately, these functional studies could provide a big boost in patient care.

“Being able to take a breath in while the x-ray is on,” said Nelson, “and being able to do all the calculations to generate that functional ventilation data off of that study, it’s going to be a tremendous advancement in doing high-throughput screening in populations for all these lung diseases.

To view the original article, please click here