20 Apr 2017

4Dx Preclinical Scanner Project to Rapidly Manufacture 2 Preclinical Scanner Units for Delivery in Major US Hospitals

Melbourne, Australia, 19 April 2017: 4Dx  Group “4Dx”, Hydrix Pty Ltd “Hydrix”, and Monash University are collaborating “4Dx Pre-Clinical Scanner Project consortium” to rapidly manufacture two pre-clinical scanners for delivery to two major American medical research hospitals by the end of the year. A further three units will be supplied to other world leading hospitals by the end of the 2018.

This project will deliver technology that is a world first in innovative respiratory analysis and diagnostic systems. 4Dx provides a unique 4-Dimensional perspective and expert analysis of data to clinical practitioners.  The technology results in lower costs, provides more information and faster validation of treatment with reduced radiation exposure, while also allowing for earlier detection of disease and intervention by doctors. The technology enables clinicians to capture images that effectively provide highly detailed footage of the motion and airflow within breathing lungs.

162 million respiratory diagnostic procedures are performed within the OECD each year, at a cost in excess of AU$25 billion per annum. A share of this market will create a new multi-billion-dollar industry in Victoria. This industry will see the creation of highly skilled jobs in design, engineering, software development, R&D and clinical trials in the Victorian economy.

4Dx technologies are globally unique and with strong interest from a number of major US hospitals 4Dx has the opportunity to secure a strong share of the US respiratory health clinical technology market. The technology opens up a new niche for the export of high value advanced technology manufactured in Victoria.

This innovative diagnostic was developed through research programs conducted at Monash University, with support and funding from a number of Australian and American government agencies and peak body groups.

Monash University Deputy Vice-Chancellor and Vice President (Enterprise) Mr Ken Sloan says, “the technology provides an enormous opportunity to impact global health and is a brilliant example of the leading role Monash University research teams are playing in world class innovation. By harnessing our leading research capability and driving government and commercial partnerships, Monash enterprise is tackling real world, high impact challenges, while also advancing economic growth.”

The approval process for clinical human use will be undertaken in conjunction with the utilisation of the pre-clinical scanning technology on small animals at US medical research hospitals. The partnership with major US hospitals to take up the clinical scanner technology will enable human clinical use in key facilities with a view to rapid global adoption of the technology.

4Dx CEO and founder Andreas Fouras says, “having these key US hospitals commit to a 4Dx scanner demonstrates their confidence in our technology and lays the foundations for the introduction of human research scanners in the near future.”

The Pre-Clinical Scanner Project is supported by the Victorian Government, with the project expected to create 56 new jobs and generate at least AU$6.7 million export revenue over the two year period. The consortium will directly co-invest $1.395 million in the project, with 4Dx committing to an additional $6.85 million investment into research and development operations in Victoria.

Hydrix Business Development Manager Paul Carboon says, “we are excited to support 4Dx in the design finalisation and assembly of the first batch of preclinical scanners. It is a great Victorian success story of technology that was created at Monash and is now being commercialised by 4Dx. This project leverages Hydrix’s significant experience in the development and commercialisation of x-ray based innovative products targeted at the Global Markets. It is fantastic to be able to secure the development and manufacturing of these products here in Victoria.”

4Dx CEO and founder Andreas Fouras also says, “4Dx envisages this project will provide a significant new advanced manufacturing, export and jobs opportunity for Victoria from what will be rapid global demand for disruptive 4Dx research and clinical technologies.”

Gaining Victorian Government funding support under the Future Industries Fund Sector Growth Program is vital to ensure the consortium is able to provide certainty to manufacture in Victoria and supply of the first two ventilator-scanner units to US research hospitals by the end of the year.

Minister for Industry and Employment, Wade Noonan says “through the Sector Growth Program, the Victorian Government is making it possible for innovative organisations such as 4DX Limited, Hydrix Pty Ltd and Monash University to undertake this ground breaking project which will improve the management of respiratory conditions.”   

17 Mar 2017

4Dx visits London, participates in House of Lords event

4Dx is pleased to inform you that our Chairman and CEO, Andreas Fouras, will be lead speaker at a lunchtime debate at the All Party Parliamentary Engineering Group ‘APPEG’ in the House of Lords, London on Tuesday 21st March.  The debate series represents a plank of the APPEG program to enable contact and involvement between parliamentarians and the engineering profession.

Professor the Lord Broers, Co-Chair of the Group, will introduce the debate on exciting advances in medical imaging.  “We are delighted to have Professor Fouras, Chairman and CEO of medical technology company 4Dx who founded this life-changing medical technology company, which aims to augment the capabilities of respiratory diagnostics currently available, leveraging information that has until now remained hidden in X-ray images.”

4Dx Executive Director, Steve Peuschel, is currently in London with Andreas as part of a global 4Dx roadshow presenting data from the first 4Dx in-human study to a wide range of organizations key to the company’s strategy.  This included a presentation by Andreas at the International Imaging workshop at the University of Pennsylvania in the United States.  Steve was excited by feedback from the world leaders in lung imaging.  “The response to our presentations in Philadelphia was incredibly positive.”

In addition, the company delivered presentations in Washington DC to the Cystic Fibrosis Foundation – the U.S. peak body for Cystic Fibrosis research.  The 4Dx roadshow now continues in Europe with industry and potential hospital partners, a key focus of the latter half of the trip.

13 Mar 2017

4Dx ANNOUNCES PRELIMINARY CLINICAL TRIAL DATA AT PRESTIGIOUS WORLD LUNG IMAGING EVENT

4Dx has publicly released preliminary clinical study data on the 2nd March at the prestigious World Lung Imaging Workshop at the University of Pennsylvania. Founder and CEO, Dr. Andreas Fouras, was invited to deliver the latest data to world leaders in lung imaging and pulmonary medicine. This globally recognised event brings together leaders at the forefront of the industry to present and share the latest developments in lung imaging.

“The quality of the imaging is spectacular,” said Debiao Li, PhD, Director of the Cedars-Sinai Biomedical Imaging Research Institute and Professor of Biomedical Sciences at Cedars Sinai where the study is being conducted.This technology will give us unique capabilities.”

4Dx’s software technology provides accurate and sensitive data with a unique 4-dimensional perspective to clinical practitioners, and has been extensively validated in pre-clinical studies. The technology has the potential to provide more information, and faster validation of treatment with reduced exposure, while also allowing for earlier detection of disease.

The announcement of these results by 4Dx, demonstrates compelling evidence of the leap from the laboratory to the clinic, opening the door for huge market potential as 4Dx continues to engage with leading U.S hospitals.

4Dx technology enables clinicians to capture images that effectively visualise and quantify motion of airflow at high resolution within the breathing lungs.  Within the $1.4 trillion respiratory healthcare sector, there are 162 million respiratory diagnostics procedures performed each year, for a clearly identified $30 billion per annum addressable market.

The public announcement of preliminary clinical data at this prestigious event is a huge milestone for the company, with 4Dx expecting increased interest from key clinical groups as well as investors.

Founder and CEO Andreas Fouras says “We are extremely thrilled to have been given the opportunity to present data that shows the potential of our technology to change the lives of millions through earlier and better informed intervention”.

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.

09 Feb 2017

NEW STAFF APPOINTMENT: KAREN SIU, PhD- Programme Manager- Medical Device Development

Dr Karen Siu obtained her PhD from Monash University in 2003 in X-ray Physics. Her postdoctoral work as an Australian Synchrotron Research Program Fellow allowed her to explore the applications of synchrotrons, or highly intense x-ray sources, to biomedical research studying cancers of the brain and breast. She focussed on synchrotron imaging for understanding the origins and development of lung disease, in particular cystic fibrosis and asthma. In her 11 years at Monash, she built multidisciplinary and international research collaborations to investigate novel methods of preclinical imaging and new measures of airway health- attracting significant funding for her research.

As a synchrotron imaging expert, Dr Siu was a key player in early studies that demonstrated the feasibility of coupling state of the art x-ray imaging with particle imaging velocimetry (PIV) techniques from fluid mechanics. These early studies on various preclinical models built the foundations of 4Dx’s patented lung imaging technology.

Before joining 4Dx, Dr Siu was User Program Coordinator at the Australian Synchrotron, which oversaw the processes by which Australian and international researchers gain access to national research infrastructure. Coupled with her previous role as Head of X-ray Imaging at Monash Biomedical Imaging, Dr Siu brings a keen interest in research management, research infrastructure and stakeholder engagement to her new role at 4Dx.

Dr Siu will oversee the company’s first FDA Premarket Notification for 4Dx’s radiotherapy devices. Successful clearance of this device will allow the company to commercially market, a key milestone for this product and for the company’s product line. Dr Siu says, “I am excited to be joining 4Dx at a time when the company is growing and maturing rapidly. It’s a thrill to be a part of the evolution of a research idea into a marketable product that will change lives”.

10 Jan 2017

New Scanner Locates Defects in Lung Function

Cedars-Sinai has been awarded a National Institutes of Health grant to buy a new type of scanner that provides detailed, real-time imagery of lung functioning in laboratory animals. Cedars-Sinai so far is the only U.S. institution scheduled to acquire this advanced instrument, which can help detect lung diseases in their early stages.

“The quality of the imaging is spectacular,” said Debiao Li, PhD, director of the Cedars-Sinai Biomedical Imaging Research Institute and professor of Biomedical Sciences. “This instrument will give us unique capabilities.” Li is the principal investigator for the $600,000 project, a joint effort with the Women’s Guild Lung Institute at Cedars-Sinai.

Using a type of low-dose X-rays, the 4Dx Small Animal Scanner generates high-resolution, 3-D images of lung-tissue motion and airflow throughout the lungs. These moving images allow investigators to view and measure defective functioning in specific areas of the lung, before a disease progresses and spreads.

The new scanner addresses a dilemma in detecting pulmonary fibrosis, edema, emphysema and other lung disorders. The dilemma is this: While computed tomography — the gold standard for lung imaging — can provide detailed views of damaged tissues, the images are static and don’t show how well these tissues are working. Current tests of lung functioning can only measure the performance of the lungs as a whole.

“Pulmonary function tests are notoriously insensitive at detecting early stages of lung disease, when potential therapies might be most efficacious,” said Andreas Fouras, PhD, a research scientist at the Biomedical Imaging Research Institute and visiting professor. “The problem is that if you have something happening in a corner of the lung, the rest of the lung compensates. So you can get fairly normal results on the tests even when disease is present.”

Fouras is the founder of 4Dx Ltd., a medical technology company based in Melbourne, Australia, that developed the 4Dx Small Animal Scanner. Along with Heather Jones, MD, assistant professor of Medicine and Biomedical Sciences at Cedars-Sinai, he will co-direct a new Lung Imaging Program at the Biomedical Imaging Research Institute.

Jones and Fouras said the new scanner could save time and money by enabling researchers to track the progression of lung disease within a single laboratory animal over its lifespan. Current technology typically requires post-mortem examinations of multiple animals, each modeling different stages of a disease, to obtain this data, they explained.

The 4Dx Small Animal Scanner is expected to be available for use by the end of this year, Fouras said. Investigators from Cedars-Sinai will be the primary users, but outside scientists will have access as well. “We hope this instrument will foster a consortium of lung researchers in the Los Angeles area and beyond,” Jones said.

This image shows the degree of expansion (from high, in red, to low, in blue) of different areas of a mouse lung during ventilation.

To view the full article with accompanying imagery please click here.

30 Nov 2016

AUSTRALIA’S 4DX MAKING WAVES IN U.S. HEALTHCARE

Melbourne, Australia, November 30, 2016:  Australian medtech startup 4Dx is making a bold foray into the US diagnostics marketplace, inking deals with major US hospitals and attracting one of the country’s most prominent oncologists to join its Board of Directors.

Dr Bob Figlin will join the 4Dx board from December 1st.  Dr Figlin is Deputy Director of the Integrated Oncology Service Line, and Deputy Director at the Samuel Oschin Comprehensive Cancer Institute, part of the world-renowned Cedars-Sinai Medical Center in Los Angeles. He is also currently the director of the Hematology Oncology Division at the institute.

Dr Figlin says, “4Dx has developed some of the most promising and exciting technology I’ve ever seen in the fight against disease. It will be a privilege to be able to use my medical and business experience to assist the company through this phase of its growth.”   Dr Figlin co-founded biotechnology company Agensys, which later sold as part of a nine-figure deal.

4Dx has also established formal clinical partnerships with several of the biggest and most advanced hospitals in the US, including Cedars-Sinai, The Cleveland Clinic, the Children’s Hospital Los Angeles, Virginia Commonwealth University, and the University of North Carolina at Chapel Hill.

The unique software developed by 4Dx generates moving, ultra-high-resolution images of motion and airflow in lung tissue. This revolutionary technology enables clinicians to view and measure abnormal lung function at the earliest stages of disease providing clinicians with new technology to significantly enhance traditional respiratory diagnostic methods.

The company is currently accepting investment monies which will be used to finance a US expansion and further clinical trials as it moves towards FDA approval, which is anticipated for next year.  The Series A Capital Round is expected to close oversubscribed on December 9th.  A second round of fundraising is planned for early 2017.

29 Nov 2016

Prominent Oncologist and Researcher Joins 4Dx Board

Melbourne, Australia, November 30, 2016: Australian technology start-up 4DX has attracted one of the biggest names in global oncology as its latest Board member.

Robert A. Figlin, MD, FACP, joins the 4Dx board on December 1st.  Dr Figlin is Deputy Director of the Integrated Oncology Service Line. He also serves as the Deputy Director at the Samuel Oschin Comprehensive Cancer Institute, part of the world-renowned Cedars-Sinai Medical Centre in Los Angeles and is Director of the Haematology Oncology Division at the institute, where he is in charge of integrating research and clinical strategies across all the Cedars-Sinai campuses.

Since his arrival at Cedars- Sinai six years ago, he has established the Experimental Therapeutics Program and successfully recruited clinical research staff in critical specialty areas such as breast cancer, bone marrow transplant, gastrointestinal oncology, genitourinary oncology, survivorship, and cancer biology.

Dr Figlin says, “4Dx has developed some of the most promising and exciting technology I’ve ever seen in the fight against disease. It will be a privilege to be able to use my medical and business experience to assist the company through this phase of its growth.”

Dr Figlin co-founded Agensys – an early stage biotechnology company focussed on developing novel therapies for cancer.  The company has since been sold to Astellas Pharmaceuticals as part of a nine-figure deal.

4Dx founder and chair, Andreas Fouras, says, “Bob Figlin brings unparalleled experience and expertise in cancer therapies to 4Dx, where enhanced cancer treatment is among our first priorities. “Bob brings a vast medical knowledge and adds enormous capacity to our board’s business decision making capacity.”

Lung cancer is the biggest killer of all cancers and the current standard treatments of chemotherapy and radiotherapy have devastating effects on the lungs. 4Dx technology is non-invasive and will positively impact the way medical professionals are able to diagnose, and treat their patients.

“4Dx is undergoing significant acceleration and is thrilled to have a clinician, researcher and entrepreneurial thinker in Bob Figlan join our team.”

“This revolutionary technology and the development of unique software to generate moving, ultra-high-resolution images of motion and airflow in lung tissue enables clinicians to view and measure abnormal lung function at the earliest stages of disease in a way that has not been possible before now.”

As well as their association with Cedars- Sinai, 4Dx has also created partnerships with other leading hospitals such as the Cleveland Clinic and the Children’s Hospital Los Angeles in the US, and The Alfred and Peter Mac in Australia.

22 Nov 2016

4Dx To Close Series A Capital Raise

Melbourne, Australia, November 23, 2016: 4Dx Limited is pleased to announce that, due to an overwhelming response, as of 5pm, Friday, 9th December, 2016, the company’s $4m Series A capital round will be officially closed.

It is anticipated that the round will close oversubscribed.

4Dx founder and Chairman, Andreas Fouras, said, “4Dx is extremely pleased with the response to our capital raise. The domestic investment community has demonstrated a deep understanding of our proposition, and the value inherent in it.”

“We believe this result indicates a very clear acceptance of the need for 21st century diagnostic technology in the medical marketplace. The enthusiastic reception 4Dx has received delivers 4Dx a broad base of investors and makes us highly optimistic about the prospects of a second round of capital raising in early 2017.”

4Dx has invented a four-dimensional, non-invasive, software-based imaging technology that maps regional lung motion and air flow as the lungs breathe.

The capital round places a valuation of $36m on 4Dx Limited.

Funds from the Series A investment round will be used to take the company’s first software product to market, including clinical studies to further validate the product, as well as the development and submission of its first application for U.S. Food and Drug Administration (FDA) clearance.

The respiratory diagnostic sector represents a global market of over US$25 billion per annum, and 4Dx has a clear plan to address this market, building the company one product at a time.

The 4Dx technology has been extensively patented, with core patents granted in key jurisdictions including the US and Australia. It has been proven through published preclinical studies over the past 10 years.

 

21 Nov 2016

‘Next Cochlear’ 4Dx closes capital raise as FDA approval enters sight

The Australian Financial Review featured 4Dx in todays Technology section online.

by Yolanda Redrup

Medical imaging startup 4Dx has raised $2.5 million from a range of retail and high net worth investors, which the business will invest in its clinical trials that will see the company approved by the US Food and Drug Administration by mid next year.

The company, which already has one major deal with Los Angeles hospital Cedars Sinai to use its lung imaging technology, also has an additional $2.5 million committed that is expected to close this week, taking its total series A raise to more than $5 million.

Chief executive Andreas Fouras said the company had developed a strong investor base featuring healthcare professionals and business bigwigs from retail, resources and banking and finance, making him confident the company could go achieve its ambitions of being as successful as Cochlear.

“These investors are just dipping their toes in the water at the moment with us, so that makes me excited about what it means for their ability to take a stronger position going forward when we release strong results next year,” he said.

“The world is starting to notice 4Dx … We’ve got hospitals cold calling us now from the UK, the US and Australia, and asking how they can get access to our technology early … I think we could have 10 of the world’s biggest hospitals using our technology within 12 months of FDA approval.”

Dr Fouras was a Monash University mechanical engineering professor, specialising in wind tunnel imaging, but left his academic career, sold his house and moved to Los Angeles to develop 4Dx.

Current lung imaging technology techniques give an overall picture of the amount of air a lung is taking in, but 4DX’s technology highlights if there are parts of the lungs which are receiving less air, helping in the early diagnoses of lung diseases and more effective treatment.

While the technology is at present being used just for lung diseases, the company has started to invest in research and development to expand it to other organs and conditions. At the moment it has a human clinical trial under way to extend the technology to heart imaging.

“It has the technological capability to be expanded outside of the lungs … we have some patents for heart imaging already and the clinical trial has had promising results,” Dr Fouras said.

“We want to be a global diagnostics company. In the US, and globally, there are significant pressures on the costs of diagnostics, and technology that should be seen as a profit centre is viewed as a burden. So we’re ready to come in and change that and deliver modern, affordable technology that can disrupt the space.”

After completing the lung imaging clinical trial in the first quarter of 2017 and securing FDA approval by mid-year, the company hopes to raise an additional $20 million or more, which will enable it to commercialise its other products currently in development and scale its operations globally.

“We expect to raise the $20 million in two stages through the well-established process of a pre-IPO raise and then an IPO,” he said.

“But the big milestone for us next year will be going public with the clinical trial results. Then we’ll be able to show how well the technology works in comparison to the existing technology in the marketplace. At that point we’ll go back to the market and establish a funding model going forward.”

As the technology was developed while Dr Fouras was at Monash, Monash has held the patents for the technology until now. Dr Fouras negotiated a deal with the university to have all the IP moved to the company when the business had successfully raised more than $6.4 million in total.

“Monash have worked very hard to be supportive and more engaged with industry … Monash said once we’d raised that amount they’d feel comfortable that were weren’t at risk of falling over due to a lack of capital … but we’ll continue to have a royalty agreement with them.”