Category: News

08 Sep 2017

4Dx assigned Intellectual Property relating to core 4Dx technology

4Dx is pleased to announce that key intellectual property relating to the Company’s 4DxV technology has been assigned from Monash University to 4Dx Limited.

The intellectual property (IP) was developed by 4Dx Chairman and CEO, Andreas Fouras, while working at Monash University and was previously licenced by 4Dx from Monash University. After reaching an investment milestone in the licence agreement between 4Dx Limited and Monash University, Monash University assigned the IP to 4Dx Limited on 1 September 2017. The assigned IP includes nine granted patents and eight patent applications across jurisdictions such as the United States of America, Europe, Australia, Japan, Singapore, Canada, India and New Zealand.

4Dx will now begin the process of having the patents and patent applications amended to list 4Dx Limited as the patentee/applicant.

28 Aug 2017

Continued interest in 4Dx technology from leading USA Hospitals

4Dx is excited to announce two upcoming deals with leading USA hospitals.

4Dx has been invited to support groundbreaking lung transplant research being conducted at UCLA over the next 12 months. 4Dx will be providing scans using raw X-ray images captured on existing UCLA equipment. The 4Dx scans aim to give insight into different biological pathways rejection and identify rejection earlier. Working with UCLA Medical Center, currently ranked #5 of 5,565 registered hospitals in the USA, is a major boost to 4Dx’s public profile.

Researchers at the Cleveland Clinic have agreed terms with 4Dx to purchase a 4Dx pre-clinical scanner next year. This technology allows clinicians to capture images that provide highly detailed footage of the motion and airflow within the breathing lungs of mice and other small animals. The Cleveland Clinic is the #3 ranked pulmonary specialist hospital in the USA.

4Dx is also pleased to announce that it has completed construction of its first commercial pre-clinical scanner on order from Cedars-Sinai Medical Center in LA. The scanner is undergoing compliance testing that will then clear the product for import into the USA.

Each pre-clinical scanner will be a source of recurring software-as-a-service (SaaS) revenue into the future, as each machine will be a hub for 4Dx scans.

 

28 Aug 2017

FDA Update & Future Plans

Earlier this year, 4Dx delivered a 510(k) submission to the FDA for clearance of its 4DxV technology in the radiotherapy setting. Following that submission, the FDA responded with a Request for Additional Information. To clarify the FDA’s request, 4Dx sought and gained a meeting with the FDA. While the FDA identified a potential pathway for success regarding the application, it is clear that significant time and resources would be required.

Through the meeting with the FDA, and further discussions with our regulatory consultants, 4Dx has chosen to take a more streamlined approach in taking its technology to market. This will involve progressing directly with an application for products in the Company’s core target market – the respiratory diagnostics space.  To fully focus on this plan, 4Dx has decided to withdraw the current application.

4Dx will focus efforts on this plan to gain clearance for its core product by capitalising on the open dialogue we have with the FDA about the core product’s development. The Company expects to be in a position to present a plan to the FDA in late 2017 and will report back to shareholders in early 2018 with an update.

In forming this strategy, 4Dx sought to increase its access to regulatory expertise beyond our regulatory consultant and FDA agent, Emergo. 4Dx is pleased to announce that Brian Bollwage, a regulatory strategy veteran with nearly 40 years of experience working with the FDA, is now assisting 4Dx in this important area.

In parallel with its regulatory efforts, 4Dx continues to make strong progress in building revenue opportunities, particulalry in business to business market sectors where regulatory clearance is not required.

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.