Category: News

23 Mar 2018

Series B capital round update

Melbourne, Australia, March 2018: 4Dx Limited is pleased to announce that the $5M Series B capital round is fully subscribed. However, based on continued strong interest in the round, the Board has agreed to extend the offer period for a limited time to accept oversubscriptions.

4Dx Chairman & CEO, Andreas Fouras, said, “4Dx is extremely pleased with the response to our capital raise. The Australian investment community has again demonstrated its strong support for our value proposition and acknowledged the progress made over the past 24 months.”

“We believe this result reaffirms the demand for new analytical technologies to improve global lung health. The continued enthusiastic reception 4Dx receives gives us many options for future growth capital, including a potential listing”.

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 values 4Dx at $47m.

Funds from the Series B investment round will be used to take the company’s core 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 this year.

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.

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 as well as a clinical studies over the past 18 months.

19 Mar 2018

4Dx FDA Regulatory Update

4Dx attended a 510(k) pre-submission meeting with the FDA in Silver Spring, Maryland, on March 15th, well ahead of the planned date of April 26th.  The meeting was very cordial and productive, providing 4Dx with valuable feedback regarding our planned pipeline of regulatory clearances.  Approved FDA meeting minutes typically take up to a month to be promulgated after which 4Dx will be in a position to provide a more comprehensive update.

08 Jan 2018

4Dx Lung Technology’s Equine Application Featured

From The Sydney Morning Herald DECEMBER 31 2017:

4Dx’s dimensional imaging technology largely focuses on early detection and monitoring of lung diseases in humans, such as cystic fibrosis.

Now, 4Dx is keen to adapt the technology to racehorses and has engaged leading Australian equine veterinary surgeon Glenn Robertson-Smith to explore its application.

4Dx and Dr Robertson-Smith have been in discussions with Cranbourne Racing Club chief executive Neil Bainbridge and are looking to establish the world’s first equine prototype 4Dx machine at the club’s training centre.

Dr Robertson-Smith said there are many potential applications of the technology to horses. “Horses suffer from a vast number of lung diseases and evaluating them or the response to treatment has been extremely difficult in the past,” he said. “If we were able to understand the disease, how or when it occurs and how it responds to treatment or training, then we could manage affected horses much better,” Robertson-Smith said.

The 4Dx technology could determine changes to the lungs within hours. “In contrast, existing methods of assessment, including CT scans, X-rays and ultrasound, could not see any lung changes within at least a week and in some cases 14 days,” he said.

A significant application of 4Dx would be in predicting performance, Dr Robertson-Smith said. Horses are rare in that at maximum performance they use all of their lung capacity. This means that horses with an innate or genetically-determined better lung function would be more successful racehorses.

The 4Dx technology would offer a predictor of lung capacity and function, and as such would have huge potential if it could be applied to yearling racehorse purchases.

31 Oct 2017

4Dx participates in Great Strides run for cystic Fibrosis

Last Sunday, the 4Dx team participated in the Melbourne Great Strides 8K to raise money and awareness for Cystic Fibrosis Community Care (CFCC). CFCC is a non-profit organization working to support those living with and affected by cystic fibrosis.
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4Dx’s technology aims to help with early detection and monitoring of lung diseases, such as cystic fibrosis. 4Dx raised over $1,300 during the event and hopes to lend its support to this and other causes in the future.

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

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.

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”.