Category: News

24 Jun 2018

Australian National Imaging Facility (NIF) to Establish 4Dx Research Eco-system in Adelaide

4Dx is pleased to announce that following increased Federal Government budget to the National Imaging Facility (NIF), a 4Dx technology translational research eco-system will be established in Adelaide.

Operating out of the SAHMRI LARIF Node of NIF location, collaborators will be able use 4Dx technology on mice, sheep, pigs and in clinical research studies, in a turn-key operation.

Co-funding is being actively sought and a media release is currently under development.

To find out more about the NIF, please click here.

23 Jun 2018

2018 American Thoracic Society (ATS) Conference

4Dx attended this year’s American Thoracic Society (ATS) Conference held May 18-23 in San Diego.

ATS represented a unique opportunity to launch 4Dx Group brands to industry and communicate our unique offering to Physicians and Researchers.  It also facilitated dialogue with the pharmaceutical industry.  Our core conference objectives were to solicit interest in Top 50 hospitals to collaborate with 4Dx.

The trade show exceeded all expectations:

  • Strong engagement from visitors with quality collaboration interest shown from targeted organisations
  • ATS ranked 4Dx stand in top 4% of all exhibitors (# 3 in our category)
  • 420 individual 4Dx leads captured
  • 14x collaborator/KOL 1:1 meetings conducted at the stand
  • Requests from a number of “Top 50” organisations to collaborate with 4Dx, with the  expectation that priority collaboration agreements will be in place by end of Q3

To watch an overview of 4Dx at ATS 2018, please click here.

22 Jun 2018

Second National Institutes of Health Grant to 4Dx

A second major USA hospital has received a grant award of US $600,000 from the United States National Institutes of Health for the purchase of a 4Dx preclinical lung scanner.  Scheduled for delivery later this year, the second scanner will greatly increase the profile of 4Dx and showcase how 4Dx technology will assist in the diagnosis, monitoring and treatment of asthma.

A joint media release is currently being prepared.

 

 

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.”