Category: News

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
03 Jul 2018

Seeing Asthma Differently with the 4Dx Scanner. Targeting specific airways instead of overall airflow

 

Cleveland Clinic Lerner Research Institute was recently awarded funding from the National Institutes of Health (NIH) to purchase a leading-edge preclinical scanner from 4Dx Limited, a Melbourne-based medical technology company, to investigate the causes and treatment of asthma. Cleveland Clinic becomes only the second institution in the world to own a 4Dx preclinical scanner (joining Cedars-Sinai Medical Center, Los Angeles), and the first to use it in the study of asthma. This new technology will push forward Cleveland Clinic’s asthma program, which is already one of the strongest and most funded in the country.

Asthma is a heterogeneous group of diseases. The specific airways that are affected vary from patient to patient and between types of asthma. Although researchers and clinicians have long known that asthma presents differently in different airways, the disease is diagnosed using a breath test that measures the average air flow in all airways. While this diagnostic approach is accurate, it cannot identify subregions of the disease process.

Kewal Asosingh, PhD, principal investigator for the NIH grant, believes the preclinical scanner — which works by analyzing X-ray images to measure air flow throughout each of the lungs’ airways — may transform how asthma severity is evaluated. “It will help physicians monitor the specific airways involved in asthma accurately, which will enable us to understand and treat the disease in a more targeted manner,” he says.

The team at Lerner Research Institute will use the scanner to test in preclinical models drugs currently approved to manage and treat asthma, as well as new compounds developed at Cleveland Clinic. They will measure the effects that new and existing drugs have on specific airways. They may find, for example, that drugs that improve overall airflow might not actually target the diseased airways, and vice versa.

With purchase of the preclinical scanner, Cleveland Clinic will be in the unique position to conduct preclinical assessment of new drugs and validate results in clinical studies using 4Dx’s clinical product (software imaging processing that analyzes airways visualized using standard clinical scanners). This will allow Cleveland Clinic scientists and physicians to conduct translational analyses in patients, helping to accelerate the important path to new clinical discoveries.

“As the incidence of asthma is on the rise, it is critically important that we can accurately diagnose and treat the disease to the best of our ability. The 4Dx scanner is the key to both,” adds Dr. Asosingh.

Dr. Asosingh is staff scientist in the Department of Inflammation and Immunity and Scientific Director of Flow Cytometry at Cleveland Clinic.

To view the original article, please click here

25 Jun 2018

4Dx 2017 Retail Investment Round Closing 28 June

4Dx Limited is pleased to announce that our retail fundraising offer, under our Offer Information Statement disclosure document dated 20 October 2017, will be closing on 28 June 2018, fully subscribed.  We are currently taking oversubscriptions and the offer remains open to all Australian residents.  Please visit: http://invest.4dx.com/ to access our online application portal.

Existing shareholders may participate through the “Shareholder Offer”, and new investors may participate through the “Public Offer”.  It is essential that cleared funds are received before close of business next Thursday 28 June 2018.  We warmly welcome the sharing of these details to your extended network.  Following closure of the investment round, and with no concrete plans for any further retail rounds, this may be the last opportunity for retail investment in 4Dx.

The company has been overwhelmed with the level of interest in our world-first technology and take this opportunity to thank everyone who has expressed interest in 4Dx, and welcome all new shareholders to the 4Dx Group.

We look forward to providing you with company updates as we continue to expand, and encourage you to access the news section of our website:
http://4dx.com/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.
temporary (2)

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.