Category: Press

22 May 2020

Lung tracker considers ASX tilt

As printed in the The Age
Friday 22nd May 2020
Page 27 | Section: BUSINESS

 

ASX medtech hopeful 4D Medical has joined a pack of Australian start-ups hoping to get a green light from the US Food and Drug Administration (FDA) to market its product in the coronavirus era.

4D Medical has developed a software platform that analyses chest X-rays to help doctors better track respiratory impairments. TheXV Technology uses an algorithm to generate reports for hospital staff so they can better plan treatments for patients in respiratory distress.

While the product doesn’t replace tests for COVID-19, the hope is that the software could help hospitals determine treatment paths faster and track patient progress in the pandemic era.

4D Medical confirmed yesterday the FDA granted it permission to market the product in the US. The startup is still a private company but management is eyeing an ASX listing in the months to come.

22 May 2020

Biotech Daily – May 21

4D MEDICAL (FORMERLY 4DX)

Melbourne’s 4D says the US Food and Drug Administration has cleared its “four-dimensional” XV lung ventilation analysis software imaging product for sale in the US.

4D said that the XV technology was not intended to replace primary diagnostic tests, such as the molecular tests to prove the presence of Covid-19, but was “designed to provide … quantitative support for diagnosis and follow-up examinations”.

4D chief executive officer Dr Andreas Fouras said the XV technology provided “critical information about the functional state of a patient’s lungs in the treatment of all illnesses of the lungs, such as asthma, emphysema, pulmonary fibrosis and lung cancer”.

“In the case of Covid-19, XV can be used to triage patients into the right treatment setting and to quickly determine how well a treatment is working,” Dr Fouras said.

4D said the XV could be implemented immediately, using existing hospital and clinical infrastructure with no capital expenditure or training required.

The company said that the XV was provided as a software-as-a-service diagnostic tool, available through an internet “cloud” subscription.

4D said that imaging departments conduct an X-ray sequence using existing fluoroscopy equipment and the software “rapidly and automatically analyzes and applies its proprietary algorithms to identify and quantify any functional impairment”.

The company said that the XV lung ventilation analysis software generated a Ventilation Report which was sent to the hospital to enable clinicians to determine the most effective treatment course of action and allocation of finite hospital resources.

4D said the end-to-end process could be completed and generate a report in three hours.

“The clinical trials and peer reviews that have been undertaken over the past 15 years in conjunction with the FDA’s 510(k) clearance, provide a solid foundation for 4D Medical to obtain regulatory approval to offer its XV technology in other geographic markets such as Australia, Europe and Asia,” Dr Fouras said.

4D said it began the Australian Therapeutic Goods Administration approval process in January 2020 and had partnerships with medical researchers and hospitals in Australia for clinical trials of the XV technology.

Dr Fouras told Biotech Daily that 4D had “a small US sales team and we are increasing it as we speak”.

“We want to build the evidence and data and then make a decision on partnering for distribution,” Dr Fouras said. “It is quite likely we will keep it in-house.”

Last year, the then 4Dx said it had raised $15 million in a pre-initial public offer and intended to conduct an initial public offer within 12 months (BD: Dec 10, 2019).

4D is a public unlisted company.

02 May 2020

Invention Breathes New Life Into Treatment

As printed in The Daily Telegraph, Thursday 30th April 2020
By Charles Miranda

A TEAM of Australian scientists has created a groundbreaking “field ventilator” to help combat coronavirus in remote regions of Australia and overseas where hospital emergency resources are limited.

And critically they are going into production in Australia and not China meaning there are no issues with supply lines and they can be directly dispatched from here to those most in need including to allies in the Pacific with challenged healthcare systems.

A consortium of leading doctors, engineers and medical researchers had already teamed up as part of the Australian Lung Health Initiative to develop the world’s first lung function scanner.

But the coronavirus pandemic prompted the team to fast-track the development of a low-cost ventilator that does not need a hospital or ICU-trained staff to operate.

Medical tech group 4Dx founder and biomedical engineer Andreas Fouras developed the device initially as a research tool but COVID-19 and fears of a global shortage of ventilators prompted a rethink. The new product is now ready for use.

“I’m actually sincerely hoping no one uses it which is the funny thing to say about putting so much time and effort into it,” Professor Fouras said.

“But it has become clear no one could build them fast enough or cheap enough to supply in large numbers to places that are not as fortunate as the great hospitals we have in Australia.” He said there was nothing else on the market like it. The field ventilators cost $2000 as opposed to $16,000 for an ICU model.

 

02 May 2020

Device to Help Win Virus War

Ventilator Boost for Regions

 

As printed in The Advertiser, Thursday 30th April 2020
By Charles Miranda

ADELAIDE scientists have helped create a groundbreaking “field ventilator” to combat coronavirus in remote regions across Australia and overseas.

And the device will go into production in Australia, which means no issues with supply lines and allows the ventilators to be directly dispatched to those most in need, including allies in the Pacific with challenged health care systems.

A consortium of leading doctors, engineers and medical researchers from South Australia and Melbourne had already teamed up as part of the Australian Lung Health Initiative to develop the world’s first lung-function scanner.

But the coronavirus pandemic prompted the team to fast-track the development of a low-cost ventilator, which does not need a hospital or ICU-trained staff to operate it.

Andreas Fouras, the founder of Melbourne-based medical tech group 4Dx, developed the device initially as a research tool.

However, COVID-19 and fears of a global shortage of ventilators prompted a rethink.

Extra work by the South Australia Health and Medical Research Institute and the University of Adelaide, as well as independent peer reviews and testing, mean the product is now ready for use.

“I’m actually sincerely hoping noone uses it, which is the funny thing to say about putting so much time and effort into it,” Professor Fouras, pictured, said of the device. “But it has become clear no one could build them fast enough or cheap enough to supply in large numbers to places that are not as fortunate as the great hospitals we have in Australia.”

He said there was nothing else on the market like it, with ventilators tending to fall into two categories – either emergency ones, or more sophisticated instruments in a Western hospital ICU.

The field ventilators cost $2000 as opposed to $16,000 for ICU models.

Prof Fouras said his device was critical, given the perceived shortage of hospital and ICU beds, particularly in the Pacific Islands during the COVID-19 emergency.

He said the device had been made with simplicity in mind.

“We’ve made sure the device is really not only unbreakable but nice and simple to use,” he said.

“Turn it on and it’s good to go, hopefully to save lives.”

It was Prof Fouras and his med-tech firm that last month developed a way to fast-track coronavirus diagnosis, reducing the turnaround time from 48 hours to three hours.

01 May 2020

Aussie Ventilator a Grey Area

As printed in The Herald Sun Friday, 1st May 2020
By Miranda Devine & Charles Miranda

A VICTORIAN biotech company awarded a $31 million federal contract to build Australian-made ventilators for coronavirus patients has admitted multiple components will be sourced overseas, including from China.

And the crucial section of the machine, which attaches the ventilator to the patient, known as the “patient circuit”, was not included in the contract. It will have to be procured overseas.

Industry Minister Karen Andrews awarded the contract to Grey on April 5, saying the imperative was to bring the supply chain home.

Meanwhile, a team of Australian scientists has created a groundbreaking “field ventilator” to help combat coronavirus in remote regions of Australia and overseas where hospital emergency resources are limited. The ventilator will be produced in Australia.

Melbourne-based medical tech group 4Dx founder and biomedical engineer Andreas Fouras developed the device initially as a research tool but COVID-19 and fears of a global shortage of ventilators prompted a rethink.

He has worked with the South Australia Health and Medical Research Institute (SAHMR), the University of Adelaide as well as independent peer reviews and testing, the product is now ready for use.

10 Mar 2020

Lung imaging software may fast-track coronavirus diagnosis

4DX chief executive and founder Andreas Fouras. Picture: Roy VanDerVegt
4DX chief executive and founder Andreas Fouras. Picture: Roy VanDerVegt

 

Posted on The Australian, 11 March 2020

An Australian medical technology company is hoping to forge the pathway to a fast-tracked coronavirus diagnosis by reducing the ­diagnostic time to three hours.

4DX is seeking to partner with an Australian hospital to conduct clinical trials of its lung imaging analysis software at an Australian hospital. There’s international interest brewing, with Duke University in the US and a Chinese university already wanting to use the technology.

The company’s chief executive and founder, Andreas Fouras, is an Australian aeronautical engineer whose research into wind flow across plane wings expanded into lung health analysis technology.

“It makes for a test that is really fast and completely reliable because there is no opportunity for human error to be included in how our tests are run,” Professor Fouras said. “The way that the virus impacts your lungs is it creates these regions that become inflamed and have reduced airflow and that’s the way in which the virus makes you sick. We’ve been able to prove that we are a very early detector of any disease in the lung.”

Pathology labs in Australia are currently screening for corona­virus using nasal and throat swabs that take 24-48 hours to be read by a specialist.

4DX says its technology has a three-hour turnaround from testing to diagnosis. Doctors would send a lung X-ray to the company which they would run through algorithm to reveal any signs of lung damage or reduced airflow.

 

Author: Adeshola Ore
Adeshola Ore is a reporter at The Australian. She previously reported and produced radio for BBC World Service in London and freelanced for Thomson Reuters Foundation in Melbourne. Adeshola holds an Honours Degree in Sociology from The University of Melbourne.

 

03 Jan 2020

Stockhead article names 4Dx as one of six IPOs to watch for in 2020

A new Stockhead article was posted yesterday naming 4Dx as one of six Australian IPOs to watch for in 2020.

See below for the article text, or click HERE to read directly from Stockhead’s website.

Thank you, Stockhead!

 


4Dx

4Dx is a med-tech with a lung imaging platform. It helps detect diseases such as lung cancer and identify side-effects to disease treatments. It uses no dyes whatsoever, needs no injections and uses 35 times less radiation than the next best scan, according to the ASX hopeful.

Back in October 4DX said the tech passed a 13-month clinical trial showing it was superior. Perfect timing, because CEO Andreas Fouras was seeking broker interest for an IPO that very same week. No date for listing has been set.

He told Stockhead the other major milestone he was targeting in 2020 was FDA approval. While 4DX’s lung imaging tech has not yet been approved in other markets, Fouras said because the FDA was the hardest, if 4Dx could make it in America it could make it anywhere.

READ MORE: 4Dx’s lung imaging technology just passed a clinical trial. Next step – an ASX listing

10 Dec 2019

4Dx $15 million Pre-IPO News Hits News Outlets

New news releases from BioMelbourne Network and Biotech Daily, Dec. 10, 2019:

(https://biotechdispatch.com.au/news/4dx-raises-15m-in-oversubscribed-capital-raise)

 

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10 December 2019

Melbourne, Australia: Australian medical technology company 4Dx Limited has raised $15 million in a heavily oversubscribed pre-IPO.

The funds raised via the unsecured converting note issue will be used to drive 4Dx’s go-to-market strategy by adding to the US sales and distribution capability and augmenting the Software-as-a-Service (Saas) sales platform, as well as continued product research and development.

“The scale of the demand is encouraging as we head toward an initial public offering,” said Chairman and CEO Andreas Fouras. “This shows the market is starting to recognise the significant opportunity presented by our unique four-dimensional lung imaging technology and our well-defined commercial strategy.”

4Dx, which has three respiratory diagnostic software products currently under development with the first product before the FDA, expects to launch an initial public offering within the next 12 months.

The capital raising follows last month’s excellent results in a clinical trial of its patented four-dimensional lung imaging technology.

The confirmatory clinical trial showed that 4Dx’s XV Technology™ gave clinicians much more detailed information than the commonly used pulmonary function test (PFT) and computed tomography (CT) imaging methods. This aligns peer-reviewed preclinical evidence that the unique and non-invasive XV Technology™ enables unprecedented insight into pulmonary function, which is critical in the analysis and treatment of respiratory diseases such as COPD, asthma and cystic fibrosis.

Further information:
Rudi Michelson, Monsoon Communications
Mobile (+61) 411 402 737
rudim@monsoon.com.au

About 4Dx:

4Dx is a software company aiming to deliver the global gold standard in respiratory diagnostics for all lung disorders, including, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis and cancer.

The unique 4Dx technology accurately and quickly scans lung function as the patient breathes, to provide sensitive, early diagnosis and to monitor changes over time. Our Software-as-a-Service (SaaS) scans deliver much more complete results, showing the subtlest variations in lung function down to the finest details, using lower levels of radiation than traditional methods.

Respiratory diagnosis is a $30 billion per annum global industry that 4Dx aims to disrupt and grow through technology that provides clinicians with greater insights into diseases of the lung. 4Dx will bring about a step change in lung health by providing better information to doctors and patients.

Better information means better decisions, and better outcomes.

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