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likely to IPO in August 2020. In these Covid times, there is likely to be some interest. FDA approved in May 20.


4DMedical (formerly 4Dx) is a medtech company based in Melbourne, Australia, established to commercialize four-dimensional lung imaging platform, XV Technology.â„¢


4DMedical’s XV Technology process is a software-as-a-service (SaaS) diagnostic tool, available through secure cloud subscription, and can be implemented immediately, utilizing existing hospital and clinical infrastructure with no capital expenditure or training required. Imaging departments simply electronically send an X-ray (using existing fluoroscopy equipment) to 4DMedical.


XV Technology is not intended to replace molecular tests as the primary diagnosis method for COVID-19; however, 4DMedical believes its ventilation reports will prove essential in providing quantitative support for diagnosis and follow up examinations for patients with, or recovering from COVID-19.


4DMedical software then rapidly and automatically analyzes and applies its proprietary algorithms to identify and quantify any functional impairment. The software generates a ventilation report and sends it to the hospital to enable clinicians to determine the most effective treatment course of action and allocation of finite hospital resources. The end-to-end process can be completed and a report generated within three hours.

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  • 4 weeks later...

In the eight years since former Monash University professor Andreas Fouras founded soon to be listed lung imaging medical technology company 4D Medical, he has put everything on the line to get his business to where it is today.


When the company floats on the ASX on Friday with a market capitalisation of $193 million and an issue price of 73¢ per share, it will vindicate the decision by Dr Fouras and his family to sell their house, put all their savings into the business, give up their lives in Australia and move to the US.


It is honestly surreal ... I was originally the inventor and for me the challenge was to prove the technology worked, Dr Fouras, the company's chief executive, told The Australian Financial Review. I realised there was no one else that could take it and make a difference with it. It was a chance to touch millions of lives and genuinely make a difference and that's a bigger opportunity than many inventors dream of.


Dr Fouras was previously a Monash University mechanical engineering professor, specialising in wind tunnel imaging, but left his academic career and moved to Los Angeles to develop 4D Medical, which was until recently named 4Dx.


The company's lung imaging device leverages Dr Fouras' background in aeronautical engineering to highlight if there are parts of the lungs receiving less air, helping in the early diagnosis of diseases such as asthma, chronic obstructive pulmonary disease (COPD) or lung cancer. Current imaging techniques just give an overall picture of the amount of air lungs are taking in.


Before the float, the business had raised almost $19 million through equity capital raises and an additional $17.4 million in convertible notes.


When the company lists on Friday, it will have the support of funds including Perennial Value Management, Ryder Capital, Pendal Group, EFM Asset Management, OC Funds Management and Quest Asset Partners, which have all bought into the IPO.


Dr Fouras said the listing was oversubscribed, but would not say by how much. However, he said no investor had received the full allocation they had requested and the company had needed to increase the size of the capital raise to $55.8 million from its target in June of $45 million, to account for the interest.


As a result the addressable market is much larger than we first anticipated, hence we are happy to make an even larger bid into the IPO as the investment case had improved and derisked significantly, he he said. Post FDA approval we are clearly very focused on the progress 4D Medical makes in the US, which is by far the biggest market in the world. Beyond that we are interested to see the broader implications for the technology moving from monitoring air flow to blood flow and the like.


When Mr Smith was introduced to the business, he was attracted by the involvement of Dr Sam Hupert, the co-founder and CEO of medical imaging company Pro Medicus and a member of 4D's advisory board. Mr Smith was optimistic the company could grow to be a medtech success story like Cochlear or Resmed and he believed it could get there more easily, since it had its roots in technology. It is really a software company, not a device company, so it should require less capital to grow and have higher margins. Given this quality earning stream, if product adoption is rapid then we expect the market would put a high value on the business, he said.


Like Mr Smith, Ryder Capital chief investment officer Peter Constable is optimistic about the future of 4D, but said it was important for investors to be patient and take a long term outlook. He also backed the business in 2019, having been introduced to Dr Fouras in 2017. Those overnight Australian success stories are 20 plus years in the making, as will 4D Medical future success, so it is not one for the impatient, he said. We originally invested on the basis of some obvious use cases for the XV technology [non invasive imaging tech] in relation to traditional lung diseases ... however, more recently we have been actively thinking through the application of the XV technology in the diagnosis and treatment of COVID-19, particularly during the recovery phase, as some of the early evidence points to COVID-19 causing long-term damage to the respiratory function of many patients. With XV technology able to sit on existing X-ray infrastructure, it could provide a timely, cost-effective solution to assist the world scale in its diagnosis, treatment and monitoring of COVID-19-induced lung disease.


The application of its technology in the current pandemic is something Dr Fouras considers an immediate priority and will form part of its sales push into the US later this year. Our tech is very safe. It has much lower radiation than a CT scan and provides the ability to follow-up patients and do scan after scan, which means I'm confident we're best placed in the market for the follow-up of COVID patients. We know there is lung damage even for those who do not end up in hospital, and for those who are in the ICU and come out, they are still unwell for months after, he said.

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  • 1 month later...

has been bouncing around the $1.40 to 1.60 range since IPO, so it came in underpriced, some might say. Turnover has been low.


Today, a kick of 12% based on the TGA approving the 4DMedical XV Lung Ventilation Analysis Software (XV LVAS) for inclusion in the Australian Register of Therapeutic Goods.

• XV LVAS utilises the 4DX proprietary XV Technology™, which converts sequences of Xray images into four dimensional quantitative data by using patented mathematical models and algorithms

• XV LVAS is 4DMedicals first Software as a Service offering and can provide immediate benefits to Australian physicians and patients, including assisting in the ability for physicians to diagnose respiratory diseases earlier and with more sensitivity while using existing hospital and clinical equipment

• As a result of TGA Class 1 approval, 4DMedical is now well positioned to progress the global rollout of XV LVAS having received FDA 510(k) clearance in May 2020.

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We are something like six months ahead of when we had originally planned to get it. It's one of the reasons we are so excited because this is an acceleration, Dr Andreas Fouras said.

Australia and the US are the two places where we have a direct sales force ... so it is a great commercial outcome.


Emotionally, as an Aussie it also feels like we're bringing the tech home by getting clearance here. The US FDA approval was very important commercially, it was a big milestone and the toughest to get, but this one tastes a little better.

The lung imaging device leverages Dr Fouras background in aeronautical engineering as a Monash University professor to determine if there are parts of the lung receiving less air. Its technology converts sequences of XRay images into four dimensional quantitative data, allowing physicians to better diagnose and treat patients with respiratory diseases such as asthma, chronic obstructive pulmonary disease and lung cancer.


Current imaging techniques give an overall view of how much air the lungs are taking in, but do not reveal whether certain sections of someone's lungs are receiving less air. The business received wide-ranging FDA approval for its device in May, with the device approved for all indications.


Dr Fouras said the business would be able to beef up its local sales team quickly to start selling its product into Australian hospitals.

The good news is we are well connected here. It's our home territory and we feel good about our ability to attract and bring talent onto the team ahead of schedule, he said.


We are committing to interacting and working with hospitals really quickly and having commercial sales in the next calendar year. There is a lot of opportunity for that to go well.


We are well known in Australia and have great relationships in the market. It may not be as big as the US, but in a lot of ways it is easier to navigate. In short, I am really excited about the pipeline and how long it takes to get going precisely we'll have to wait and see


4D Medical is already working on its next products, with its second set to be one that monitors blood flow in the lungs. In its prospectus it had flagged development completing on this product in mid 2021 and targeting FDA approval in 2023.


Dr Fouras said development on this was ahead of schedule and if it were not for COVID 19, the company would have been in a position to start clinical trials this year.

The R&D is looking very strong, he said. I would be hesitant to talk about when it could be cleared [by regulators], but in testing the product is looking really fantastic and every sign is that in the worst case scenario, we will be on time [with development], but it's likely we will be well ahead of the schedule in the prospectus.
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4DMedical currently has over 12 clinical trials in its pipeline at various stages of development


Airways ... In asthma, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis and cystic fibrosis, the early stage of disease is extremely important for the adoption of appropriate therapeutic measures


Inflammation ....In COPD, silicosis, pulmonary fibrosis, constrictive bronchiolitis and other chronic inflammatory lung conditions, exacerbations result in progressive and irreversible airflow obstruction and respiratory failure


Intervention .... Surgery, transplant or interventional procedures to repair or remove lung tissue or airways due to lung cancers, emphysema, fluid or infection


FY21 outlook

• Accelerate rollout of XV LVAS to priority hospitals in the U.S. and Australia

• Continue recruitment of sales and marketing staff in the U.S. and Australia to accelerate revenue generation

• Invest in product development to enhance the compatibility of 4DMedical technologies with existing Xray systems

• Conduct clinical trials to increase awareness, education and necessary evidence of efficacy to drive product adoption

• Progress the product pipeline .... Ventilation Perfusion (VQ) and Contrast Free Pulmonary Angiography products

• Advance global regulatory processes, most notably progressing Medical Device Single Audit Program



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....In order for the company to succeed, they will need to build up more and more evidence to prove that their innovation is sufficiently better than the alternatives that hospitals (and therefore patients) should pay to use it.


The process of convincing the medical establishment to use new technology is not easy, because clinicians typically want to be sure, and need to be convinced that the new technology brings real benefits. This process usually takes longer than impatient investors are willing to wait, and ultimately relies on convincing diverse parties that this technology can improve outcomes and reduce the cost of total care......


... [CEO Andreas] Fouras can explain why his technology is better in a single sentence. He says: By imaging the breathing lungs, it is possible to see what is really important, which is how they work, not what they look like. This is important, because they are not just trying to replicate human diagnostic abilities with machines (which is a typical faux "innovation" that rarely succeeds) but actually to improve diagnostic ability. And I think that is what this company is trying to do. Only if you give better results to patients and payers alike will you stand a chance of changing behaviour quickly. 4DX seems to understand this, and argues that they can offer competitive pricing below incumbent technologies....



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  • 4 weeks later...

and another step in the right direction

• 4DMedical to commence the first U.S. clinical pilot of its XV Lung Ventilation Analysis Software offering at St. Joseph Hospital located in Orange County, California

• XV LVAS will be used to assist in screening for a variety of lung conditions, including COVID-19

• The clinical pilot follows on from XV LVAS receiving FDA 510(k) clearance in May 2020 and Class 1 approval from the Australian Therapeutic Goods Administration in September 2020

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  • 2 weeks later...
  • 2 weeks later...

and kept going, another 40+c lower. Early optimism tempered by (belated?) later realism?

As 4DMedical commences its commercialisation phase, the Company's strategy remains focused on securing clinical pilots and completing clinical trials with leading hospitals and healthcare institutions.


Clinical trials are independent research studies that validate the accuracy of 4DMedical's XV LVAS on patients with specific indications and respiratory diseases. The results of clinical trials are published in medical journals and can assist in driving the adoption of XV LVAS for specific use cases. The Company currently has a strong pipeline of clinical trials at various stages of development and focused on addressing some of the most complex, prevalent, and costly lung conditions.


Clinical pilots allow hospitals and medical institutions to implement and review XV LVAS in standard clinical practice ahead of potential commercial integration. 4DMedical is in discussion with several potential clinical pilot partners which it will aim to convert into customers and/or reference sites.

The combination of clinical pilots and clinical trials will form the foundation to securing scale and, importantly, assist the Company to capture a significant portion of the US$31 billion global respiratory diagnostics market.

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