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4DX - 4DMedical Limited (1 Viewer)

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4DMedical is a medical technology company focused on commercialising its patented respiratory imaging platform, XV Technology to enhance the capacity of physicians to diagnose and manage patients with respiratory diseases.

The global respiratory diagnostic market is estimated to be US$31 billion. Though this market is large and growing, in modern medical facilities, respiratory diagnostics are dominated by three procedures: the pulmonary function test (invented in the 1860s), the X-ray (invented in the 1890s) and the CT (invented in the 1970s). 4DMedical's XV Technology has a number of advantages that can aid market adoption:
  • XV Technology provides a non-invasive modality for physicians to understand regional lung motion and air flow, and to identify respiratory deficiencies earlier and more sensitively;
  • XV Technology is designed to be fully compatible with existing hospital and clinic equipment so not requiring any capital expenditure; and
  • XV Technology will be delivered through a cloud-based Software as a Services (SaaS) model, allowing 4DMedical to deliver its technology more quickly and at a lower cost base to existing procedures.
All of 4DMedical's technology and intellectual property has been pioneered by the Company's in-house development team and validated by a number of clinical trials in partnership with leading U.S. hospitals. Continued engagement with key opinion leaders in the field may provide 4DMedical access to early opportunities such as early use of products in a clinical research setting.

In May 2020, the Company received FDA 510(k) clearance for the use of its XV Technology in its ventilation analysis software and is currently being sold in the U.S. The core driver of near-term sales growth will be the rollout of the Company's flagship software product XV (Ventilation) in the US. The market for respiratory diagnostics is the U.S. alone is US$13.7 billion and 73.5 million diagnostic procedures per year.

It is anticipated that 4DX will list on the ASX during August 2020.

https://4dmedical.com
 

Dona Ferentes

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

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.

slated to IPO on 14 August, 2020. Raising $55million
FDA approval given in June 2020
https://4dmedical.com/
 

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hitting the boards at 11am, today. .... likely above the 73c issue price

Yes somewhat above. Indicative opening price 210 at the moment. Will be interesting to see how that changes in the next half an hour to open. Likely to be significantly less than that as currently buyers/sellers are simply jockeying for position.
 

Dona Ferentes

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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.

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.

....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.

Perennial's head of smaller companies and micro caps, Andrew Smith, said since his fund bought into 4D in November 2019, its business case had improved [with FDA approval]
"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 de-risked significantly," 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 4D's future, 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's future success, so it's 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," he said. "We know there is lung damage even for those who don't end up in hospital, and for those who are in the ICU and come out, they're still unwell for months after."
https://www.afr.com/companies/healt...et-to-sizzle-as-funds-pile-in-20200805-p55iwb
 
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I can see why the Instos grabbed 4DX at 75c but too expensive a punt at $1.41 in the Covid and post Covid era when hi-tech will be difficult to sell to government who are the end health insurers.

The Doctors and Funders concentration will be on keeping things simpler and cheaper.

gg
 

Dona Ferentes

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interesting start. Selling dried up quickly

(1 minute chart, first day)
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Dona Ferentes

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4DX is in a trading halt until 01 Oct, , pending an announcement by the Company to the market regarding a regulatory approval.
 

Dona Ferentes

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TGA has approved 4DMedical’s XV Lung Ventilation Analysis Software (XV LVAS) for inclusion in the Australian Register of Therapeutic Goods.
• XV LVAS utilises the Company’s proprietary XV Technology™, which converts sequences of X-ray images into four-dimensional quantitative data by using patented mathematical models and algorithms
• XV LVAS is 4DMedical’s 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

- up 10% on news :)
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Dona Ferentes

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kicking goals

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’s technologies with existing X-ray 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
 

Dona Ferentes

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"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..."

my December pick.

(hold)
 

Dona Ferentes

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• First commercial use of 4DMedical’s XV Lung Ventilation Analysis Software (XV LVAS™) completed successfully in Victoria, Australia
• Installations of XV LVAS anticipated across Australia from early 2021 as national infrastructure is established by 4DMedical
• Achieved ahead of schedule, the first commercial scan marks a key milestone for the commercialisation of 4DMedical’s XV Technology

I like it when new companies achieve their goals, and especially ahead of schedule.
SP up during the day (and turned around what has been a bit of a decline over the last few weeks)
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Dona Ferentes

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top pick in 2021 comp.

The company has leverage into a market that should grow. Low capital requirements for what is a high margin biz.
SaaS; can utilise existing technology ... but need to develop product awareness.
And I don't think Covid is going away in a puff of smoke, and there are applications for 4DX

Some dozen clinical trials in progress, which should expand the service offering

(hold )
 

Dona Ferentes

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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.....

and
... [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.' ...

https://arichlife.com.au/why-i-bought-some-...ve-stock-i-own/
 

Dona Ferentes

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moving along.

• 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
 

Dona Ferentes

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A trading halt is requested pending an announcement by the Company to the market regarding the outcome of a material grant.
 

Dona Ferentes

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Lung imaging software company 4DMedical has secured almost $70 million in funding from a mix of government and institutional investors to develop a lung scanner that emits a fraction of the radiation of a CT machine.
On Thursday [04 March] the company said it had closed an oversubscribed $40 million placement to institutional investors, priced at $1.55 per share and it had also been awarded a $28.9 million from the government’s Medical Research Future Fund, via its Australian Lung Health Initiative consortium.

with the SPP closing on Monday, today's lift will help some to commit. Was under the $1.55 until start of week, after a sell off over the last week/ few months(though there is a stated $1 million max ... that can be only 33 shareholders putting in the max amount !!)
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