The Newsletter...........................................
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- Update from the Chairman
- 4Dx Raises $15 Million in Pre-IPO Offering
- 4Dx Welcomes New Board Members
Update from the ChairmanAs 2019 draws to a close, I’m very happy to report on the remarkable year and all the progress made at 4Dx. At last month’s AGM, I had the pleasure of highlighting the milestones achieved this year, as well as share our plans for the coming year. I believe 2020 will be our busiest and most successful year yet.
In early 2019, we received word that ALHI (a consortium led by 4Dx in partnership with Monash University, The University of Adelaide, SAHMRI, Telethon Kids Institute and Micro-X) was
one of only ten Stage One recipients of the Australian Federal Government’s MRFF Frontier Health & Medical Research Grant of AUD$1million. ALHI represents a blue-sky opportunity to integrate 4Dx technology into the development of two world-first, low-dose, dedicated human lung scanners. This stage One win places us on a shortlist to compete for up to $50 to $100 million of funding over a 5-year period, with funding to be announced by June 30, 2020.
In May, we exhibited a second time at the American Thoracic Society (ATS) conference in Dallas, TX. The 4Dx team worked day and night to ensure a strong follow-up appearance to last year’s freshman outing. The
hard work paid off; not only did we generate 500 new expressions of interest, but we were also awarded Best in Show.
We were extremely pleased to be able to present data from our clinical trial at both ATS in May and The American College of Chest Physicians (CHEST) conference in October. Over
the course of that research study, we were able to demonstrate XV Technology’s abilities to measure lung function and ventilation in rich detail, consistently monitoring each patient’s lungs to detect, locate, and track the loss (or improvement) of lung function either due to the progression of disease or as a result of treatment. In fact, in a number of cases we were able to quantify the effects of treatmentmonths in advance of other current standard medical tests of CT and Spirometry (PFT). This not only shows the promise of XV Technology to assist with earlier diagnosis, but it also allows for closer monitoring of treatment and its effectiveness.
The results of our confirmatory clinical trials
illustrated the sensitivity of XV Technology to identify lung function deficits earlier than existing modalities and was the final requirement for our U.S. Food and Drug Administration (FDA) 510(k) submission which was completed in November. With the average timeframe for FDA approval being 112 days for Class II medical devices, we are hoping for regulatory clearance for the 4Dx Ventilation Report in 2020.
Earlier this month, we began preparations for conducting our IPO in 2020 through a pre-IPO capital raising. In addition to strong support from institutional investors, 4Dx also enjoyed significant support from existing sophisticated and professional shareholders to participate in the converting note offer. The scale of the demand we experienced was extremely encouraging, and we quickly
raised over $15 million to support 4Dx’s continued growth, with a focus on building sales and marketing infrastructure in the US.
This year also saw a continued strengthening of the 4Dx board. Dr. Sam Hupert joined us in late 2019 as both an investor and an Advisory Board member. He is the current CEO of Pro Medicus, a highly successful medical imaging IT company that develops Radiology Information Systems (RIS) and Picture Archiving and Communication Systems (PACS) for radiology departments across the globe. Pro Medicus is listed on the ASX with a current market cap in excess of $2 billion.
Also joining the 4Dx team was Lil Bianchi, MSC, GAICD, as a Non-Executive Director in December. Lil’s governance, strategy and capital raising experience in CEO, board and senior executive settings has helped her lead corporations in periods of massive growth as they pivot to stock market listings and international sales.
Rounding out the additions is Bruce Rathie, current Independent Non-Executive Director of PolyNovo. PolyNovo is a medical device corporation with distribution in Australia, New Zealand and the US, and is listed on the ASX with a current market capitalization in excess of $1 billion. His expansive skill set to 4Dx draws upon his experiences in management, finance, law, compliance & regulation, technology and biotechnology, as well as start-up IPO management and technology commercialization.
Our successes of 2019 have 4Dx positioned for a very exciting and productive 2020. Thank you for accompanying us on this journey, and we look forward to an even bigger and better 2020!
Sincerely,
Andreas Fouras
Chairman and CEO"
