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December 2017 Newsletter

Dear investor,

As we rapidly move towards Christmas and holidays for many Australians and New Zealanders, Volpara is moving into some of its traditionally busiest weeks and months for sales in the US. At the start of our financial year (1st April 2018), we forecast growth of over 200% in Annual Recurring Revenue (ARR).
We can now say with some confidence that that we are going to meet and exceed that by the end of our financial year. This shows we are executing well on our sales plans, in tandem with keeping costs controlled.

The last few weeks have seen some notable occurrences:
  • FDA declaring breast density a priority for 2018
  • Our largest trade show RSNA 2017, with record solid leads with AI a main feature
  • Launch of Enterprise 2.1 with added risk features and reduced cost-of-goods
  • First VolparaEnterprise SaaS customers renewing
  • Signing up of Memorial Sloan Kettering (MSK), New York to VolparaEnterprise™
  • Regulatory clearances in Taiwan and Japan
  • Multiple new papers covering cancer risk through to compression and oophorectomy
We hope you enjoy this newsletter, and look forward to 2018 where there is every sign that we are going to continue to make very substantial commercial progress alongside helping women with breast cancer.
We hope you enjoy our final newsletter for 2017.

Regards,
 
Ralph P. Highnam, PhD
CEO & Chief Scientist
FDA makes density a priority for 2018
US FDA Commissioner, Scott Gottlieb, M.D has set out major priorities for the organisation in 2018, naming the modernisation of mammography quality standards as key to improving women’s health. Dr Gottlieb says a proposed new rule will recognise advances in technology, helping women to get the most up to date information about their breast density.

Read FDA Commissioner, Scott Gottlieb’s blog here.
Volpara at RSNA 2017: Record leads and a first peek at new products
Each year, the Radiological Society of North America (RSNA) hosts its annual meeting in Chicago featuring hundreds of companies presenting their wares to some 55,000 attendees. This year’s meeting had a clear theme – AI – featuring in both academic talks and in the trade show booths, with special areas set up for companies targeting these technologies. The Volpara booth presented two product concepts for feedback purposes. The first was VolparaEnterprise Live!™ – a real-time feedback system on image quality for the technologist. The second was VolparaEnterprise Now!™ – a dashboard highlighting the current status of x-ray systems along with a timeline of events of interest.

RSNA 2017 marked a maturing for Volpara: we had a record number of solid leads, exhibited an established product with numerous supporting abstracts, and fielded a strong and educated sales force to engage prospective customers.

Read Ralph's full RSNA wrap up here
Video: 2017 – YEAR IN REVIEW

In this interview, Dr Ralph Highnam, CEO provides his perspective on the year that was, including updates on progress and sets out targets for the year ahead. Watch here

Memorial Sloan-Kettering Cancer Center signed
Volpara signed up Memorial Sloan Kettering Cancer Center, the world’s oldest and largest private cancer centre. The deal will see the Company’s intelligent, cloud-based VolparaEnterprise™ platform process the screening images from 50,000 women each year. The signing affirms Volpara’s position as the market leader in breast cancer screening, and demonstrates the value clinics place on its technology. 

The Cancer Centre collaborates with other leading institutions and foundations to deliver important research and education beyond its patient care operations. It has a history in partnering to utilise artificial intelligence, with Watson for Oncology, interpreting clinical information to better inform treatment options.
Volpara Receives Regulatory Clearance in Japan
Also in November, Volpara received regulatory approval as a Class II medical device in Japan for the full suite of VolparaEnterprise™ products. The products will be sold in Japan via Japan Healthcare with the help of Volpara’s APAC sales team. The Company already has multiple research sites installed and active with VolparaDensity™ software, including Hokkaido Cancer Centre, Niigata Cancer Centre, Hokuto Hospital and Showa University School of Medicine; and formally launched VolparaEnterprise™ software at the Japanese Association of Breast Cancer Screening meeting held in Tokushima earlier last month.

Japan screens five million women each year for breast cancer using mammography, and has an estimated 3,200 mammography machines making it one of the world’s largest users of mammography outside the US.
Customer success story: Florida, USA
Issue: Our client has multiple breast screening sites across Florida, each with multiple technologists, making it extremely difficult to accurately monitor, evaluate and improve performance. As this is critical requirement of the FDA’s EQUIP regulations, the compliance officers sought a central point to monitor a range of metrics across the sites.

Approach: The client employed the use of VolparaEnterprise™ which effectively brought the data from all sites into one central portal. This enabled the compliance officers to ensure adherence to EQUIP regulations as well as improving overall efficiency.

As the technologists became aware of the monitoring of every single image, performance improved. Where weaknesses were identified, technologists were able to watch instructional videos through the platform to refine and enhance technique.
 
Outcome: The graph below shows the percentage of images classifies as good or perfect increasing over a five-month period from 44 percent to 54 percent using VolparaEntrprise™.

The percentage of good and perfect images is an indicator of image quality as well as the ability to detect breast density.

Higher quality images are integral to being able to effectively and efficiently detect cancer.
Introducing Dr Monica Saini, Volpara’s Consultant Diagnostic Radiologist

Cancer is the ultimate egalitarian, anyone is susceptible. This makes it the most fascinating of subjects. While I am curious about the biology of cancer, even closer to my heart is the patient and their journey.

This led me to specialise in womens’ imaging and undergo an additional fellowship, training in digital mammography, ultrasound, breast MRI and breast biopsy. Continue reading

Recent research
Influence of breast compression pressure on the performance of population-based mammography screening
Results suggest that if too much pressure is applied during mammography this may reduce sensitivity. In contrast, if pressure is low, this may decrease specificity. Continue reading
Breast tissue density change after oophorectomy in BRCA mutation carrier patients using visual & volumetric analysis
Volumetric breast density (VBD) significantly decreased after oophorectomy from a median VBD of 12.5% at baseline to 10.2% post-surgery which was driven by a reduction in fibroglandular volume. Continue reading
Volpara in the news
Volpara turns world-leading digital health technology into a remarkable financial success
TechInvest

ASX-listed digital health specialist is on target to achieve its aim of exceeding 200% in Annual Recurring Revenue (ARR) for the 2018 Fiscal Year (FY).

A world leader in technology development for the early detection of breast cancer, Volpara Health Technologies (ASX: VHT), achieved impressive ARR growth of 600% for FY 2017 and continues to record remarkable growth on the financial and technical side. Continue reading

Japanese approval for Volpara
BiotechDispatch
Volpara Health Technologies (ASX:VHT), a digital health company focused on the early detection of breast cancer, has announced the full VolparaEnterprise suite of products has received regulatory approval as a Class II medical device in Japan. Continue reading

 
Volpara launches Enterprise Live! For quality, risk software
Biotech Daily

Volpara says it has launched two new products to maintain consistent quality in breast screening and help identify women who may be at high risk of developing cancer. Volpara said it launched the Enterprise Live mammography quality control tool and Volpara Risk software to identify high risk women at the Radiological Society of North America meeting in Chicago, from November 26 to December 1, 2017. Continue reading


 
Will Artificial Intelligence help health-tech stocks find their bounce?
Stockhead

Health-tech companies are rapidly embracing Artificial Intelligence (AI), but investors seem to be taking longer to catch on.

The share prices of AI-related small caps began moving upwards in September, following the rest of the market, according to a report by Morgans analyst Scott Power.

Mr Power says he’s seeing a lot of interest in medical services companies that use AI, such as diagnostics businesses Capitol Health (ASX:CAJ), Volpara Health Technologies (ASX:VHT), ResApp (ASX:RAP), and Impedimed (ASX:IPD).  Continue reading

Breast density in the news
Breast density legislation introduced in Congress with bipartisan support
Radiology Business

Thirty-two states enacted breast density reporting legislation in the last eight years, but no such bills have been passed on a federal level. Could that soon change?

The Breast Density and Mammography Reporting Act of 2017 (HR 4122, S 2006) has now been introduced in both the House of Representatives and the Senate with bipartisan support. 

View the article here

Breast cancer screening should be more frequent for overweight women, scientists say
The Telegraph

Overweight women should be screened for breast cancer more frequently as they have a greater chance of rapidly developing hard-to-treat tumours, a new study shows.

An investigation revealed that those with a BMI of 25 or above were more likely to be diagnosed with tumours two centimeters or larger - the threshold between stage one and stage two cancers - than women of a healthy weight.

View the article here
High breast density a risk factor for breast cancer
ABC Radio National

The survival rate for breast cancer in Australia has improved significantly in recent years.

As long as the cancer hasn't spread to other parts of the body — more than 95 per cent of women will still be alive five years after being diagnosed.

One risk factor is high breast density — women with dense breasts are four to five times more likely to get this kind of cancer than other women.

The audio from the interview is available here
Upcoming events
19 January - ACR North Carolina Annual Breast Imaging Review Course - Charlotte

28 February - ECR 2018 - Vienna

9 March - NCoBC - Las Vegas

21 March - Australian Healthcare Week 2018 - Sydney

12 April - SBI/ACR Breast Imaging Symposium - Las Vegas

19 April - Breast Screen Australia Conference - Adelaide

www.volparasolutions.com



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WE Buchan · 132-136 Albert Road · South Melbourne, Victoria 3205 · Australia

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