Volpara Health Technologies (ASX:VHT) on the impact of new US FDA breast-screening image requirements
November 15, 2016 at 10:00 pm EST
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16 November 2016 - Volpara Health Technologies (ASX:VHT) CEO, Dr Ralph Highnam, discusses the impact of new US FDA breast-screening image requirements and how its VolparaEnterprise cloud solution will assist clinicians.
Transcription of Finance News Network Interview with Volpara Health Technologies Limited (ASX:VHT) CEO, Dr Ralph Highnam.
Clive Tompkins: Hello I’m Clive Tompkins reporting for the Finance News Network. Joining me from Volpara Health Technologies Limited (ASX:VHT) is CEO, Dr Ralph Highnam. Ralph, welcome back.
Dr Ralph Highnam: Very good to be here.
Clive Tompkins: Can you start off with a quick introduction to Volpara?
Dr Ralph Highnam: Volpara is a software company specialising in breast imaging. We’re really focused on reducing mortality and cost of breast cancer.
Clive Tompkins: You’ve just released your first half results. What were the highlights?
Dr Ralph Highnam: The highlights for me were the revenue increase of a few per cent on the previous year, some really good sales our first sales of VolparaEnterprise, our new cloud-based product. And then just in terms of the overall loss, it was exactly as expected, given the increase in sales force that we put out into the US this year, high quality sales team. And they’re all exceptionally positive around what they’re doing.
Clive Tompkins: Volpara has received some good news from the US FDA with regard to the launch of their EQUIP initiative?
Dr Ralph Highnam: Over the last year or two, we’ve had a lot of requests from our customers to provide them with quality assurance metrics. Such as, how well is the breast positioned in the image, how is the breast compression and to talk about radiation dose between the machines and between operators, and so on. It seems like the FDA has almost been listening to those same customers, because in October they actually launched what they called, the EQUIP initiative.
The FDA’s fundamentally said that the Achilles heel of breast imaging at the moment, in the US is all about patient positioning and breast compression. So they’re requiring all sites to actually comply with EQUIP, which is a quality control program to try and improve clinical image quality, by measuring and improving positioning, compression and so on during imaging.
Clive Tompkins: What’s the opportunity for VolparaEnterprise?
Dr Ralph Highnam: The FDA initiative is obviously going to have a cost impact on most sites. And we’re already getting calls in now from sites, struggling to understand really what the FDA is requiring. VolparaEnterprise actually meets most of their needs. So we are a big cost saver, in terms of the 8,700 sites that virtually need to comply with these strict new regulations around position, quality, compression and so on.
Clive Tompkins: For other jurisdictions looking to implement image quality requirements in light of the US move?
Dr Ralph Highnam: It’s a really interesting dynamic. Most of the world is population based screen programs, and they’ve already got quite strict quality assurance programs in place. So we’re actually talking to a whole pile of those programs now, about essentially automating their current quality control and thereby, saving a lot of money.
Clive Tompkins: Your other product, VolparaDensity, which you’re a brand leader in. What’s happening in that product?
Dr Ralph Highnam: Very exciting Clive. To date the use of VolparaDensity has been around risk of missing cancer. The other clinical use, which is really the missing part of the jigsaw when it comes to breast density, is the risk of developing cancer. And there’s a new risk model coming out from Tyrer-Cuzick in London, which is going to start to incorporate for the first time, into a breast cancer risk model breast density. And we’re very proud that VolparaDensity is the only commercial input selected, for that model.
Clive Tompkins: Ralph Highnam, thanks for the update.
Dr Ralph Highnam: Thanks Clive, always a pleasure to be here.
Volpara Health Technologies Limited is a New Zealand-based company, which makes software for healthcare providers to understand cancer risk, enabling patients to make personal care decisions and guide recommendations about additional imaging, genetic testing and other interventions. Its artificial intelligence (AI)-powered image analysis enables radiologists to quantify breast tissue with precision and helps technologists produce mammograms with optimal image quality, positioning, compression and dose. Its software streamlines operations and provides performance insights that support continuous quality improvement. Its software is used in over 2,000 facilities by more than 5,600 technologists, impacting nearly 15 million patients globally. It helps providers conduct more than three million cancer risk assessments each year and can be deployed stand-alone or fully integrated with electronic health record systems, mammography reporting systems, imaging hardware and genetic laboratories.