Sales of Kardia, Alivecor’s mobile-enabled electrocardiogram, ought to get a boost from data suggesting that it is an effective way to screen for atrial fibrillation. But arguably the real opportunity for the group comes from its collaborations with pharma companies, which are interested both because earlier AF diagnosis boosts sales of anticoagulants, and because Alivecor’s device could be of great help in drug development.
“We’re being hosted by Pfizer-Bristol-Myers Squibb in their booth … they’re very interested and have purchased and distributed quite a number of devices around the world in order to find more AF, prevent more strokes – and sell more Eliquis,” said David Albert, Alivecor’s chief medical officer.
In the Rehearse-AF study Kardia was provided to patients with risk factors for stroke, which can be caused by AF, so that they could record their heart traces at home, twice a week for a year. The data, presented at the ESC meeting in Barcelona this morning, showed that this enabled four-fold greater detection of the arrhythmia than routine care, where patients were seen by their doctors every six months or so.
During the study period, 19 of the 501 patients in the Kardia group were diagnosed with AF compared with five in the 500-strong control group – a significant difference with a p value of 0.007. But showing earlier diagnosis of AF is not really what cardiologists want: a trial that definitively proves that use of Kardia cuts stroke rates would be real news.
A group of researchers is attempting to get such a trial off the ground. “There’s an international organisation called AF Screen, which has submitted a grant application to the NHS for a 120,000-patient study, because that’s the kind of numbers you’ll need to answer that question,” Mr Albert said.
“That’s not the kind of study Alivecor can finance. I don’t know if they’re also applying to pharma companies – Pfizer-Bristol, Boehringer Ingleheim, Bayer – to see if they’re interested, because again it’s potentially dramatically expanding their customer base,” he added.
Kardia costs $99, and people who wish to monitor their heart rate can buy it from a number of suppliers including Amazon. In the clinical setting it is used by medical professionals at sites including the Cleveland Clinic and the Mayo Clinic; Mr Albert said that cardiologists at Massachusetts General recommend the system to their patients so they do not have to come in to have a heart trace taken. He says the company has sold at least 150,000 of the devices.
The UK NHS is doing a pilot trial with 5,000 general practitioners over the next year, to find AF in patients and prevent stroke, while the US managed care group Kaiser Permanente is doing a similar study. Mr Albert said treating a single stroke costs Kaiser Permanente around $120,000, so prevention is a priority for them.
According to data presented by Swansea University's Professor Halcox, the screening programme with Kardia carried a cost per AF diagnosis of £8,255 ($10,692). Asymptomatic AF is currently diagnosed when patients arrive for a routine health check and their doctor happens to run an ECG. In other words, this cost comes on top of standard care.
The bulk of this cost is staffing: the ECGs must be checked by cardiologists to make the diagnosis. Alivecor is working to develop better algorithms which would limit the involvement of cardiologists, perhaps by better identifying normal and abnormal rhythms so fewer have to be checked. Professor Halcox told EP Vantage that this could cut the cost per diagnosis figure markedly, though he declined to put a figure on it.
All those customers, all that data
To make inroads into healthcare systems Alivecor will have to show that the cost of screening is outweighed by the savings made by preventing strokes, and that will take time. In the meantime the company has another resource it can monetise: its data.
Mr Albert said that 15,000 people use the Kardia device every day. “It’s a significant generator of big data. We have 17 million-plus ECGs in our database, we’ll get close to 900,000 [more] just this month. Because we have this big data it’s attractive to a lot of researchers.”
It is surely attractive to pharma companies too, though when asked if Alivecor was working with drug developers in this context Mr Albert would only say that Alivecor had been “approached”.
With a novel technology with great potential and no competitors – others have tried and failed to develop similar devices, Mr Albert said – Alivecor could be a tempting acquisition target.
“It’s impossible to speculate on exits – people ask, our investors are always interested. We’re building value. All those customers, all that data,” he said. He points out that Omron, the largest maker of over-the-counter medical devices such as blood pressure monitors, is a significant investor in Alivecor, and that there are “synergies” between the two groups.
He did, perhaps, drop a hint regarding Alivecor’s future: “I can't tell you about an exit. I can tell you that every major medtech company, every major pharma company is very aware of Alivecor.”
|Alivecor's venture funding|
|Financing date||Financing round||Investment ($m)||Investors|
|March 16, 2017||Series D||30.0||Omron Healthcare, Mayo Clinic and existing shareholders|
|June 11, 2012||Series B||10.5||Burrill & Company, Khosla Ventures, Oklahoma Life Sciences Fund and Qualcomm Ventures|
|August 23, 2011||Series A||3.0||Burrill & Company and Qualcomm Ventures|