Biocurious: EBR Systems is on a ‘glide path’ to FDA approval for its novel heart device
EBR Systems is super confident the US medical gatekeeper will approve Wise, the world’s first wireless pacemaker device.
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The US regulator is due to decide on approving EBR’s Wise leadless pacemaker on or before April 13
The company is preparing to enter the US$3.6 billion US market with a targeted approach
EBR’s expanded Silicon Valley manufacturing hub protects the company from Trump’s tariffs
EBR Systems (ASX:EBR) CEO John McCutcheon is adamant the US Food & Drug Administration (FDA) will approve the company's Wise, the world’s first leadless pacemaker device.
“They are not going to reject it – I will risk my career on that,” he says.
“They could ask questions to respond to – which means there’s more work for us to do – but I don’t think that is going to happen, either.”
Under the approval process, the FDA has 180 days to review a pre-market approval application – applicable for high-risk devices such as Wise.
But the clock can stop if the agency has follow-up concerns for the applicant to answer.
McCutcheon says a so-called 100-day meeting with the FDA in December went “swimmingly”, with no controversial issues emerging.
The company submitted its response to some follow-up questions on January 13 – and the final 90-day clock started ticking.
“We are on the glide path here," McCutcheon says.
Getting Wise
Pacemakers often are called 'ticker kickers' but more formally they are known as cardiac resynchronisation therapy (CRT) devices.
CRT addresses the problem of the right ventricle contracting before the left ventricle, resulting in the heart not pumping enough blood.
Wise – as in ‘wireless stimulation endocardially’ – enables stimulation of the tricky left ventricle.
While pacemakers have been around for decades, the problem is that about 4% of leads fail every year.
Mobile phone users would be happy with such a reliability rate, but we’re talking about a vital bodily function …
The left ventricle is trickier is because it circulates arterial blood straight to the brain.
The right side (venous blood) circulates through the lungs and is less prone to clotting.
The size of a grain of cooked rice, the Wise device is embedded in the heart and is powered by a subcutaneous battery close to the ticker.
A transmitter picks up the groove of the right ventricle and sends a signal to the Wise electrode, which converts ultrasound energy to electrical energy to stimulate the left ventricle.
EBR was founded in 2003 by electrophysiologist Dr Debra Echt, ultrasound scientist Dr Axel Brisken and former pacemaker engineer Richard Riley.
The EBR moniker derives from their surnames.
Girding for product launch
EBR’s FDA entreaty was supported by a 183-patient pivotal study which blitzed its primary and secondary endpoints.
For instance, patients showed an average 16% reduction in left ventricle end systolic blood volumes – a good thing – compared with the targeted 9.3% drop-off.
EBR estimates the initial US total addressable market at US$3.6 billion a year, but it won’t be an “everything and everywhere” approach.
“I caution investors not to expect a rocket-ship takeoff,” he says.
McCutcheon says EBR and Wise don’t have a sales history and – despite the device’s clinical benefits – heart surgeons may be wary at first.
“Every technology is different,” he says. “As bright as we think we are … we want to test our model before going all-in.”
That way, management can fix up problems – such as wrong personnel – before the business is scaled up.
“Some companies make the mistake of being so confident they go everywhere with a shotgun approach," McCutcheon opines.
In 2026, EBR plans to roll out Wise to the 200 to 250 heart clinics that account for more than 50% of the US CRT market.
Trump 2.0 looks okay for pay
On reimbursement, EBR is confident of a per-procedure payment of US$45,000, which is the amount EBR charges the hospital.
Given Wise’s ‘breakthrough device’ status add-on payments are available, but they won’t kick in until October.
McCutcheon says Trump 1.0 – Trump’s first White House gig – was favourably disposed to the medical device industry.
“Going by history I don’t expect much to change. If anything, our guys expect Trump might be more pro-industry on the reimbursement side.”
Building a US presence – literally
EBR makes its devices at Santa Clara, in the heart of Silicon Valley alongside the HQs of obscure small-cap techs such as Apple and Google.
Last month EBR signed up for a larger 4751 square metre facility, just down the road from its current digs.
The “very favourable” terms” on the 11-year lease include a one-year rent holiday and the landlord chipping in US$4 million in tenant improvements.
“We need to build out the shell and will move in in 2026,” McCutcheon says. “It’s a blank slate, we can build it to suit”.
While local manufacturing protects the company from a Trumpian tariff tussle on imported gear, it’s not just about the ‘made in America’ mantra.
“The engineers and manufacturing expertise are there in Silicon Valley,” he says.
“We want to keep reiterating and reinventing, so to have manufacturing and R&D co-located is really valuable to a company like us.”
... while not ignoring the rest of the world
In the near term, EBR is focusing on Australian and UK assent, off the back of the expected FDA imprimatur.
McCutcheon expects local Therapeutic Goods Administration approval within a year.
The Australian market is only about one-tenth the size of the US, proportionate to the population difference, but with less appealing reimbursement.
“Still, we have employees and investors here, so we have other motivations to come to market here," McCutcheon says.
EBR's growth plans conspicuously exclude mainland Europe, even though the company won so-called CE Mark assent for Wise in 2015.
The trouble is, this was under an old scheme called the Medical Device Directive, which was phased out in favour of the Medical Device Regulation.
For Monty Python fans, this might sound like the fine distinction between the People's Front of Judea and the Judean People's Front, but in reality the new regimen is "costly and burdensome".
EBR opted to let the CE Mark lapse.
In the meantime the FDA has got "better and better" to deal with, McCutcheon says.
We’ll stay put, thanks
To date, more than 500 patients have been embedded with the Wise device, with the first Australian patient implanted in February 2018.
EBR shares have felt the love, too, having gained more than 130% over the last 12 months for a fleshy market cap of more than $600 million.
The company listed in November 2021 at $1.08 apiece.
EBR is happy to remain solely ASX-listed, with no plans to follow a string of Australian biotechs that have listed on the Nasdaq – not all of them triumphantly.
“You need to be careful. Some companies have been tripped up by not doing it at the right time,” McCutcheon says.
“We are really happy with our ASX presence. The stock is running up and we are getting rewarded for meeting our goals.”
Of course, the key goal is FDA approval – and the betting is in favour of McCutcheon not having to polish up his Linked In profile in a little over a month’s time.
Originally published as Biocurious: EBR Systems is on a ‘glide path’ to FDA approval for its novel heart device
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