Tim Moran is a 25-year medtech industry veteran and President and CEO of Avertix.
The US company has developed The Guardian System – the first and only FDA-approved Class III implantable device designed to detect heart attacks in real-time.
Tim talks to Health Tech World about the technology and its potential impact on the global cardiovascular disease epidemic.
HTW: Hi Tim. Could you tell us about the context behind the development of The Guardian System?
TM: There’s almost 9 million heart attack survivors in the US today. And unfortunately, about 25 per cent of those patients will end up having a second event.
What’s more concerning is that about 20 per cent will be completely silent heart attacks.
There’ll be none of the typical symptoms like crushing chest pain, or numbness in the arm. But those are the worst because the patient doesn’t take any action.
By the time they realise what’s happening, so many hours have passed that the event has a significant impact on their heart muscle.
That becomes a chronic, ongoing issue.
How does The Guardian System tackle the problem? What makes it different to other implantable devices?
Our small, implantable cardiac device looks similar to a single-chamber pacemaker. It’s placed in the upper-left chest with a single lead that goes into the right ventricle.
But the secret sauce is in the algorithm. Once the device is implanted in the patient’s chest, it looks at ST segment elevation or depression.
Our device will wake up every 90 seconds to look at the patient’s baseline normal electrogram for any elevation or depression and compare it to their normal baseline.
S segment elevation/depression is the gold standard for identifying the onset of a heart attack.
We’re the only ones that are able to do it with such fidelity that the FDA has granted us approval to sell.
The Centers for Medicare and Medicaid Services also did their own independent review and put reimbursement in place.
In our randomised controlled study of 1,000 patients, we reduced the time from onset to ER, by almost 8x to 1.6 hours.
That’s a massive, statistically significant reduction, that nothing else has been able to achieve.
We detected 42 silent heart attacks during the study alone in patients who had little to no symptoms.
That to me is the most incredible thing about the technology.
What attracted you to Avertix?
First of all, the technology is truly de novo. No one else has been able to do what The Guardian does.
Our cardiac implant predicts and detect heart attacks as they are beginning and alerts the patient so they can get to the emergency room as soon as possible
Secondly, it’s a very large market.
Cardiovascular disease is the leading cause of death worldwide. Our mission is to try to improve the outcome of patients that will have a heart attack.
You’ve been in medtech development for 25 years.
Is the development journey getting shorter? Are things as hard as they’ve ever been? Or have new developments and collaborative tools made things easier post-Covid?
I started out at a large organisation.
The challenges are different when you’ve got a lot of resources and you’re trying to drive to above market growth rates and you have a lot more dollars to spread around.
Being on smaller side for the past eight years, I’ve found that I love the ability to be nimble.
We can cut back on bureaucracy and really focus on the most important needle moving efforts that can create shareholder value and drive the company forward.
I think that the development cycle for technology is improving. But PMA is a much more difficult, stringent regulatory approval process, than a 510 K product, for example.
We’ve got a Class III implantable that requires significant clinical data to be generated.
Our long and expensive alerts trial that got us where we want to be and really puts fences around the competition.
How does The Guardian help patients take control of their own health?
The product has a six-year battery life. During this time, the patient’s cardiac profile changes, so it needs to constantly update.
So it is truly tailored to that specific patient, which is really important.
The device gives patients a sense of security, too.
Before Guardian, people were afraid to do all their normal activities like exercise because they worried about triggering another event.
But we also make sure to tell patients: If you have symptoms but the device isn’t vibrating and you’re not getting any alerts, you still need to go to the ER.
We are an adjunct to symptoms that means patients don’t have to rely on symptoms alone.
Has there been any resistance from professionals? Do they trust the data?
Because we have the data and physicians understand how significant it is to get this type of approval for a Class III device, we haven’t faced much resistance in terms of data and accuracy.
All in all, physicians really like that we’re providing almost a chronic care monitor.
Most of these patients who have had a prior heart attack also have comorbidities, such as diabetics, obesity or smoking that further increase the chances of having a cardiac event.
Physicians appreciate that this is a device enables round-the-clock monitoring that they wouldn’t have had before.
And if a heart attack occurs, they’ll get a notification and will get themselves to ER.
Not only are we spotting heart attacks when they occur, we can detect things like atrial fibrillation too.
And the data is not getting interfered with like Apple Watches or patch technology.
Over the past 15 years there’s been an explosion of consumer heart monitoring tools like those you mentioned.
Has this been a help or hinderance to what you do?
Has it meant that health professionals are more open to monitoring the heart in new ways? Or has it made it harder to stand out from these accessible consumer devices?
We’ve always said that there’s a purpose for all of these devices. It all comes down to what the patient really needs, and that’s best identified by their physician.
We see ourselves as the gold standard of ST segment analysis.
But maybe someone doesn’t need an implantable device for afib, maybe a patch is fine for them. So it’s about the patient population that that we serve.
How will the technology evolve from here?
The next gen will include cloud connectivity which will give us bi-directional communication with the data sent wirelessly to physicians and family-members.
We aim to have this submitted to the FDA next year.
The rise of patient monitoring presents a really interesting opportunity to evolve the device, but also add a new revenue stream.
As an early stage growth company, we’ve got a lot of personalities.
We’ve assembled a terrific team with ambition to do a lot. My job is to balance that with execution today.
There’s potentially other form factors that can utilise our tech. Maybe in a future generation, we won’t actually need to have the lead directly in the heart, so it could be even less invasive.
You could even have a subcutaneous version, and we’ve done some IP work in that area already.
But think about the data that we’re capturing from, eventually, thousands of patients.
New algorithms are being written where you can take EKG data, put it through AI, and determine other things that may happen with these patients or even other ways to treat these patients.
We think that there’s a data monetisation opportunity over time as well.
But the more implants we do, the broader penetration in the market, the more data we capture, the better opportunities for that in the future.
What does your timeline look like in terms of reaching across the US and globally?
We’ve signed a few major agreements already this year, one which represents more than 50 hospitals across the country.
We now have a handful of their sites implanting on a consistent basis.
We also signed Advantest Health which has about 40 hospitals, primarily in the mid-Atlantic Southeast area.
And then a few months back we announced Trinity which was created by a group of top cardiologists in Tampa, Florida.
Not only will they do implants at their surgery centre, but they also rotate to upwards of seven to 10 hospitals.
We really liked that ‘land and expand’ approach to commercialisation.
Earlier this year, we announced a significant partnership in the MENA region, with a group that will start focusing on generating Guardian revenues and commercialisation in Saudi Arabia and UAE.
Not only is that a significant population, but it is also a single payer system, so prime for a product like ours.
We anticipate that we’ll start to seeing revenue in MENA at the end of the first quarter of 2024.
You’ll see more global reach happening. But want to be very smart and efficient about it.
Is there anything else in the pipeline that you haven’t mentioned, in terms of the evolution of the product? Are there any potential barriers ahead?
When you talk to physicians, it really hits home with what we were doing as a company and what our mission is.
There are always market challenges. But our biggest challenge is just driving awareness
Every day, we meet a doctor that has not yet heard about the Guardian and what it can do for patients.
We’ve adopted a really smart approach where we’re in all the places with the highest prevalence of coronary artery disease.
The other thing that I would mention is that generating additional clinical data over time is going to be really helpful. Firstly, because it drives awareness.
A physician presented data at a recent conference which showed that there was a 150 per cent increase in medication adjustments of antiarrhythmic medications for high risk patients who had a Guardian
This shows that Guardian is providing physicians with invaluable data that they’ve not had before.
That data allows them prescribe either more or less of certain cardiac medications so that they can treat their patients better.
Without Guardian, people run to the ER, thinking something’s going on. That clogs emergency room. And sometimes it’s an erroneous visit.
It’s very costly to the healthcare system.
Everyone has that fear of dad having another heart attack and worrying about it every day.
We feel like we really play a key role in reducing the fear and uncertainty that comes along with having through this.
Our tagline is ‘keeping families together.’
That really resonates because, if someone has had a heart attack, the impact is not just on the patient, but their entire supporting cast.
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