Basement to Breakthrough: Imricor transforms heart treatment with MRI

Imricor co-founder Steve Wedan says the company’s work over almost two decades is coming together
Company has developed the world’s only MRI-compatible devices for cardiac ablation procedures
Imricor on track for US-FDA approval for atrial flutter in 2025, with approval received in Europe

Special Report: Some of the world’s most successful companies began in humble spaces like basements and garages — think Amazon, Apple, Microsoft, and Disney.

Imricor Medical Systems (ASX:IMR), co-founded by electrical engineer and now CEO and chairman Steve Wedan was similarly launched from the basement of his Minneapolis home.

Today, IMR leads the way in advancing MRI-compatible products in the global US$8bn cardiac catheter ablation market, aiming to improve both the effectiveness and safety of procedures for patients and medical professionals alike.

“If you could rewind about 18 years when starting a company in the basement with all these ideas of how you’re going to change the world and realise how long the road is going to be you might think twice,” Wedan told Stockhead on his visit to Australia.

“Doing something like this isn’t just about making an ablation catheter that is MRI compatible, but also every single device used in that procedure.

“Everything you needed for the procedure we had to reinvent from scratch and on top of that we had to put partnerships together with all three major MRI vendors – Siemens, Philips and GE – to ensure compatibility.”

Wedan said there was an enormous amount of work which went into technical and business development.

“We didn’t want to develop everything so found device companies who would want to partner on different items like in room monitors, headsets and all the miscellaneous devices to make it possible to do these procedures under an MRI,” he said.

“But now it is exciting because all that work is done with all the devices developed, all the capital equipment and our NorthStar 3D mapping system developed, and third-party partners are ready.”

Career advancing MRI tech and understanding

When it comes to the advancement of magnetic resonance imaging or what is commonly referred to as MRI, Wedan has a distinguished career.

He previously worked for GE Medical Systems designing MRI scanners and ultrasounds and as an industry consultant in the field of MRI compatibility.

Through a research project with physicians from Johns Hopkins University, Wedan identified magnetic fields in MRI scanners could cause dangerous interactions in patients with metallic foreign bodies along with device malfunction, such as interference with a pacemaker.

As a result, standards changed to protect patients from the hazard. Wedan has won awards for his work and is a member of various international standards committees in the fields of MRI safety and the compatibility of implanted and interventional products in MRI.

From Johns Hopkins University idea to reality

While at Johns Hopkins, Wedan worked with physicians on another compatibility problem – making catheters that could be used in MRI for cardiac ablations to treat arrhythmias.

Ablations are performed by an electrophysiologist who makes a small incision in the groin, guiding a catheter through a vein to the heart.

They use radiofrequency to create a lesion that restores normal heart rhythm.

The procedure is done under X-ray fluoroscopy, which shows hard structures like ribs and the catheter but doesn’t reveal the soft tissue of the heart.

However, lack of visibility makes it difficult to ensure the entire arrhythmia-causing area is treated, resulting in a first-time success rate as low as 50% and often requiring multiple procedures.

X-ray use also exposes patients and staff to ionizing radiation, and doctors must wear heavy lead gowns during what can be lengthy procedures lasting upwards of four hours for complex cases.

Wedan joined the Johns Hopkins team, came at it from a different approach and essentially formed IMR as a result in 2006.

“We are moving forward to finally deliver on the promise that the folks at Johns Hopkins had in the mid-1990s to do these procedures in MRI,” he said.

“We did all the work to put it in place and it is exciting and fulfilling to see it all come together.”

Small steps to prove technology

Heart arrhythmias largely present as three indications – atrial flutter (AF), atrial fibrillation (Afib) or ventricular tachycardia (VT).

IMR is currently undertaking its Vision-MR Ablation of Atrial Flutter (VISABL-AFL) pivotal clinical trial supporting US FDA approval of its products, which it hopes to achieve in 2025.

In Europe, where the company has already received regulatory approval for AF, it’s about to start the VISABL-VT clinical trial for its second indication, ventricular tachycardia.

“Atrial flutter ablation is rather straight forward so it’s a good way to do a fast clinical trial, get the whole platform of devices approved and on the market to start growing the installed base,” Wedan said.

“Then when you move to the next step and more complex procedures like ventricular tachycardia or atrial fibrillation ablation you are only studying the ablation catheter because everything else is already approved.”

In Europe the platform has been established and clinicians are undertaking AF ablations.

An IMR clinical trial showed an ablation to treat AF was 45% faster, with a 100% chronic success rate with no radiation when performed using MRI.

Wedan said atrial flutter accounts for only about 10-20%% of procedures undertaken by an electrophysiologist and is the simplest of ablation procedures.

IMR is now working to show more complex ablation procedures could be done better with MRI.

“Next is ventricular tachycardia and that can change the world, and we think will be very groundbreaking,” he said.

The company plans to start a VT and Afib trial in the US in 2026.

“FDA approval will open the world’s largest market with some of the best reimbursement,” Wedan said.

IMR is preparing to build out a strong sales team in its target US market under the leadership of Greg Englehardt, a former staffer from global medical device powerhouse Medtronic.

“It’s a well-trodden path to launch in the US with great data and we know where the ablations are happening and that is the stage we are setting right now,” he said.

Smart health economics

When it comes to health economics, there is a strong argument for clinicians and organisations to take up IMR’s MRI system for performing cardiac ablations.

Imricor believe safety for staff and patients will improve, and the requirement for redo procedures and time to perform these procedures will reduce.

Establishing an iCMR (interventional cardiac magnetic resonance) electrophysiology lab may also be less than an X-ray one according to internal survey data.

“MRI systems are more expensive than X-ray systems but by the time you fit out the whole room around the MRI and the X-ray system they cost about the same or less,” he said.

“When I started Imricor I thought we’ll have to make an argument for why an increased upfront investment is worth it.

“But that is not the case, and the data shows our iCMR labs cost less than or just as much as the conventional X-ray lab.”

He said there are certain tools needed for an ablation performed under X-ray not needed with MRI.

“That means the per procedure comes down significantly,” he said.

“So, less costs to start up, less cost per procedure with the promise of MRI to do procedures faster and with higher effectiveness.”

Wedan said that would generate more revenue and higher margins for the physician and hospitals.

“If you can do in one procedure what might have taken two or three then it’s also good for the payor – the government or insurance company paying for the procedure,” he said.

“The per patient cost goes down and we already fit into the reimbursement structures that are in place so we don’t need to seek reimbursement which can be an additional challenge for new health technologies”

This article was developed in collaboration with Imricor Medical Systems, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.