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Rudolf Schulze Vohren, Nano4Imaging - MR-Compatible and Visible Solutions for MRI's | LSI Europe '24

Nanotechnology in our customized markers is the only way to reach multimodal visibility though complex nanoparticles, and integrating into medical devices makes devices visible and steerable in MRI and CT.
Speakers
Rudolf Schulze
Rudolf Schulze
CEO, Nano4Imaging

Rudolf Schulze Vohren 00:02
Hello. I'm Rudolf Schulze Vohren, CEO of Nano4Imaging, and I'm pleased to present our company and its tracker technology. Tracker enables interventional MRI and has the potential to revolutionize radiology. More and more physicians want to perform interventional MRI because many patients need safer and more precise interventions, especially vulnerable patients who require procedures without radiation and contrast agents, and hospitals require more efficient workflows and the reduction of occupational health risks. However, the lack of devices and software is a major bottleneck for the rapid expansion of interventional MRI. MRI can do much more than just take diagnostic images. It is also ideal for interventions because, unlike in CT, you can see soft tissue perfectly and perform interventions in real time, because it has theranostics capability, and you avoid harmful radiation and don't need contrast media. Finally, MRI has a smaller and less damaging impact on the environment. However, there are a few challenges to overcome. First, devices containing metal cannot be used in MRI; therefore, we have developed Emory Glide, the first available non-metallic guide wire. Second, our Magnify MRR markers, which are nano coatings, make devices in the MRI visible. Third, the software algorithms recognize MR markers and allow the tracking and positioning of devices like a GPS or a parking assistant. The industry is also making progress. Thanks to AI, scan time has been drastically reduced, and costs of new MRI scanners are reduced by 50%. Thanks to helium-free and low-field technology, hospitals can operate MRI at the same cost level today as CT equipment. Let me summarize. Our tracker technology consists of three components: first, an MRI-compatible device; second, MR markers applied to devices; and third, a navigation system. Our USP is a smart connection between MR markers and the software. The tracker can be applied with all interventional devices. It's a cost-effective solution, and it will set a new standard in interventional MRI. Let me show you how it works. In the following video,

Rudolf Schulze Vohren 03:09
the tracker software interrogates the DICOM data files for the presence of the passive MRI markers on the devices. In this video, we will show you how this is done during abdominal angioplasty of a thoracic aortic stenosis. In this case, a guide wire with three tip markers with a specific distance from each other is inserted via the femoral access and moved slowly upward towards the predefined stenotic area. Our software traces the number and distance of the markers, just like a GPS system. It traces the position of the device through the tip, even when the markers go out of the selected plane. The software will detect the three markers and show the position due to the three-slice scanning. Now that the wire is positioned in the target area, the angioplasty balloon catheter can be moved over the wire to the region of interest. It has two markers on each side and can be moved over the guide wire towards its distal position. In fact, the two balloon markers can be matched to the three markers of the guide wire pre-positioned in the stenotic area. The guide wire is then retrieved to allow balloon inflation. At all times, the markers on the tapered tips of the balloon remain visible.

Rudolf Schulze Vohren 04:24
We are already using our Emory Glide in routine, among them our Training Center, Dallas Children, and the London Royal Free Hospital. Until today, 250 procedures have been performed in the indication, pulmonary pressure measurement, without any complaints. Major industry partners are already on board. I would like to highlight Siemens briefly. They want to integrate our software into their Magneto scanners. We are first movers; so far, no major OEM is active in catheterization and tracking software for interventional MRI. Apart from this segment, our technology can leverage its strength in biopsy, ablation, and injection. There is already a market for interventional procedures in MRI; according to this research, it will grow very fast to 2.3 billion within the next five years. Software and catheterization, the segments we focus on, will become the two biggest categories worldwide. There are over 50 million catheterization procedures. Our pipeline focuses on 555, an easy number to remember: 1,000 procedures across 10 indications. Our products address two sales channels. The software will be sold to MRI system manufacturers, and devices are sold directly to hospitals. Besides the basic tracking software, we developed organ-specific modules. On the device side, we have catheters, balloons, and needles in our pipeline. The US is our first go-to market, later Europe and Asia. Currently, we are exporting Emory Glide directly to pediatric clinics. Sales will increase when our US team is in place, beginning of next year. Once new devices have been approved, we will expand to the adult segment in 2026. We currently employ 15 professionals. Our team excels in machine learning, regulatory, and production. It is led by proven executives with extensive industry experience in med tech and startup building. The beginning of our collaboration with Siemens was a very important milestone we achieved last year. Last month, we signed a production agreement with our tech to be closer to our US customers. The very important milestone for next year will be the FDA approval of our software. Our technology allows us to establish a leading position in a new market, and we are ambitious. With rapid scaling up, we want to achieve break-even with sales of 12 million in 2027. Today, Nano4Imaging has raised 12.5 million. The upcoming Series A round is for 10 million; it will be sufficient to reach break-even. The EU confirms the readiness to contribute up to 50% of this amount. Family offices and local VCs on our cap table will also join fast-growing new markets, if they always do provide consolidation opportunities. Therefore, we anticipate being included in the shopping list of major OEMs within the next strict three years. Thank you very much. Applause.

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