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Matthieu De Beule, CEOFounded in 2009 as a spinoff from Ghent University,FEops is the world’s first and only patient-specific simulation technology for structural heart interventions. The technology surpasses the granularity of basic anatomical measurements within the heart by accurately predicting how devices can interact with each unique patient.Their flagship solution, the FEops HEARTguide™, produces imaging that can help build standardized compute models of patients’ hearts so that appropriate cardiovascular devices can be designed. This would also allow R&D teams to clearly understand the device's working while in a particular patient’s body.
Charting a Legacy in Cardiovascular Simulations
As there is a clear shift towards the use of minimally invasive approaches from standard open-heart treatments, physiciansrely ever more on medical imaging to make very important decisions on factors such as implant size and positions.This is not always straightforward since it can often become challenging to imagine how devices will interact with different patients. As Matthieu De Beule, CEO of FEops, puts it, “Patients’ unique anatomy is where we come into play, because we use imaging in a functional way. The way we build standardized computer models of that patient’s heart allows the physician to understand the case in an integrated and detailed manner. The doctor can thus assess the risk of complications preoperatively, to ultimately make procedures safer and more efficient.”
FEops’ solution is a fully cloud-based platform. By combining routine preoperative cardiac CT images with patient-specific computer models, FEops HEARTguide™ predicts the interaction between e.g. the Transcathether Aortic Valve Implantation (TAVI) device to treat aortic stenosis and the patient’s unique anatomy, including post-implantation deformation, allowing physicians to assess the risk for paravalvular leakage and conduction abnormalities.
FEops has already modeled more than 2500 structural heartcases with FEops HEARTguide™, which is commercially available in Europe, Canada and Australia for the TAVI and Left Atrial Appendage Occlusion (LAAo) workflow. The company is currently in the process of getting an FDA clearance through a de-novo pathway forits LAAo workflow, which is expected in the second half of 2021.
Accelerating Cardiovascular R&D
To FEops, the main value of being a simulation specialist and medical innovator comes from the advantage they offer to clients end to end.
The way we build standardized computer models of that patient’s heart allows the physician to understand the case in an integrated and detailed manner
This is a space in which FEopshas shifted the paradigm, having created validatedmodels of the heart. Developers can now move forward without making a device prototypeand test design iterations in real patient models, risk-free. As De Beuleputs it,“It is as close as you can get to a patient without even having to make a prototype. We are currently involved in lots of next-gen developments of structural heart devices with several companies of all sizes—from huge enterprises to startups all over the world.”
From an RnD perspective, using patient models can help develop a detailed understanding of the device's performance and behavior. For instance, if specific changes are made to a device, their potential impact on the patients can be observed. This can be quite useful in the selection process of patients.
Alternatively,the FEops platform can help create very accurate models that can predict complications more precisely than the current medical device technologies out there. While running clinical trials, this can be quite useful, as one can make sure that the right device is being selected for the right patient or the right patient for the right device.
For instance, Transcatheter Mitral Valve Replacement (TMVR) is a potential therapeutic option for the treatment of severe mitral regurgitation. Early clinical experience supports the feasibility of TMVR but also highlights low enrollment in TMVR studies due to physicians' concerns about the risk of left ventricular outflow tract (LVOT) obstruction. FEops responds to this clinical challenge with the development of its unique FEops HEARTguide™ TMVR workflow. It offers accurate simulation-based information about the effects of replacement device positioning and deformation within each patient's anatomy. This provides physicians with better insights into the replacement device's sizing and helps them identify the optimal position to avoid left ventricular outflow tract (LVOT) obstruction.
Overall, the digital twin model that FEops offers helps minimize chances of complication and maximize chances of procedural success. “The better you are informed upfront, the higher your chances are,” adds De Beule.
Answering the Physician’s Call with Cutting Edge Tech
FEops delivers unparalleled levels of visibility and is quite intuitive and easy to use for clinicians and healthcare providers. The physicians or the field therapy specialists from device companieswho assist physicians can upload the patient's images to the cloud. And once the data is obtained, the company can process the medical imaging and build the computer models. FEops HEARTguide™ can thereby run simulations of different treatment scenarios, different devicesizesand different positions. Within 24 to 48 hours, the resultsare sent back to the cloud so that the physician or the therapy specialist can confirm the receipt of the images.
The heartteam can then use the secure portal to interactively play with these 3D models to get a detailed understanding of the different possible treatment scenarios.
Technically there are two components in this process, the first of which is image segmentation. Starting with DICOM images, 3D reconstructions of the heart’s anatomy are produced. The platform, however, goes a few steps further to create a compute mold to the finite element model. The result is the second component, i.e., FEops’ proprietary mechanical modeling strategies that run on finite element analysis. The technology was already being used for years in the automotive and aerospace industries, making FEops the first to bring that to the structural heart community. The cardiovascular model incorporates the material properties of all the different tissues involved in specific regions of thepatient body and the device, enabling the user to study them in detail.
"We are also currently involved in lots of next-gen developments of structural heart devices with several companies of all sizes—from huge enterprises to startups"
There have been thousands ofpatients whose cases FEops HEARTguide™ has “worked on” side by side with cardiologists in the cath lab. Having curated a diverse database of real patients' heart anatomies from these cases, FEops can glean highly customized insights derived from these data to test in silico and draw up all the possible and likely interactions between device prototypes and different heart anatomies.This will help create a better understanding of how different potential design iterations will behave.
Evolving the Way of Medical Research
Having worked with a plethora of different patients and gathered data on all of their cases, the company has expanded their intake to include trials from even larger sample sets. The PREDICT-LAA study is a physician initiated study with Prof. Ole De Backer and Dr. Philippe Garotas PI’s and is co-sponsored by Abbott and FEops. The final enrollment is expected in Q3 of this year.
FEops is also planning to extend its offeringfrom the procedure planning phase to the procedural guidance phase, which means that physicians can use their technology preoperatively to plan and peri-operatively to guide their procedures. Together with the big imaging players, like GE, Philips and Siemens, FEops is working on technologies that allow users to visualize the simulation results during the intervention, which allows themto have clear landmarks during the intervention of where to land the specific device.
In the months to come, FEops plans to leverage their experience of having worked with more than 2500 patients to launcha novel AI platform and incorporate it into FEops HEARTguide™. Thiswill help upload, process, and download medical images over the cloud in a secure way providing a full anatomical analysis on top of FEops’ unique digital twin technology. It is no wonder then that FEops has been pretty successful in their two venture capital rounds, having raised 7.3 million Euro. Additionally, they have raised 5.9 million Euro in public funding, of which the last one was a grant of € 3.2 million from the European Innovation Council (EIC) accelerator program. The company is using the grant for accelerating the clinical evidence gathering and business implementation of FEops HEARTguide™ on a global scale.
With resources at hand and innovation at its heart, FEops is well on its way to revolutionizing the cardiovascular simulation space forall.
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