FEops
Experts in Personalized Computer Modeling for Structural Heart Interventions

More than five million people in the U.S. are diagnosed with heart valve disease every year. According to international market research and consulting firm, iData Research, heart valve replacement is one of the most common procedures performed in cardiac surgery, constituting nearly a quarter of the total procedures. In this scenario, considering that even the slightest of mistakes could result in life-threatening complications, there is a consensus that procedure planning plays a crucial role in transcatheter structural heart interventions. As it stands now, the current gold standard for procedure planning technology for transcatheter structural heart interventions relies on technology that has been used for the last 10-15 years. This involves taking medical images, conducting measurements on these images, and then guestimating by a simple overlay, the best fitting device size, and position for that subject. Needless to say, with a minimally invasive procedure, the physicians fully rely on medical imaging, which is far behind the capacity of modern technology.

As a pioneer in patient-specific 3D simulations for cardiovascular interventions, FEops is changing this whole paradigm by taking out the guesswork from procedure planning. A fast-growing medtech company headquartered in Ghent, Belgium, FEops is an expert in personalized, predictive planning for structural heart interventions. Apart from being a developer of advanced computational modeling and simulation technology, FEops offers several tools that not only enable physicians to improve clinical outcomes but also empower medical device manufacturers to bring quality products to the market faster.

Through its novel simulation technology suite, FEops offers physicians and cardiovascular device manufacturers detailed pre-operative insights into the interaction between transcatheter structural heart devices and the patient's anatomy. Alongside improving patient outcomes, the company's simulation technology adds immense value to the structural heart product lifecycle, accelerating R&D, as well as clinical trials. "We are developing and commercializing the next generation procedure planning technology for transcatheter structural heart interventions. Our ultimate aim is to remove the guesswork by introducing a standardized predictive pre-operative procedure planning so that patients receive the best fitting device size at the optimal position, right from the first attempt of the physician," asserts Matthieu De Beule, co-founder and CEO at FEops.

Making Structural Heart Interventions' Worries a Thing of Past

The story of FEops began in 2009, right amid the financial crisis, when two PhDs students at Ghent University, Matthieu and Peter Mortier, decided to step into the medical simulation market. After developing a simulation technology during their post-graduate study, the duo established FEops to provide consulting services for medical device companies. "We started FEops with a mission to provide companies with support and advice on design for their devices based on our knowledge of computer modeling. We soon realized that there was more potential in our technology if we applied our expertise and blended computer modeling of devices with patients' information and images," states De Beule.

Since then, given the gradual rise in the patient population undergoing transcatheter device procedures, there have been many developments in the area of structural heart interventions. Today, minimally invasive surgical procedures are being preferred by patients and physicians worldwide due to their effectiveness and efficiency. For instance, for patients deemed too old or unfit to undergo Aortic valve replacement (AVR) through traditional open-heart surgery, transcatheter aortic valve implantation (TAVI) has become a growing alternative as it's less invasive. More recently, the indication of TAVI has been extended to low-risk patients. With an aim to reduce complication rates for TAVI by pre-operative risk management, FEops' launched its first product, TAVIguide—a cloud-based pre-operative planning service for Transcatheter aortic Valve Implantation (TAVI), in key markets in Europe.

Our aim is to enable wider adoption of transcatheter approaches by minimizing the risk of life-threatening complications and improving patient care

This was made possible after FEops secured €1.3 million series A funding led by Capricorn Venture Partners and PMV, two large, independent investment companies.

De Beule exclaims that while the present TAVI planning relies on pre-operative imaging such as computed tomography (CT) or echography, precise measurements of the pre-operative patient anatomy are not enough to avoid complications. "We did a proof of principle to show that a computer model can predict how a device interacts with a patient. By combining pre-operative CT imaging with advanced computer simulations, our clinical evidence depicted that the TAVI guide technology can effectively predict how a particular medical device will interact with a specific patient," says Peter Mortier, co-founder and CTO at FEops

FEops HEARTguide^™: A Physician's Go-to Tool

With an aim to guide structural heart interventions toward increased safety and efficacy and stay ahead in the growing market for transcatheter valve therapies, FEops secured Series B funding in September 2017, led by Valiance, a specialist investment firm. The company is utilizing the €6 million investment to expand its product roadmap to all transcatheter structural heart interventions, centered on FEops HEARTguide™—a cloud-based framework—to provide physicians with easy access to the FEops simulation technology.

As a one of a kind procedure planning environment, FEops HEARTguide™ uses advanced personalized computational modeling and simulation to provide medical device manufacturers and clinicians insights into the interaction between transcatheter structural heart devices and specific patient anatomy, preoperatively. FEops HEARTguide™ is available on the European and Canadian market with an indication for use in TAVI and LAAO. This scalable, automated, and AI-enabled platform provides physicians with unique insights to evaluate device sizing and positioning. It also contributes to better clinical outcomes and improved procedure efficiency. FEops HEARTguide™ effectively predicts the interaction between the TAVI device and the patient's unique anatomy, including post-implantation deformation by combining routine pre-operative CT (Computed Tomography) images with patient-specific computer simulations. It allows physicians to assess the risk for aortic regurgitation and conduction abnormalities.

Enabling Faster Development of Better Implants

FEops partners with medical device manufacturers to offer its tailor-made platform, which can predict potential complications such as leakage and obstruction and help improve the procedure. By combining SIMULIA Abaqus finite element analysis (FEA) software from Dassault Systèmes with proprietary software, FEop's HEARTguide™ develops digital 3D-anatomically correct finite element models of patients' aortic roots. The different virtual procedural alternatives assist the physicians in being optimally informed before performing the real procedure.

FEops goes beyond classic pre-op planning tools when it comes to supporting transcatheter mitral valve replacement (TMVR) intervention in patients with severe mitral annular calcification (MAC). "We already have CE mark for TAVI and LAAO, and we are developing our simulation technology as a unique pre-op planning tool for TMVR. It would provide physicians with better insights on the replacement device's sizing through accurate simulation-based information about the overall effects of replacement device positioning and deformation within each patient's anatomy," states De Beule.

FEops HEARTguide™ houses variable anatomy from hundreds of real patients and can effectively model current or future devices across a varied group of patients.

It moves beyond the traditional bench and pre-clinical models and offers a future in-silico platform for the physician training and clinical trial environment. Instead of recommending the clinicians on what model would be the best fit for a patient, FEops provides them with an advanced analysis of the medical data with its predictive models and help them make an optimal decision. Moreover, FEops' simulation technology allows clinicians to understand the complications in their earlier cases better. "We build these models by first running a retrospective study of patients that have been treated already and then run the simulation based on the primitive CT. Based on the comparison of the simulation results with the patient's actual outcome, we train our algorithms to have a good match," says Mortier.

The platform doesn't require installing anything locally, allowing FEops to update its technology quickly, resulting in cost and time savings for clients. "We had a new update recently, and due to our scalability, we were able to make it available to everyone without any problems, even amidst this COVID-19 pandemic," explains Nico Uwents, Director of Business Development at FEops.

The company's pipeline extends to offering dedicated planning tools with potential in the development, testing, and market adoption for improved device-based solutions. To investigate the possible positive effect of computer simulation using a CT scan of the LAA performed before the procedure, FEops, along with Abbott Laboratories, an American multinational medical devices company, is co-sponsoring the PREDICT-LAA trial. The prospective investigator-driven trial aims to generate a robust body of clinical evidence with FEops HEARTguide™’s efficiency in contributing to better procedure planning and patient outcome.

Improving Patient Care with its Expertise

Having carved a unique niche in the market, FEops has received ISO 13485 certification for quality. Success stories of several physicians also stand as a testament to FEops' capabilities and expertise. For instance, Dr. Ole De Backer of Rigshospitalet, Copenhagen, Denmark exclaims the prowess of FEops' solutions as, "I have the strong hope and believe that preprocedural planning with FEops HEARTguide™ will transform percutaneous LAA closure into an even more safe and more efficient procedure for patients with non-valvular atrial fibrillation and contraindications for oral anticoagulant therapy."

The success of FEops is powered by a diverse team of highly motivated experts with PhDs in computational biomechanics and other related fields along with a board and leadership team that includes industry veterans as stakeholders. The list consists of Rob Michiels, a veteran of the U.S. medical device industry, and Jose (Pepe) Calle Gordo, a global medical device executive, with over 30 years of experience. Along with them, Christian Vincent, Director of Therapy Development at FEops, brings a track record of success over three decades in the cardiovascular device industry.

Under the leadership of De Beule; Peter Mortier, co-founder & CTO; Nico Uwents, Director of Business Development; and Isabelle, Decroos CFO FEops has gradually transformed from a small academic spin-off into a fast-growing venture capitalbacked leader in the medtech sector. The company has garnered massive traction in the U.S., Canadian, Chinese, as well as European markets and has modeled more than 1600 patients spread over 79 hospitals in 21 countries. FEops recently received a grant of €3.2 million from the European Innovation Council (EIC) accelerator program. The company plans to utilize the grant for accelerating the clinical evidence gathering and business implementation of FEops HEARTguide^™ on a global scale.

For the future, De Beule stresses on the fact that the concept of predictive planning is extremely useful in the clinical space and has a lot of value throughout the product life cycle. "It includes R & D, support in the clinical program to improve patient enrollment, training new implanters for the risk factors, and the commercial rollout of the device to foster effective market penetration and therapy adoption while reducing overall cost. We aim to enable wider adoption of transcatheter approaches by minimizing the risk of life-threatening complications and improving patient care," concludes De Beule.