Innovatie

Flux One - A Robot that Helps Surgeons to Treat Blocked Arteries

Opschaling

Flux Robotics is developing a magnetic guidewire system for treating critical limb ischemia, targeting obstructions in leg arteries. Early studies indicate its potential in passing Chronic Total Occlusion (CTO) lesions, offering a safer alternative to current techniques.

Medisch technologische innovaties

Robotica

Regio Overijssel

Help ons versnellen

We invite collaboration with academic institutions or research labs specializing in medical device development, vascular biology, or robotics. Specific expertise in peripheral artery disease and Chronic Total Occlusion (CTO) would be highly beneficial. Assistance in refining the technology and conducting advanced research would be invaluable.

Christoff Heunis

https://www.fluxrobotics.nl/

Probleemstelling

Critical limb ischemia (CLI) results from severe blockages in the arteries of the lower extremities, which significantly reduces blood flow. The prevalence of CLI in diagnosed PAD cases is over 11%, with approximately 67% of CLI patients having both femoropopliteal and infrapopliteal disease. However, many CLI issues remain undertreated due to the challenges of crossing chronic total occlusions (CTOs). CTOs are present in around 40% of PAD patients, and up to 90% of lower limb major amputations (LLAs) result from PAD. There is a significant unmet medical need for effectively crossing lesions and ensuring successful CTO treatment in both above-the-knee (ATK) and below-the-knee (BTK) regions.

Oplossing

Flux Robotics is developing a system for treating critical limb ischemia. The product is an integrated software-hardware solution consisting of a magnetic guidewire technology. It is designed to assist surgeons with passing Chronic Total Occlusion (CTO) lesions in peripheral arteries (specifically, in the superficial femoral artery and popliteal artery). Early studies on artificial blockages show the ability of magnetic guidewires to pass through CTOs, which is a promising alternative to current recanalization techniques. The aim is to offer a safer alternative for managing difficult obstructions in peripheral leg arteries to avoid patient amputations.

VWS-missies

Specifically, our technology contributes to improving patient outcomes in vascular health, a critical area within the broader health and care sector. By offering a safer and more effective method for managing difficult obstructions in peripheral leg arteries, this innovation aims to reduce the need for amputations, thus significantly enhancing patient care and treatment outcomes. This aligns with the VWS missions' goal of transforming healthcare through innovative solutions that address urgent medical needs and improve the quality of life for patients.

Doelgroep

Patients with Peripheral Artery Disease (PAD): Particularly those facing severe conditions like chronic limb ischemia and at risk of amputation. The prevalence of PAD is significant; globally, it affects over 200 million people. The aging population and increasing rates of diabetes and obesity contribute to the growing incidence of PAD, potentially expanding the target audience.

Vascular Surgeons and Interventional Radiologists: These medical professionals directly deal with the treatment of PAD and would be primary users of this technology.

Hospitals and Healthcare Facilities: Especially those with specialized vascular departments or those focusing on minimally invasive surgical techniques (1500 in the US).

Healthcare Payers and Insurers: Interested in cost-effective and efficient treatments that reduce long-term healthcare costs and improve patient outcomes.

Verlaging zorgkosten

The magnetic guidewire system contributes to reducing healthcare costs in several ways, notably highlighted by the 47% increase in efficiency observed during user feasibility pre-clinical trials:

Increased Efficiency: The 47% increase in efficiency implies shorter procedure times. This can reduce the costs associated with surgical and hospital resources.

Improved Success Rates: Higher efficiency potentially translates into improved success rates in treating chronic limb ischemia, leading to fewer repeat procedures and associated costs.

Reduced Complication Rates: More precise and efficient procedures may lower the risk of complications, subsequently decreasing the need for additional treatments and long-term care.

Decreased Need for Amputations: By effectively managing limb ischemia, the technology can reduce the incidence of amputations, which are costly in terms of follow-up care, rehabilitation, and prosthetics.

Verdienmodel

We have a high-tech razor-and-blades business model. This model endables the company to make money on the Flux system (analogous to the razor), while the recurring revenue will be made from selling instruments and accessories for the system. Those instruments and accessories wear out as they're used in surgeries and need to be replaced. We also aim to provide services to surgeons for clinical collaboration, remote consultation, and training.

Geïnvesteerd vermogen

€ 100 duizend-1miljoen

Concurrentie

Competitors include tendon-driven systems, robotic arms, and tele-operative robotic systems. The commercial benefit of our system is that mobile coils are designed to offer increased versatility and speed in independent generation and control of forces. Our product has a smaller footprint, it is mobile and does not result in excessive exposure to radiation. Finally, we can control smaller, more flexible devices with fewer incisions. This results in lower risk and pain, and faster surgeries.

Unieke kenmerken

Currently, tendon-driven instruments (referred to as “steerable guidewires”) are maneuvered by physically manipulating external handles connected to flexible cables, mimicking how tendons in the body work. Its magnetic capability sets the Flux One system apart - a significant departure from traditional guidewire techniques. While current methods rely heavily on the surgeon's skill and 2D X-ray projections, our system offers a more intuitive and controlled experience. The technological breakthrough lies in the magnetic properties of the guidewire, allowing for more precise and safer lesion traversal. Compared to existing solutions or those in development, Flux One stands out due to its integration capabilities with imaging systems (notably, the Artis Pheno from Siemens Healthineers) and the potential to reduce procedure times and complications.

Intellectueel eigendom

Patent pending
IP license

Organisatie

A blend of a technology and healthcare company, focusing on medical device innovation. Initially, a small to medium enterprise, expanding as the product moves from development to market (start as a small to medium-sized enterprise, ranging from 50 to 200 employees). Growth in staff, particularly in R&D, regulatory affairs, and sales, is planned. Potentially forming partnerships with healthcare providers, research institutions, and larger medical device companies.

Beschrijving pilotfase

The "Flux One Magnetic Navigation System" was tested in practice through a human-in-the-loop phantom case study. This approach involved real human operators using the system in a controlled environment that simulates actual surgical conditions. Here's how the testing was conducted:

Phantom Case Study Setup: The test was designed to simulate real-life conditions of fenestrated endovascular aortic repair (f-EVAR) procedures. A phantom model, which is a physical anatomical replica often used in medical training and equipment testing, was employed. This model replicated key aspects of human vascular anatomy relevant to the procedure.

Operator Involvement: Eleven operators were involved in the study. These operators, presumably with relevant medical or surgical expertise, were tasked with navigating a guidewire through the phantom anatomy using the Flux One system. This setup aimed to assess both the system's performance and its usability by actual practitioners.

Performance Metrics: The primary metric for assessing the system was the time taken to navigate the guidewire to predetermined targets within the phantom anatomy. This metric is crucial as it directly relates to the efficiency and potential clinical effectiveness of the system in reducing procedure times.

Usability and User Experience Evaluation: In addition to the performance metrics, the study also employed the System Usability Scale (SUS) and a User Experience Questionnaire (UEQ) to evaluate the system's usability and the overall user experience. These tools are standard in assessing how intuitive and user-friendly a new technology is, which is critical for its adoption in clinical settings.

Betrokken partners

Vascular surgeons from Medisch Spectrum Twente and UMCG.

Surgeons and other medical practitioners were key in assessing the usability and ergonomic design of the device. Their feedback on the system’s handling, ease of use, and integration into the surgical workflow was crucial for its refinement.

Aantal gebruikers pilot

0-10

Onderzoeksresultaten

Outcome Analysis: The results showed a significant reduction (47%) in guidewire navigation times compared to traditional methods, demonstrating the system's potential efficiency. Furthermore, the system successfully reached all predetermined luminal targets within the phantom, indicating its effectiveness in navigating complex vascular pathways.

Rapportage pilot

Pilot Results.pdf

Implementatiestrategie

The end users of the system, primarily surgeons and interventional radiologists, would receive the product through their affiliated medical institutions, which would purchase or lease the system from our manufacturers or distributors. Training and support would be provided to ensure that medical professionals are adept at using the system effectively in their surgical procedures.

Reeds in gebruik

n/a

Behaalde prestaties of gewonnen awards

Recipient of the MIT Feasibility grant (€20000) in 2022 for developing the magnetic coil
Winner of the Pioneers in Healthcare Award (€60000) in 2022 for a pilot study with Medisch Spectrum Twente (local hospital in Enschede, NL)
Recipient of the ZGT Wetenschapfonds (€50000) in 2022 for a pilot study with Ziekenhuisgroep Twente (local hospital in Hengelo, NL)
Winner of the NWO Take-off Feasibility Study subsidy (€40000) in 2021 for the product feasibility tests
UT in the Media Award (2021) for promoting the technology on social media
Winner of the “Best Start-up” and “Creative Mules Design Package” awards of the 2021 UT Challenge (2021, Enschede, Netherlands)
Finalist at the Digital Summit Euregio 2021 Congress (2021, Münsterland, Germany) and SLUSH 100 competition (2021 and 2023, Helsinki, Finland)

Productontwikkeling

Confidential

Internationale ambitie

We will be aiming for widespread adoption of our technology across various international healthcare systems. By establishing footholds in diverse European regions, each with their own unique medical landscapes and regulatory environments, we are positioning ourselves to navigate the complexities of the global medical device market. We already have grown our network to collaborations with medical institutions, research centers, and industry stakeholders in key European regions, including the Nordics, Italy, France, and Germany.

Omzet

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