Welcome to EONflow
In a world where healthcare diagnostics often struggle with bulky infrastructure and manual processes, EONflow steps in to bridge the gap. Our mission is to bring simplicity, speed, and accuracy to Point-of-Care (POC) testing through our groundbreaking microfluidic platform.
Why Choose EONflow?
In today’s fast-paced world of healthcare, getting quick, reliable test results shouldn’t be complicated or require bulky machines. EONflow is here to change the game, providing a simple, handheld solution that anyone can use, anywhere. Imagine having the power of a full laboratory right in your hand — that’s what EONflow delivers.
Here’s Why EONflow Stands Out:
Truly Portable & User-Friendly
EONflow fits right in your hand and doesn’t need any heavy equipment or complicated setups. Just pop in a cartridge, lock it in, and you’re ready to go — perfect for busy clinics or remote locations.
Instant Plug-and-Play
No need to fumble with tubes or cables. EONflow’s plug-and-play design makes testing as easy as pressing a button, so you can focus on what matters: getting accurate results fast.
Precise Liquid Handling, Every Time
Our cutting-edge technology controls liquids with incredible precision, without the need for traditional valves. This means fewer moving parts, less chance of error, and consistent, high-quality results every time.
High Sensitivity You Can Trust
EONflow can detect even tiny amounts of markers, like the SARS-CoV-2 spike antibody, on par with lab-based tests. This means you get lab-level accuracy without the wait or hassle.
Affordable Testing for All
We know budgets can be tight, so we’ve made our cartridges easy and cost-effective to produce. This keeps the price per test low, making advanced diagnostics accessible to more people.
Built to Grow with You
EONflow’s modular design means it’s ready for the future. Whether you need to add new sensors or integrate with wireless devices, EONflow can adapt to meet your evolving needs.
The Technology Powering EONflow
Our proprietary technology utilizes advanced electro-pneumatic pressure control, enabling precise, automated liquid handling without the complexities of traditional valve systems. This innovation not only enhances the accuracy of tests but also reduces operational costs and setup times, making EONflow a truly disruptive solution in the POC diagnostics market.
Applications Across Healthcare
EONflow is versatile and ideal for various diagnostics applications, including:
- Molecular Diagnostics: Detecting pathogens with high sensitivity and specificity.
- Cell Analysis: Automating complex assays for research and clinical settings.
- Personalized Healthcare: Enabling rapid, tailored diagnostics for personalized treatment plans.
A Growing Market Opportunity
With the increasing demand for portable, automated POC diagnostic solutions, EONflow is positioned to meet the needs of a multi-billion dollar market. Our technology caters to clinics, laboratories, and remote healthcare settings, making diagnostics faster, more affordable, and accessible.
Our Path to Regulatory Approval
At this early stage of development, EONflow is positioned as a promising new prototype in the field of Point-of-Care (POC) diagnostics. Our regulatory strategy is focused on rigorous testing, quality assurance, and aligning with international standards to ensure a smooth transition from prototype to market-ready product by 2025.
🌐 1. Establishing a Quality Foundation (Q4 2023 – Q2 2024)
We are currently laying the groundwork with a strong Quality Management System (QMS) based on ISO 13485:2016 standards. This will guide the development process, ensuring consistency and compliance with medical device regulations from the outset. Our initial focus is on:
- 🔍 Design Controls: Implementing a structured design and development plan to document every stage of the prototype.
- ⚠️ Risk Management: Conducting a comprehensive risk assessment based on ISO 14971:2019, identifying potential hazards early in the design phase.
🧪2. Pre-Clinical Testing and Prototype Optimization (Q1 2024 – Q3 2024)
As we refine the prototype, our priority is to validate its core functions through extensive pre-clinical testing:
- 📈 Performance Evaluation: Testing the precision of the electro-pneumatic pressure control system and confirming fluid handling capabilities for complex immunoassays.
- 🧬 Sensitivity and Detection Limits: Conducting initial tests to demonstrate the device’s detection limit, targeting comparable sensitivity to lab-based ELISA assays.
- 👥 User Feedback: Gathering feedback from early users, including lab technicians and healthcare providers, to refine the user interface and cartridge design.
🗣️ 3. Early Regulatory Engagement and Planning (Q2 2024 – Q4 2024)
To streamline the approval process, we plan to engage early with key regulatory bodies:
- 🤝 Pre-Submission Meetings: Scheduling meetings with the FDA and relevant European Notified Bodies to discuss the regulatory pathway, testing requirements, and necessary documentation.
- 🔬 Feasibility Studies: Initiating small-scale feasibility studies in controlled lab environments to generate initial performance data and user feedback.
🏥 4. Initial Clinical Validation (Q1 2025 – Q2 2025)
The next step is to conduct formal clinical validation trials to demonstrate the safety and effectiveness of EONflow in real-world scenarios:
- 🧑⚕️ Pilot Clinical Trials: Conducting small pilot trials with selected healthcare partners to validate the device’s performance in detecting specific biomarkers (e.g., SARS-CoV-2 spike antibodies).
- 📊 Data Collection and Analysis: Collecting comprehensive data on sensitivity, specificity, and repeatability to build a strong case for regulatory submission.
📝 5. Regulatory Submissions and Approvals (Q3 2025 – Q4 2025)
With robust validation data in hand, we will proceed with the formal regulatory submission process:
- 🇪🇺 CE Mark Application (EU Market): Compiling the technical file and submitting for CE Mark certification under the In Vitro Diagnostic Regulation (IVDR). This includes a complete Clinical Evaluation Report (CER) and risk analysis documentation.
- 🇺🇸 FDA 510(k) Submission (US Market): Preparing a detailed 510(k) submission to demonstrate substantial equivalence to existing devices, focusing on the unique features of EONflow that enhance usability and portability.
- 🌏 International Market Approvals: Initiating parallel submissions for other key markets, such as Canada (Health Canada), Australia (TGA), and select Asia-Pacific countries, to expand global reach.
🚀 6. Preparing for Market Launch (Late Q4 2025)
As we approach regulatory approvals, our focus will shift to scaling up production, finalizing distribution partnerships, and initiating pilot programs:
- 🏭 Production Scaling: Optimizing the manufacturing process for the injection-molded cartridges and assembling the first batch of market-ready devices.
- 📦 Pilot Deployment: Launching pilot programs with early adopters in clinical settings to gather post-market feedback and refine any final adjustments before full-scale distribution.
| 🌐 Milestone | 🗓️ Target Date |
|---|---|
| 🌐 QMS Implementation | Q1 2024 – Q3 2024 |
| 🧪 Pre-Clinical Testing and Optimization | Q2 2024 – Q4 2024 |
| 🗣️ Early Regulatory Engagement and Planning | Q3 2024 – Q1 2025 |
| 🏥 Initial Clinical Validation | Q1 2025 – Q2 2025 |
| 📝 Regulatory Submissions and Approvals | Q3 2025 – Q4 2025 |
| 🚀 Preparing for Market Launch | Late Q4 2025 |
Join Us on Our Journey
EONflow is more than just a diagnostic device; it’s a vision for a future where high-quality, rapid testing is available to anyone, anywhere. As we prepare to launch EONflow and begin the regulatory approval process, we invite partners, investors, and healthcare providers to join us on this exciting journey. Together, we can make diagnostics simpler, faster, and more accessible for everyone.
Get in Touch
Want to learn more about EONflow or discuss partnership opportunities? Reach out to us today and discover how we can work together to shape the future of healthcare.
Made in Canada & Open-Source Commitment
EONflow is proudly designed, developed, and manufactured in Canada, reflecting our dedication to quality, innovation, and local expertise. In addition to our commercial product, we are also committed to advancing the field of microfluidics by offering an open-source version of our platform. By sharing the core design files and firmware under an open-source license, we aim to empower researchers, educators, and innovators around the world to customize, adapt, and build upon our technology. This initiative underscores our belief in collaboration and transparency, helping to accelerate the development of new diagnostic solutions for a global impact.
