Frequently Asked Questions
Find answers to common questions about Hapchot, AI4Deep, and irreversible electroporation (IRE) technology. For additional information, see our Regulatory Compliance page.
Technology & How It Works
What is irreversible electroporation (IRE)?
Irreversible electroporation (IRE) is a minimally invasive tumor ablation technique that uses short, high-voltage electrical pulses to create permanent nanopores in cell membranes, leading to cell death. Unlike thermal ablation methods, IRE preserves surrounding tissue structures like blood vessels and nerves, making it ideal for tumors near critical anatomy.
How does AI4Deep help with tumor ablation procedures?
AI4Deep is an AI-powered 3D simulation software that assists interventional radiologists with complex tumor ablation procedures. It provides pre-operative planning to optimize electrode placement, intra-operative assistance, and a surgical training platform to improve tumor coverage and reduce the risk of recurrence.
What makes AI4Deep different from other ablation planning software?
AI4Deep combines artificial intelligence with digital twin technology to create personalized 3D simulations based on patient-specific medical imaging. It is the only software that is able to provide a visualisation of the dose delivered during an electroporation procedure.
What imaging modalities and technical requirements does AI4Deep need?
AI4Deep works with standard medical imaging modalities including CT and MRI scans. Specific technical requirements for hardware, software compatibility, and imaging protocols will be provided to partner institutions during the collaboration setup phase.
Regulatory & Approval
Is AI4Deep FDA approved or CE marked?
No, AI4Deep is currently a research prototype in development and is not yet FDA approved or CE marked for clinical use. The software is being developed in collaboration with INRIA, CNRS, and Hôpital Avicenne (APHP) for research and validation purposes only. Clinical approval and regulatory clearance are planned for future phases.
What is the current regulatory status of AI4Deep?
AI4Deep is in the research and development phase. It is not approved for clinical use and should not be used for patient care decisions. The development follows medical device regulations with plans for future FDA and CE mark applications as the technology matures and validation studies are completed.
Clinical Application
Who can use AI4Deep?
Currently, AI4Deep is available only for research collaborations with interventional radiologists, oncologists, and medical researchers at partnering institutions. Once clinically approved, it will be designed for use by trained interventional radiologists and medical professionals performing tumor ablation procedures.
What are the indications for using AI4Deep?
AI4Deep is still the subject of research and development and has not been approved for clinical use. However, it is expected to be used in the treatment of deep-seated liver tumors, non operable with Standard of Care (SoC) procedures.
Research & Evidence
What research supports AI4Deep?
AI4Deep is developed through a research collaboration with INRIA (French Institute for Research in Digital Science and Technology), CNRS (National Centre for Scientific Research), and Hôpital Avicenne (APHP). The technology is based on peer-reviewed research in medical imaging, computational modeling, and machine learning for interventional radiology.
Which hospitals and institutions are involved with AI4Deep?
AI4Deep is developed in partnership with leading French research and medical institutions including INRIA, CNRS, Hôpital Avicenne (APHP), and CHU Poitiers. These collaborations provide clinical expertise, validation data, and research support for developing the AI-powered ablation planning technology.
Are there published studies on AI4Deep effectiveness?
Research on AI4Deep is ongoing, and validation studies are being conducted at partner hospitals. A key study supporting our technology is: Sutter O., et al., "Towards Perioperative, Numerically-Assisted Irreversible Electroporation for Hepatocellular Carcinoma: Clinical Outcomes Informed by Numerical Simulations" (2025), DOI: 10.1007/s00330-025-12223-7. Publications and clinical trial results are progressively made available as studies are peer-reviewed.
Access & Partnership
How can hospitals or research institutions partner with Hapchot?
Hospitals and research institutions interested in collaborating on AI4Deep development or participating in validation studies can contact Hapchot through the website contact form. We welcome partnerships with interventional radiology, oncology and urology departments, oncology centers, and medical research institutions interested in advancing tumor ablation technology.
Is AI4Deep available for research collaborations?
Yes, AI4Deep is available for research collaborations with qualified medical institutions and research organizations. Collaborative opportunities include validation studies, clinical trials, and technology development partnerships. Contact Hapchot to discuss potential research collaboration opportunities.
What is the timeline for availability and commercial launch?
AI4Deep is currently in the R&D phase with validation studies ongoing. The Surgical Training platform (AI4Deep Lab) is planned for availability in 2026. The timeline for regulatory approval (FDA/CE mark) and commercial launch of the clinical modules depends on successful completion of clinical trials and regulatory review processes.
Medical Disclaimer
AI4Deep is a research prototype and is not FDA-approved or CE-marked for clinical use. The information provided on this website is for educational and research purposes only and should not be used to make medical decisions. Always consult with qualified healthcare professionals for medical advice.
Have More Questions?
If you have additional questions or are interested in research collaborations, please get in touch.
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