Periodic Reporting for period 2 - HyperCollar4D (Radical Improvement of Cancer Treatment without Additional Negative Side Effects)
Periodo di rendicontazione: 2023-04-01 al 2025-06-30
Netherlands-based Sensius changes the way cancer is treated. By adding thermotherapy to radio- or chemotherapy, the company creates a new balance between surviving and quality of life, improving both compared to classic treatments. Heating of a tumour improves the outcome of radio- or chemotherapy, but it does not add toxicity. Sensius' HyperCollar4D is the first device based on hyperthermia for head and neck cancer. The goal of the project is to complete the development and ensure the certification of the HyperCollar4D (renamed to Focus System) is in place. The project consists of product prototyping & manufacturing, pre-commercial market activities and regulatory compliance to be able to take Focus System to the market.
From January 2022 – December 2024 Sensius has progressed well. The focus during this period was to startup the work program, derisk the critical product development areas and setup the quality management system (according to ISO 13485). The progress and main achievements in these areas:
- Awarded the product development contracts to key suppliers Technobis High Tech Solutions and Motive Engineering, and engaged project management and QA/RA consultancy service providers to ensure the right team to support Sensius in delivering the project.
- Antenna position simulations have been completed
- First testing done of the water bolus using small & large dummy models
- Setup of robotized test system for engineering of the amplifier
- Test setup for the water and electrical connection between base unit and applicator has been build as functional model.
- Two feasible solutions of the patient positioning have been developed
- Completed derisking of main product development issues.
- Obtained ISO 13485 certification following a detailed build up of the quality management system and training.
- Strong market traction from clinics
Sensius is encouraged by its achievements and remains confident in bringing the project to a successful end.
- Awarded the product development contracts to key suppliers Technobis High Tech Solutions and Motive Engineering, and engaged project management and QA/RA consultancy service providers to ensure the right team to support Sensius in delivering the project.
- Antenna position simulations have been completed
- First testing done of the water bolus using small & large dummy models
- Setup of robotized test system for engineering of the amplifier
- Test setup for the water and electrical connection between base unit and applicator has been build as functional model.
- Two feasible solutions of the patient positioning have been developed
- Completed derisking of main product development issues.
- Obtained ISO 13485 certification following a detailed build up of the quality management system and training.
- Strong market traction from clinics
Sensius is encouraged by its achievements and remains confident in bringing the project to a successful end.
Sensius is well on track with regards to the pre-commercial activities. It is successfully developing its sales pipeline. Relationship with leading research clinics intensified and new interested clinics showed interest to learn more about our solution. The first Letter Of Intent with Erasmus MC was signed. Next to developing the sales pipeline Sensius kicked off the landscaping of reimbursement in two of the target countries (The Netherlands and Germany) to develop a roadmap to ensure sufficient reimbursement in these markets.
Sensius is also setting up partnerships with local agents to act as its representatives and continuous to maintain relationships with strategic global partners to be able to accelerate sales when the time comes.
New technology development has also progressed. Multiple grants have been awarded to support Sensius with its future products. Sensius is the lead sponsor of the CARES project. It provides financial support and technology to enable neo-adjuvant chemotherapy dose escalation in the tumor to prevent mastectomy. This project strengthens Sensius’ position as a provider of a modular solution for thermotherapy for multiple body sites and facilitates any clinic’s decision on a positive business case, since more patients will be indicated for a thermotherapy treatment. In the RADIATHE project, Sensius, Technical University Eindhoven and Erasmus MC collaborate to develop improved instrumentations and workflows on quality assurance. These results will increase comfort and confidence at clinics on the administration of thermotherapy and thus lower any adoption threshold. And lastly, the SENS-TERM project aims to develop hardware and software for personalized, quality-controlled thermotherapy planning and treatment administration in H&N cancers, based on electromagnetic fields. The other project partners in SENS-THERM are Technical University Eindhoven, Erasmus University Medical Center Rotterdam and ZMT Zurich MedTech.
Sensius is also setting up partnerships with local agents to act as its representatives and continuous to maintain relationships with strategic global partners to be able to accelerate sales when the time comes.
New technology development has also progressed. Multiple grants have been awarded to support Sensius with its future products. Sensius is the lead sponsor of the CARES project. It provides financial support and technology to enable neo-adjuvant chemotherapy dose escalation in the tumor to prevent mastectomy. This project strengthens Sensius’ position as a provider of a modular solution for thermotherapy for multiple body sites and facilitates any clinic’s decision on a positive business case, since more patients will be indicated for a thermotherapy treatment. In the RADIATHE project, Sensius, Technical University Eindhoven and Erasmus MC collaborate to develop improved instrumentations and workflows on quality assurance. These results will increase comfort and confidence at clinics on the administration of thermotherapy and thus lower any adoption threshold. And lastly, the SENS-TERM project aims to develop hardware and software for personalized, quality-controlled thermotherapy planning and treatment administration in H&N cancers, based on electromagnetic fields. The other project partners in SENS-THERM are Technical University Eindhoven, Erasmus University Medical Center Rotterdam and ZMT Zurich MedTech.