Periodic Reporting for period 1 - NeuroProtect (NeuroProtect – A novel therapy to prevent Chemotherapy-Induced Peripheral Neuropathy)
Berichtszeitraum: 2023-11-01 bis 2025-04-30
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and disabling side effect of cancer treatment. It causes pain, numbness, and functional loss that may persist long after therapy, lowering quality of life and sometimes forcing dose reductions that compromise cancer care. Existing preventive or therapeutic options are scarce and largely ineffective, creating a clear unmet need. NeuroProtect tackles this challenge with Localised Microvascular Compression Therapy (LMCT)—a novel, non-pharmacological method that briefly reduces blood perfusion in the extremities during chemotherapy infusion. By limiting delivery of neurotoxic agents to peripheral nerves, LMCT aims to prevent CIPN without reducing the anti-cancer effect of treatment.
Overall objectives: Develop and optimise wearable LMCT prototypes for clinical use; demonstrate in laboratory models and healthy volunteers that LMCT safely and reproducibly lowers local perfusion in a defined therapeutic range; establish risk and design controls compliant with ISO13485 and ISO14971 standards to enable clinical translation and regulatory approval; and draft a first-in-human clinical protocol while building the intellectual-property and market framework needed for commercialisation.
Expected impact: By proving LMCT is feasible, safe, and well-tolerated, NeuroProtect paves the way for clinical studies and market entry. Anticipated benefits include: medical and societal gains—preventing CIPN could markedly improve quality of life, allow full dosing of life-saving chemotherapy, and cut long-term disability and care costs; innovation and economic value—the patented LMCT device creates a new class of supportive oncology care and opens opportunities for licensing, industrial partnerships, and further research into related applications such as mucositis prevention; health-system efficiency—lower CIPN incidence would reduce the need for pain management and rehabilitation, easing pressure on healthcare services.
Role of social sciences and humanities: Although primarily a biomedical engineering and clinical innovation project, NeuroProtect integrates human-centred design and patient-reported outcome measures—approaches informed by social sciences and humanities. Early involvement of patients and oncology clinic staff shaped usability, comfort, and workflow integration, ensuring that the technology meets real-world needs and enhances patient acceptance.
Overall objectives: Develop and optimise wearable LMCT prototypes for clinical use; demonstrate in laboratory models and healthy volunteers that LMCT safely and reproducibly lowers local perfusion in a defined therapeutic range; establish risk and design controls compliant with ISO13485 and ISO14971 standards to enable clinical translation and regulatory approval; and draft a first-in-human clinical protocol while building the intellectual-property and market framework needed for commercialisation.
Expected impact: By proving LMCT is feasible, safe, and well-tolerated, NeuroProtect paves the way for clinical studies and market entry. Anticipated benefits include: medical and societal gains—preventing CIPN could markedly improve quality of life, allow full dosing of life-saving chemotherapy, and cut long-term disability and care costs; innovation and economic value—the patented LMCT device creates a new class of supportive oncology care and opens opportunities for licensing, industrial partnerships, and further research into related applications such as mucositis prevention; health-system efficiency—lower CIPN incidence would reduce the need for pain management and rehabilitation, easing pressure on healthcare services.
Role of social sciences and humanities: Although primarily a biomedical engineering and clinical innovation project, NeuroProtect integrates human-centred design and patient-reported outcome measures—approaches informed by social sciences and humanities. Early involvement of patients and oncology clinic staff shaped usability, comfort, and workflow integration, ensuring that the technology meets real-world needs and enhances patient acceptance.
Technical and scientific activities and main achievements
NeuroProtect set out to prove the concept of Localised Microvascular Compression Therapy (LMCT) as a preventive strategy for chemotherapy-induced peripheral neuropathy (CIPN), progressing through prototype engineering, physiological validation, and clinical translation.
Prototype development and bench testing
Preliminary LMCT prototypes with pneumatic bladders and electronic controls were built and refined. Bench testing on sensor-enabled hand models confirmed accurate, reproducible compression and guided optimisation of pressure distribution, ramping protocols, and sterile, patient-safe materials.
Healthy volunteer validation
Two volunteer studies established and confirmed a therapeutic pressure window of 40–60 mmHg that safely reduced local blood perfusion without hypoxia, while remaining comfortable over chemotherapy-length sessions.
Risk analysis and clinical readiness
Comprehensive risk and design analyses were completed to ISO14971 and ISO13485 standards, producing a Design History File for regulatory submissions and supporting a first-in-human clinical protocol with one hand treated and the other as control.
Outcomes
The project delivered an optimised, clinically ready LMCT prototype, demonstrated scientific feasibility and safety in bench and human studies, and generated essential regulatory documentation—providing a strong foundation for first-in-human trials and further clinical translation.
NeuroProtect set out to prove the concept of Localised Microvascular Compression Therapy (LMCT) as a preventive strategy for chemotherapy-induced peripheral neuropathy (CIPN), progressing through prototype engineering, physiological validation, and clinical translation.
Prototype development and bench testing
Preliminary LMCT prototypes with pneumatic bladders and electronic controls were built and refined. Bench testing on sensor-enabled hand models confirmed accurate, reproducible compression and guided optimisation of pressure distribution, ramping protocols, and sterile, patient-safe materials.
Healthy volunteer validation
Two volunteer studies established and confirmed a therapeutic pressure window of 40–60 mmHg that safely reduced local blood perfusion without hypoxia, while remaining comfortable over chemotherapy-length sessions.
Risk analysis and clinical readiness
Comprehensive risk and design analyses were completed to ISO14971 and ISO13485 standards, producing a Design History File for regulatory submissions and supporting a first-in-human clinical protocol with one hand treated and the other as control.
Outcomes
The project delivered an optimised, clinically ready LMCT prototype, demonstrated scientific feasibility and safety in bench and human studies, and generated essential regulatory documentation—providing a strong foundation for first-in-human trials and further clinical translation.
Results
NeuroProtect successfully demonstrated that Localised Microvascular Compression Therapy (LMCT) is a feasible, safe, and well-tolerated method to reduce local blood perfusion and thereby prevent chemotherapy-induced peripheral neuropathy (CIPN). Key technical and scientific results include:
• A fully optimised and validated wearable LMCT prototype suitable for first-in-human trials.
• Proof of mechanism, showing reproducible perfusion reduction in the therapeutic window (40–60 mmHg) without tissue damage, confirmed in healthy volunteers.
• Regulatory readiness, with complete risk analysis and design documentation aligned to ISO14971 and ISO13485 standards.
• A draft clinical protocol developed with oncology specialists for forthcoming patient studies.
Potential impacts
• Medical and societal impact: Preventing CIPN could dramatically improve the quality of life for cancer patients, reduce chronic pain and disability, and enable optimal chemotherapy dosing.
• Economic and healthcare impact: Lower long-term treatment costs and less need for pain management and rehabilitation, reducing pressure on health services.
• Innovation and market potential: A first-in-class, non-pharmacological device opens new opportunities in supportive oncology care and related indications (e.g. mucositis prevention), with strong intellectual-property protection in place.
Key needs for further uptake and success
To translate these results into widespread clinical use, the following steps are envisaged:
• Further research and demonstration: Conduct first-in-human clinical trials to confirm efficacy and refine treatment protocols.
• Regulatory and standardisation framework: Engage early with regulators to define device classification, clinical trial design, and CE/ISO certification requirements.
• Access to markets and finance: Secure follow-on public or private funding to support clinical trials and scale manufacturing.
• Commercialisation and IPR support: Finalise patent filings and pursue licensing or strategic partnerships with medtech companies active in oncology supportive care.
• Internationalisation: Prepare for multi-centre and multinational trials to enable global market access.
Overview of results at project end
The project delivered proof-of-concept validation of LMCT, a clinically promising device-based therapy for preventing CIPN. It achieved full technical feasibility, regulatory-ready documentation, and a clear clinical development pathway. NeuroProtect has thus built a robust foundation for the next phase of translation and commercial uptake.
NeuroProtect successfully demonstrated that Localised Microvascular Compression Therapy (LMCT) is a feasible, safe, and well-tolerated method to reduce local blood perfusion and thereby prevent chemotherapy-induced peripheral neuropathy (CIPN). Key technical and scientific results include:
• A fully optimised and validated wearable LMCT prototype suitable for first-in-human trials.
• Proof of mechanism, showing reproducible perfusion reduction in the therapeutic window (40–60 mmHg) without tissue damage, confirmed in healthy volunteers.
• Regulatory readiness, with complete risk analysis and design documentation aligned to ISO14971 and ISO13485 standards.
• A draft clinical protocol developed with oncology specialists for forthcoming patient studies.
Potential impacts
• Medical and societal impact: Preventing CIPN could dramatically improve the quality of life for cancer patients, reduce chronic pain and disability, and enable optimal chemotherapy dosing.
• Economic and healthcare impact: Lower long-term treatment costs and less need for pain management and rehabilitation, reducing pressure on health services.
• Innovation and market potential: A first-in-class, non-pharmacological device opens new opportunities in supportive oncology care and related indications (e.g. mucositis prevention), with strong intellectual-property protection in place.
Key needs for further uptake and success
To translate these results into widespread clinical use, the following steps are envisaged:
• Further research and demonstration: Conduct first-in-human clinical trials to confirm efficacy and refine treatment protocols.
• Regulatory and standardisation framework: Engage early with regulators to define device classification, clinical trial design, and CE/ISO certification requirements.
• Access to markets and finance: Secure follow-on public or private funding to support clinical trials and scale manufacturing.
• Commercialisation and IPR support: Finalise patent filings and pursue licensing or strategic partnerships with medtech companies active in oncology supportive care.
• Internationalisation: Prepare for multi-centre and multinational trials to enable global market access.
Overview of results at project end
The project delivered proof-of-concept validation of LMCT, a clinically promising device-based therapy for preventing CIPN. It achieved full technical feasibility, regulatory-ready documentation, and a clear clinical development pathway. NeuroProtect has thus built a robust foundation for the next phase of translation and commercial uptake.