Periodic Reporting for period 1 - MPT system (Innovative, cost-effective, ultra-compact MRI-guided therapy system for diagnosis and immediate treatment of Parkinson's Disease)
Período documentado: 2019-06-01 hasta 2019-09-30
There is ample evidence that pinpoints neurological disorders as one of the greatest threats to public health. The World Health Organization reported that up to 1B people, nearly one in seven of the world’s population, suffer from neurological disorders; around 220M Europeans and 100M Americans suffer from some form of brain disorder, burdening the healthcare systems for around €500B annually. Parkinson’s disease is the second most common age-related neurodegenerative disorder after Alzheimer’s disease. It is a disabling chronic progressive neurodegenerative disorder clinically characterized by akinesia, tremor, rigidity, and postural instability. An estimated 10M people worldwide suffer from PD disease: about 1.2M people are located in Europe while 1M are in US; this is more than those affected by multiple sclerosis, muscular dystrophy, and amyotrophic lateral sclerosis combined.
There is currently no truly long term effective treatment for PD. The first line of treatment, at the early stage of PD, is represented by therapeutic drugs and medications. However, it has been demonstrated that drugs work in a period no longer of 3-5 years and usually create addictive and painful side-effects, such as vomiting, heartburn, blurred vision, insomnia and fainting. Deep brain stimulation (DBS) is the most common treatment for patients with moderate to severe medically intractable idiopathic PD, for which drug therapy would be inefficient
Neuroparticle has developed the Magnetic Particle Therapy (MPT) system, the first, patented, ultra-compact & low-cost therapy-ready MRI system effectively capable of performing brain imaging and non-invasive delivery of therapeutic particles for DBS. The introduction of such disruptive real-time image-guided magnetic particle therapeutic system will replace the surgical treatments required by the conventional DBS treatment in PD.
The objectives of the feasibility study were to evaluate technical and regulatory requirements for introduction of the MPT system into the European market, complete the design of the MPT system components, produce a first complete MPT system and validate its safety in a first in human clinical study. The overall objective is to improve patients’ quality of life and reducing the costs associated with PD disease in the long run
There is currently no truly long term effective treatment for PD. The first line of treatment, at the early stage of PD, is represented by therapeutic drugs and medications. However, it has been demonstrated that drugs work in a period no longer of 3-5 years and usually create addictive and painful side-effects, such as vomiting, heartburn, blurred vision, insomnia and fainting. Deep brain stimulation (DBS) is the most common treatment for patients with moderate to severe medically intractable idiopathic PD, for which drug therapy would be inefficient
Neuroparticle has developed the Magnetic Particle Therapy (MPT) system, the first, patented, ultra-compact & low-cost therapy-ready MRI system effectively capable of performing brain imaging and non-invasive delivery of therapeutic particles for DBS. The introduction of such disruptive real-time image-guided magnetic particle therapeutic system will replace the surgical treatments required by the conventional DBS treatment in PD.
The objectives of the feasibility study were to evaluate technical and regulatory requirements for introduction of the MPT system into the European market, complete the design of the MPT system components, produce a first complete MPT system and validate its safety in a first in human clinical study. The overall objective is to improve patients’ quality of life and reducing the costs associated with PD disease in the long run
Neuroparticle completed a full analysis of the technical and business potential of the MPT system. The company scouted for possible customer hospitals and secured the interest of one research centre, enabling volume requirements to be established for full operations.
Neuroparticle designed and secured a value chain which will be capable of supporting the company to efficiently deliver the required volume of MPT systems and identified the optimum sales channels.
Neuroparticle also identified the optimisation work required in the manufacturing process to effect scale-up within the scope of a Phase 2 innovation project. From a regulatory perspective, Neuroparticle designed a first in human study to prove the safety of the MPT system during the EIC Accelerator innovation project and identified the regulatory activities to progress towards the CE Mark in Europe. Furthermore, Neuroparticle calculated detailed four year financial projections for commercialisation and analysed the financial and infrastructure requirements for achieving global sales.
Neuroparticle designed and secured a value chain which will be capable of supporting the company to efficiently deliver the required volume of MPT systems and identified the optimum sales channels.
Neuroparticle also identified the optimisation work required in the manufacturing process to effect scale-up within the scope of a Phase 2 innovation project. From a regulatory perspective, Neuroparticle designed a first in human study to prove the safety of the MPT system during the EIC Accelerator innovation project and identified the regulatory activities to progress towards the CE Mark in Europe. Furthermore, Neuroparticle calculated detailed four year financial projections for commercialisation and analysed the financial and infrastructure requirements for achieving global sales.
The expected outcome is to finalise the MPT system optimisation activities, produce the first complete and fully operating system, and to complete clinical validation activities such that EU market readiness will be achieved by the end of the Phase 2 project. The adoption of MPT System will revolutionize the treatment of PD, and generate tangible savings for the healthcare system both in the short and longer term