Periodic Reporting for period 1 - Predistroke (Portable solution for prehospital diagnosis of stroke in the ultra-acute phase)
Periodo di rendicontazione: 2019-03-01 al 2019-08-31
Medfield Diagnostic undertook this project opportunity to change the clinical landscape for the early and differential diagnosis of stroke and brain damage. For both types of diseases, it is important to quickly find a bleeding or clot in the brain in order to give the patient the right treatment. If not, the brain is deteriorating fast and the problem for patient and society in lack of life quality, disabilities and cost for potentially lifelong care and rehabilitation is greater by the minute. This is why the expression “Time is Brain” is coined within Stroke and Trauma care. Minutes can make a great difference between life and death, between saved braincells or damaged forever, between recovery and lifelong disability.
Medfield Diagnostics has developed MD100. It is a portable, more affordable and easy-to-use decision support for the aforementioned clinical dilemma. The device utilizes changes in the electromagnetic properties of the brain to develop algorithms to prognose clot and intra cranial haemorrhage. After having provided proof-of-principle in smaller clinical trials and developed a robust prototype, the company undertook this phase 1 project in order to perform a feasibility study for the product. The outcome of the works is two-fold. Firstly, Medfield has prepared an extensive business plan that will guide a large-scale prospective clinical trial to validate the device and optimize the go-to-market strategy. The plan includes an insightful analysis of the market conditions, R&D resources of the company, as well as the clinical requirements set for solutions of this type. Secondly, Medfield has developed a detailed clinical study design to be performed in the more advanced development stages. The study has been designed to address both types of diseases and provide a versatile scientific input for all the related research and product-related developments. The objective is to support early stroke and intracranial haemorrhage diagnostic leading to more effective personalized treatment accessible to a much wider population of patients across the EU.
Medfield Diagnostics has developed MD100. It is a portable, more affordable and easy-to-use decision support for the aforementioned clinical dilemma. The device utilizes changes in the electromagnetic properties of the brain to develop algorithms to prognose clot and intra cranial haemorrhage. After having provided proof-of-principle in smaller clinical trials and developed a robust prototype, the company undertook this phase 1 project in order to perform a feasibility study for the product. The outcome of the works is two-fold. Firstly, Medfield has prepared an extensive business plan that will guide a large-scale prospective clinical trial to validate the device and optimize the go-to-market strategy. The plan includes an insightful analysis of the market conditions, R&D resources of the company, as well as the clinical requirements set for solutions of this type. Secondly, Medfield has developed a detailed clinical study design to be performed in the more advanced development stages. The study has been designed to address both types of diseases and provide a versatile scientific input for all the related research and product-related developments. The objective is to support early stroke and intracranial haemorrhage diagnostic leading to more effective personalized treatment accessible to a much wider population of patients across the EU.
The feasibility assessment has been developed using the Strategic Business Planning Methodology. This methodology has allowed Medfield to progress from the clinical development strategy to the finalisation of the financial and commercialisation targets aligned with an overall business development strategy of the company. The data collected has provided valuable insights into the current trends and opportunities on the market, activities undertaken by the competitors and the recent clinical development results.
Identification of suitable clinical centers to the multicenter is ongoing. Our goal is to enroll at least 3 centers per country in the countries we have planned to launch in and that not has been involved in our earlier studies (i.e. Denmark, Finland, Germany, France, Spain, Italy and Belgium). We aim for well-known and highly scientifically respected centers in respective indication.
Algorithm data collection
Once the device is CE-certified, a med-tech company usually sets up a large-scale, international study to confirm the solutions´ effectiveness in the target medical indication. Afterwards, the CE-certificate can be extended. Medfield Diagnostics has decided to follow this strategy. Thus, Medfield Diagnostics plans to CE certify the MD100 with a performance to detect intracranial haemorrhage 20 ml or larger in 2019 (TBD). The CE-certificate will facilitate conducting the international study that is planned to verify MD100’s capacity to exclude small intracranial bleedings and to validate usability and evaluate safety in a prehospital and hospital setting. After the study, we will apply for extending the claim for our CE-certificate.
Claims/indication verification
To support the device road map to go from model R5 to R6 the claim “Differentiate stroke from healthy persons, detect bleedings >2 ml” needs to be verified. Two large-scale, multicentre clinical trial to gain sufficient clinical data to justify the claim that the MD100 can detect intracranial bleedings 5 ml or smaller need to be conducted. Medfield aim to sponsor and conduct the studies. As such, the clinical trials will deliver the clinical evidence required for a largescale deployment and
commercialization of the MD100:
- Build a patient measurement database to improve and verify the diagnostic precision
- Validate the usability and safety of the device in the prehospital acute stroke and trauma care chain
- Get acceptance from European KOLs within hyper-acute stroke and trauma care
Reference database
A reference database will be built from data acquired during the two clinical trials. The database will be used as training data for the MD100 machine learning algorithm to detect intracranial bleedings. Thereafter, the MD100 system (hardware + software algorithm) will be verified for use as a decision support in a prehospital and hospital settings.
Identification of suitable clinical centers to the multicenter is ongoing. Our goal is to enroll at least 3 centers per country in the countries we have planned to launch in and that not has been involved in our earlier studies (i.e. Denmark, Finland, Germany, France, Spain, Italy and Belgium). We aim for well-known and highly scientifically respected centers in respective indication.
Algorithm data collection
Once the device is CE-certified, a med-tech company usually sets up a large-scale, international study to confirm the solutions´ effectiveness in the target medical indication. Afterwards, the CE-certificate can be extended. Medfield Diagnostics has decided to follow this strategy. Thus, Medfield Diagnostics plans to CE certify the MD100 with a performance to detect intracranial haemorrhage 20 ml or larger in 2019 (TBD). The CE-certificate will facilitate conducting the international study that is planned to verify MD100’s capacity to exclude small intracranial bleedings and to validate usability and evaluate safety in a prehospital and hospital setting. After the study, we will apply for extending the claim for our CE-certificate.
Claims/indication verification
To support the device road map to go from model R5 to R6 the claim “Differentiate stroke from healthy persons, detect bleedings >2 ml” needs to be verified. Two large-scale, multicentre clinical trial to gain sufficient clinical data to justify the claim that the MD100 can detect intracranial bleedings 5 ml or smaller need to be conducted. Medfield aim to sponsor and conduct the studies. As such, the clinical trials will deliver the clinical evidence required for a largescale deployment and
commercialization of the MD100:
- Build a patient measurement database to improve and verify the diagnostic precision
- Validate the usability and safety of the device in the prehospital acute stroke and trauma care chain
- Get acceptance from European KOLs within hyper-acute stroke and trauma care
Reference database
A reference database will be built from data acquired during the two clinical trials. The database will be used as training data for the MD100 machine learning algorithm to detect intracranial bleedings. Thereafter, the MD100 system (hardware + software algorithm) will be verified for use as a decision support in a prehospital and hospital settings.
The technique of using microwave technology is quite new and the efficacy and position of potential competitors are not known and have not been implemented in clinical practice yet. Therefore, the competitors today are the substitute techniques and instruments already in clinical practice today, i.e. NIHSS (National Institutes of Health Stroke Scale) and Moreover, microwave propagation in human tissues has an advantage over both impedance, ultrasound and near infrared technologies via the easy penetration of the human skull. This is the fundamental basis for the novelty and market potential claims of MD100. A microwave-based system has the advantage of being completely safe and without side effects. As the technology is radiation-free, it can also be used as a monitoring device during thrombolytic treatment and thereby avoid complications in the form of intracranial bleeding, which is a known risk of the treatment. The MD100 is the only alternative applicable in both hospital and pre-hospital settings for triaging as well as monitoring, see table below. CT. Medfields’s position is to offer an instrument with high sensitivity and specificity, that is safe and can be an objective complement in the triage and diagnose of a patient with brain injury (i.e. stroke or Traumatic brain injury). All in order to get the patient faster to the right hospital and correct treatment.
In the future with further development of our instrument and further development of the interventions and treatments of brain injuries, our instrument might be able to replace some diagnostic tool in order to get a faster, correct treatment.
During the feasibility study for MD100, we conducted a detailed analysis of competitive solutions. Below is the overall spectrum of products that have similar applications to our product.
In the future with further development of our instrument and further development of the interventions and treatments of brain injuries, our instrument might be able to replace some diagnostic tool in order to get a faster, correct treatment.
During the feasibility study for MD100, we conducted a detailed analysis of competitive solutions. Below is the overall spectrum of products that have similar applications to our product.