Periodic Reporting for period 3 - IscAlert (A Breakthrough Biomedical Sensor for the Continuous Real-Time Detection of Ischemia, a Contributor in over 10 million Annual Deaths Globally)
Okres sprawozdawczy: 2022-11-01 do 2023-10-31
Sensocure is an ambitious Norwegian company, established in 2011, to commercialise IscAlert, the World's first implantable micro sensor for the early detection of ischemia.
Ischemia is a restriction in blood supply to tissues, causing a shortage of oxygen, nutrients and inadequate removal of metabolic waste, eventually leading to cell death. Ischemia is suffered by 30m people globally every year, 10m of whom unfortunately lose their lives. Ischemia is highly preventable if it can be detected early. Unfortunately existing detection solutions simply cannot provide the early, accurate and real time monitoring required by physicians.
In contrast, IscAlert is a user friendly, fast, robust and cost effective real-time monitoring system. It conforms to current medical practice, improves patient outcomes and substantially reduced healthcare costs e.g. less corrective surgery and need for intensive care.
We have made significant progress in the past 18 months. Following the completion of pre-clinical trials of the TRL6 sensor in 2018, Sensocure has now completed a TRL7 version of the IscAlert sensor. This design is smaller, cheaper and significantly more sensitive than the previous version. We now need to embark upon our next and final steps towards commercialisation; completing clinical trials, gaining Class II CE Marking medical device approval for sale in Europe and scaling up our production processes.
In addition to EC support for the EIC Accelerator project, the EIC Fund has approved up to €3.5million in equity investment in Sensocure. This will allow us to scale operations and undertake FDA approval for sales in US markets. By 2027, we will employ an additional 113 staff, annual sales of 38,000 sensors, and have generated total accrued revenues of €59.92m and profits €16.95m.
Market success will save lines and improve patient outcomes, delivering savings to healthcare providers of €102m p.a. and freeing up 18,300 hospital days.
Ischemia is a restriction in blood supply to tissues, causing a shortage of oxygen, nutrients and inadequate removal of metabolic waste, eventually leading to cell death. Ischemia is suffered by 30m people globally every year, 10m of whom unfortunately lose their lives. Ischemia is highly preventable if it can be detected early. Unfortunately existing detection solutions simply cannot provide the early, accurate and real time monitoring required by physicians.
In contrast, IscAlert is a user friendly, fast, robust and cost effective real-time monitoring system. It conforms to current medical practice, improves patient outcomes and substantially reduced healthcare costs e.g. less corrective surgery and need for intensive care.
We have made significant progress in the past 18 months. Following the completion of pre-clinical trials of the TRL6 sensor in 2018, Sensocure has now completed a TRL7 version of the IscAlert sensor. This design is smaller, cheaper and significantly more sensitive than the previous version. We now need to embark upon our next and final steps towards commercialisation; completing clinical trials, gaining Class II CE Marking medical device approval for sale in Europe and scaling up our production processes.
In addition to EC support for the EIC Accelerator project, the EIC Fund has approved up to €3.5million in equity investment in Sensocure. This will allow us to scale operations and undertake FDA approval for sales in US markets. By 2027, we will employ an additional 113 staff, annual sales of 38,000 sensors, and have generated total accrued revenues of €59.92m and profits €16.95m.
Market success will save lines and improve patient outcomes, delivering savings to healthcare providers of €102m p.a. and freeing up 18,300 hospital days.
The first clinical trial, the Baseline study, was started at the Oslo University Hospital in September 2021. The protocol and approval for the study was completed in April 2021. Due to Covid-19 and national restrictions, as well as restrictions at Oslo University Hospital, the clinical trials were delayed. Nevertheless, the clinical study was completed in June 2022, including 50 patients and with very good results showing that IscAlert is a safe and reliable monitor of ischemia with continuous and real-time measurements.
The process of CE marking approval for IscAlert as a Class IIa medical device is initiated with the Notified Body. We have experienced long lead times at the Notified Body. Technical work is completed and the formal application has been submitted. The initial audit is estimated to Q1/2024.
The replantation study was started in January 2023. Data from the ongoing study verifies that circulatory disturbances in replanted fingers are detected by measuring a rise in CO2 and a fall in temperature in the affected fingers. The reconstructive study was started in October 2023. The compartment syndrome study is approved by the National Authorities and is planned to start in January 2024. The clinical study will continue as planned beyond the project period.
Work on pre-market design refinements is completed. Calibration devices has been developed and manufactured, optimized for clinical use. In parallel with the ongoing clinical trials, a calibration system consisting of a calibration device, sensor container and calibration method has been developed utilizing data from manufacturing, from laboratory testing and clinical use. The calibration device is validated in the Clinical Baseline study for the IscAlert system. The calibrator cost has been reduced, and the new calibration method reduces the calibration time for the IscAlert sensor.
Existing manufacturing processes have been optimized and a scalable production capacity is demonstrated.
The process of CE marking approval for IscAlert as a Class IIa medical device is initiated with the Notified Body. We have experienced long lead times at the Notified Body. Technical work is completed and the formal application has been submitted. The initial audit is estimated to Q1/2024.
The replantation study was started in January 2023. Data from the ongoing study verifies that circulatory disturbances in replanted fingers are detected by measuring a rise in CO2 and a fall in temperature in the affected fingers. The reconstructive study was started in October 2023. The compartment syndrome study is approved by the National Authorities and is planned to start in January 2024. The clinical study will continue as planned beyond the project period.
Work on pre-market design refinements is completed. Calibration devices has been developed and manufactured, optimized for clinical use. In parallel with the ongoing clinical trials, a calibration system consisting of a calibration device, sensor container and calibration method has been developed utilizing data from manufacturing, from laboratory testing and clinical use. The calibration device is validated in the Clinical Baseline study for the IscAlert system. The calibrator cost has been reduced, and the new calibration method reduces the calibration time for the IscAlert sensor.
Existing manufacturing processes have been optimized and a scalable production capacity is demonstrated.
Results from clinical trials so far are according to expectations.
Publication of results will be done consecutively when clinical trials are completed.
Regarding potential impacts: Ischemia is a restriction in blood flow to tissues, causing a shortage of oxygen, reduced availability of nutrients and inadequate removal of metabolic wastes. Ultimately, this leads to cell and organ death, which can be fatal. The following conditions are particularly relevant as initial application for IscAlert:
• Haemorrhagic shock is caused by rapid blood loss and results in dangerously low tissue perfusion across the entire body. It accounts for 1.9 million deaths annually and is the leading cause of preventable mortality following trauma.
• Septic shock is a potentially fatal medical condition that occurs when sepsis (organ damage in response to infection), leads to dangerously low blood pressure and abnormalities in cellular metabolism. Approximately 30 million people suffer from the condition worldwide each year, causing 6 million deaths annually. A major obstacle in the treatment of sepsis is response time, with varied and non-specific symptoms often going undiagnosed. Where sepsis is diagnosed and treated early, mortality can be reduced substantially.
• Compartment syndrome (CS) (150,000 cases p.a.) is where the pressure within a muscle compartment of the body (e.g. lower leg) rises due to muscle swelling after trauma. This limits blood flow leading to necrosis and, limb amputation.
• Reconstructive surgery complications include failure of blood flow after reconnection due to thrombosis, emboli or external pressure, resulting in necrosis in the free flap. Such complications are seen in several types of flap surgery (e.g. in breast reconstructions after mastectomy, ear, nose and throat (ENT) reconstructions after tumour removal, and finger replantation following accidental amputation. Cases of tissue necrosis can be as high as 30% in many of these procedures.
Publication of results will be done consecutively when clinical trials are completed.
Regarding potential impacts: Ischemia is a restriction in blood flow to tissues, causing a shortage of oxygen, reduced availability of nutrients and inadequate removal of metabolic wastes. Ultimately, this leads to cell and organ death, which can be fatal. The following conditions are particularly relevant as initial application for IscAlert:
• Haemorrhagic shock is caused by rapid blood loss and results in dangerously low tissue perfusion across the entire body. It accounts for 1.9 million deaths annually and is the leading cause of preventable mortality following trauma.
• Septic shock is a potentially fatal medical condition that occurs when sepsis (organ damage in response to infection), leads to dangerously low blood pressure and abnormalities in cellular metabolism. Approximately 30 million people suffer from the condition worldwide each year, causing 6 million deaths annually. A major obstacle in the treatment of sepsis is response time, with varied and non-specific symptoms often going undiagnosed. Where sepsis is diagnosed and treated early, mortality can be reduced substantially.
• Compartment syndrome (CS) (150,000 cases p.a.) is where the pressure within a muscle compartment of the body (e.g. lower leg) rises due to muscle swelling after trauma. This limits blood flow leading to necrosis and, limb amputation.
• Reconstructive surgery complications include failure of blood flow after reconnection due to thrombosis, emboli or external pressure, resulting in necrosis in the free flap. Such complications are seen in several types of flap surgery (e.g. in breast reconstructions after mastectomy, ear, nose and throat (ENT) reconstructions after tumour removal, and finger replantation following accidental amputation. Cases of tissue necrosis can be as high as 30% in many of these procedures.