Periodic Reporting for period 5 - SAMBAfun (System for AcceleroMeter-Based Assessment of cardiac FUNction)
Berichtszeitraum: 2020-12-01 bis 2021-05-31
In patients undergoing open-heart surgeries, cardiac monitoring is used to track the functioning of the heart and identify complications. However, cardiac failure and other severe complications can escape detection using current monitoring technologies, given the trade-offs between invasiveness, real time measurements, accessibility and accuracy of data that current technologies impose. Given the high-risk profile of these surgeries, failure to timely detect complications leads to increased mortality and morbidity, which in turn results in increased hospitalization costs and lower quality of life for the affected patients. To put it in context, postoperative complications in Europe amounts to €6 billion annually. Together, the growing pervasiveness and overall persistence of cardiac diseases urge the need for more effective cardiac monitoring technologies that address the known shortcomings of:
* Pulmonary artery catheters which are highly invasive and increase the risk of bleeding
* Electrocardiogram (a.k.a. ECG), which provides low-accuracy data on ischemia and other dysfunctions
* Echocardiogram (a.k.a. Echo), which is regarded as the gold-standard for accurate measurement of heart function but cannot be used for long-term, post-operative monitoring because it requires a skilled echocardiographer present at all times.
For effective cardiac monitoring, surgeons need real time data, 24h continuous monitoring during and post-surgery (at least for the first 3 critical days), and an accurate biosignal that can be trusted for immediate detection and assessment of cardiac events. No current technology enables this with low invasiveness and risk, an unmet clinical need we aim to address. Cardiaccs and Osypka will bring to market a patented solution that involves adding a 3-axis accelerometer to a standard epicardial pace lead, which is routinely used for most cardiac surgical patients, to assess cardiac motion and contractility in real time, both during and after surgery – and up to 7 days. Instead of using catheters which can increase the rate of surgical complications, surgeons can do surgery as usual and view live heart motion data that can be used to assess abnormal events as they happen with similar accuracy to the best non-continuous monitoring devices, such as echocardiography. Data from CardiSense will appear on a monitor and an alert function will let surgeons and ICU nurses know as soon as a complication is picked-up on the continuously analysed data.
Overall objectives:
The major objective of the SAMBAfun project is to bridge the current gaps in the innovation process for a market-sought and highly innovative Class III medical device – CardiSense. This is driven by expectation of a commercial launch by 2022Q2, supported by an immediate willingness to buy observed in our market research. Although the CardiSense device has proven efficacy, documented in multiple peer-review publications, we still need to overcome several barriers to bring it to market.
O1 Build up the system features requested by surgeons
O2 Perform randomized clinical trials
O3 Health Economic Assessment (HEA) to secure support reimbursement and economic benefit claims
O4 Design for manufacturing and assembly (DFMA) and prepare certifications to reach global markets
O5 Commercialisation starts in initial target markets by 2022
* Pulmonary artery catheters which are highly invasive and increase the risk of bleeding
* Electrocardiogram (a.k.a. ECG), which provides low-accuracy data on ischemia and other dysfunctions
* Echocardiogram (a.k.a. Echo), which is regarded as the gold-standard for accurate measurement of heart function but cannot be used for long-term, post-operative monitoring because it requires a skilled echocardiographer present at all times.
For effective cardiac monitoring, surgeons need real time data, 24h continuous monitoring during and post-surgery (at least for the first 3 critical days), and an accurate biosignal that can be trusted for immediate detection and assessment of cardiac events. No current technology enables this with low invasiveness and risk, an unmet clinical need we aim to address. Cardiaccs and Osypka will bring to market a patented solution that involves adding a 3-axis accelerometer to a standard epicardial pace lead, which is routinely used for most cardiac surgical patients, to assess cardiac motion and contractility in real time, both during and after surgery – and up to 7 days. Instead of using catheters which can increase the rate of surgical complications, surgeons can do surgery as usual and view live heart motion data that can be used to assess abnormal events as they happen with similar accuracy to the best non-continuous monitoring devices, such as echocardiography. Data from CardiSense will appear on a monitor and an alert function will let surgeons and ICU nurses know as soon as a complication is picked-up on the continuously analysed data.
Overall objectives:
The major objective of the SAMBAfun project is to bridge the current gaps in the innovation process for a market-sought and highly innovative Class III medical device – CardiSense. This is driven by expectation of a commercial launch by 2022Q2, supported by an immediate willingness to buy observed in our market research. Although the CardiSense device has proven efficacy, documented in multiple peer-review publications, we still need to overcome several barriers to bring it to market.
O1 Build up the system features requested by surgeons
O2 Perform randomized clinical trials
O3 Health Economic Assessment (HEA) to secure support reimbursement and economic benefit claims
O4 Design for manufacturing and assembly (DFMA) and prepare certifications to reach global markets
O5 Commercialisation starts in initial target markets by 2022
Approvals have been obtained from both Norwegian and Danish competent authorities and the clinical trial has formally started, although the first patients are not expected to be enrolled until September 2021 due to hospital restrictions related to COVID-19 that are expected to ease the next month. The project was presented in February 2020 at the 30th annual meeting of Scandinavian Society for Research in Cardiothoracic Surgery and was much appreciated as an important tool for future post-operative cardiac monitoring. There is a strong interest in the CS1 system among cardiac surgical doctors and cardiovascular scientists, and CDS now sells the CS1 system for research use to get user input and feedback on features and functions.
With the outbreak of COVID-19 more resources have been focused on execution of tasks where interaction and physical presence at hospitals is not required. Work has begun to position CS1 in reimbursement regimes in Scandinavia and Germany by mapping actual cost codes and estimate the potential savings that CS1 may generate to the hospital. A pre-submission meeting with the FDA has been held, and the clinical protocol has been updated to ensure US regulatory compliance.
Manufacturing lines are now ready for implementation to increase yield and reduce manufacturing costs. A patent application has been filed covering new methods for improved monitoring of the heart function based on accelerometer data and development of new features using machine learning techniques for optimal display of accelerometer data has started.
With the outbreak of COVID-19 more resources have been focused on execution of tasks where interaction and physical presence at hospitals is not required. Work has begun to position CS1 in reimbursement regimes in Scandinavia and Germany by mapping actual cost codes and estimate the potential savings that CS1 may generate to the hospital. A pre-submission meeting with the FDA has been held, and the clinical protocol has been updated to ensure US regulatory compliance.
Manufacturing lines are now ready for implementation to increase yield and reduce manufacturing costs. A patent application has been filed covering new methods for improved monitoring of the heart function based on accelerometer data and development of new features using machine learning techniques for optimal display of accelerometer data has started.
So far only preparatory activities have been performed and the focus has been to provide an optimal device, ready for clinical trials. This phase does not provide options for progress beyond state of the art.