Periodic Reporting for period 6 - SAMBAfun (System for AcceleroMeter-Based Assessment of cardiac FUNction)
Reporting period: 2021-06-01 to 2022-12-31
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
The clinical study started in October 2021 and 9 open-heart surgery patients have been enrolled at Oslo and Aarhus University Hospitals. The patients were subject to standard operating techniques and study procedures, and data from the CardiaSense CS1 system was recorded during and after surgery. The study start was heavily delayed due to the COVID-19 outbreak in 2020 and the number of patients recruited as part of this project was lower than planned due to clinical study protocol limitations and device deficiencies discovered. The amount of data recorded was therefore limited, and the regulatory approval process could not start. The analysis of the data gathered in the project, however, is very promising as it was observed that changes in heart function measured by CS1 corresponds to changes in heart function measured by echocardiography. As a result of the activities in the SAMBAfun project, accelerometer signals from the heart surface have been recorded for the first time in history in a closed chest condition. Unfortunately, a design defect was observed and the amount of patients recruited in clinical study was reduced due to insufficient time to complete a design change.
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. Due to the increasing complexity of the regulatory approval process, CDS now also considers entering the US market as an alternative to obtaining CE mark, and a potential multiple predicate 510 (k) has been proposed.
The projects results have been presented in several fairs and conferences by OSY. Here we would like to mention the BMT fair in Innsbruck, the ESREF Conference in Berlin, and the NANS fair in Florida. Furthermore, OSY used its comprehensive business contacts to communicate to the results to our clients. Further improvement of manufacturing lines is needed 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. In total, the project has resulted in one new patent granted and two new patent applications pending. Multiple distributor opportunities have been explored, however the delays in clinical study completion and regulatory submission has reduced the possibility of marketing the technology and disseminating results to clinicians. Once the clinical study can resume, CDS and the project partners are well positioned to bring the technology to market and demonstrate its clinical utility.
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. Due to the increasing complexity of the regulatory approval process, CDS now also considers entering the US market as an alternative to obtaining CE mark, and a potential multiple predicate 510 (k) has been proposed.
The projects results have been presented in several fairs and conferences by OSY. Here we would like to mention the BMT fair in Innsbruck, the ESREF Conference in Berlin, and the NANS fair in Florida. Furthermore, OSY used its comprehensive business contacts to communicate to the results to our clients. Further improvement of manufacturing lines is needed 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. In total, the project has resulted in one new patent granted and two new patent applications pending. Multiple distributor opportunities have been explored, however the delays in clinical study completion and regulatory submission has reduced the possibility of marketing the technology and disseminating results to clinicians. Once the clinical study can resume, CDS and the project partners are well positioned to bring the technology to market and demonstrate its clinical utility.
With the SAMBAfun project, we have been able to record accelerometer and velocity data from the surface of the heart post operatively in a closed chest condition and can compare data with echocardiographic imaging techniques.