Validation tests are entering the decisive second phase
BOCAhealth is portable, user-friendly and digital. The system offers doctors a risk prediction score, something unique in the field of bioimpedance analysis. With these factors, BOCAhealth already stands out clearly from its competitors. But of course this is only relevant if the measurement accuracy can keep up with the solutions of the competitors. We therefore dealt with this question very early on in product development: is the BOCAhealth measurement as good as that of the devices that have already established themselves on the market?
For this purpose, we have carried out a validation study. In the first phase, a sample with 53 healthy volunteers was first measured using the current gold standard bioimpedance device. This means that this is currently widely used in the healthcare system and therefore sets the benchmark in terms of measurement accuracy. The measurement was then carried out again with the BOCAhealth. In this way, the accuracy of BOCAhealth compared to the competitor device could be examined. This was done by looking at the AC resistance values, which represent the conductivity of the examined body. Measurements were made at different frequencies of 8, 16, 32, 128 and 256 kHz.
It can be seen from the graph that there is a high degree of agreement in the impedance values at the different frequencies, which speaks for the high stability and high accuracy of our measurement results.
In addition, the total body water measurement was compared in a sample with 40 volunteers. The positive results confirm the first impedance test:
After the first step of the validation has been successfully completed, we are now preparing the second one: checking the measurement accuracy in patients with chronic kidney disease, one of the main target groups for BOCAhealth. 150 patients are included in the official clinical trial. Before and after a hemodialysis session, these are tested first with the gold standard and then with the BOCAhealth. This is intended to check the measurement accuracy before and after therapy. It is part of the CE certification process for approval as a medical device. The second phase of the validation tests is therefore decisive for the market launch of the product and can now be implemented thanks to the support of the aescuvest crowd.