Three clinical studies have demonstrated the safety and effectiveness of the B4C System and its intended use.
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A critically ill adult subject diagnosed with human immunodeficiency virus-associated cryptococcal meningitis received ICP monitoring with a previous sensor version of the B4C System while undergoing standard treatment over thirty-four (34) days. The subject underwent real-time non-invasive ICP monitoring at four defined time points before and after treatment to collect four ICP waveforms. Waveform morphology of the ICP pulses at these time points was visually assessed with other recorded clinical parameters to determine whether the waveforms were indicative of the clinical status of the patient. The pulsatile waveform from ICP monitoring on Day 12 before lumbar puncture revealed P2>P1, amplitude of tidal wave greater than that of percussion wave, reflecting characteristics of relative peak height consistent with the presence of neurological symptoms. P1>P2 after lumbar puncture, demonstrating improvement towards the characteristic P1>P2>P3, where P3 is dicrotic wave, as expected with reduction in ICP post-treatment. Morphology of the waveforms obtained from Day 34 were more closely representing normal brain compliance (P1>P2>P3), which is consistent with reduction in ICP following the series of treatment and discharge that same day. Results of this early study demonstrated that the B4C System is able to continuously monitor ICP changes to acquire signals consistent with the patient’s clinical status.
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Study 2 - Analysis of a Non-Invasive ICP Monitoring Method in Patients with Traumatic Brain Injury
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The primary endpoint was the comparison of ICP waveform morphology obtained with the nICP and iICP sensors. A secondary endpoint was the comparison of the nICP and ABP waveforms. Waveforms were compared in a lower dimensional space constructed based on signals in the frequency domain. Similarity between the two devices’ signals was inferred from the Euclidean distance between the non-linear projection in a lower dimensional space of the window power spectral densities (PSD) of the respective signals, in which PSD was calculated using the short- term Fourier transform. Intra-individual statistical comparisons were performed using the non-parametric Mann-Whitney U test for not normally distributed data points with a significance level set at p<0.05. Measurement of similarities are presented in the following table.
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Measure of similarities between iICP, nICP and ABP
Subject ID | |||||||
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Similarities | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
iCP-niICP | 35.0 | 27.2 | 26.9 | 16.9 | 36.3 | 54.7 | 30.3 |
ABP-niICP | 117.3 | 86.6 | 86.9 | 77.9 | 78.1 | 106.6 | 76.3 |
The difference between the iICP-nICP and nICP-ABP was found to be statistically significant for all seven subjects, p<0.05, using the Mann-Whitney U test. Study results demonstrated that a greater similarity exists between the waveforms generated from the signals of the Codman® Microsensor Basic Kit and B4C System than between the B4C System sensor and arterial blood pressure measurements. Although the study had a limited sample size, the intra-individual similarities of the invasive and noninvasive ICP signals as functions of time suggest comparable effectiveness of ICP monitoring between the Braincare Sensor and the invasive Codman® Microsensor Basic Kit, which is representative of the standard of care. Additionally, no adverse events related to the use of the B4C System were reported, supporting safety of the Braincare sensor for monitoring intracranial pressure.
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Study 3 - Evaluation of Multi-Center Clinical Data On a Novel Non-Invasive Sensor Device for Safe and Simplified Intracranial Pressure (ICP) Monitoring
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Results of this study demonstrated a statistically significant correlation in the ICP signal and waveform parameters between the B4C System and the gold standard invasive ICP monitoring device measured over time. The study outcomes demonstrate comparable effectiveness between the Braincare device and commonly used invasive ICP devices for use in monitoring and assessing variations in ICP waveform associated parameters over time.