IN VITRO (OUTSIDE LIVING ORGANISM) TESTS

In order to analytically validate the efficacy and safety of the MBP system, PKC intends to conduct in vitro tests to explore system capabilities and limitations associated with flow rate, volume, duration, power consumption, wireless communication, repeatability, reliability and various artificial intelligence (AI) routines controlling and regulating the performance of the MBP apparatus.  To that effect PKC will undertake the effort of designing, developing and implementing a rigorous and statistically significant bench test (per FDA (1992) 80/20 ruling to adequately power the hypothesis tests) complementing the animal study. These tests will be used to validate the assumption of an improved diffusion model using local delivery of medicating agents under the regimens of the MBP schedule using the following end points:

Accuracy – demonstration of the MBP’s ability to locally deliver the medicating agent so as to regulate the volume and schedule.

Close-loop feedback – demonstration of the MBP’s ability to regulate the amount of medicating agent delivered based on parameters such as VEGF levels in a simulated environment as detected by the UV LED spectrometer.

Biocompatibility and engineering consideration – demonstration of the system performance and endurance under various laboratory controlled conditions will enable PKC to validate system capabilities and limitations associated with flow rate, volume, duration, power consumption, wireless communication, repeatability, reliability and various AI routines controlling and regulating the performance of the MBP apparatus. The entire set of the analytical parameters will be examined in light of safety considerations for the operation of the MBP system.

The objective of the in vitro study is to test the performance, efficacy and safety of the MBP under analytical conditions relative to these primary end points. The primary safety endpoints are defined as the absence of structural abnormalities, adverse events and cases of brain injuries due to inadequate performance of the MBP apparatus. We intend to employ radiopaque contrast agents such as iopamidol (Isovue-370) simulating pharmacodynamic conditions so as to enable X-ray video (Ziehm Vision FD Imaging systems) to continuously monitor the diffusion model (Figure 9). We expect this method to demonstrate the ability of MBP to accurately dispense the medicating agents by measuring surface area and absorption rate.