Microbot Medical announces data from independent lab study of SCS
Microbot Medical announced that it has "validated the operational effectiveness" of the company's Self-Cleaning Shunt, or SCS, in a recent independent in-vitro laboratory study. The company also shared images of its SCS from the laboratory study that demonstrate the device prevented shunt occlusion. The study was conducted at Envigo CRS Israel, a provider of non-clinical contract research services and research models. Human brain glioblastoma cells were used in order to assess performance of the SCS in a test system with accelerated cell growth rate, accumulation and obstruction rates. The study commenced in October 2018 and after 30 days it demonstrated: gignificant cell growth and accumulation in a non-operating SCS and a significant inhibition in cell growth in the constantly operating SCS with very little to no cell attachment on the robotic brush, or ViRob, and on the opening where the robotic brush operates. The study also demonstrated that the company's SCS has the ability to operate after cells had accumulated on the catheter holes and the robotic brush. Moreover, SCS activation demonstrated the potential to disintegrate existing occlusions formed on the robotic brush and on the opening where the robotic brush operates. In addition to this study, the company previously announced data from two pre-clinical studies that were performed at leading U.S. academic institutions. In-vitro study, which was performed at Wayne State University, supports the SCS' potential as a viable technology for preventing occlusion in shunts used to treat hydrocephalus. In-vivo animal study, which was performed at Washington University School of Medicine, supports the safety profile of the company's SCS as a CSF catheter. The follow up study, which is being conducted by the same academic institutions, commenced in October 2018 and includes a larger sample size compared to the initial studies. The primary and secondary endpoints will seek to validate the safety and efficacy of the SCS that will be activated in both in-vitro and in-vivo models. The company's objective is to conclude the follow up study and announce the data in the second half of 2019. The company plans to use the findings either for its regulatory submissions in the US, Europe and other jurisdictions, or as part of a pre-submission meeting request, depending on the final results of the ongoing follow-up study.