-In-vitro study, which was performed at Wayne State University, supports the SCSTM’s 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 in St . Louis, supports the safety profile of the Company’s SCSTM as a CSF catheter.
The primary and secondary endpoints will seek to validate the safety and efficacy of the SCSTM that will be activated in both in-vitro (lab) and in-vivo (animal) 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.