@par220
This review is standard procedure and does not speak to the efficacy of the procedure, only confirms that best practices are followed by an outside body (DSMB) as expected by the FDA.
To be clear the following is my conjecture:
What is new in this article is the information about the timeline. The clinical trial documents gave a timeline suggesting that the trial results will be available mid 2019; however, this article is mentioning that the clinical trial will not complete enrolling patients until mid 2019. The initial goal was to enroll 200 patients, only 110 will be enrolled by January 2019. Following the last patient’s enrollment, first there is a several month treatment period, then comes the observation period of another 6 months. This puts the completion of the study towards mid 2020 and possibly the results being prepared and published at the end of 2020 or later. Any possible approval of the procedure by FDA (only if the results are favorable) for usage and subsequent approval by the insurance companies for payment with this timeline is pushed further into late 2021 at the earliest.
In my view, that is a significant delay compared to what the CEO has been saying up until recently i.e. an early 2020 availability.