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Re: None

Wednesday, 03/30/2022 11:56:18 AM

Wednesday, March 30, 2022 11:56:18 AM

Post# of 6305
The 35 patients I think are a total of Inspire 1.0 and Inspire 2.0 patients. It was 15 patients in Inspire 1.0 when a patient died that was later determined not to be due to the NSS implantation. The FDA at the time also wanted a control arm that we did not have in Inspire 1.0.

Inspire 2.0 is 20 patients total of which 17 have enrolled to date that we know of. 15 + 20 = 35. This is how I see the meaning of the total number of patients having a total of 35.