Serious Adverse Events10 grade 3 and grade 4 SAE's reported. Of these, all but 2 resolved within 8 days thankfully. My question would be about the timing of when these SAE's occurred. I imagine that any adverse event during the time the patient is in the trial has to be reported.
Since this is mostly a one and done or two for fun treatment, SAE's could be reported many months out from the treatment which is perhaps why the company is saying they believe events are unrelated to the drug and device. After all these are elderly patients with very complicated health issues.
With other treatments that are weekly and ongoing I could see where adverse events could be more closely linked to the drug.