Table 3.
Safety summary
| Assessment | Summary |
|---|---|
| Angiography | No stenoses present at 90 days |
| Animal health | All animals were healthy, and no clinically significant changes were noted throughout the duration of the study |
| Clinical pathology (bloodwork) | No clinically significant observations or abnormal trending was observed between baseline, interim (30 days) and terminal (90 days) timepoints for treated vs. control animals |
| Gross pathology (necropsy) | No macroscopic evidence of injury to downstream or adjacent tissues (small bowel, psoas muscle, kidneys, liver, gall bladder, proximal duodenum, and head, body and tail of the pancreas) |
| Histopathology of the treatment area (common hepatic artery and surrounding tissues) |
Histologic findings were consistent with favourable tissue responses 90 days following treatment: • Treated vessels were completely endothelialized and did not contain any evidence of thrombus • There was no evidence of clinically significant mural injury (e.g., arterial dissection), excessive neointima formation or occlusive process • Repair and remodelling of vessel walls and perivascular tissue was considered complete • Inflammation was minimal to absent |
| Norepinephrine assessment |
Average NE reductions at 90 days for the treated animals vs. controls Liver: 88% Pancreas: 78% Duodenum: 95% Kidney: 78% |