Vivos Inc (RDGL)

[KDOG9]

This part was interesting. I’m trying to decide if they just had to change the indication to be very specific to get approval then can expand later.


Specifically, our new focused Indication for Use is “Delivering highly localized therapeutic radiation to cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection.”