EDAP TMS S.A. (EDAP)

[gatescrash]

Focal 1 was submitted as a "treatment for malignant prostate tumors", that's different than the other current Ablatherm and Ablatherm Fusion FDA approvals, and why EDAP needed to resubmit the application with more (new) clinical data.

The current "Ablatherm" approved products were submitted for the ablation of tissue, but not specifically for cancerous tumors; so when\if Focal 1 is finally approved it'll mean that the FDA is saying the product is an actual treatment for the Big C in the prostate.

Wording means everything and Focal 1's approval will also most likely cause insurance companies to implement actual reimbursement for treatment, past the current Medicare\Medicaid C code. This also means that the FDA most likely won't approve as quickly as they did the Ablatherm Fusion because they would be approving a brand new designation for the Focal 1 and not just a robotic enhanced Ablatherm tissue ablation device.