Replies to post #10501 on Neovasc Inc (NVCN)

[Never_Post]

Three points come to mind as of your post.

1. That the REDUCER has NUB1 status in Germany / EU (European Union). Specifically,

"A prerequisite for a NUB application is the completed approval procedure (CE) for medical products. With the CE marking for medical devices, it is possible for the inpatient sector to use these products."

"CE marking is the medical device manufacturer's claim that a product meets the essential requirements of all relevant European Medical Device Directives."

"The CE mark is a legal requirement to place a device on the market in the EU."

NUB1 is meant to bridge the gap between standard procedures for inpatient treatment and the higher cost of innovative procedures. The practice is that hospitals budget on a standard procedure basis and need to add in the cost of new innovative procedures at an approved amount. NUB1 provides the funds to fill the gap.

2. If BSX requires FDA approval would not the CE and NUB 1 approval in Europe possibly bridge this gap. As well as per CEO, "900 implants of REDUCER have taken place."

Separately (3rd point), I would like to re-iterate that the REDUCER has no direct competitors. Trying to determine whether there are any known competing products in development.

The Reducer is targeting a patient population that has failed to gain relief of their symptoms, despite other medical treatment options. A refractory patient by definition is resistant to other therapies. A patient who has refractory angina is not a surgical candidate, cannot benefit from existing interventional cardiology therapies and is not receiving adequate relief from available drug regimens to manage their chest pain. As such there are currently no direct competitors to the Reducer as the patient will have exhausted all other treatment options before the Reducer is considered.

http://www.neovasc.com/wp-content/uploads/2018/03/NVCN_Q4-F17-MDA_FINAL.pdf