Neovasc Inc. (NASDAQ:NVCN) Q3 2019 Earnings Conference Call - Final Transcript

Nov 07, 2019 • 04:30 pm ET

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Neovasc Inc. (NASDAQ:NVCN) Q3 2019 Earnings Conference Call - Final Transcript

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Q & A
Operator
Operator

Thank you. [Operator Instructions] We will take our first question from Danielle Antalffy from SVB Leerink. Please go ahead.

Analyst
Danielle Antalffy

Hi. Good afternoon, everyone. Thanks so much for taking the questions. I have a few questions, Fred and Chris. I guess my first question is, given the capital structure and capital needs of the Company right now, can you talk a little bit about the rationale behind the timing of the hiring of a Chief Operating Officer? It's the first part of the question. The second part of the question is, maybe you could talk about Bill's marching orders early on and sort of where you're looking for him to add value.

Executive
Fred Colen

Yes. So thanks, Danielle. This is Fred. So now we are extremely pleased to bring Bill on-board. Bill is a very strong strategic thinker and he will add a lot of value, in particular, on the commercialization side. So he is going to focus very much so on continued commercialization strategies for the Reducer as well as for the strategic positioning of the Reducer in the marketplace. He can also provide a lot of insight in potential additional applications for the Reducer and to come up with a very comprehensive and detailed plan for what kind of markets, what kind of other applications might there be for the Reducer. So we are actually very pleased with Chris -- with Bill coming on-board. I think he is going to play a major role in the planning activities for next year and into the future as well as in the -- his assistance in guiding us and our salespeople related to further increase commercial activities for the Reducer on a global basis. So I think that he is actually joining us at the right time and I'm sure he is going to provide a lot of additional value to the Company.

Analyst
Danielle Antalffy

Got it. Thank you for that and congrats on that hire. My next question for you is on the PMA filing for Reducer. I'm just curious if you can provide any color behind your -- I know you guys have been in conversation with the FDA. Any color you can give that gave you at least enough comfort to take this path as to sort of what -- how your conversations went with FDA there.

Executive
Fred Colen

Yes. So as you know, we have been working very closely with the FDA to explore the best path to market for the Reducer in the US. And I think we have explained already publicly some of the issues we're running into going down the path of an HUD. The 8,000 patient restriction is somewhat problematic because there is a large patient population that benefit from this device, and the device is not just built for a Class 4 patient population, but for a much broader patient population. So we were running with best efforts on all sides, including us as well as the FDA, into some snags there.

The other point is that we have