The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: Great. Good afternoon, everyone. Dave, I was hoping you could expand on the questions that came back to you from the FDA on the depth
electrode. What were the nature of these questions?
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: And I know you've talked about this before, and you just mentioned it again, but just on the [bio comp] piece of it. So you're pretty confident
regarding the materials that were found there? There's no sort of questions on whether that is going to move forward, it's more of just a clarification
on their part?
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: Yes, I was just going to say on that point, given your experience in other medical devices and these rounds of questions, do you think another
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: Understood. That makes sense. And then any updates on how Zimmer is preparing for more commercialization once this is approved? Just any
updates on -- from the FDA on their own drill bit submission, and then just education with reps in the epilepsy centers?
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: Okay. Got it. And then, it looks like you're pretty confident on the ablation electrode, and that being a 510(k). What's the chance that that could
morph into a PMA as you move forward here? And then on the submission timelines for the 510(k), I would assume that incorporates all the need
to generate bench data animal studies? Just how concrete are those submission timelines that you put out today?
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: And actually on that point, any of the design and development work that you need to do, is that solely on the RF generator or is there any more
work that needs to be done on the actual electrode itself?
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: Got it. And then just last question for me. Just maybe expand on the next steps here with the chronic use electrode, just how to turn that from the
accelerated aging data we have here to a commercialized product?
Question: Alex Nowak - Craig-Hallum Capital Group LLC - Analyst
: Okay. That's great. Appreciate the update. Thank you.
Question: Ben Haynor - Alliance Global Partners, Inc. - Analyst
: Good afternoon, guys. Thanks for taking the questions. First off for me, just kind of following up on Alex's last question there. On the chronic side
of things, you mentioned in the press release a week or so ago, entering the research market. And then obviously you touched a little bit upon the
strategic licensing angle.
Can you give us a little color -- more color, on what the research might -- market might look like? And then also, have you had discussions with
strategics on the chronic use front?
Question: Ben Haynor - Alliance Global Partners, Inc. - Analyst
: Okay, great. That's helpful. And then I guess, on the R&D front, I think you get sent some devices for kind of the high definition electrodes to a -- I
think it was Mayo and Carnegie Mellon. Any feedback there or what's the latest on the HD electrode front?
Question: Ben Haynor - Alliance Global Partners, Inc. - Analyst
: Got it. And then I guess lastly for me, you were in the Zimmer Biomet booth at the American Epilepsy Society meeting there. What was the feedback
on the cortical electrodes at the meeting?
Question: Ben Haynor - Alliance Global Partners, Inc. - Analyst
: Well, I guess both.
Question: Ben Haynor - Alliance Global Partners, Inc. - Analyst
: Yes. Okay. Great. Well, that's all I had, gentlemen. Thanks for taking the questions.
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