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 - Analyst
: Great, good morning, everyone. The resubmission of the depth electrode was around rerunning the biocompatibility test in [saline]. Could you
just walk through the test results? Did anything stood (sic - stand) out to you or everything was pretty much just all greenlight, good to go?
Question: Alex Nowak - Craig-Hallum Capital Group - Analyst
: No, that's very good to hear. Maybe just on the conversations you've had now with the FDA since submitting the -- resubmitting the 510(k) back
here, if I remember correctly, it should be a special 510(k), so a 30-day review clock. Have you had any conversations with the FDA? I know the FDA
is backlogged. So I think your commentary around expecting approval Q1 2022 makes sense. But just any update with the FDA or -- yes, around
that?
Question: Alex Nowak - Craig-Hallum Capital Group - Analyst
: That's great, that's good to hear. Maybe expand on Zimmer's launch plan once the depth electrode is approved. Just what has been the initial
response from the neuro centers that Zimmer has already reached out to? And just given the initial stocking orders, how are you thinking about
-- upon a full commercial launch here with ROSA ONE, just how you are thinking about ordering patterns going forward?
Question: Alex Nowak - Craig-Hallum Capital Group - Analyst
: Yes, okay. And then just two more questions. Could you walk through the necessary actions to get FDA approval of the ablation electrode and
then just what are the key items to watch there?
Question: Alex Nowak - Craig-Hallum Capital Group - Analyst
: Yes, understood. And then just the last question, this one is a longer-term question here. But can you walk through the game plan around the
chronic electrode? Just how to get that ready for use in -- whether or not spinal cord stim or deep brain stim? Just a little bit of a game plan there.
Question: Alex Nowak - Craig-Hallum Capital Group - Analyst
: That's great. Really appreciate the update. Thank you.
Question: Ben Haynor - Alliance Global Partners - Analyst
: Good morning, gentlemen. Can you hear me okay?
Question: Ben Haynor - Alliance Global Partners - Analyst
: Good deal. Congrats on all the progress and thanks for all the color here. I was just wondering on the Zimmer forecasts, you mentioned how they
have been consistently increasing [load]. Is it safe there to presume that that's based upon the feedback and the reception that they've got in
feeling out the market and the potential market for the product?
Question: Ben Haynor - Alliance Global Partners - Analyst
: Okay, great. That's helpful. And then just on the accessories on their end, on Zimmer's then, do you have a sense of when those will be ready? I
mean, you guys can obviously only control your side of things. And then on your side, given the increasing forecasts, how does your ability to kind
of ramp up manufacturing stand?
Question: Ben Haynor - Alliance Global Partners - Analyst
: The color there is helpful. And then just kind of on the clinical data front, anything we should be on the lookout for there? I know you had the recent
kind of presentation, publications. And then do you have a strategy on -- that you're kind of developing for the ablation electrode in terms of
publications or clinical data that you are planning to get out there?
Question: Ben Haynor - Alliance Global Partners - Analyst
: Okay, great. Well, that's all I had, gentlemen. Thanks for taking the questions.
| 
