Q2 2022 Neuroone Medical Technologies Corp Earnings Call
Okay.
Ladies and gentlemen, thank you for standing by and welcome to the Neuro One medical Technologies Corporation second quarter fiscal 2022 earnings conference call.
Ladies and gentlemen, thank you for standing by and welcome to the NeuroOne Medical Technologies Corporation, second quarter of fiscal 2022 earnings conference.
Today's call will be conducted by the company's Chief Executive Officer Dave Rosa and its Chief Financial Officer Ron
Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa and its Chief Financial Officer, Ron Mcclurg before I turn the call over to Mr. Rosa I'd like to remind you that this conference call will include forward looking statements within the meaning of U S. Federal security laws with respect to future operations.
Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meeting of U.S. Federal Security Laws with respect to future operations, financial results, events, trends and performance which are based on management's beliefs and assumptions as of today's call or other specified date. Forward-looking statements may involve
Actual results events trends and performance, which are based on management's beliefs and assumptions as of today's call or other specified date.
Forward looking statements may involve known and unknown risks uncertainties and other factors, which may cause actual results to differ materially from those expressed or implied by such statements.
uncertainties, and other factors which may cause actual results to differ materially from those expressed or implied by such states.
see our earnings release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ.
Our earnings release, and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ.
Except as required by law, we undertake no obligation to update such forward-looking statements.
Except as required by law, we undertake no obligation to update such forward looking statements with that said I'll turn the call over to Dave Rosa CEO of neuro one Dave.
With that said, I'll turn the call over to Dave Rosa, CEO of Neuro One. Dave?
Thanks operator and thank you to everyone attending our call this afternoon.
Thanks, operator, and thank you to everyone attending our call. This afternoon.
During and since the second fiscal quarter, we remain focused on advancing our thin film electrode platform technology with respect to both diagnostic and therapeutic applications.
During and since the second fiscal quarter, we remain focused on advancing our thin film electrode platform technology with respect to both diagnostic and therapeutic applications. In addition, we made progress on reducing product costs and ensuring the ability to meet Zimmer biomet.
In addition, we made progress on reducing product costs and ensuring the ability to meet Zimmer Biomets expected product demand by initiating the process to qualify additional manufacturing sources. Let's begin with.
Expected product demand by initiating the process to qualify additional manufacturing sources.
To begin with diagnostic applications.
Although the FDA did not provide clearance in March 2022 to increase the duration of use from less than 24 hours to less than 30 days for our Evo SEG product line, we feel strongly that we met the ISO 10993 standard Part 12 and Part 18 requirements for biological evaluation of medical devices.
Although the FDA did not provide clearance in March 2022 to increase the duration of use from less than 24 hours to less than 30 days for our Evo Seg product line, we feel strongly that we met the ISO 10, 993 standard part <unk> and part 18 requirements.
For biological evaluation of medical devices as.
As such, the company filed an appeal with the FDA in March 2022 regarding their decision.
As such the company filed an appeal with the FDA in March 2022 regarding their decision on.
On April 14th, the FDA held an official call with the company to hear our appeal.
On April 14th the FDA held an official Paul with the company to hear our appeal.
Dr. William Wustenberg, a renowned biocompatibility expert who provided the data analysis for FDA submission, explained the scientific rationale to the FDA as to why the company believed it met the criteria that I earlier referenced.
Dr. William boosting bird renown biocompatibility expert who provided the data analysis for FDA submission explain the scientific rationale to the FDA as to why the company believes it met the criteria that I earlier referenced.
The FDA had no questions regarding Dr. Wustenberg's presentation and informed us that the decision would be made on our appeal by May 14th or 30 days from the day of the call. We are currently away.
The FDA had no questions regarding Doctor wisdom, Berg's presentation, and informed us that a decision would be made on our appeal by may 14th or 30 days from the date of this call.
We are currently awaiting this decision.
As previously disclosed, we immediately initiated a parallel path by commencing additional biocompatibility tests on the Evo SEG product line in the event we are not successful in our appeal.
As previously disclosed we immediately initiated the parallel path by commencing additional biocompatibility test on the Evo Seg product line in the event, we are not successful in our appeal.
Given the length of the test and time required for the testing firm to complete the final report, we would expect to get that final report in mid-August and file our 510K submission thereafter, if needed.
The length of the test and time required for the testing firm to complete the final report we would expect to get that final report in mid August and file our 500 10-K submission thereafter if needed.
We remain extremely confident that the product will again successfully pass the biocompatibility testing as the evo cortical and SEG products have 100% of the time passed all biocompatibility testing for their intended use.
We remain extremely confident that the product will again successfully passed the biocompatibility testing as the IBO cortical and SCG products at 100% of the time passed all biocompatibility testing for their intended use.
We also remain confident that the design and materials used for the electrodes are sufficient given we have clearances from FDA for both our EVO cortical line for less than 30 days diagnostic use and an FDA clearance for less than 24 hour use for diagnostic purposes for our EVO SEG product line.
We also remain confident that the design and materials used for the electrodes are sufficient given we have clearances from FDA for both our Evo cortical line for less than 30 days diagnostic use and an FDA clearance for less than 24 hour use for diagnostic purposes for.
Our Evo Seg product line.
If and when FDA clearance for less than 30-day use is received, the company will begin to fulfill stocking orders that have been placed by Zimber Biomet, our distribution partner, or the Evo SEG family product line.
If and when FDA clearance for less than 30 day used is received the company will begin to fulfill stocking orders that had been placed by Zimmer biomet, our distribution partner for the Evo SCG family product line.
Just last week, both Zimmer and neuro one we're also approached by an account to use the Evo SCG device for intra operative use an E com diagnostic procedures, which would be for less than 24 hour use this.
Just last week, both Zimmer and Neuro1 were also approached by an account to use the Evo SEG device for intraoperative use in ECOG diagnostic procedures, which would be for less than 24-hour use.
This may give us the opportunity to obtain clinical experience with the electrode in the near future.
This may give us the opportunity to obtain clinical experience with the electrodes in the near future.
The company also participated in a physician advisory board meeting hosted by Zimmer Biomet to gain feedback from neurosurgeons on the EVO, SEG, electrode, and accessories required for the procedure.
The company also participated in a physician advisory Board meeting hosted by Zimmer Biomet to gain feedback from neurosurgeons on the Evo SCG electrode and accessories required for the procedure.
We remain encouraged by the positive feedback we received at this meeting from the neurosurgeons that attended.
We remain encouraged by the positive feedback we received at this meeting and the neurosurgeons that attended.
The company is continuously exploring opportunities to leverage the unique low profile of our electrodes to support cutting edge research around the U.S.
The company is continuously exploring opportunities to leverage the unique low profile of our electrodes to support cutting edge research around the U S.
As part of this effort. We also recently displayed our Evo electrode product line at the University of Minnesota, Neuromodulation Symposium, where leading researchers and collaborators were gathered with unique focus on psychiatry and neuromodulation.
As part of this effort, we also recently displayed our EVO electrode product line at the University of Minnesota Neuromodulation Symposium, where leading researchers and collaborators were gathered with a unique focus on psychiatry and neuromodulation.
We also presented at the Gordon Research Conference 2022 Neuro-Electronic Interfaces meeting.
We also presented at the Gordon Research Conference 2022, neuro electronic interfaces meeting.
The company also took steps to qualify a second source to manufacture electrodes for both the EVO cortical and SEEG product lines in order to reduce supply risk for the expected demand from Zimmer Biomech.
The company also took steps to qualify a second source to manufacturer electrodes for both the Evo cortical and <unk> product lines in order to reduce supply risk for the expected demand from Zimmer biomet.
This is critical as we have continually heard from physicians that product supply and back orders are prevalent with respect to both cortical and SEG electrodes.
This is critical as we have continually heard from physicians that product supply and back orders are prevalent with respect both cortical and SCG electrodes.
This obviously causes delays in both diagnosis and treatment for patients.
This obviously causes delays in both diagnostics diagnosis and treatment for patients.
Another area the company has been evaluating are opportunities for reducing costs.
Another area of the company has been evaluating our opportunities for reducing cost.
We are currently completing the validation of a new cable assembly manufacturer which will help significantly reduce cost for this component.
We are currently completing the validation of a new cable assembly manufacturer, which will help significantly reduced cost for this component.
In terms of product enhancements, we also expect to release our third generation connector which is lighter, smaller and less expensive in the second half of this year.
In terms of product enhancements, we also expect to release, our third generation connector, which is lighter smaller and less expensive in the second half of this year.
Additionally, the company is working to extend shelf life for both the EVO Cortical and SEG product line.
Additionally, the company is working to extend shelf life for both the Evo cortical and Seg product lines. This will provide significant value to our customers and managing inventory and put much less pressure on our supply chain.
This will provide significant value to our customers in managing inventory and put much less pressure on our supply chain.
Now moving to our combined diagnostic and therapeutic ablation electrode program.
Now moving to our combined diagnostic and therapeutic ablation electrode program.
We are pleased to report that the project remains on schedule. We continue to receive encouraging physician feedback regarding the potential ability to improve the way epilepsy and potentially other neurological conditions are treated today by eliminating second hospitalization and surgery. RBC Medical Innovations, our hardware and software partner, remains on track to deliver prototypes of the RF generator in calendar Q3 of this year.
We are pleased to report that the project remains on schedule and we continue to receive encouraging physician feedback regarding the potential ability to improve the way epilepsy and potentially other neurological conditions are treated today by eliminating the second hospitalization and surgery RB.
RBC medical innovations, our hardware and software partner remains on track to deliver prototypes of the RF.
Generator in calendar Q3 of this year.
Company is currently progressing with the development of accessories required for use with the system.
Company is currently progressing with the development of accessories required for use with the system.
Following the completion of the RF generator prototypes, development of the accessories, and additional preclinical testing, we expect to submit a 510K application in the first calendar quarter of 2023 for FDA clearance.
Following the completion of the RF generator prototypes development of the accessories and additional preclinical testing.
We expect to submit a 500 10-K application in the first calendar quarter of 2023 for FDA clearance.
Now, let's move to a chronic use electro development last quarter, we announced the successful completion of accelerated five year testing, which demonstrated reliable reporting without any issues associated with fluid permeation.
Now let's move to our chronic use electrode development. Last quarter, we announced successful completion of accelerated five-year testing, which demonstrated reliable recording without any issues associated with fluid permeation.
We then released the successful results of our accelerated five year stimulation testing in March, which was quite exciting as electro durability up to five years use has been a great challenge for the thin film industry.
We then released the successful results of our accelerated five year stimulation testing in March which was quite exciting as electro durability up to five years use has been a great challenge for the thin film industry.
While we have more development and manufacturing work to do, we remain encouraged by these early results.
While we have more development and manufacturing work to do we remain encouraged by these early results are.
Our initial focus with our chronic stimulation program remains with spinal cord stimulation, the treatment of chronic back pain due to failed back surgery.
Our initial focus with our chronic stimulation program remains with spinal cord stimulation the treatment of chronic back pain due to failed back surgery.
We are also in discussions with a prominent research institution regarding the development of a specialized electrode that would capitalize on the thin film features for a few exciting applications in Parkinson's disease potentially certain psychiatric disorders. We will provide additional information.
We are also in discussions with a prominent research institution regarding the development of a specialized electrode that would capitalize on the thin film features for a few exciting applications in Parkinson's disease potentially certain psychiatric disorders.
We will provide additional information as this progresses.
In January , we announced the appointment of Chad Wilhelmy as Vice President of Quality, Control, and Regulatory Affairs.
In January we announced the appointment of Chad Wilhelmi, as vice President of quality control and regulatory affairs.
We continue to strengthen the talent level within the company with the appointment of Dr. Maria Vamara, an industry recognized expert with thin film electrode technology.
We continued to strengthen the talent level within the company with the appointment of Dr. Maria Humira and industry recognized expert with thin film electrode technology.
She will help drive the development process for our spinal cord stimulation program.
She will help drive the development process for our spinal cord stimulation program.
During the quarter, the company was also featured on the Claim and Countdown nationally syndicated financial program airing on the Fox Business Net.
During the quarter. The company was also featured on the claimant count down nationally syndicated financial program airing on the Fox business Network. We also presented at the Roth Capital Partners investment banking conference and the Oppenheimer Virtual Health care Conference.
We also presented at the Roth Capital Partners Investment Banking Conference and the Oppenheimer Virtual Healthcare Conference.
In closing, the company remains confident in the current design and test results of the Evo SEEG product line and have a plan in place no matter the outcome of our FDA appeal meeting.
In closing the company remains confident in the current design and test results.
Evo Seg product line and have a plan in place no matter the outcome of our FDA appeal meeting.
Most importantly, we are more confident than ever about the value and differentiators our products will bring to their respective markets.
Most importantly, we are more confident than ever about the value and differentiators our products will bring to their respective markets. I'm also pleased in our progress to reduce cost decreased supply chain risk and development progress with our ablation program chronic use electrodes and new connector we re.
I'm also pleased in our progress to reduce costs, decrease supply chain risk, and development progress with our ablation program, chronic use electrodes, and new connectives.
We remain enthusiastic and confident as we continue to address both our short-term and long-term company objectives.
Remain enthusiastic and confident as we continue to address both our short term and long term company objectives.
Thank you for your time and attention. I would now like to turn it over to Ron McClurg for a review of fiscal first quarter, sorry, second quarter financial results. Ron.
Thank you for your time and attention I would now like to turn it over to Ron <unk> for a review for a review of fiscal first quarter, sorry second quarter financial results.
Thank you Dave.
Product revenue was $37,000 in the second quarter of fiscal 2022 compared to product revenue of $18,000 in the second quarter of fiscal 2020.
Product revenue was 37000 in the second quarter of fiscal 2022 compared to product revenue of 18002nd quarter in fiscal 'twenty one.
Collaboration revenue was delayed in the second quarter of fiscal 2022 due to the FDA
Collaboration revenue was delayed in the second quarter of fiscal 2022 due to the FCA decision compared to collaboration revenue of $20000 in the second quarter of fiscal 2021.
compared to collaboration revenue of $20,000 in the second quarter of fiscal 2021.
Vibration revenue in the prior year was derived from the Zimmer Development Agreement and represented the portion of the upfront initial development fee payment that was eligible for revenue recognition as of March 30.
Collaboration revenue in the prior year was derived from the Zimmer development agreement and represented the portion of the upfront initial development. The payment that was eligible for revenue recognition as of March 30 <unk>.
Total operating expenses in the second quarter of fiscal 2022 were $3 million compared to $2 4 million in the same period of the prior year.
The total operating expenses in the second quarter of fiscal 2022 were $3 million compared to $2.4 million in the same period of the prior year. R&D expenses were $3 million compared to $2.4 million in the same period of the prior year.
R&D expenses in the second quarter.
or 1.8 million compared with 1.3 million in the same period of fiscal 2020.
Or $1 8 million compared with $1 3 million in the same period of fiscal 2021.
SG&A expense in the second quarter of fiscal 'twenty, two was $1 2 million compared with $1 1 million in the prior year period.
SGNA expense in the second quarter of fiscal 22 was 1.2 million compared with 1.1 million in the prior year.
Our net loss is 3.1 million for the first second quarter of fiscal 2022 compared to a net loss of 2.4 million in the second quarter of fiscal 2021.
Our net loss was $3 1 million for the second quarter of fiscal 2022 compared to a net loss of $2 4 million in the second quarter of fiscal 2021.
As of March 31, 2002, the company had cash of $12 9 million compared to $16 2 million at December 31, and.
As of March 31st, 2022, the company had cash of $12.9 million compared to $16.2 million at December 31st and $6.9 million at September 30th, 2021, our fiscal year at.
$6 9 million at September 32021, our fiscal year end.
Once again the company had no debt outstanding at March 31, 2022.
Once again, the company had no debt outstanding at March 31.
That concludes my remarks, I'll now pass it back to the operator to open up the call for questions and answers. Thank you.
That concludes my remarks. I'll now pass it back to the operator to open up the call for questions.
Thank you. At this time, we'll be conducting a question and answer session.
Thank you at this time, we'll be conducting a question and answer session.
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Our first question comes from Alec Nolak with Craig Hallam. Please proceed with your question.
My first question comes from Alex Nowak with Craig Hallum. Please proceed with your question.
Great. Good afternoon, everyone. This is connor on for Alex.
Great. Good afternoon, everyone. This is Connor on for Alex. You know, I guess, first of all, I'd be interested to hear, you know, just kind of updated conversations with Zimmer and the agreement, you know, are they experiencing any, any sort of, you know, delays on their side? You know, I know you mentioned the meeting with the neurosurgeons, you know, so just any more color on the Zimmer piece at this point.
I guess first of all I'd be interested to hear just kind of updated conversations with them are in the agreement.
Are they experiencing any any sort of delays on their side.
I know you mentioned the meeting with the neurosurgeons.
So just any more color on the Zimmer piece at this point.
Yeah, so Zimmer obviously is part of our agreement with them was that they would provide the bulk of the accessories that are needed to use this device with the robot.
Yes, so zimmer.
Obviously as part of our agreement with them was that they would provide the bulk of the accessories that are needed.
To use this device with the robot.
That is not yet done, so yes, they are still not yet done with all the accessories.
That is not yet done so.
So yes they are.
They are still not yet done with all the accessories.
You know, the feedback that we've gotten from them is that things are progressing feedback during the meeting with physicians was positive regarding their accessories. But we're really talking about, when I say accessories, drill, a drill bit, cotterie device, you know, a ruler that's used inside the brain.
The feedback that we've gotten from them is that things are progressing feedback during the meeting with physicians was positive regarding their accessories now, but we're really talking about when I say accessories drill drill bit cottery device.
That's used inside the brain so.
You know, we're not we're not discussing, you know, projects that that typically have long timelines, especially given that most of these are accessories are really in their wheelhouse.
We're not we're not discussing.
Projects that typically have long timelines, especially given that most of these are accessories are really in their wheelhouse.
But no, they're not finished with all the accessories either.
But no there are not finished.
With all of the accessories either.
Sure, Okay, and then I guess just thinking about this year.
Okay and then I guess just thinking about this year you know regardless of what happens with the FDA decision here coming up shortly you know you're planning this this other study just in case I believe it was the subacute toxicity testing you know I guess going thinking about that how should we think about costs trending throughout the year um just any any detail that would be helpful okay
Regardless of what happens with the FDA decision here coming up shortly.
We're planning. This this other study just in case I believe it was in the sub acute toxicity testing I guess thinking about that how should we think about costs trending throughout the year just any detail there would be helpful too.
Yeah, Ron do you want to take that.
Sure. The, most of the costs that we're incurring at this point in time are related to our ongoing projects and product development, specifically, we have, we have switched our focus in the development side to the combination device that Dave mentioned earlier, the RF ablation device. And then also working on some of those longer term products.
Sure.
The most of the costs that we're incurring at this point in time are related to our ongoing projects and product development, specifically, we have switched our focus in the development side too.
The combination device that Dave mentioned earlier, the RF ablation device and then also working on some of those longer term.
Products, which would be the chronic.
The electrons that would be used for chronic use both.
the electrodes that would be used for chronic use, both in recording as well as in stimulation.
Recording as well as in stimulation.
The, we have incurred some additional costs during primarily the second quarter the most recent one as it relates to additional testing and components that were needed for the testing and those were as I said reflected in our fiscal second quarter results. At this point in time there will be not a material increase in any costs related to that testing. Most of that.
We have incurred some additional costs during primarily the second quarter.
The most recent one.
As it relates to additional testing and components that were needed for the testing.
Those were as I said reflected in our fiscal second quarter results. At this point in time, there will be not a material increase in any costs related to that testing.
Most of that has been accounted for at this point.
Okay. That's.
Sure, that's helpful. All right, that's it for me at this point. I'll hop back in the queue. Thanks.
That's helpful. Alright, that's it for me at this point I'll hop back in queue. Thanks.
Thank you. Thank you.
Our next question comes from Ben Hayner with Alliance Global Partners. Please proceed with your question.
Our next question comes from Ben Hayner with Alliance Global Partners. Please proceed with your question.
Good afternoon, gentlemen. Thanks for taking the questions. I was just wondering if you could provide any more color on the appeal call with the FDA, I mean, you know, you mentioned that they didn't ask any questions, but did they give you any kind of
Hey, good afternoon, gentlemen, thanks for taking my questions. I was just wondering if you could provide any more color on the appeal call with the FDA.
You mentioned that they didn't ask any.
Questions, but did they give you any kind of.
I don't know if feedbacks, the right word but.
I don't know, feedback's the right word, but information on the initial rejection or anything on that front.
Information on.
The initial rejection or anything on that front.
Yes so.
Thanks for the question, Ben, too. So FDA, in most of the meetings, in a wide variety of topics that I've attended with them, there's usually not a tremendous amount of dialogue. Keep in mind, this was a one-hour meeting. That's part of the official appeal process. You'd get an hour to state your case.
Thanks for the question Ben too so.
So FDA in most of the meetings and a wide variety of topics.
That I've attended with them.
There is usually not a tremendous amount of dialogue and keep in mind. This was a.
A one hour meeting.
That's part of the official appeal process, you would get an hour to state your case.
You know, the FDA had, I think it was, the final count was 14 individuals, so it's, I think, you know, kind of limiting for them as well to ask questions, but, you know, our presentation probably took about 20, 25 minutes.
<unk> had I think it was the final count was 14 individuals. So I think kind of limiting for them as well to ask questions but.
Our presentation, probably took about 2025 minutes.
and the point person at FDA that was really running the meeting.
And the point person that FDA that was really running the meeting.
at the end of our presentation did reach out to his team to see if there was any questions on
At the end of <unk>.
Our presentation did reach out to his team.
See if there was any questions on the rationale of the Doctor Wisdom Berg provided and there were none.
the rationale that Dr. Wustenberg provided, and there were none. And that was really the extent of the call. But I think it was really well laid out by Dr. Wustenberg. So I'm not sure that FDA would have had
And that was really the extent of the call, but I think it was really well laid out by Dr. Loosen birth, so I'm not sure that FDA would have had.
know, a lot of questions on it. We did provide the presentation a few days in advance, so the FDA did have the ability to at least, you know, review the material. This wasn't the first time they were saying it. But that was really the bulk of the discussion other than them informing us, you know, as to when they would get back to us.
A lot of questions on it we did provide the presentation a few days in advance so.
The FDA did have the ability to at least review the material. This wasn't the first time they were saying it.
But that was really the bulk of the discussion other than them informing us.
As to when they would get back to us.
Okay, so it kind of seems like a bit of an odd situation, not asking any questions, but it's understandable why it works that way. And then, you know, just if you do, if they come back and say, you know, continue doing the test that's about compatibility test that you've already commenced.
Okay.
Yes.
And it kind of it seems like a bit of an odd situation that I ask any questions, but I understand why.
Why it works that way.
And then just if you do come back and say.
Continue doing the test.
Ability tests that you've already.
When you resubmit that if you have to I mean this is a.
You know, when you resubmit that, if you have to, I mean, is there really any change to the submission aside from the biocompatibility that would need to take place?
Or really any change to the submission of aside from the biocompatibility sales so it needs to take place.
No.
No. So that was, you know, when you look at the questions that FDA had in the latest submission, really what their issue was was with this particular test. So there wasn't, you know, anything in addition to that, you know, that would cause us to redo anything or, or, you know, have to perform anything that we, any testing that we hadn't performed before.
That was when you look at the questions that FDA had.
In the latest submission really what.
What their issue was was with this particular test so there wasn't anything in addition to that.
That would cause us to redo anything or.
Sure.
You don't have to perform anything that we any testing that we added performed before.
Yeah.
Okay, okay, got it. And then, you know, just given your activities with Zimmer, you know, you guys going out and qualifying new suppliers, the fact that you've got the first order and inventory and ready to ship, you know, it doesn't seem like Zimmer's any less gone whole about the product than they have. I mean, is that a fair characterization?
Okay.
Got it and then.
Just given your activities with Zimmer you guys got a qualifying new suppliers.
<unk> got the first <unk>.
And inventory ready to ship.
It doesn't seem like Zimmer is any less gung ho about the product.
Yes.
I mean is that a fair characterization.
In my opinion, yes, you know, I'm, you know, I think, you know, just the mere fact that they invited us to, you know, to their meeting, you know, that they that they had with this advisory board, you know, all the signs that we see from them is that they're still engaged, you know, with this program, they're still excited and, you know, they haven't given us any reason to think otherwise.
In my opinion, yes.
Yes.
I think just the mere fact that they invited us to.
They're meeting.
That they that they add with this advisory board.
All the signs that we see from them is that they're still engaged.
With this program, we're still excited and.
They haven't given us any reason to think otherwise.
Okay, great. And then, you know, maybe any more color on how the spinal cord stem development's going and anything you could share about Dr. Romero's background that would be relevant.
Okay, Great and then.
And maybe any more color on how the <unk>. Despite of course stem developments going and anything you could share about.
Dr <unk> background.
That would be relevant.
Yes, so about her background.
Yeah, so about her background, she's got a wealth of experience.
He's got a wealth of experience.
with polyimid materials. So that's the materials that we're using today. She's also very familiar with
With polyamide materials. So that's the materials that we're using today.
He is also very familiar with.
with our, we'll call it our new design without giving too much away and we really needed to provide some additional resources. You know, I think litmus test for us with this five year testing and our comfort level to say, okay, yes, we really think that that these devices.
With our we'll call it our new design without giving too much away.
And we really needed to provide some additional resources I think the litmus test for US was this five year testing.
And our comfort level to say, okay. Yes, we really think that that these devices will have the durability that we need.
You know, we'll have the durability that we need and, you know, after, after seeing the results, you know, we went out and, you know, felt that we really needed to have a specific person focus on this from a development standpoint.
And after after seeing the results.
We went out and felt that we really needed to.
To have a specific person focus on this from a development standpoint, she has got great manufacturing experience great thin film experience.
She's got great manufacturing experience, great film experience.
You know, if you did a Google search of her, you'd see her, you know, as an author in some of the papers. So, my time with her has been short since she's relatively new with the company. But, you know, I'm really shocked at how advanced she is, and even some of the ideas she has that she has for, you know, making this spinal cord stem electrode even more exciting than, you know, what.
You did a Google search over you'd see her.
As an author and some of the papers. So my time with or has been in shorts and she is relatively new with the company but.
I am really shocked at how advanced she is.
And even some of the ideas. She has that she has for.
Making this spinal cord stem electrode even.
Even more exciting than what.
what I had originally expected. So I think what we're gonna wind up with, and I don't wanna get too far of myself, but the path that I saw and the opportunity that I saw with the electrode, I think she's got some other ideas to make it even more interesting with physician. So we've recently gone out and brought on some,
What I had originally expected so I think what we're going to wind up with I don't want to get too far myself, but.
The path that I saw on the opportunity that I saw with the electrode.
I think she's got some other ideas to make it even more interesting.
With physician so we've recently gone out and brought on some.
some, both neurosurgeons as well as anesthesiologists who, you know, also place a number of these devices and do a number of these procedures and initiate discussions with them about, you know, some of these new ideas and, you know, there's an excitement level. We still got a lot of work to do, but I think she's really going to accelerate the process for us and I think some of her ideas already are
Some of both.
Neurosurgeons as well as anesthesiologists, who.
Also place a number of these devices and do a number of these procedures.
Initiated discussions with them about some of these new ideas.
There is an excitement level, we still got a lot of work to do but I think he is really going to accelerate the process for us and I think some of her ideas already or.
so much further beyond what I had even anticipated.
So much further beyond what I had even anticipated.
So today, too, and on that front, we might have some intriguing thoughts.
So stay tuned on that front than we might have some intriguing.
Please go ahead.
Yeah, I think that some of the advantages that I saw with the technology, I think she's expanding beyond that with what she feels we may be able to do with the design of this electrode.
Yes.
Think that some of the advantages that I saw with the technology I think she is expanding beyond that with with what she feels we may be able to do with the design of this electrode.
So.
Now, once we get a little further along, we'll disclose more about what we're doing, but I don't wanna go into too much detail at this stage.
No one's once we get a little further along that we'll disclose more.
What we're doing but I don't want to go into too much detail.
Age.
Well, that's all I had gentlemen, thanks for taking the questions and we'll be in touch.
Fair enough.
That's all I had gentlemen, thanks for taking the questions.
They touch.
Thank you.
We've reached the end of the question-and-answer session, and this concludes today's conference. You may disconnect your lines at this time, and we thank you for your
We've reached the end of the question and answer session and this concludes today's conference you may disconnect. Your lines at this time and we thank you for your participation.