NeuroOne Medical Technologies Corp (NMTC) 2023 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. And welcome to the NeuroOne Medical Technologies Corporation first-quarter fiscal year 2023 financial results conference call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; and Chief Financial Officer, Ron McClurg.

女士們，先生們，謝謝你們的支持。歡迎參加 NeuroOne Medical Technologies Corporation 2023 財年第一季度財務業績電話會議。今天的電話會議將由公司首席執行官 Dave Rosa 主持；和首席財務官 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 US federal securities 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.

在我將電話轉給羅莎先生之前，我想提醒您，本次電話會議將包括美國聯邦證券法意義上的前瞻性陳述，涉及未來運營、財務業績、事件、趨勢和業績，這是基於管理層截至今天電話會議或其他指定日期的信念和假設。

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. See NeuroOne's corporate update, press 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.

前瞻性陳述可能涉及已知和未知的風險、不確定性和其他因素，這些因素可能導致實際結果與此類陳述明示或暗示的結果存在重大差異。有關可能導致實際結果不同的特定風險和不確定性的信息，請參閱 NeuroOne 的公司更新、新聞稿和 SEC 文件。除法律要求外，我們不承擔更新此類前瞻性陳述的義務。

With that said, I'll turn the call over to Dave Rosa, CEO of NeuroOne. Dave?

話雖如此，我將把電話轉給 NeuroOne 的首席執行官戴夫羅莎。戴夫？

Thanks, operator, and thanks, everyone, for your attendance today.

謝謝接線員，也謝謝大家今天的出席。

During our first fiscal quarter, we achieved one of the most significant milestones in the company's history when we received FDA 510(k) clearance for the Evo sEEG electrode for less than 30 days use. Zimmer Biomet is still targeting the end of the first calendar quarter of 2023 to begin a limited commercial launch. We're particularly excited about the synergies that exist between using Zimmer's ROSA robotic platform with our Evo sEEG electrode.

在我們的第一個財政季度，我們獲得了 FDA 510(k) 對使用不到 30 天的 Evo sEEG 電極的許可，這是公司歷史上最重要的里程碑之一。 Zimmer Biomet 仍計劃在 2023 年第一季度末開始有限的商業發布。我們對使用 Zimmer 的 ROSA 機器人平台與我們的 Evo sEEG 電極之間存在的協同作用感到特別興奮。

The company also shipped the initial Evo sEEG limited market release order to Zimmer Biomet during the first fiscal quarter and continue to manufacture product to meet additional orders for a future full product launch.

該公司還在第一財季向 Zimmer Biomet 發出了最初的 Evo sEEG 有限市場發布訂單，並繼續製造產品以滿足未來完整產品發布的額外訂單。

We also made tremendous progress with our OneRF therapeutic ablation electrode system as we completed a successful animal feasibility study with Dr. Jamie Van Gompel at the Mayo Clinic in Rochester, Minnesota. The results confirm that the system is capable of both recording brain activity and ablating brain tissue using the same electrode.

我們在 OneRF 治療性消融電極系統方面也取得了巨大進步，因為我們與明尼蘇達州羅切斯特梅奧診所的 Jamie Van Gompel 博士成功完成了動物可行性研究。結果證實，該系統能夠使用同一電極記錄大腦活動和消融腦組織。

I'm also pleased to report that we met our goal of completing the development of the system by the end of calendar year 2022. We are excited that the system is performing to our specifications, and our final steps are to complete design validation testing. We also remain on target to submit a 510(k) application to the FDA early in the second calendar quarter of 2023.

我也很高興地報告，我們實現了到 2022 日曆年年底完成系統開發的目標。我們很高興系統按照我們的規格運行，我們的最後步驟是完成設計驗證測試。我們還計劃在 2023 年第二季度初向 FDA 提交 510(k) 申請。

Now I'll discuss our efforts in developing electrodes that could be used for chronic stimulation and recording.

現在我將討論我們在開發可用於慢性刺激和記錄的電極方面所做的努力。

Our focus remains on treating chronic back pain due to multiple failed back surgeries. Our goal is to offer a percutaneously placed paddle electrode that can be deployed in a comparable manner to existing percutaneous systems, while offering an increased stimulation area, improved conformability, and lower energy requirements.

我們的重點仍然是治療因多次背部手術失敗而導致的慢性背痛。我們的目標是提供一種經皮放置的槳狀電極，它可以以與現有經皮系統類似的方式部署，同時提供更大的刺激面積、更好的適應性和更低的能量需求。

We have already developed and tested percutaneous delivery system prototypes that have received positive feedback from key opinion leaders.

我們已經開發並測試了經皮給藥系統原型，這些原型得到了主要意見領袖的積極反饋。

The company also engaged in discussions with potential strategic partners and are exploring opportunities to expand our offerings to other markets. While there is nothing definitive yet regarding these discussions, I am pleased to see the level of interest in our technology.

該公司還與潛在的戰略合作夥伴進行了討論，並正在探索將我們的產品擴展到其他市場的機會。雖然關於這些討論還沒有定論，但我很高興看到對我們技術的興趣程度。

We are also continuing to explore the potential for our technology to offer the ability to deliver genes or drugs as well as record the agent's impact to the patient. We expect to conduct preclinical feasibility studies to assess the device's potential but are enthusiastic based on physician feedback to date.

我們還在繼續探索我們的技術的潛力，以提供傳遞基因或藥物以及記錄藥物對患者影響的能力。我們希望進行臨床前可行性研究以評估該設備的潛力，但根據醫生迄今為止的反饋，我們對此充滿熱情。

The company was also active with poster presentations highlighting the Evo sEEG electrode performance at the following meetings: Congress of Neurological Surgeons, Society of Neuroscience, and the American Epilepsy Society. Our products were also displayed at the Zimmer Biomet booths at the CNS and AES meetings. We will continue to target key society meetings to present our data in an effort to increase our exposure.

該公司還積極在以下會議上通過海報展示強調 Evo sEEG 電極的性能：神經外科醫生大會、神經科學學會和美國癲癇學會。我們的產品還在 CNS 和 AES 會議上的 Zimmer Biomet 展位上展出。我們將繼續針對重要的社會會議展示我們的數據，以努力增加我們的曝光率。

And relating to increased exposure, I also had the pleasure of being interviewed on the show, Mornings with Maria, during the quarter as well. In addition, the company was invited to ring the Nasdaq stock market closing bell to celebrate the FDA clearance milestone for the Evo sEEG technology.

關於曝光率的增加，我也有幸在本季度的節目“Mornings with Maria”中接受了採訪。此外，該公司還應邀敲響納斯達克股市收市鐘，以慶祝 Evo sEEG 技術獲得 FDA 批准的里程碑。

Thanks for your time and attention. I would like to now turn the call over to Ron McClurg for a more in-depth review of our fiscal first-quarter financial results. Ron?

感謝您的時間和關注。我現在想將電話轉給 Ron McClurg，以更深入地審查我們第一財季的財務業績。羅恩？

Thank you, Dave. Product revenue was $115,000 in the first quarter of fiscal 2023 compared to product revenue of $34,000 in the first quarter of fiscal '22. We had collaboration revenue of $1.46 million in the first quarter of fiscal '23 compared to collaboration revenue of $6,000 in the first quarter of fiscal '22.

謝謝你，戴夫。 2023 財年第一季度的產品收入為 115,000 美元，而 22 財年第一季度的產品收入為 34,000 美元。我們在 23 財年第一季度的合作收入為 146 萬美元，而 22 財年第一季度的合作收入為 6,000 美元。

Collaboration revenue is derived from the Zimmer development agreement and represents a portion of the exclusivity licensing payment that is eligible for revenue recognition as of December 31, 2022.

合作收入來自 Zimmer 開發協議，代表截至 2022 年 12 月 31 日有資格確認收入的獨家許可付款的一部分。

Total operating expenses in the first quarter of fiscal '23 were $3.2 million compared with $2.8 million in the same period of the prior year. R&D expense in the first quarter was $1.6 million compared with $1.1 million in the same period of fiscal 2022. SG&A expense in the first quarter of fiscal 2023 was $1.66 million compared with $1.74 million in the prior-year period.

23 財年第一季度的總運營費用為 320 萬美元，而去年同期為 280 萬美元。第一季度的研發費用為 160 萬美元，而 2022 財年同期為 110 萬美元。2023 財年第一季度的 SG&A 費用為 166 萬美元，而去年同期為 174 萬美元。

We had a net loss of $1.7 million or $0.11 per share for the first quarter of fiscal '23 compared to a net loss of $2.8 million or $0.18 a share in the first quarter of fiscal '22.

我們在 23 財年第一季度的淨虧損為 170 萬美元或每股 0.11 美元，而 22 財年第一季度的淨虧損為 280 萬美元或每股 0.18 美元。

As of December 31 of 2022, the company had cash and short-term investments of $7.6 million compared to $11.1 million as of September 30, 2022, our most recent fiscal year-end.

截至 2022 年 12 月 31 日，公司的現金和短期投資為 760 萬美元，而截至 2022 年 9 月 30 日，即我們最近的財政年度結束時，公司的現金和短期投資為 1110 萬美元。

The company had no debt outstanding as of December 31, 2022.

截至 2022 年 12 月 31 日，公司無未償債務。

That concludes my remarks. I'll now pass it back to the operator to open up the call for Q&A.

我的發言到此結束。我現在將把它傳回給接線員，以打開問答電話。

(Operator Instructions) Alex Nowak, Craig-Hallum Capital Group.

（操作員說明）Alex Nowak，Craig-Hallum Capital Group。

Okay, great. Good afternoon, everyone. I know we are waiting for Zimmer to receive FDA approval for drill bits and some various accessories to go on the ROSA robot. And that was all going to be done after commercializing the depth electrode. So just where does Zimmer stand with those 510(k)s?

好的，太好了。大家下午好。我知道我們正在等待 Zimmer 獲得 FDA 批准用於 ROSA 機器人的鑽頭和一些各種配件。而這一切都將在深度電極商業化之後完成。那麼 Zimmer 對那些 510(k)s 有什麼看法呢？

Yeah. Regarding Zimmer, there was only one device that required a 510(k), and that was the drill bit, Alex. And they did receive 510(k) clearance on that.

是的。關於 Zimmer，只有一種設備需要 510(k)，那就是鑽頭，Alex。他們確實收到了 510(k) 許可。

Okay. So with that in hand, is there anything else that -- I guess, what is the next barrier to doing the commercialization at the end of this calendar year? Or is it more or less getting the reps trained, getting the product out there into the field, getting the initial sites trained up? Is there any other roadblocks or barriers to watch for, or is everything pretty much ready to go?

好的。所以有了這個，還有什麼——我想，在這個日曆年年底進行商業化的下一個障礙是什麼？還是或多或少地對銷售代表進行培訓，將產品推向現場，對初始站點進行培訓？是否還有其他需要注意的障礙或障礙，或者一切都準備就緒了嗎？

Well, they're still procuring some of the accessories. So at this time, I'm not aware that they have all the product that they need in terms of the accessories in-house yet. But in terms of regulatory holdups or anything like that, there shouldn't be.

好吧，他們仍在採購一些配件。所以目前，我還不知道他們是否擁有內部配件所需的所有產品。但就監管阻礙或類似問題而言，不應該有。

And yes, all the other things that you mentioned -- field training, site training -- the sites have been identified, at least the target sites that they plan on going to. But all that work really needs to be done in the next six weeks.

是的，你提到的所有其他事情——現場培訓、現場培訓——這些地點已經確定，至少是他們計劃去的目標地點。但所有這些工作確實需要在接下來的六週內完成。

Okay, understood. And then so, you've got the depth approved, which is great. Zimmer is committed to the launch, and they're ready to go with the ROSA robots. So how do we think about that launch? Is this going to be within the next 12 months to -- think of it like a hockey stick sort of worldwide launch? You're going to see it being used in a lot of ROSA cases -- maybe a majority of ROSA cases. Or should we expect it to be a bit more of a pilot rollout to select ROSA users? Just how do we think about modeling this?

好的，明白了。然後，您已經獲得批准的深度，這很棒。 Zimmer 致力於發布，他們已準備好使用 ROSA 機器人。那麼我們如何看待這次發射呢？這是否會在接下來的 12 個月內——把它想像成一種全球發布的曲棍球棒？你會看到它被用在很多 ROSA 案例中——也許是大多數 ROSA 案例。或者我們是否應該期望它更多地是針對選擇 ROSA 用戶的試點推出？我們如何考慮對此進行建模？

Yeah. So it's not going to be a worldwide launch. The device is only going to be commercialized in US. So we don't have OUS clearance, but it will be a controlled rollout.

是的。所以它不會在全球範圍內發布。該設備只會在美國商業化。所以我們沒有 OUS 許可，但這將是一個受控的推出。

So there are -- I do think that the first three to six months, we're obviously going to be making sure that everything is fine with the technology, which is really why you do a limited launch. We don't expect that there's going to be any issues based on the experience that we have. But it'll be a very controlled methodical launch at least in the first to second quarter.

所以有 - 我確實認為前三到六個月，我們顯然會確保技術的一切都很好，這就是你進行有限發布的真正原因。根據我們的經驗，我們預計不會出現任何問題。但至少在第一季度到第二季度，這將是一次非常可控的有條不紊的發布。

And then after that, I would expect -- I mean, the goal is for the technology to be used in all the procedures and all the robotic procedures.

然後在那之後，我希望 - 我的意思是，目標是在所有程序和所有機器人程序中使用該技術。

And to that point, in the initial KOL discussions that you've had, either yourself or Zimmer or together, with the KOL (technical difficulty) their initial feedback, do these initial sites intend to replace all their electrodes that they use with your electrode? Is it going to be using like a one-off situation at first and then slowly ramps?

就這一點而言，在您自己或 Zimmer 或一起進行的最初 KOL 討論中，根據 KOL（技術難度）他們的初始反饋，這些初始站點是否打算用您的電極替換他們使用的所有電極？一開始會像一次性情況一樣使用，然後慢慢增加嗎？

Yeah. So I haven't participated in discussions about how they plan on using it when Zimmer has held the meetings. I mean, we've definitely been able to attend the sessions where these doctors have been. But the feedback was -- that was really requested was on the electrode itself and the feel of it, the tactile feel of it, the features of it. There was definitely no discussion about using this in just select cases.

是的。所以我沒有參與關於他們計劃在 Zimmer 召開會議時如何使用它的討論。我的意思是，我們絕對能夠參加這些醫生去過的會議。但反饋是——真正需要的是電極本身及其感覺、觸感和特性。絕對沒有關於在特定情況下使用它的討論。

There would be no reason to use any other electrode over our electrode. And at least, none of that ever came up in any of the discussions that I participated in or had ever heard of. So this is intended to be a replacement for all of the sEEG electrodes that are being used today.

沒有理由在我們的電極上使用任何其他電極。至少，在我參與或聽說過的任何討論中，這些都沒有出現過。因此，這旨在替代當今使用的所有 sEEG 電極。

Okay, that's great. And then just two more questions. The first one is just any update around the pulse generator that you plan on using for the product to use electrode? I know you've talked about some potentially -- some strategic partnerships there in the past. Is there any update?

好的，那太好了。然後還有兩個問題。第一個是關於您計劃用於產品使用電極的脈衝發生器的任何更新？我知道你過去曾談論過一些潛在的——一些戰略合作夥伴關係。有更新嗎？

And then just the second question with regards to capital -- needs for capital -- just how to think about that. And should we also think about there could be -- whether it be something similar to Zimmer where you have non-dilutive capital come in through a partnership?

然後是關於資本的第二個問題——資本需求——如何思考這個問題。我們是否還應該考慮可能 - 是否與 Zimmer 類似，您通過合夥企業獲得非稀釋性資本？

Yeah. So I'll answer the capital part first. So yes, I mean, at some point, during the course of 2023, we're going to need capital. But regarding the ablation technology that I talked about, we'll just say there's been strategic interest in that technology.

是的。所以我會先回答大寫部分。所以是的，我的意思是，在 2023 年的某個時候，我們將需要資金。但關於我談到的消融技術，我們只會說對該技術有戰略興趣。

So the goal here is to explore non-dilutive capital first, and those discussions are happening now. That's always going to be the first option. And if not, obviously, there's other ways of generating capital.

所以這裡的目標是首先探索非稀釋性資本，這些討論現在正在進行中。這永遠是第一選擇。如果沒有，顯然還有其他產生資本的方式。

We have an ATM in place. We can always do a capital raise as well. But our efforts right now are really focused on non-dilutive capital, because of the interest in the ablation system that we have. And I'm sorry, but I forgot what your first question was.

我們有一台自動取款機。我們也可以隨時進行融資。但由於我們對消融系統的興趣，我們現在的努力實際上集中在非稀釋性資本上。對不起，我忘了你的第一個問題是什麼。

That's okay. Just any update around the pulse generator for chronic use?

沒關係。關於長期使用的脈衝發生器的任何更新？

No, I mean, the same options that we had before, we still have. So there's really nothing new with that. What we are working on, in addition to the electrode, is now we have to start designing the connectors so that the electrode can communicate with the system that we're intending to use. But nothing further on negotiations or anything like that.

不，我的意思是，我們仍然有與以前相同的選擇。所以這真的沒有什麼新鮮事。除了電極之外，我們正在努力的是現在我們必須開始設計連接器，以便電極可以與我們打算使用的系統進行通信。但沒有進一步的談判或類似的事情。

Okay, understood. Appreciate the update. Thank you.

好的，明白了。感謝更新。謝謝。

Thank you, Alex.

謝謝你，亞歷克斯。

Ben Haynor, Alliance Global Partners.

Ben Haynor，Alliance Global Partners。

Good afternoon, guys. Thanks for taking the questions. Just wanted to check one thing. Did you say Zimmer was launching -- planning on launching by the end of this calendar quarter, or was it the end of this calendar year?

下午好，伙計們。感謝您提出問題。只是想檢查一件事。你是說 Zimmer 正在推出——計劃在本日曆季度末推出，還是在本日曆年末推出？

It will not be this calendar year. It would be this calendar quarter.

不會是這個日曆年。這將是這個日曆季度。

Okay. I thought I heard that right. Okay, just making sure. Can you --?

好的。我以為我沒聽錯。好的，只是確定一下。你可以嗎 - ？

Don't scare me, Ben. Don't scare me.

別嚇我，本。別嚇我

Okay. Okay. Because I -- maybe I misheard it. I apologize. And then can you characterize the product forecast on the sEEG electrode that you've gotten, and then any implications that has for manufacturing on your end?

好的。好的。因為我——也許我聽錯了。我道歉。然後你能描述你得到的 sEEG 電極上的產品預測，然後對你的製造有什麼影響嗎？

Yes, so I mean, we have forecast that Zimmer has given us over the next 12 months. We're actually manufacturing right now, as I said in my comments, units for the rest of the year. So I'm not sure, in essence, what you're -- if you're wondering like what the impact is from a manufacturing capability. Is that where you're going, or is it something different?

是的，所以我的意思是，我們已經預測 Zimmer 在未來 12 個月內給了我們。正如我在評論中所說，我們現在實際上正在製造今年剩餘時間的設備。所以我不確定，本質上，你是什麼 - 如果你想知道製造能力的影響是什麼。那是你要去的地方，還是有什麼不同？

Well, yeah. I mean, I know historically or at least at points historically, you've mentioned that the product forecast is that Zimmer has given you -- [may have been] increasingly favorable or aggressive -- I don't know the right way to characterize it --but just getting that -- try to get at what their outlook is. Has that changed any positively or negatively? And then does that change what activities you have to undertake on the manufacturing side?

嗯，是的。我的意思是，我從歷史上或至少在歷史上知道，你提到過 Zimmer 給你的產品預測——[可能] 越來越有利或激進——我不知道正確的描述方式它——但只是得到它——試著了解他們的前景是什麼。這有積極或消極的變化嗎？那麼這是否會改變您在製造方面必須開展的活動？

Yeah. Well, I think you always have to be concerned with your supply chain of being able to meet, not just demand or the forecast that you have, but beyond that. So that -- we've been spending a lot of time with our supply chain to make sure that they can exceed what we're doing.

是的。好吧，我認為你總是必須關注你的供應鍊是否能夠滿足，而不僅僅是你擁有的需求或預測，但除此之外。所以——我們一直在我們的供應鏈上花費大量時間，以確保他們能夠超越我們正在做的事情。

So in terms of Zimmer and their attitude, I think Zimmer has always been excited about this technology from the time we signed the contract a few years ago. I mean this is the technology that's really synergistic with their robot. And they remain, at least, in all the discussions I have with them just as excited to get going as we are.

所以就 Zimmer 和他們的態度而言，我認為 Zimmer 從我們幾年前簽訂合同時就一直對這項技術感到興奮。我的意思是這是與他們的機器人真正協同的技術。至少，在我與他們進行的所有討論中，他們仍然和我們一樣對繼續前進感到興奮。

So I would say there's really no change. I think there's been this pent-up excitement that all of us has been waiting for over the last year. And hopefully, in the next couple of months, we'll be able to start the show.

所以我會說真的沒有變化。我認為在過去的一年裡，我們所有人一直在等待這種被壓抑的興奮。希望在接下來的幾個月裡，我們能夠開始演出。

Good. And then you mentioned, a couple of months, you've got the AANS meeting coming up here. Are there any activities you've planned around the Evo sEEG electrode that you've been privy to -- with the Zimmer launch or -- at that show or anything special planned that you can share?

好的。然後你提到，幾個月後，你在這裡召開了 AANS 會議。您是否已經計劃了圍繞 Evo sEEG 電極的任何活動，您已經知道 - 隨著 Zimmer 的發布或 - 在該展會上或您可以分享的任何特別計劃？

Yeah. I don't know what the plans are for that show outside of exhibiting. I think we also have to be careful, especially when you're doing a controlled launch, that you don't go out and try to bring too many sites on at one time.

是的。我不知道展覽之外的展覽計劃是什麼。我認為我們還必須小心，尤其是當您進行受控發佈時，不要出去嘗試一次打開太多站點。

So as I said earlier, it's going to be a very controlled methodical launch, where we walk before we run just to make sure everything's performing the way we need it to, and make sure that we have the product supply that we need when there's a full launch. But nothing that I'm aware of yet.

因此，正如我之前所說，這將是一次非常可控的有條不紊的發布，我們先走再跑，只是為了確保一切都按照我們需要的方式進行，並確保我們有我們需要的產品供應。全面啟動。但我還不知道。

Okay, no problem. And then a couple on the R&D project. You're going to submit OneRF in a couple of months here, it sounds like it. What's [going] to be beyond the V&V and the additional animal testing there?

好的沒問題。然後是研發項目的一對夫婦。您將在幾個月後在這裡提交 OneRF，聽起來是這樣。除了 V&V 和那裡的額外動物測試之外，還有什麼 [going]？

Yeah. I mean, it's really documentation beyond that, and it's not trivial. So we've completed -- let's just say we've gone through the heavy lifting. I mean, I'm not trying to minimize the amount of testing that has to be done because it's not trivial.

是的。我的意思是，它實際上是除此之外的文檔，而且不是微不足道的。所以我們已經完成了 - 可以說我們已經完成了繁重的工作。我的意思是，我並不是要盡量減少必須完成的測試量，因為這不是微不足道的。

But once we got the design behind us and the development behind us and some of these additional feasibility studies -- I mean, we feel really good about the technology and where we're at that we will be able to submit sometime early in Q2.

但是一旦我們完成了設計和開發以及其中一些額外的可行性研究——我的意思是，我們對這項技術和我們所處的位置感覺非常好，我們將能夠在第二季度早些時候提交。

Now that's barring anything unforeseen in this DV testing. I mean, there's always something that could come up. But so far, I mean, last few months, we've been doing a lot of testing with the system and are really encouraged with the performance.

現在，除非在此 DV 測試中出現任何不可預見的情況。我的意思是，總有一些事情會發生。但到目前為止，我的意思是，過去幾個月，我們一直在對該系統進行大量測試，並且對性能感到非常鼓舞。

Okay, great. And then on the drug delivery device that can stimulate and record, is that something that you could potentially generate some near-term revenue for drug trials and such or research-use only applications? I know you mentioned you plan a preclinical study. But how quickly could there be revenue associated with that device?

好的，太好了。然後在可以刺激和記錄的藥物輸送設備上，你是否有可能為藥物試驗等或僅用於研究的應用程序產生一些近期收入？我知道你提到過你計劃進行一項臨床前研究。但是，與該設備相關的收入能多快出現？

Well, it's not like you're starting over from scratch to develop this. Now if you were going to develop your own drug pump, that obviously would add to the time. But what we're trying to do is to really leverage the design that we have now to be able to do this with an off-the-shelf system -- drug pump.

好吧，您並不是要從頭開始開發它。現在，如果您要開發自己的藥物泵，那顯然會增加時間。但我們正在嘗試做的是真正利用我們現在擁有的設計，以便能夠使用現成的系統——藥泵來做到這一點。

So near-term revenue, I mean, it depends on how you define near term. I mean, this is not expected to be a PMA with an extremely long development process. But we have to make sure that we can deliver the drug in an efficacious way. Because there are things that you have to take into consideration in terms of backflow and even drug dispersion that we've only done some initial testing on.

所以近期收入，我的意思是，這取決於你如何定義近期。我的意思是，預計這不會是一個開發過程極其漫長的 PMA。但我們必須確保我們能夠以有效的方式提供藥物。因為在回流甚至藥物擴散方面你必須考慮一些事情，我們只做了一些初步測試。

So if your question is really like in the next 6 months, no, I don't think we'll be ready to generate revenue in that time frame. But the goal here is to expedite this as quickly as we can.

因此，如果您的問題真的是在接下來的 6 個月內，不，我認為我們不會準備好在那個時間範圍內產生收入。但這裡的目標是盡快加快這一進程。

And I do think, Ben, that the feedback that we have is that, it would not only have a place for research studies, but it could also have clinical benefit. So with the device in place, you could deliver a drug theoretically through the lumen and actually see the impact to the brain tissue that a neurosurgeon is intending to remove. And depending upon the reaction to that drug, it may inform the surgeon that this may not be a good thing to do -- to remove this particular tissue.

我確實認為，本，我們得到的反饋是，它不僅可以用於研究，還可以具有臨床益處。因此，有了這個裝置，理論上你可以通過管腔輸送藥物，並實際看到神經外科醫生打算切除的對腦組織的影響。並且根據對該藥物的反應，它可能會通知外科醫生這可能不是一件好事——去除這個特定的組織。

So there's definitely some therapeutic benefit to what this can do clinically as well. And we're investigating whether or not we can proceed with this with a 510(k).

因此，這在臨床上也可以起到一定的治療作用。我們正在調查是否可以通過 510(k) 繼續進行。

Okay. Okay. So stay tuned there. And then lastly from me, regarding the spinal cord, still electrode, anything we should be on the lookout there for in the near term, maybe on -- potential for a partnership agreement?

好的。好的。所以請繼續關注那裡。然後最後來自我，關於脊髓，仍然是電極，我們在短期內應該在那裡尋找的任何東西，也許是——潛在的合作協議？

Yeah. That I can't talk about because, I mean, there is a possibility. But there's really nothing I can report at this time. I do think you'll see some additional reports on just preclinical testing that we're doing and really, in particular, how we're going about it.

是的。我不能談論這個，因為，我的意思是，有可能。但目前我真的沒有什麼可以報告的。我確實認為你會看到一些關於我們正在進行的臨床前測試的額外報告，特別是我們將如何進行。

But as far as any strategic discussions and things like that, that's going to take some time, assuming that it continues to move forward. So really can't talk anymore about that.

但就任何戰略討論和類似事情而言，假設它繼續向前發展，這將需要一些時間。所以真的不能再談這個了。

Okay, got it. Thanks for taking the questions, guys, and congrats on the progress.

好，知道了。感謝您提出問題，伙計們，並祝賀您取得的進展。

Thanks, Ben.

謝謝，本。

And we have reached the end of the question-and-answer session. And I'll turn now -- turn the call over to Dave Rosa for closing remarks.

我們已經結束了問答環節。我現在轉過來——將電話轉給戴夫·羅莎 (Dave Rosa) 作結束語。

I just want to, again, thank everyone for joining the call today. Please stay tuned for future progress. I think we really think it's going to be an exciting year this year with respect to the new technology that we've been developing.

我只想再次感謝大家參加今天的電話會議。請繼續關注未來的進展。我認為我們真的認為，就我們一直在開發的新技術而言，今年將是令人興奮的一年。

Thanks again and have a good evening.

再次感謝，祝您晚上愉快。

And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束，此時你們可以掛斷電話。感謝您的參與。