Operator: Good day, everyone, and welcome to the BIOCARDIA Q2 26 Financial Results and Corporate Update Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then 1 on your touch-tone on your touch-tone telephones, or keypads. To withdraw your question, you may press star and then 2. Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available at press approximately 1 hour after the end of today's conference. I would now like to turn the floor over to Miranda Peto of Biocardia Investor Relations. Please go ahead, Miranda.
Miranda Peto Benvenuti: Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter A. Altman, President and Chief Executive Officer and David McClung, the company's Chief Financial Officer. During this call, management will be making forward looking statements including statements that address Biocardia's expectations future performance and operational results, references to management's intentions beliefs, projections, outlook, analysis and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technology, and obtaining regulatory approval. Forward looking statements involve risks and factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in Biocardia's reports on Form 10 ks filed with the SEC on 03/24/2026, And in our subsequently filed quarterly reports on Form 10 Q. The contents of this call contains time sensitive information that is accurate only as of today 08/12/2026. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Dr. Peter A. Altman, Biocardia's President and CEO. Peter, please proceed.
Peter A. Altman: Thank you, Miranda. Good afternoon to everyone on the call. The highlights of this second quarter have been the positive outcomes of 3 important meetings with regulatory agencies in Japan The United States, on the approvability of our cardiac cell therapy for the treatment of ischemic heart failure and on the approvability of our HELIX transcendo cardio delivery catheter, which we use in our therapeutic programs. Let's take each of these in turn. In May, we announced that Japan's Pharmaceutical and Medical Device Agency or PMDA, provided the consultation record of advice which supports our advancing to Shonin premarket regulatory submission for approval of the CARDiAmp cell therapy. PMDA noted that the positive outcomes seen in our CARDI AMP trials were credible. We have remaining questions to address before, and as part of the submission for regulatory approval for this therapy. Specifically, PMDA requested BIOCARDIA demonstrate that enrolled patients were on guideline directed medical therapy. and not eligible for revascularization procedures. Both of which were required per the CardiAmp heart failure trial clinical protocol. They also requested additional details for each incidence of all cause death heart transplantation, or left ventricular assist device implantation. PMDA also provided guidelines and requested an initial proposal for further developing the post marketing study with details on center selection, physician selection, training and outcomes to be assessed. Biocardia believes these requests will be addressed to PMDA satisfaction and the post marketing study to be developed together with PMDA and Japanese medical societies will be straightforward. In addition to answering these questions in great quarter. detail, BioCardia is preparing for the Shonin regulatory submission in Japan next. We are working to complete the electronic trial master file conduct third party Japanese good clinical practice audits to PMDA standards and structure clinical research data in accordance with C DISC standards, which support data consistency traceability and regulatory compliance. We are reviewing extensive product documentation internally and expect to soon sign an agreement with a designated marketing authorization holder or DMAH to help finalize the submission as they will act as the local regulatory representative to enable BIOCARDIA sales of CARDI amp cell therapy in Japan. Our expected initial indication will be for approximately 20 thousand patients in Japan. With approval approximately 12 months after we complete our shonin submission. During this period, we would expect to be educating physicians and finalizing the details of the post marketing study and its logistics so that we are ready to begin at all centers as soon as reimbursement has been established. Reimbursement in Japan follows Shonin approval and will be determined based on discussions with the Ministry of Health, Labor and Welfare. In Japan, another cell therapy for the same indication was approved in March of this year. And has received confirmation that they have been approved for reimbursement in July at $326 thousand per treatment. This underscores the need recognized in Japan for such a therapy that cardiac cell therapy is now a real market in Japan and that cardiac cell therapy has potential to be an enormously valuable therapy. While these 2 cell therapies are different, we believe the minimally invasive delivery and autologous nature of CARDiA Amp. Coupled with its greater clinical experience will be attractive to both physicians and their patients. With approval and reimbursement, we would expect adoption to be relatively rapid in the post marketing study with world-class physician leaders who have already been generous in their support of our efforts. Although our initial approval is only expected to be for 20 thousand patients in Japan, We note that there are approximately 300 thousand patients in Japan with ischemic heart failure today. Japan's world-class interventional cardiologists performed 250 thousand cardiac catheterization interventions per year. Are enhancing both physician and patient success in the post marketing study where there will be reimbursement is likely to result in a significant business that has a very positive impact on patients and society in Japan. Shown in approval of CARDI Amp cell which includes the Helix biotherapeutic delivery catheter may also help other developers of cardiac biologic therapy in Japan. It is worth noting that the 2 publicly traded peer companies in Japan advancing cardiac cell therapies each have market capitalizations of $250 million and to our knowledge, BioCardia has performed more than 20x as many clinical procedures as both of these firms combined. Each is pursuing a different catheter delivery approach but we do feel we could be a valuable partner if we have not entered into an exclusive development agreement with a competitive party. We also have important issued patents on delivery in Japan. In June, we announced the results of our second significant regulatory discussion. Our Q Sub meeting with FDA's Center for Biologics Evaluation and Research, The meeting minutes from FDA confirm that the ongoing CardiAmp Heart Failure II trial may support premarket approval for market clearance. This was significant as previously the FDA had not provided the support that 1 trial should be sufficient for approval for this large clinical indication. FDA said the data was interesting and the message we are hearing is that the CardiAmp Heart Failure II trial is viewed as a confirmatory trial. There were no questions on safety or on delivery in the meeting, and our sense is that for the agency, the confirmatory trial is all about the efficacy of the study. We are expected to have additional discussions with the agency on the outcome measures in the study, in particular around the third tier of the composite outcome of quality of life. We continue to actively enroll in the cardiac CardiAmp Heart Failure II trial to take this study to completion as our confirmatory Phase III study. 4 clinical sites have enrolled in the study and are actively recruiting patients. 3 additional patients are expected to qualify for the study this month, and 2 are scheduled for their procedures this month. There have been no safety issues of which management is aware. Rate of enrollment here is driven primarily by resources deployed, and we are actively onboarding additional centers. In May, we had our third regulatory interaction on the de novo pre submission with FDA for the HELIX transendocardial delivery catheter system. FDA agreed that there are 2 pathways for Helix marketing clearance and raised no concerns on Helix safety data device performance or compatibility with general classes of agents. FDA's preferred route of Helix approval was simultaneous with the approval of the CardiAmp cell therapy system for the treatment of heart failure. FDA also suggested a follow on pre submission incorporating agency advice could enable Helix approval via the de novo pathway. However, we still do not have the formal meeting minutes from this meeting, which were expected June 12th. We did hear from FDA this morning by email that confirms our understanding, and FDA has said that they would have the formal minutes sent to us soon. Our assessment is that the Helix transendocardial delivery catheter system has the best safety, efficiency, and ease of use of any catheter of its kind. It takes years to generate this level of data. Which we have for more than a dozen clinical trials with approximately 500 patients. We feel it is unlikely that another transendocardial delivery system will be able to have this amount of data within the next 5 years. This catheter has been previously CE marked and approved for market release in Europe. The key value propositions for the FDA approval of Helix are enhanced partnering for Biocardia around Helix and simpler regulatory submissions for therapeutic approvals including our CARDI amp cell therapy in heart failure. On the business development front, we have active conversations in the Asia Pacific region on our cardiovascular therapeutics. While BioCardia fully expects to have boots on the ground in Japan, for the post marketing study as we transfer all of our experience to Japanese physician centers the DMAH is transferable. And the broader commercialization will be enhanced by an experienced team. Our expectation is that any deal has potential to include funding to advance CardiAmp for its second indication for chronic myocardial ischemia and our allogeneic CardiALLO therapy for inflammatory heart failure. To market clearance as well. Such a deal would enhance our efforts in the United States on all 3 of these programs. Business development on biotherapeutic delivery is also active. We believe we can help many of those in development particularly for gene based therapy. There is a great deal more possible with intramyocardial delivery that is not well appreciated by many firms today. These possibilities are enhanced by the potential of heart 3 d fusion imaging we are working diligently with our respected partner, CARTO, to bring to the clinic and to the market as soon as possible. Today, we believe we have the capital to complete the significant and potentially transformative milestone of PMDA submission of CardiAmp therapy. In parallel to the deals we are working to realize, a modest financing with long investors would accelerate the confirmatory cardiac heart failure 2 program. With that, I will now pass the call to David McClung, our CFO who will review our second quarter 26 financial results. David?
David McClung: Thank you, Peter, and good afternoon, everyone. I will now review the highlights of our financial results for the quarter and 6 months ended June 30, 2026. Net cash used in operations during the 3 months ended June 2026 was approximately $1.7 million increased slightly from the $1.6 million used in the 3 months ended June 2025. Net cash used in operations for the 6 months ended June 2026 of $3.4 million increased slightly from the $3.3 million used in the 6 months ended June 2025. These small increases are primarily due to the timing of supplier payments. During the second quarter, BioCardia raised net proceeds of approximately $4.9 million under our at-the-market facility at an average price of $1.22 per share. Funding from this facility has a lower cost of capital than traditional financing vehicles and does not involve the issuance of stock warrants or other dilutive securities. The company ended the quarter with cash and cash equivalents totaling $5.4 million providing runway into 2027. As we ended the quarter with ended the quarter with $2.7 million in equity, which we believe keeps us compliant now with NASDAQ listing standards. Total expense decreased by $400 thousand quarter-over-quarter, to $1.6 million in the second quarter of 26 compared to $2.1 million in the same quarter of 2025. For the 6 months ended June 2026, total expense decreased $900 thousand to $3.9 million from $4.8 million. The primary driver of these changes, research and development expense decreased $500 thousand to $900 thousand in the second quarter of 26 compared to $1.4 million the second quarter of 25 and it decreased $800 thousand to $2.1 million for the 6 months ended June 2026 compared to $2.9 million for that same period in 2025. The decreases relates primarily to the closeout of the CardiAmp heart failure trial partially offset by expenses for early enrollment in the CARDI Amp heart failure 2 trial and continuing regulatory activities to advance CardiAmp in Japan. Selling, general and administrative expenses remain consistent at $700 thousand quarter-over-quarter. For the 6 month period ended June 2026, SG&A decreased slightly to $1.8 million from $1.9 million for the 6 months ended June 2025. Our net loss was $1.6 million for the second quarter of 26 compared to $2 million in the second quarter of 25. For the 6 month period ended June 2026, our net loss was $3.9 million compared to $4.9 million for that period in 2025. The June SEC proposal to eliminate the baby shelf limitation that constrains access to registered offerings and ATM programs for smaller companies is expected to be beneficial for Biocardia when implemented. It would be great if this were available to Biocardia in Q1 27. This concludes management's prepared comments. And we are now ready to take questions from attendees.
Operator: Ladies and gentlemen, at this time, we will begin the question-and-answer session. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys. If at any time your question has been addressed, you would like to withdraw your question, you may press star and then 2. At this time, we will pause momentarily to assemble the roster. Our first question today comes from Joe Pantginis from H. C. Wainwright. Please go ahead with your question.
Joe Pantginis: Hi, guys. Good afternoon. Thanks for taking the questions. So Peter, a couple of things, I guess, spanning geographies. Let me go backwards with regard to your prepared comments. So with regard to the pending FDA minutes, obviously, we will wait to see what they say, but what would you say are the key points that are outstanding?
Peter A. Altman: Well, hello, Doctor. Pantginis. it is great to speak with you, Joe, and thank you for the question. The first element on this is the nuances for the de novo submission for Helix. So we have some good clarity on how this has potential to be the first transendocardial biotherapeutic delivery catheter approved by FDA via the de novo route. And really, the only thing we need clarity on is them to say, yes. that is the tweak for submission. The key issue with FDA is they have a very challenging time approving a delivery system for a biologic for a clinical indication, and a route of administration for which no therapeutic has yet been approved. And they have found ways to do that with sort of a skirt around with other firms, with other routes of administrations historically. Our conversation with them was approaching it head on saying, look. This is what we are trying to do. This is what the data says. Our expectation is that there internal processes are so rigid that we are going to have to also do a similar end around for our approval for this catheter system. And we have the data to support it and the experience to support it. So it is a de novo, so there is no other catheter approved with this route of administration. But for those on the call who may not be entirely familiar with the Helix transendocardial catheter. it is based on a design of active fixation pacing leads, which have been used in 1 million patients. And our data is second to none as published by independent parties. So I have also-- we have raised with the agency that there are many folks who are pursuing routes of administration for their therapeutic development that either makes no sense or is driven by the great desire to not have investigational delivery platform woven into their efforts. And so I think we can, the agency appreciates the value proposition of enabling approval of Helix. As I said in my prepared comments, their first choice would be approval with the CardiAmp cell therapy that is easy for them. that is straightforward for them. But I think they also recognize that by not having an approved delivery system, they are basically hampering the whole field of development. And so for all biologic interventions, in cardiology. And then my expectation and hope is that the Helix will be the first such product. The downside of a de novo for Biocardia is that does enable others to then file a 510(k) referencing our de novo but our expectation is they will have to demonstrate some of the performance characteristics that we can demonstrate. And so that will be a pretty significant barrier to entry still. Got it. Got it. No, I appreciate that color a lot.
Joe Pantginis: So 2 more questions if you do not mind, but going now to the focus-- please, welcome Joe. Hey. So, the first 1 is 2-pronged. So if you get approval in Japan, you said the initial target market is about 20 thousand patients. What efforts or what kind of components would be considered to expand that market? Number 1, And the second part is, obviously, you mentioned important I guess, derivative there with regard to ReHeart and the reimbursement that they are getting for about $326 thousand. I know it is hard to talk about comps sometimes, but maybe you could do a bit of a compare and contrast beyond what your prepared comments said.
Peter A. Altman: Sure. So on the 20 thousand patients for the initial indication, I think the way that has expanded is by success in this post marketing study. In Japan today, the patients that we will be treating truly have few options. They do not do a lot of heart transplantation in Japan. because they do not like the concept of implantation of other people's organs in another patient. And that is an advantage for our autologous cell therapy. But it also means that left ventricular assist devices, which is an implanted device, also has some reservations, by the patient community there. So the key thing to expand that 20 thousand patients is to have this post marketing study go as smoothly as possible, to have the physician experience be akin to what it is today in The United States, and we think we can deliver that. So that is-- as we go to Japan, PMDA has said they want us to stay with this program as it advances, and we will definitely be involved as this post marketing study is initiated and performed But our sense is with 250 thousand percutaneous coronary intervention procedures done per year, They have a very hungry interventional cardiology community for new therapies, and they have a very large patient population that has no real options. And so our sense is that just by delivering a great experience in this post marketing study, and beginning to educate the physicians that, working with PMDA, the indication, will expand in short order. And on the second comment on the how does this play with respect to the reimbursement and what are the differences between CardiAmp and the other re heart therapy that is approved Well, today, ReHeart requires surgical implantation. Which means that patient's chest has to be opened up as if you were doing a coronary artery bypass procedure or heart transplantation procedure. And then the cells are laid on the surface of the heart. Because they are not autologous, our expectation is that they will require chronic immunosuppression. And immunosuppression in these patients who have just had cardiac surgery can introduce other issues. Thirdly, is what we are doing with our approach You know, the data we have is pretty robust. And their data-- we have not seen their data. But my expectation is they have a total of 8 patients they have treated historically. So I think going in there with our experience and our data becomes compelling. And so as we look at, you know, their reimbursement, you know, that gives us a lot of room to have reasonable pricing And my sense is you know, that our confidence that our pricing will be strong for BIOCARDIA is there completely. If they are reimbursed at that level, that is great for them, and we wish their patients every positive. But I think it presents an opportunity where they are educating and they will be learning over the next year as we will be working through the regulatory process and I think on the other side of this, they will be a great peer company. We may also actually Joe, be able to help them on delivery. I mentioned that they are pursuing a different delivery approach today, but, you know, we have a great depth of experience. And so they are a potential partner to us. As well as arguably a competitor today with a different cell therapy approach. Our approach, interestingly, is an autologous mononuclear cell preparation. Theirs is an induced pluripotent stem cell preparation, the cells are intended to become cardiomyocytes. But they do not speak of their mechanism of action as 1 of replacing heart cells, but rather of triggering an angiogenic response. So there is still a lot that we are going to learn about them and that they will learn about us ahead. And hopefully, the physician community as well. But I am pretty confident that CardiAmp has a real Role In Japan. And can help quite a few patients.
Joe Pantginis: Thank you, Peter for that. Can you hear me? Yes, I can, Joe. Oh, perfect. Because my call actually dropped off. I was able to get back on real quick, so I heard your answers. So I am glad it was still connected. So my last question is regard to Japan, but more, I guess, expanding the concept. If you do get approved in Japan, plus all the discussions and data that you have with the FDA, how that might be applicable to additional geographies?
Peter A. Altman: it is a great question, Joe. Great question. So Japan is considered a first world country. And I think we have said previously that their inspection of our facilities and their approval of CardiAmp weighs in other countries around the world. So we have already had conversations around potential relationships in Brazil and United Arab Emirates. And, you know, those would arguably follow after we were successful with an approval in Japan. So I think Japan has potential to be much bigger than it is both in Japan, but also in rest of world. And it is tied into some of the harmonization on the inspection work that is been done. But, yeah, I think it has great potential. Thanks for the added color, Peter. Thank you, Joe. Appreciate the questions.
Operator: Our next question comes from James Molloy from Allianz Global Partners. Please go ahead with your question.
James Molloy: Hi, guys. Good afternoon. Thank you for taking my questions. I want to follow up a little more on Joe Pantginis' question about Japan. Can you walk me through sort of how the designated marketing authorization holder, how their partnership works, Is it like a traditional partnership? You would have with a partner in any other geography where they sell you, get a royalty. Can you break down how that will work? And is that partner I think you say in your prepared remarks, hoping to sign them soon. Is that partner, like, guaranteed to be signed or what are the next steps should you anticipate there?
Peter A. Altman: So appreciate the question, Jim. Appreciate you being on the call. The DMAH the designated marketing authorization holder, is a nuanced element of submission in Japan. So in this situation, this is actually a party that we contract with who essentially works for Biocardia. To represent all of the regulatory and quality issues associated with the cardiac cell therapy in Japan. This is-- when you do a distribution deal, or a partnership in Japan, oftentimes, partners will want to own the authorization. They will want to be the marketing authorization holder because it becomes harder to transfer But when you have a designated marketing authorization holder, it is completely transferable. So it does not prevent us from doing distribution deals or licensing deals more likely. For these therapies and enable others to advance them. And it is a party that we have already met with. We are already talking about the specifics, and we are working on budgeting and contracts. But it is a party that Biocardia will pay to support us from a regulatory perspective. And there will be other parties that are involved on doing the good clinical practice audit of our information to support them so that they have a great deal of confidence as they help us pull together our dossier for the submission. That they will know that their related entities have done this work. And although we are not working with them yet today, you know, they are plugged into this group that we are working with in Japan today. So through that, we have a good relationship and a high confidence that we have the right people that we are going to be working with downstream.
James Molloy: And how's that how does it look if you sell into this 20 thousand market, $326 thousand -- $6 billion, if I have my math right, opportunity. And that is probably a little high. But if you sell $100 million does the Japanese partner, the DMAH, do they sell that and then they then you get a royalty of that? Or how does that-- No.
Peter A. Altman: Actually, we yeah. So they handle really fundamentally the regulatory and quality responsibilities. We can actually go and sell in Japan and work with-- each and every hospital in Japan has a localized distributor. Even if you are a distributor of products, you still have to go to these localized distributors that take up to 10% of the total product value. Fundamentally, Biocardia at present, our plan is we will be the ones selling CardiAmp for the post marketing study. Which you know, could be anywhere from a couple hundred patients to a thousand patients, and we are we are relatively agnostic to that. Because we are doing substantially the same thing in all instances. And it will be a great deal easier than what we are doing in CardiAmp trials in The United States because there is no control Every patient's a treated patient. And some of the research science that we have done behind the scenes will not be taking place in Japan. So it will be much easier than what we are doing today And, and it will be relatively straightforward. Japan's not an enormous country geographically. So a small team can get around the country quite readily. And, we have not figured out all the logistics and nuances of it yet, but you know, in Japan, I have said previously that when we had our meeting with PMDA, all we had a number of really distinguished wonderful cardiologists in the room, both on our side of the table trying to help us and on PMDA side of the table as their consultants helping them. And everybody in the room wants to be involved in this post marketing study. Which is a huge advantage because you know, there is real leadership in the Japanese cardiovascular community in that room. So that is always the hardest part is to get the leadership support for advancing a program, and I think we have already got it very strongly. So my sense is we will work with PMDA and determine exactly how many centers we will be in this post marketing study. And after the submission is in, we will work with those centers to educate them and train them and get them experienced and aware. We will also be attending, Japanese society meetings for both the Japanese Heart Failure Society and the Cardiovascular Interventional Therapeutic Society. And enabling physicians to conveniently you know, be exposed to products and the data And then by the time we have the approval and the reimbursement, all of those centers should be ready to go. And so the post-marketing study should happen. Relatively quickly. I have said in our corporate presentation or we have said in our corporate presentation that we expect the adoption profile to be roughly on par superior to that. Of what it has been for percutaneous aortic valves. it is a new intervention for the interventionalists. But it is a therapy that treats a population. In fact, we may have an even more rapid adoption because I would describe our procedure as far more straightforward than the implantation of a valve percutaneously and that the patient population does not have the option of surgical delivery. And there is no surgeons who are competing with the interventionalists on those procedures for those patients. So I think the adoption profile will be actually quite compelling.
James Molloy: Okay. Great. Final question for me. You do note, the CardiAmp HF2 trial, 4 sites enrolled in the study, actively recruiting, 3 additional patients are supposed to go in this month. Any updates on is it 4 centers total currently that are enrolling and any updates on how many patients have enrolled in the trial to date?
Peter A. Altman: Yeah. Yeah, we are not putting out the total number of patients. The enrollment is not going in blazing speeds. We have these 4 centers, all actively enrolling, all have patients in the queue. We have conversations with a number of other centers who want to come on board, and we are working through that process And, you know, it is it is being done while our clinical team is addressing all of these issues for PMDA. So it will continue to accelerate over time. But, really, the main effort right now, milestone that we have got is our top priority is getting this PMDA submission in. So and it and it is happening. We also mentioned and I mentioned in the call that we are having conversations with the FDA on you know, the primary outcome measure The third tier in our composite-- so we have 3 tiers. All cause mortality, nonfatal cardiac MACE, and then the third tier is quality of life, so that every patient contributes to the endpoint. And that third tier has had a lot of criticism in the scientific community in the last 6 months. And the FDA has pushed back on that criticism but there are ways of handling data that are pretty sophisticated. And we know that the FDA knows more about how best to handle that endpoint than anybody else. On the planet. And so we are going to be engaging with the FDA and hopefully get some guidance from them on exactly how to specify the use of that endpoint within our primary outcome measure. We are also planning on streamlining the trial to really focus on that primary outcome measure, which will also enhance enrollment And by not having this all these other centers on board at this point, it just makes it easier for us to change these little nuances before we roll out more broadly. Thank you for taking the questions. Appreciate them, Jim. Be well.
Operator: Star and then 1. Our next question comes from Deepankar Roy from Brookline Capital Markets. Please go ahead with your question.
Deepankar Roy: Hi, good afternoon. Thanks for taking our questions. We had 2 questions. 1 about the PMDA specific outstanding requests. So the question is how much incremental work would this require? You know, compiling this documentation. Is this pulling data from already collected? Or would it require, like, new source data verification? Because we believe this could push the Q4 2026 Shonin submission timeline as well.
Peter A. Altman: Right. So, this is-- with-- so first Deepankar, thank you for joining the call. I appreciate the question. The nuance here is we feel we have got all of the data that they would like to see pretty readily available to us. 1 of the nuances of it, I think 1 of the hardest thing is on the guideline directed medical therapy. So there are a couple of little things that we are chasing. So in our study, guideline directed medical therapy for those who work in heart failure primarily means that they are on today the 4 pillars of heart failure therapy care. And those 4 pillars, are 4 drugs that all patients should be on. In our trial, unless there is certain reasons 1 might not be on those medications. So in our trial, we had better compliance than any of the other leading trials of the same era that we have looked at. So we definitely have great compliance, physician compliance to prescribing per the guideline directed medical therapy. So that is the first thing. Very comfortable there. The second thing is some of the patients, we do not have the exact details on why they were not on guideline directed medical therapy. And that is data that we are collecting. I think it totals out of the 115 patients on the 4 drugs I think there is a total of like, 8 patients or so or 9 patients where they each have 1 drug each. We have to chase down. Because there is not the evidence in the record on exactly why they were not on that. We do not know that we need it. We just know it is part of the PMDA question. So I think that is the only data that we do not already have in hand that we are that we are we are chasing down, and, and we think it is relatively straightforward together.
Deepankar Roy: Alright. Thank you and No. No worries. Question DMA selection. So what is the expected cost structure for the relationship? And would this the shortened submission timeline depend on having that relationship before the submission can proceed.
Peter A. Altman: The tell me to understand the cost relationship. I am I am missing-- can you repeat the question? The DMH yes. Yes. Yeah. I thought you said DMA. So the it is relatively straightforward. it is not a significant It will be a you know, the initial the initial cost so we already have a dossier that is pulled together, but we have been developing with our regulatory consultants. And we will separately be doing the good clinical practices audits with another group that our DMAH is close to. And so those 2 pieces will come together, and they are relatively straightforward. Not expensive, and I do not expect any delays. We have already met face to face and we have common friends. So I think it is relatively straightforward. So the, shown in submission timeline would not be affected I do not think it will be affected. We have, again, we have to complete the efforts to enable the good clinical practice audit. We have gotta enable the PMDA to go through you know, the answers to the questions that we have got. And then we are preparing formal CDISC data as if we were doing an FDA submission for approval. And I think the CDISC data is probably the longest pole in the tent. It has not been asked for, but we think it is good just as we put a bow on Cardiamp HF with the idea that it is also gonna support what we do, for CardiAmp HF2. We are gonna put it in that format. So I think the CDISC format is the longest pole in the tent at present.
Deepankar Roy: Right. Thanks for taking my questions.
Peter A. Altman: No, I appreciate them Deepankar. Thank you.
Operator: And with that being our final question, we will be turning the floor back over to doctor Altman for any closing comments.
Peter A. Altman: Thank you, James. So for all on the call, our efforts advancing our cell based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. The positive regulatory interactions we have just discussed for approval in Japan and The United States introduced potentially transformative milestones that are meaningful for patients, the physicians who are caring for them, but also for our shareholders. On behalf of our entire BioCardia team, I thank all for their continued support. You make what we do possible. And I wish you all a great afternoon. Take care.
Operator: The conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.