Welcome, everyone, to Stage 2. We are going to talk about NIH product development funding for your innovations as a part of entrepreneurial ecosystem. And while NIH is a very important part of this ecosystem, it takes a village to support entrepreneurs and innovators to develop a product. With me, there are four fantastic speakers. Thank you all for joining us for this panel. And I would like to take next few minutes for speakers to introduce themselves. Starting with Renee. Hi, my name is Renee Arnold. I'm an entrepreneur in residence, EIR, with NIH, NHLBI specifically. Julia will talk about the Innovation and Commercialization Office. So I'm lucky enough to be with the Innovation and Commercialization Office. My area of expertise is health economics outcomes research and evidence development in support of reimbursement. We're also fortunate to have experts in intellectual property, regulatory affairs, clinical trials, and investability. And we really help the small business awardees go to investor conferences. So here we're going to be talking a lot about non-dilutive funding, and how we help them understand what they need to do when they go to investor conferences to get dilutive funding and to get off of NIH's dime eventually. We want you on our dime initially. We're thrilled to have you all consider NIH funding, and I'm happy to be a part of this panel. Thanks. I'm Ken Nelson, a partner in the MedTech Advantage Fund. MedTech Advantage Fund is going to be investing exclusively in MedTech Innovator and other alumni companies. MedTech Innovator is the biggest medical device digital health startup accelerator globally. Prior to that, I worked in cardiac rhythm management for Guidant and then Boston Scientific for about 10 years. And then after that, I spent a dozen or so years building the teams that commercialized and launched the patch products first for iRhythm, then for biotelemetry, and then for Barty Diagnostics, which are three of the four biggest players in cardiac digital health and remote patient monitoring. And then over the past couple years, I've joined a half-dozen cardiac startup boards as well as the innovation advisory boards for both American Heart Association and Heart Rhythm Society. So excited to be working with the group today. And I think Julia and I met at the first HRX several years ago, if I remember correctly. So glad to be doing this panel together. All right. Hi, everyone. Erica Tyburski. I have a background in biomedical engineering, and today I'm wearing a couple of hats for this presentation. I've got a hat with the Atlanta Center for Microsystems Engineered Point-of-Care Technologies, which I'll talk about a little bit more in depth as we go. Essentially, we fund projects that are past prototype in translation. Like several of the services at NIH, we offer support on regulatory, clinical trials, analytical testing, human factors, usability, that we can actually get hands-on with a lot of these devices, given that a lot of microsystems and wearables, as you can see in this conference, fall in the cardiac space. I think it's a good opportunity if you're just starting out, have a couple ideas, to apply through NIH or any of our centers. I also run a company called Sanguina. We make diagnostics and smartphone applications. And I think my perspective will be maybe a few years behind some of my other panelists in that I am still funded by NIH, so I can talk about being an awardee and having that responsibility. I've also been able to get investor funds alongside that. So as NIH just stated, there is an evolution process. I think it doesn't all have to be at once, in terms of going for investor cash versus non-dilutive funding. And there's certainly some non-dilutive funding that can go quite far beyond prototypes. So just knowing about them could really help map you out for success. So happy to be here and talk about all of the opportunities. Hello. I am Mohan Tanikachalam. My background, I am a cardiac surgeon and also an academic cardiac surgeon, so I'm also involved in public health. Since 2015, I've led a joint Tufts Medical School and MIT team that's come up with a fundamentally different approach for continuous blood pressure, absolute blood pressure measurement, and advanced hemodynamics. And then as of June of 2020, we moved it to a company called Dynacardia. I'm the CEO of the company. And over the last three years, we continue to have NIH support. We're close to around $5.5 million. And how do you take a fundamental innovation into actually a product has been extremely helpful to us. So I'm happy to share our journey and how NIH funding has been very helpful to us. And that has also helped us to raise a significant amount of private capital as well. Other important part is not only funding, you're able to tap into NIH ecosystem, be it regulatory or reimbursement and all those strategies. It's just been extremely helpful to us. So I'm happy to share those experiences. Thank you, everyone. My name is Julia Berzhanskaya. I wear a couple hats within NIH. One is I'm program director for RICH, which is Research, Evaluation, and Commercialization Hub Network, similar to the program that Erica is part of, but different. And I'm also an innovator support lead at the Innovation and Commercialization Office, National Heart, Lung, and Blood Institute. So one program is trans-NIH. Another one is institute-specific. And I can also bring a couple of those perspectives. So we have a few slides for you. Please bear with us. And if you miss something, feel free to contact me. And we would be happy to share the slides, of course, with speaker's permission. I want to talk about SBIR basics. If you have not heard about SBIR program yet, I'm going to talk about NHLBI priorities, about NIH SBIR programs in general, about non-SBIR product development programs. Might be surprise for some, but they exist. And also about entrepreneurial training, if we have time. So SBIR-STTR is a congressionally mandated program. And annually, it's more $1.2 billion. Of dedicated funding, we are set aside from NIH research and development budget. $1.1 billion approximately goes to Small Business Innovation Research Program. It's a different type of grant. And a little less goes to Small Business Technology Transfer Program, where small business is expected to partner with academic institution. The program might seem complex, but it's really as easy as one, two, three. So you get Phase I, which is designed for feasibility and prototyping study. That's followed by Phase II, full R&D. And then some institute, including NHLBI, where I work now, has Phase IIB. So it's a Phase II competitive renewal. So the amount of award changes with inflation. If you see different numbers in some of the prior presentations, that's the reason. So right now, it's a little bit more than $300,000 for one, two years for Phase I. And a little bit more than $2 million for Phase II. And Phase IIB also has a similar $2-3 million amount of money. So if you're counting, you can get, if successful, up to $5 million or more in non-dilutive funding. A good amount of money to support your product development. Our Office of Innovation and Commercialization at Heart, Lung, and Blood Institute is there to accelerate the translation of discoveries and innovations into new biomedical products and services for heart, lung, blood. And not many people know that NHLBI also supports sleep diseases and disorders. We have about $130 million per year in SBIR and STTR funding. That includes more than 200 of active projects. More than 50% of these are devices, so that's important for you to know. And more than 50% of SBIR awards are cardiovascular sciences. So it's a good amount of money that is available to you if you decide to come. This diagram is somewhat complex. I'm going to talk about a few programs highlighted here. And the main point that I wanted to bring home still hear me? Is that at any stage of your product development from idea to commercialization we probably would have a program for you. So talk to us if you're early. So the programs that I'm responsible for in ERICA part of, REACH and POCTURN they're on the left. Basically getting out of basic translational research. We have a number of programs aligned with Phase 1 and Phase 2 SBIR. And then we keep working with companies for support investor initiatives, something that Rene mentioned here. Up to two years after the company is done with NIH grant. So your success is very important to us. So the programs that I have mentioned they include NCEA REACH. I wanted to talk about challenge mechanism. I'm going to talk about special interest notices of interest, funding opportunity announcement, how to find them. Support services, Rene mentioned. And also known as BIR product development funding. So here is somewhat complicated picture of the REACH program over the years. So over the years there were three installments. NCEA was first. That was an HLBI focused program. Then the program was so successful that an engineer aligned to REACH 1.0 REACH 2.0 from 2019. So this is a program we are stepping up my oversight and office oversight now. And now there is a new REACH 3 hubs set up. Over the time of this program we supported more than 435 projects. More than 2 billion of follow-on dollars were raised and more than 3,000 of academic innovators were trained. The second opportunity I wanted to mention is a challenge. And this particular challenge for maternal health is currently closed but because I am a part of maternal health innovation group at NIH I wanted to talk about this. There are a number of opportunities that are coming around this very important problem. And the challenge provided much lower barrier entry into NIH ecosystem. So you don't need to write a great length application but there are evaluation criteria including scientific, clinical, accessibility and user experience, regulatory and commercialization. That's how these applications were evaluated. And there were 8 million prizes distributed among the companies. So if you are working in a specific area keep your eyes open on challenge.gov for some of these announcements. You are not responsible for memorizing all these opportunities that are stated here. And again slides are going to be available but couple things that I wanted to highlight is that NHLBI has NHLBI specific Bridge Phase 2B awards and they would allow you after your regular Omnibus funded Phase 2 apply for additional funding in areas that we are considering challenging. For example small market awards support rare diseases and pediatric devices and there is a regular Bridge award. And of course I could not skip mentioning some of the notice of special interest. So the one on the bottom includes quantum sensing and biomedical applications. That's another program that I'm responsible for. If you are developing quantum sensor, please talk to me. One program that I'm not highlighting here is Smart and Connected Health. It's not necessarily aimed at innovators but this program to support development of artificial intelligence that we have between NIH and NSF could be interesting to you as academic investigator. Okay, so another opportunity for us to support you innovators is this tailored product development support that we provide through Entrepreneur in Residence one-on-one consultation. You have to be an NIH grantee though. Mentor network and through other partnering opportunities. And then finally I wanted to mention if you don't have a company yet it's not a problem. Of course we want you to create a company and come to us through SBIR program but Catalyze an NHLBI specific product definition program has a number of opportunities listed here. The next application due date is November 21st and this program is much more flexible in terms of who is eligible and not. And finally we are running out of time for my part of the talk but I wanted to mention that NIH realized that it's hard to apply to small business innovation research grant and we are setting up new programs. NIH Entrepreneurship Bootcamp for example the due date for this has passed but look up for more opportunities to get training. There is diversity funding there is Innovation Corps at NIH and a number of other programs. And this is how to contact our office my email is up there you can also email to NHLBI underscore SBIR mail NIH dot gov and there are a number of links on this slide that might be helpful to you in finding those opportunities across all stages. We welcome innovators at all stages. So I'm going to pass it right now to Rene to talk maybe about your experience with entrepreneurs and as an entrepreneur in residence but also perhaps about Springboard which is another community participant in supporting innovators. Great, thanks Julia. So besides being an entrepreneur in residence I have my own small business. I've had a few SBIR grants I just got a good score recently on one I forgot how long it takes between getting the score and the final funding it takes a while and the good thing about federal government funding is you don't have to once you do get a good score it's there you don't have to invoice for it and wait 60 days for payment but everything is slower with the federal government and with these programs so you really have to have commercial, if you've got a small business you have to have commercial clients and you can have the federal government but one of the good things of course is that it's prestigious to get an NIH grant and it's a good proof of concept and investors if that's the stage that you're in like to see things like that it de-risks the program it's non-dilutive funding as Julia said so the EIR program was actually mostly started through NHLBI when I had my early SBIR grant we had nothing like this and it's funny that it was an NHLBI grant that I had so I wish that I had had all of this stuff I knew about health economics and outcomes research because that's my area of expertise but IP, investability you know regulatory, clinical trials I really could have used this help and as Julia said we're available through any phase that you have as long as you have funding through NHLBI in this particular case but it's been so successful, it's been running for about 10 years I believe the whole EIR program that now it's spread to other institutes and centers, National Institute on Aging, NIA has I think two of us, two EIRs and other institutes and centers are considering having EIRs. We're part time but you know I think that we serve an interesting purpose in that we've got other lives and we can bring a lot to bear to the entrepreneurs I happen to have a small business not everybody does but quite a few of us do have side consulting businesses and so we can say hey this is how it goes this is how it works and the fact that I've had SBIR grants myself I can say don't despair it took me a long time to get this current one you just have to keep going and you know as entrepreneurs you just have to keep trying and trying and trying even though my husband thought I was out of my mind you've got a job and you've got other clients and because I'm passionate about this particular thing and if it kills me almost did no but fundraising is really difficult and so to do it and at the end of the road if you get non-dilutive funding you're not giving any part of the company away so that's a really significant aspect I think people need to think about absolutely the other thing we hear is it takes a lot of time to fill out the paperwork it really doesn't take a tremendous amount of time well plus if you've got and it's about 8-10% success rate for phase 1 and about 40-50% for phase 2 which is a huge percentage think about that most of the success rates for funding it's like 10% or less so those are huge numbers so if you can get phase 1 you've got a much better chance of getting phase 2 There's a lot of companies out there and I don't know specifically how much money that you got but it would be good to hear that from you and also from both of you but there's one company in particular that I know and their head of commercial is here it's a company called Epitel and they funded everything through FDA clearance with 14 million in non-dilutive funding from different sources including 5 or 6 million from the NIH so for the startup people in the room who are looking for funding talk to the people up here who have raised the money and it is doable a lot of people think it's impossible they're never going to get it but you're great examples of people who have gotten funding and the fact that it's not it's non-dilutive they're not taking any equity it makes it that much more worth the time and effort to do it plus you're getting great consulting from the experts at the National Institute of Health who are really helpful along the way so there's so many reasons to apply for these kinds of funding I absolutely agree and then the other thing Julie asked me to talk about was Springboard so there are other methods and these are dilutive methods of raising funds I had applied and was accepted to the Springboard program which is specifically for female led or female owned businesses they started just before 9-11 actually the year before because I was the second cohort and our application was due 3 days after 9-11 so they said we understand this is a trying time for you especially living in New York and 2 miles from the World Trade Center site so we'll give you another 3 days additional. Great, that's really wonderful but it's an interesting program and at the time it was a single cohort nationwide, 600 applications and 25 of us were selected very few got funded right after 9-11 as you can imagine it wasn't the best atmosphere at that time but since then a lot of funding has taken place and they have cohorts actually they have Australia, they've got regional cohorts they have digital health and there are other groups like that that cater to one of my colleagues actually started a minority group similar to that funding for minorities and it includes women but it's people you know underserved populations etc etc where it's harder for them to find and there's a lot of mentoring involved as well so you really should seek out non-traditional methods of funding because they are out there and you might be surprised that it might take you a little bit but people are really willing to help and it's something to consider so I'm still involved with Springboard all these years later because once you've done anything like this they go oh don't you want to give back? Yeah okay but my time is for free now like okay I'll do some of it but I'm a mentor on Springboard panels as well. Thank you for doing that. Thank you so I can give you the clicker or I can drive the slides for you and you can say something. Sure, either way. So I'm part of MedTech Innovator. I went through the program in 2019 as chief commercial officer of Bardi. And what I can tell you about MedTech Innovator, just in general about startup accelerators, a lot of times people think that they're either too far along or they've raised too much money or they're too developed to do it. When we applied to get into MedTech Innovator, the company had already raised 40 million. We were raising a $35 million Series B. We had already launched the product. We already had FDA clearance. And so there's different cohorts that they have. They have an earlier stage cohort and then one that's a little bit further along. And so if you're looking to find additional investors, if you're looking to find other sources of funding, going to one of the bigger accelerator programs in MedTech Innovators is now the biggest in the world, even bigger than just core MedTech and digital health, bigger than Y Combinator, Techstars, if you're just looking at the digital health MedTech focus. And that's where you'll meet people like Julia from the NIH or people from ARPA-H or BARDA or some of these other government entities. And what's really important there, and this is something that Julia and I were talking about prior, is that if you get funded by the NIH, that doesn't exclude you from getting funding from BARDA or ARPA-H or these other government entities. You can't get funded, and maybe Julia can add some color here. You can't get funded for the exact same project and work by multiple entities. But say you're doing a pediatric indication for the device and then you're working on a totally different adult application and indication for a device, you could get those two different things funded by different government entities. So there's just lots of opportunities to go after. And then if you don't mind, maybe jump into the next slide. Just to see the ecosystem that something like MedTech Innovator has, this isn't just a group of people that are in one region of the company. This is a global accelerator. The biggest funders of this are people like J&J, Siemens, Edwards, big medical device companies that you get exposure to their corporate development, business development people. They could end up being an investor in the company. They could end up being an acquirer of the company. But you really just get excellent advice and feedback on your pitch, on your approach, on how you're developing the technology. If you need help on the reimbursement side, there's a whole group of reimbursement experts that are part of the ecosystem. If you're trying to understand setting up a protocol, and is that protocol gonna get you not only FDA clearance, but also get reimbursement for the way you set up that protocol, a lot of times people don't do that ahead of time. So they may put a clinical study together that helps them get FDA clearance, but that is not just based on how they structure it. It won't help them at all in terms of utilization or getting payer coverage. So going to these accelerators really helps you figure things out and helps you figure out the best way to get a reimbursement pathway, get FDA clearance, and really scale the technology. And then from a non-dilutive funding standpoint, there's lots of different sources. And so because I knew we were coming into this program, I spent some time putting a whole guide together of all the various different non-dilutive funding sources. So if you're a startup and you're raising money, or you're looking to figure out what are the different sources of non-dilutive funding, either give me your card afterwards or look me up on LinkedIn, and I'm happy to share that guidebook that I put together. And I put it together for the MedTech Innovator, American Heart Association Heart and Brain Accelerator that we just started this year, but happy to share that with whoever in the group is interested. So I appreciate it, Julia. And this just goes through the program. I'll just tell you really quickly. We had over 2,000 startups that applied to get into the program this past year. We had several hundred that pitched across the globe, and then we picked 100 to go through the cohort. That's just in general how it works. And we don't take any dollars. There's no equity that the program takes. It's all non-dilutive funding that MedTech Innovator gives away. So it's really all upside, and you get introduced to people like Julia and Renee and others on the panel, and you get to collaborate with other startup founders and leadership. That's just kind of nice to kind of go through the same types of struggles together, but also figure out solutions together. So it's just a great thing to consider. And then locally, there's all kinds of academic accelerators that you can go and apply for as well. Yeah, and I can second. I was a part of your pitching as observer, and from the point of companies to get all these questions from experts in regulatory, commercialization aspect, business development, it's just priceless. I had probably more fun than at many points in my life. Yeah, I mean, and think about, you're volunteering your time, which is really great for these startups to be able to interact with somebody like you, but there's also a group of people here from the FDA that you can interact with. The companies or the organizations like Heart Rhythm Society are putting these opportunities together for the innovation ecosystem to get everybody across the ecosystem together. And it's just fantastic that people like the NIH and Julia are willing to dedicate their time to interact with startups. Here are your exits. Any notable ones? These are just from the past 12 years of the program. There's a couple more to add to this group, but there's about 50 exits now from MedTech Innovator. There's about 612 alumni companies. Sounds great. Well, let's move to Erica, but I wanted to say that there is an opportunity to ask you questions in the app. I have been told, I'm not sure how it works, but please feel free to ask your questions and if we can answer as many as we can as time allows. Erica, we can do the same with you. I can just drive your slides, is that okay? Yeah. All right, so we have an acronym. There's always an acronym. Our center is ACME POCT, the Atlanta Center for Microsystems Engineered Point of Care Technologies. And in essence, if you have a technology that involves a microsystem of any kind, microfluidic sensor, microsystem, circuit board of any kind, then you are eligible to get some help from us. We really focus on the regulatory, clinical, and real-world application of technologies. So we really like it if you have a prototype that we can already put our hands on and really rip apart and test it to the limits. We are a center that's funded by NIH. So it's actually a U54 grant on its, we've talked so much about grants. This is actually a big grant that funds our center. We were just renewed, so it was a five-year grant and we're in year six, between six and seven of our existence, based here in Atlanta, but we do serve all across the country. Just keeping that in mind, you don't have to be from Atlanta. You can go to the next slide. These are some of the buckets that we very simply help projects with. We have a great analytical testing team, clinical testing team for point of care and home-based technologies. And we also have a usability team that can work with your technologies from day one. So if you have a prototype, we can put it on people that have never seen it before. We can give it to engineers. If you say it's really not ready for that, we like a lot of hands-on work with these technologies. We also offer regulatory assessment and planning. So truth be told, there is a huge team that is behind Acme POCT and I am just one member. I actually live more on the regulatory side, just based on where the whole center is, but we have three PIs that are based here in Atlanta, each functioning with their own expertise. So we have a lead engineering PI, Eric Bogle. We have Greg Martin, who's a critical care pulmonologist. And we have Wilbur Lamb, who's a hematologist oncologist. So again, none specifically cardio, but we have a lot of connections with NHLBI and NIBIB for this effort. We use technology readiness levels in all of our assessments. So if you apply through us, we're gonna have you map out where your technology is on a technology readiness level in the context of those four domains I keep mentioning, regulatory, clinical, analytical, and then also business. So we do wanna know where's this going. And recently, we've onboarded some manufacturing insights. So not only can we do fabrication of wafers, chips, whatever it may be in a world-class clean room facility on our Georgia Tech campus, we can also help you think about how this becomes a manufacturable thing. For microfluidics, there's a really big valley of death with projects that don't realize that they have to make this a manufacturable thing that is not only affordable, but meets all the tolerances they've created. So these are our four buckets. And I think the next few slides talk about each of a couple of ones that I wanted to highlight. So we can go to the next one. I had a question. Do companies have to pay for that awesome service? No, so our model used to be that we would give a pilot grant of between 50 and $150,000. But in our renewal, our model has shifted much more to if you are selected as a company, all of these services are available to you within your award period. And we've had a few case studies done where we've helped one group finalize a control panel, which ultimately went into their 510K. They got clearance. And what we wanted to do was really bundle it so that you get hundreds of thousands of dollars in value by using the services. And how many companies do you accept into the program? So per year, it ranges. But I would say, and truthfully, now that we have this model, we're not really bound by a dollar amount that goes out to each one. So anywhere between five and 10, I would say, on a per year basis. And we probably get maybe 100 applications a year. So we're still on the bottom part of the radar. Come in, apply. There will be a QR code after this. And I should take a step back. We are one center of four or five throughout the country, each with their own specific focus. So there's one for STDs and women's health. There's one for HIV. There's one for, actually, NHLBI has CAPCAT. So that's the Heart, Lung, Blood, Sleep Disorders Center. And they have a little bit more of a focus on more advanced. So they like to focus on clinical trials that really get to the end of the tunnel. I think we end up focusing a little bit earlier. So again, past prototype, but you really don't know how it's gonna be used. You really don't know how it's gonna be manufactured, if so, and we like, we often have a funnel where we work, and then we also work with other centers if you happen to fill any of their, any of their, I guess, focuses. So just to talk about a couple of the things that we do. Homelab is a big one. This is a group that works on ergonomics, human factors, heuristics. We can look at an instructions for use document. We can look at an actual walkthrough with your product. We can do it on any demographic that you may want. So throughout the pandemic, we actually did a lot of work on the over-the-counter COVID tests that are now available either through EUA, and a few are very, very close to getting full authorization. We actually had people with limited dexterity. We had people of different age groups, people of different vision doing these tests to work on some accessibility optimization. But we do that with any sort of device. It doesn't have to be a COVID test. We just had a great opportunity during the pandemic to help out. Next slide. More in my lane, we also were able to help out quite a bit during the pandemic in getting emergency use authorizations for these COVID-19 tests. So we were part of one of the RADx initiatives that's been mentioned a couple times now, and also the Now ITAP initiative. But me and a team of eight or 10, we helped companies get over 30 EUAs during the pandemic to get tests on the market, one of our prouder moments. And in doing that, we created a very good connection with the CDRH part of FDA, which we continue to foster to this day. So like the REACH program, like any of the accelerator programs that you hear about, those relationships are really key in the value. And so we're able to get quicker answers. We're able to have the pulse on if there's something that's gonna change in the near future quicker than some. Just highlights a couple of more of our accomplishments, but in general, if there is a regulatory path, we'll find it if you work with us. Next. We also have, given that we work with a lot of wearables and sensors, a lot of them come with partnering apps. And one of the biggest questions we ended up getting was, well, I don't know how to develop an app. I just, I just, I'm the tech side. So we found that there was a big gap in many of our investigators coming in. So we actually have people that can help design and implement apps in their most basic form, if you've never done it before, called App Hatchery. So just thinking about that, it's, I don't know how often you see it, but we see many a great technology, but a lot of things now have to be Bluetooth connected, internet connected, and it's usually done through an app. So we help people with their first apps too. I think that might be my last slide. Okay. But come visit us. I think our next call is likely in the beginning of the year. But again, if you reach out to us, we can, we can talk you through our process. It's all upside, essentially. It doesn't cost the company anything if they get in, all the services are, are no cost. Correct. Wow. I didn't, I didn't know about this before. This is great. This is great. And I don't see any questions, but I wanted to make sure that Dr. Tzinitshalam has opportunity to tell us how it actually works in real life with your company. So, as I mentioned, right, and there could be some physician scientists here, you know, your challenge actually starts after you're discovering research, right? So we had a fundamentally new approach for blood pressure, but how do you actually convert them to a product? And, you know, I live in the Boston ecosystem, right? There are, there's a venture capitalist every street corner, but one of the things is as a startup, you know, they would want you to de-risk as much as possible before they want to invest in your company. Or if they want to invest in a company, they're going to take a whole big chunk of your company because you're not de-risked anything. And, and, and I can share our NIH journey, right? So our technology has wide application, can be in the hospital, in people's home, can be part of a variable, but where do you focus, right? NIH has a couple of programs like C3I, iCarbs program, through that, we could reach experts in the industry, more than a hundred physicians across the US. And so we, you know, we were able to come up with a, you know, a clearly articulated business plan. And subsequently, you know, we got this direct, the phase two grant around $2.5 million. $2.5 million. That had, enables to actually build a prototype, right? So our, we had a devices at the Cleveland Clinic, at the Mayo, and various places, to show that, you know, against an invasive arterial line, that you were able to generate that kind of data. And that sort of enabled us to speak to bigger companies, right, that were all looking for a solution. And, and then sets the stage for us to raise private capital because you're already, you know, sort of trying to cross that valley of debt everybody is talking about. So, and this is completely done dilution, like all the support. And the other area I should highlight is, now that, you know, we are in the stage where we took a lot of our time to deal with the technology, right? And also, we also have funding for the National Science Foundation, given what we had done with NIH, around $1.5 million, helped us to develop a completely different set of technology. But how do you actually measure blood pressure or other cardiac hemodynamic parameters somebody is actually moving? So we were able to build our own unique computer vision, AI, machine learning technology, able to measure in spite of patient motion, right? So, able to build these additional technologies. And now we are ready for, you know, FDA submission, and we received additional funding from NIH to actually do the testing related to FDA submission. So that is very unique. So all across this, you know, value pathway, we had the support. And the other one, you know, there was, Julia highlighted about, you know, special populations. Pregnancy and high blood pressure is a major issue. So we have been funded by NIH, specifically having an application and looking at application of our device in pregnant women. So we have an ongoing study with the New York Public Health System. And then subsequently, we're going to be going for additional funding for them, hopefully, for commercializing the technology. So this gives you additional venues through which you could source NIH funding. And, you know, there are also other applications, right? And that is, you know, real-world blood pressure has been shown, right? Blood pressure variability can later on lead to cognitive dysfunction and dementia. So these are sort of a discovery research, but still within the SPR mechanism, there are special call for proposals where you can say, hey, our technology can potentially, you know, be a solution for this clinical ask. So we are able to tap into all these various resources. And to date, how much, roughly, how much non-dilutive funding have you raised? Around $7.5 million. That's incredible, congratulations. And, you know, we're still going, right? We're still, you know, there are other opportunities you can still source some additional funding. And lastly, you know, since Julia has said I have to give this opportunity and say, you know, they have been pushing us out there. You know, me sitting here and talking about it, I didn't know about HRX. I'm a cardiac surgeon, right? Last year, they sponsored us to come here and we won the Innovation Award for 2023. They sponsored it for the American College of Cardiology. We got the Innovation Award there. So in these ways, you know, able to push us and have a technology out there, and ultimately able to have a successful commercial launch. I think that's been incredible. Definitely, thank you. We are within two minutes of the end. I didn't see any questions. Perhaps the app is not working. And if you want your app working, you know, talk to Erica, that's what I learned. That's a fantastic resource. Do panelists have any last moment messages that you would like to give to the audience and maybe people who are looking for funding to develop their products? Just as a reminder, if you want to know how Epitel raised their 14 million in non-dilutive funding, go find James Landis. He's out here in the audience somewhere. And that was their only funding through FDA clearance. And again, if you'd like the resource guide I put together of all sources of non-dilutive funding that I could find, including the NIH, happy to share that with people. Anybody else? Yeah, I'll just follow up and say that there are several events that POCTRN puts on as well. And there's something called a Big Company, Little Company Showcase, where we invite all of the big guys, all of the people listed on your acquisition list to talk to any of these awardees. And sometimes the matchmaking works out really well. It's almost like a fast speed dating and there's equal opportunity and excitement on both sides to kind of understand the market, understand how it works, what they're really looking for, what drives value. And as a company that went through it, for me, I got to speak to maybe 10 Fortune 500 companies in the span of four hours, as Rewind maybe six years as a first-time entrepreneur and never seeing anything, never would have had the opportunity to make these meetings. So just think about all of that, because it sounds like all of our resources have that opportunity. And a lot of the times, it's really getting your foot in the door, talking about how your solution works that ultimately gets you to a deal. So I think all of that's been invaluable as well. Thank you. And on the NIH side, I repeat what I said in the beginning, we are here for you at almost every stage of your idea or product development. So please talk to us. And almost nobody will give you the amount of dollars that the NIH is willing to give if you're that, if you're actually doing what you're saying you're gonna do and you get to the different phases and you're executing, they're very generous with the dollars that they give out better than any of the other resources I know. So thank you. We are at the time. Thank you, speakers. Thank you, audience. Come and find us, NIH. Place is there and you can find all of us.

NIH funding programs

biomedical innovation

non-dilutive funding

health economics

MedTech Innovator

regulatory testing

SBIR and STTR programs

entrepreneur support