Adoption & Pricing ● What’s the target monthly cost (device + consumables), and which early segments are most likely to pay out-of-pocket (e.g., caregiver/parent markets)? For context: continuous glucose monitors (CGMs) started out at $600/sensor in the early 2000s. 25 years later, they are about $75. We plan to start out around $300/sensor, with some price erosion expected over time, offset by the fact that we will multiplex our sensor (put more than one biomarker on each sensor). At launch, that puts the cost at $600/month. Our customer discovery indicates that 30% of PKU parents will pay out of pocket for the sensor. We also expect payers will cover this rapidly for PKU. For the heart failure segment, whether the patient will pay out of pocket or whether the hospital will pick up the tab until reimbursement kicks in remains an open question. The health economics for an ACO or IDN indicate they would be smart to just pay for it. We have not tested heart failure patients’ willingness to pay out of pocket yet, but expect that those who are economically able to will do so – staying alive is a really good motivator. This same heart failure adoption logic (at both the hospital system and individual level) can also be applied to multimorbidity. For diabetes, our sensor has to be part of an integrated system, since our data will feed somebody else’s insulin dosing algorithm. Until that partner is identified (pump company or CGM company?) ,we are not investing in developing the same level of granularity in modeling adoption and pricing. Our market assumptions focus on pump wearers as the beachhead.
● What’s your plan to drive patient adherence and provider workflow adoption (education, incentives, remote monitoring programs)? As a wearable, patient adherence is expected to be higher than is typical. Providers/parents will also know if the patient is or is not wearing their sensor and can follow up with the patient as appropriate. In terms of workflows, we have taken great pains to make sure we seamlessly integrate into current practice, i.e. no new provider behaviors are needed to successfully adopt the SunVida. Providers already review reports on a regular cadence, and our report will join that list. Reports will be green/yellow/red coded (green = no action, yellow = APP review, red = physician review). Alerts are seen by the patient, with the onus for action on the patient (providers strongly urged us to take this position). We recognize a substantial education task lies ahead, but thanks to CGM, that task is lessened, and we have a template to follow. There are no current plans to pursue incentives. Reimbursement & Payers
●What is your CMS and commercial payer path (coding, coverage, payment) and the specific evidence package you’ll generate to support cost-offset claims (e.g., avoided ER visits, admissions)? The first item on the agenda is the payment model. Right now, we are thinking durable medical equipment (DME, like CGM), with a reader as the DME and sensors as supplies (like CGMs). However, we are very intrigued by the notion of getting covered as a pharmacy benefit (for example, by teaming up with a PKU drug provider) and will be digging further into that possibility. For making sure providers get paid, all the codes we need already exist. The economics of the SunVida are not built around RPM codes, but those codes can be used with our device. We will use data analysis and patient consultation codes. We have multiple third-party studies that get into the nitty gritty (in the data room). For covering patient costs, for PKU, CMS is not much of a player because the population skews young. For commercial payers, our strategy is to begin with payers that meet two criteria: 1. They were relatively early to cover CGMs 2. They currently cover phenylalanine testing well The evidence package for PKU is expected to be relatively light (one of the reasons we chose PKU as our beachhead) because this is pediatric, orphan, with no current means of ascertaining Phe levels. There is a “ready to go” and very activist group of parents ready to support our efforts as well (which will grow as we attend more PKU events). For PKU coverage, this is more about not being a heartless, greedy corporation who allows brain damage to happen to kids rather than super-compelling health economics. For all the other planned indications, that is NOT the case. We expect we will need to demonstrate health economic outcomes to get coverage in heart failure and multimorbidity. In heart failure, there are multiple studies we can build on showing faster time to GDMT = better outcomes & lower costs. The risk with heart failure is there are many factors outside of the study’s control that impact total costs of care, so a heart failure outcomes study may have to be on the larger side. For multimorbidity, there are not studies to build on – but the health economics for multimorbid patients are so dire/huge, we think the study size can be modest to show improved economic outcomes. For both HF and multimorbidity, ER visit reductions and hospital admission reductions drive the economics, but mortality, lab cost reductions, logistics burden reductions, and access to care will also play a role. For diabetes, we may get by with just showing improved glycemic control, since there are now studies showing there is no such thing as too much glycemic control - more control is always better. There is also the chance that we can show reduced insulin use for the same degree of glycemic control, but with recent pricing controls being slapped on insulin, this may not be sufficiently compelling. If we can get coverage by showing glycemic control, the study will be on the smaller side. If we need to show direct economic benefit/reductions in care utilization, the study will be on the larger side. All three studies – heart failure, multimorbidity, and diabetes – would be planned to be done in conjunction with a strategic partner. Regulatory & Evidence ● Which FDA pathway are you pursuing, what are the key clinical/validation milestones to launch within your stated 12–18 months, and what endpoints will you use? This is a 510(k) premarket clearance regulatory path. Predicates are selected. Our first human study is planned for 1Q26. How quickly we move to a clinical study for FDA submission depends on how well our first human study goes. Assuming it goes great (because what startup does not assume that?), there is a substantial amount of FDA compliance testing that has to take place prior to starting the clinical study (biocompatibility, sterility, penetration testing, EMI/EMC, etc…). Note that we will submit to FDA on clinical study data, not clinical trial data. This is a subtle but important difference. Our clinical study will demonstrate the ability to measure phenylalanine accurately, and that is all it will demonstrate for our first 510(k). Later submissions will be based on more complex studies to get more aggressive on our indications language. As a result, the primary endpoints for our first 510(k) submission are straightforward – MARD (mean absolute relative difference) between Phenylalanine levels reported by our sensor and those reported by the reference method at various paired time points across the 15-day sensor life, and coefficients of variation in sensor performance. Also, the question implies we have communicated we will launch within 18 months. If that is the impression we created, apologies! Launch into the market will be late 2027 to mid-2028 (see timeline slide from our pitch deck). Competition & Defensibility ● Who are the top 2–3 competitors or likely entrants, and how do your core claims map to issued/pending patents to block fast followers? Are there any remaining IP risks? The top 3 are Biolinq, Dexcom, and Nutromics. Dexcom is more like a frenemy, they have offered to invest in us, but so far, we have declined. Nutromics is the most direct head-to-head competitor, but with the recent news of results with phenylalanine, Biolinq is becoming more of a head-to-head competitor as well (although the phenylalanine work appears to have been done under a DoD contract and should not be interpreted as a strategic pivot for Biolinq – they are still glucose-focused as far as we can tell). One point of interest – after raising more than $200M, Biolinq recently reported 7 days of Phe measurement on the bench. Spending less than $3M of 100% non-dilutive money, we have 10 days of Phe in an animal. If Biolinq raises enough, maybe they will just buy us (kind of kidding…but you never know…). Because we have such a broad suite of patent protection, and we have done such an in-depth analysis of competition, answering this question in just a couple of paragraphs cannot really do the question justice. We are very pleased with early office actions and claims being allowed, and the broadest claim we have pending covers any aptamer biosensor that is used for more than 3 days. If we get that one, we will essentially own the field. Otherwise, we have dozens of other claims building a strong patent fence. So far, every time we see a filing from a competitor that looks related to our claims, we have been first to file. There are two remaining big risks – the first is what USPTO will do to our claims prior to issuance. Will they force us to weaken any of our key claims? The fact that the leading experts in aptamer biosensing were publishing studies saying the exact opposite of the things we did that actually made our sensor last a long time really works in our favor. The second risk is that our streak of being first to file comes to an end on some important claim. Then we probably get into some horse trading with whomever filed that claim. They will almost certainly need to use some of our IP, and if we need to use some of theirs, we have plenty to trade with. This second risk is less likely, because we are shifting from platform development into manufacturing of product and have already filed the research-based platform IP we need for the foreseeable future. For more depth on competition, we urge the questioner to access our competitive report in the data room (or I can email it). For the patent stuff, it is evolving in real time as USPTO does their thing, so while we have a good patent write-up, a live conversation with Dr. Heikenfeld would be the best next step if more depth is desired on that topic. University/Grant Obligations ● What are the University of Cincinnati license terms (royalties, sublicensing, diligence milestones, march-in), and do any of the ~$6M in grants trigger revenue-share or other commercialization obligations? License terms are pretty simple. 2% royalty on net sales. 0.5% success fee at exit. $5,000 per patent issuance. $250,000 upon FDA clearance. De minimis annual license maintenance fees. For covering IP expenses, we are on a fixed monthly payment plan of $6k/month, which doubles if we raise $1.5M of investment capital. All of the UC patents are assignable to Kilele if we want that to happen (converting the license to patent ownership). We just haven’t wanted to commit the funds necessary to do that yet, because there is no compelling reason to do it at this time. For more details, a copy of the UC license is in the data room. FYI, we also owe the UC Venture Lab a 1% success fee at exit. This is unrelated to the license and is for a grant they gave us in the very early days. Capital Plan & Runway ● How are current cash and committed funds allocated (R&D, clinical, regulatory, GTM), what is the runway to key value-inflection milestones, and what additional capital (amount/timing) will you need? Right now, all expenses are more or less R&D expenses; we don’t really parse them out in detailed categories. But we do know that we plan to spend $100k on regulatory support (50% of that comes from JumpStart) leading to our next FDA Q-sub meeting, and about $120k on software development (50% of that comes from JumpStart). We are also likely to spend $50k+ on our electronics partner to get working wireless sensors ready to go (we have been spending $10k - $15k/month on them). Most of the rest of our current spend goes to maintaining our team. Our “base” burn rate is $65k - $75k/month, with “elective” burn going to 3rd parties for specific statements of work, running $25k - $75k in any given month. Happy to step through our spend plan in more detail with anybody. The first big value inflection point is our first human study, planned for 1Q26. This study will cost us $120k - $150k to execute. With our planned 1st close mid-September, we should be good to get there, but we want to raise more to give us some wiggle room and some runway afterward, as raising the Series A is expected to take a few months. While it is possible that the first human study triggers exit offers, the plan is with human study data in hand, we raise our Series A ($8M - $10M), which will be angels (current investors only, not looking to add more small angels at Series A), institutionals we have already spoken with (e.g. Cincytech, Arboretum, Ohio Innovation Fund, Laerdal Million Lives, Plains Ventures, A16z, NWA, OSF Ventures, Sonder, OCA Ventures), new institutionals, and strategics (either corporate VC arms or joint development collaborations – Abbott, Roche, Medtronic, Dexcom, Insulet, etc…). We are fine with any mix of this, even to the point of 100% strategic money. Series A could be done in two tranches if necessary. The next big value inflection point (and another likely exit trigger) will be clinical study data/publication and/or FDA clearance. We get there with the Series A money. We also would like to get a third big value inflection point on Series A money, and that is a human study with one or more biomarkers relevant to one of the very big markets (heart failure, multimorbidity, or diabetes). NT-proBNP and insulin are the two most likely candidates. At that point, exit is deemed likely if it has not already happened. Data & Partnerships ● How will data interoperate with EHRs/care-management systems (APIs, standards, security), and what is your strategy for payer/provider/pharma partnerships tied to the data asset? This is not an area we have spent a ton of time on yet; getting human data is our primary focus right now. That said, we do not plan to launch with EHR interoperability, because that requires customization for each EHR installed instance, hospital by hospital, and the bang for the buck is just not there for a startup. When that time does come, we plan to partner with an API provider to talk to EHRs. In the meantime, providers have indicated they are perfectly fine with emailed PDF reports and access through a portal. They will load the PDF into the EHR so they can see it there if they want (EHRs are chock full of such PDFs). For cybersecurity, we have our partner selected and are integrating their input into our software and hardware development conversations. Regarding payer/provider/pharma partnerships tied to the data asset, we simply have not gotten to that yet (other than knowing we want to do something in that arena at some point), so if you know anybody who is really good in that area, please make the intro! Platform Expansion ● Beyond monitoring, what’s the roadmap for medication-adherence or therapy-response use cases, and what criteria will you use to prioritize new biomarkers? At this stage in our company development, our roadmap (to use the term as something of substance vs. just tossing that word around…) does not exist beyond the green dots (see figure below) of our platform map. I preach focus focus focus to our team. We have done market analysis and some customer discovery to at least minimally qualify opportunities beyond the green dots for down the road, but we will not defocus our current efforts to dig further right now. Our focus is really the first blue dot to get to market, and managing internal R&D and strategic relationships for the 3 green dots. When people approach us about other applications, we have conversations, and sometimes we work with them (if they pay us). We have discussed sublicenses to others in fields outside of cardiometabolic monitoring, but we are the world leaders here, so it will take others time to be in a position to do anything with our IP in other fields of use. We are particularly intrigued by the pharma drug development/companion Dx use case for our technology and would welcome the opportunity to set up a subsidiary with its own management team and own cap table if we find somebody qualified and interested.
