Latest / StartUp Health NOW Podcast / Lactation Lab Gets FDA Breakthrough Device Designation to Help Babies Get the Nutrition They Need
Transcript
- 0:00[ on-hold music] I think there's still a very dismissive attitude, especially amongst some VCs. This is not a problem. Your market's not big enough. You know, this isn't a problem.
- 0:15This is just a phase, or whatever it is. And, uh, that's, that's gotta change.
- 0:20I mean, if we see anything that's happened, it's really the fertility stuff, I think, that's made the first big change and opened people's eyes to the fact that women want data, they want answers, and they want, um, more information.
- 0:36[on-hold music] Welcome to StartUp Health NOW, the podcast where we celebrate the entrepreneurs and innovators reimagining the future of health. I'm your host, Logan Plaster. My guest this week is Dr.
- 0:46Stephanie Kenaly, the founder and CEO of Lactation Lab, which StartUp Health backed in 2019. As a family doctor and as a mother, Dr.
- 0:55Kenaly saw firsthand the challenges faced by new moms when it came to feeding their babies. What she saw again and again was that moms simply didn't have information about their own breast milk.
- 1:07Was it low in any nutrients? Would the child benefit from a supplement? Why, she wondered, was there so much guesswork about something so essential to infant thriving?
- 1:17So she came up with a testing kit that analyzes breast milk to show exactly what nutrition an infant is getting, which allows mothers to replenish anything that's deficient. I wanted to dial up Dr.
- 1:27Kenaly this week for two reasons. One was to get her take on the current infant formula shortage, since she works so closely with new moms. But also to talk about some exciting news.
- 1:38Lactation Lab has just received breakthrough designation from the FDA for a device they've built that's being used in hospitals to make sure that the most at-risk babies get the nutrients they need to grow and thrive.
- 1:50Dr. Kenaly explains all about it in our interview, and how this breakthrough designation has changed her company's trajectory in some interesting ways. Enjoy. [on-hold music] Dr.
- 2:04Stephanie Kenaly, CEO and founder of Lactation Lab, thanks for joining me on the show today. I'm looking forward to talking with you. Thanks for having me. It's so nice to see you.
- 2:13So you and I have talked before about what you're building at, at Lactation Lab, but, uh, give me an overview for, for the, the listener, uh, just what you've built and what you're working on next. Right.
- 2:25So at Lactation Lab, we just launched Emily's Care, which is a new device, but basically we're working on taking the guesswork out of breastfeeding.
- 2:32It turns out that the mammary gland is the only gland in the body that does not have a diagnostic tool.
- 2:39So what we've done is really trying to take the guesswork out of breastfeeding, have an idea of what's going on, and we also realized over the last year and a half that there's an unmet need in the NICU to have accurate diagnosis, um, and d- determination of the macronutrients in breast milk.
- 2:58Okay. So, so walk me through this. I know initially it was all about testing, uh, a mother's breast milk to understand the makeup of it so she could feed her child better. So how did that segue into a device?
- 3:10You said Emily's- How that segway... Right.
- 3:12So how that happened was basically, you know, COVID hit, and we're like, "Wait a second," you know, moms are super stressed, a lot of doctor's appointments, in-person visits were being postponed for well child visits.
- 3:23And we realized we need to take the lab to the bedside. We need to get into at home testing, and how can we do this accurately? And how can we do this,
- 3:32you know, to make it not only easy, but then we started to look at, well, wait a second, what are the barriers to testing right now?
- 3:40In the NICU per se, human milk is the standard of care, and it, it, it alone d- especially for premature babies, doesn't have enough of the nutrients, so it needs to be fortified.
- 3:51And when you look at like the standard of care, which is basically to kind of like assume what's in a mom's milk and then just add a bunch of fortifiers and then feed that to the baby, you're like, wait a second, this is the one variable we can control for in the NICU.
- 4:06Mm. We know this can determine better outcomes. So within, yeah, within the first couple weeks of life, it's amazing how it determines, um, white brain matter, IQ, survival, all this stuff. Yeah.
- 4:18I was just gonna ask you to give some more details about kinda what's at stake if we don't go down this road. Yeah.
- 4:25So it, it's, um, it's kinda hard to believe, but, um, you know, in the third trimes- so again, like, no one plans to deliver prematurely. No one wants to be in the NICU. When you're in the NICU, you're in the NICU.
- 4:37And in the third trimester of pregnancy is really when all of this growth would happen, and there's a lot of increased metabolic needs for the baby.
- 4:44Um, for premature infants, this happens in the NICU, so human milk alone is not enough to meet those nee- needs, meaning high calories, high protein in particular.
- 4:54And studies have found within the first two weeks of life,
- 4:58the amount of calories and protein are essential to determine not only growth, IQ, white brain, uh, white, uh, white matter brain volume, um, cognitive abilities, and so forth.
- 5:11So it kinda goes back to this whole notion around the first 1,000 days of life, which is from the time from conception to age two, how it's critical for development, and it's, y- you know, um, can lead to...
- 5:26It, it's sort of like the optimal time to kind of program, um, y- program us really [laughs] for, like, optimal health. Yeah.
- 5:32But not doing it or not meeting those criterias really does lead to irreversible, you know, brain damage and can lead to irreversible health, health, uh, defects, and, um, you know, detrimental effects later on in life.
- 5:47L- let's roll it back. I kind of like- It lo- Yeah, I kinda joke, like, it's like, it's like the, the, the computer's being made and the software is being programmed at that time, and it can't be changed. Interesting.
- 5:56Let's roll it back a minute. Yeah. And tell me more about how you came to this challenge. I know you're, you're a family physician?That's correct. So I practiced family medicine for 15 years.
- 6:07Um, I'm also a mother, and I struggled with breastfeeding, so, um, like many healthcare founders, female founders in the, um, health tech, femtech space, I should say, personally struggle with something.
- 6:19Um, and I found there, there was a need to really know what is in milk.
- 6:23My daughter was failure to thrive, which meant she was falling off the growth chart, but yet there's so much pressure to breastfeed, even more so now than before.
- 6:31And that's when I said, you know, we need to figure out, again, like realizing there's no diagnostic tool for the mammary gland, like, why don't we know more about this?
- 6:39Why do we know so much more about cow's milk than human milk? Why are there so many unanswered questions? Why can't we figure out, is it just a count...
- 6:46Like, you know, th- this archaic view of just counting the number of pee diapers and poo diapers and so forth. And then, um, you know, I felt I am so passionate about this.
- 6:57I left my practice in April of 2020, kind of right when the pandemic really hit, and that's when I really focused on creating a device, creating an at home test, and point of care test that could be done to really accurately measure what is in human milk.
- 7:15Y- you made that quick comment about we know more about measuring cow's milk than human milk, and that clearly goes to something that you've, you've looked into. I mean, that's pretty powerful.
- 7:25G- tell me what you're talking about there. I mean, it's, it's just a lot of the literature of human milk is kind of based on these assumptions that are around cow's milk.
- 7:33The reality is that cows are bred in a way you know which ones will make, you know, high fat milk, high protein milk, then the ones that are the low producers are kind of bred out.
- 7:45But that leads me to the kind of the bigger, the bigger issue here is that from an evolutionary standpoint, there are genetic predispositions and, um, genes that are expressed which are affected by stress and environment that determine a mother's milk production ability, basically.
- 8:03So my, my big mission in life is to stop making these assumptions around breastfeeding, that just because it's natural, it's easy. Mm.
- 8:12And just like any other part of the body, it may not always work perfectly for everybody.
- 8:17So just like someone wears glasses, you don't walk down the street and make fun of the person 'cause their eyes don't work or shame them for needing glasses or contact lenses 'cause their eyes aren't doing what they're supposed to do.
- 8:30It's the same way I want us to talk and, and have that conversation with other moms. It's not going to work for every mom. Yeah. And breastfeeding is tough, so let's support those that can do it, that wanna do it.
- 8:43Those that wanna do it a little bit, great. But the reality is, it's just like every other part of our body, it may not be perfect, and it may not come easy or naturally to some. So- I've-... let's accept that.
- 8:56[laughs] I've, I've seen how in your literature, on your website, I've seen how you walk that line between saying, "Look, breastfeeding is, has these benefits, and yet-" Yeah...
- 9:04"we also support a, a mother's choice in really what works for her." I was just kinda curious if that is a challenging line to walk.
- 9:13Is, is that, um, does that come naturally or, or is that something you really have to work out day by day?
- 9:19No, I think at first, you know, when we first started, it was something that I would say I would tread like, lightly about, um, but I think the reality is, maybe it's just my cynicism over time where I'm like, enough with this all or none.
- 9:33Let's stop saying it's, you know, fed is best. Well, of course you have to feed your baby. I mean, that, you know, otherwise they should be taken away [laughs] from you.
- 9:40It's, you know, it's illegal to not feed your baby. It's criminal. Um, but my point is like this whole idea of like breast is best and it's all or none, I think that thinking, I'd like to see that go. Mm.
- 9:50I think the reality is there are a lot of health benefits to breast milk, yes, and in the NICU per se, human milk is the standard of care.
- 9:59It has been shown to be better than cow's milk-based prot- you know, protein that's in infant formula. These are facts.
- 10:07But the messaging to women I think needs to change to, you know, to the average mom, that it doesn't have to be all or none.
- 10:14And so, you know, we published a paper, for example, that was like, even if you give your kid just one ounce of milk a day, um, there's so many really interesting strains of bacteria and stuff like that.
- 10:24Like, there are health benefits to that. So I really, my, you know, again, my thinking is like let's move away from the all or none.
- 10:31And, you know, especially times, you know, with the latest formula shortage and so forth, like getting to the fact that moms need formula. There's always gonna be a need for formula.
- 10:40There's moms who don't wanna breastfeed, who choose not to and who can't. So we have to have options.
- 10:48Let's dive deeper into the device itself, 'cause my understanding is that you recently got breakthrough FDA, uh, clearance. Is that true? We don't have clearance yet. We got FDA breakthrough designation- Designation...
- 11:00for our device. Got it.
- 11:01So our device, yeah, it's, um, basically we're measuring the macronutrients, so fat, protein, and lactose in milk using an enzymatic proprietary test strip read with the app, our app, Emilee's Care app, which uses the phone as a spectrometer.
- 11:17Wow. So we've basically been able to like replace, um, a piece of lab equipment, but then pick up the nutrients because when a baby's in the NICU in particular, there are very key targeted intakes they need to have.
- 11:31They need to have an, uh, by weight, a certain amount of protein and calories per day.
- 11:36And so really the standard of care, which is kind of, you know, making these assumptions, what's in mom's milk, adding a bunch of fortifier powders, and then giving it to baby really just doesn't cut it because, you know, too much protein can cause issues for the baby.
- 11:50You know, obviously renal failure in some extreme cases. But it's like as a doctor saying, "Oh," you know, say to the pharmacy, "Oh, mix up a bag of TPN, you know, nutrition, and just give me what you got. It's okay."
- 12:01And so for the most vulnerable infants, right, the most vulnerable human beings, sometimes some babies are just 800 grams, 1,200 grams-It is imperative to know exactly what they're getting.
- 12:14And again, it goes back to the fact that, like, no one chooses to be in the NICU, no one chooses to deliver prematurely, and this is a modifiable risk factor. This is something that we have control over.
- 12:24So let's know exactly what's going into that baby's diet. Yeah. A lot of our listeners, um, [lips smack] uh, are founders themselves, and so the fact that you were able- Mm-hmm...
- 12:33to get through that FDA breakthrough designation is really significant. How difficult was that? How long did it take? Um, what strategies kinda helped you push it to the finish line? You know, um, I...
- 12:46[sighs] It was not easy. I mean, I, um... [lips smack] The program, it was mentioned to me, and I was like, "Oh."
- 12:53And then someone brought it up to me like, oh, with my idea that this could be a breakthrough device, and I was like, "Well, what?" You know, and then I started to get into more of the regulatory stuff.
- 13:02There are certain criteria you have to meet, right? So you have to be life-saving or life-changing.
- 13:07So the fact that we were able to show that nutrition in the first two weeks of life is life-changing and preve- you know, can prevent a life-threatening illness in, um, the NICU. So there's these weird criteria.
- 13:21And we, um, you know, we submitted twice. We submitted the first time, and our device was not ready to go.
- 13:27So, uh, uh, a message for all the founders out there, I think when the breakthrough designation program was originally designed, the FDA had it in mind, um...
- 13:37And, and there's a million benefits to it, by the way [chuckles] too.
- 13:39So you do get expedited priority review and so forth, and you have open conversations, um, with the FDA, or more conversations with the FDA, which is really nice.
- 13:49Um, the reality is I think the program was designed for when people had a great idea, and then they'll help you kind of bring it to market.
- 13:56And now your device really does need to be very close to being market ready, if not, you know- Yeah... [chuckles] right, right, ready to go, you know? Ready to go. Well- Ready to go...
- 14:08that's a great lead-in to kind of what's next. I mean, you... When did you get the des- the designation? We got the breakthrough designation on May 4th, and then we are a 510[k], so we are, um, preparing to submit that.
- 14:20And the good news there is, like, what normally would be an 18-month to 24-month review process is now c- is significantly shortened, and potentially could be six months. Okay.
- 14:32The breakthrough designation too, I was surprised to learn how extensive it was. I mean, our application was over 100 pages long- Wow...
- 14:40and, you know, there's some, um, some folks have told me too that, like, the breakthrough designation application is actually longer than some 510[k]s. Okay.
- 14:48So that sets you up to, um, come to market when, optimistically? Uh, by the end of the year. By the end of the year. Awesome. Okay.
- 14:57Um, another reason why we wanted to talk was you also came out, probably not as headline-worthy on your, in your mind as the FDA, uh, breakthrough designation, but very newsworthy in its own way, uh, your own, uh, infant supplement.
- 15:12And I wanted to chat with you about that- Yeah...
- 15:13just because obviously we're in the middle of an infant formula shortage, um, and you're coming out with this product really at a, an interesting moment, and I wonder if that, uh, has played into this, or what it's been like to, to bring this to market at this point in time.
- 15:29Yeah.
- 15:29We were actually ready to bring it to market a few months prior, but we're the first infant supplement to have Clean Label Project certification, which is a nonprofit that looks at consumer safety, purity, and making sure that products are free of heavy metals.
- 15:44So going through the certification process, the extra testing, making sure you source your ingredients.
- 15:49We developed this based on the, all of the samples we've ever tes- tested over the last four and a half years, looking at milk, looking at the common dietary, um, issues and, you know, then also taking into account when the American Academy of Pediatrics recommends vitamin D and iron as a supplement for all breastfeeding babies.
- 16:07How can we do this and how can we do a better job?
- 16:09I mean, it was very disturbing that, I think it was of the six supplements we tested, you know, four of them contained lead, and the other thing [chuckles] that was disturbing too is that the pH of these supplements was really, really low.
- 16:21And as a mom, I know what it's like when you try to give your kid medicine, and they're kinda like spitting it up and trying not to take it, but you're like, "Please do this."
- 16:28So these are things that we worked on over time. And so a- I, it just, it just gives a little bit of, you know, security.
- 16:34This is designed for infants, um, for breastfeeding infants, and again, it's, it's that knowing what's going on, right?
- 16:42There's a lot of reassurance that you can get by looking at the label on the back of a can of formula. You, you know that there's at minimum these ingredients in there.
- 16:51Um, I think there's been a lot of uncertainty and a lot of extra stress added to new mothers recently with the shortage, and so we're hoping that maybe this can at least maybe reassure moms that if they are nursing or breastfeeding, that this supplement can help assure that their baby's getting everything they need.
- 17:06Yeah. Yeah. I was, I was curious if this, if you saw this as, in any way as sort of fighting back against this, this shortage and sort of increasing supply. Uh, where do you produce this?
- 17:19I mean, does this in any way address some of the supply chain challenges? No. So we're not produced in any of the facil- We have a, um, you know, we, we meet the good manufacturing facilities.
- 17:30But the infant formula stuff in particular, there's only four plants in all of the United States- Oh, wow... that manufacture infant formula. And I think that's the issue.
- 17:39I mean, I just learned again today that the Abbott plant is now shut down again because of a flood. So, you know, there's a lot of theories as to why we're in this situation right now.
- 17:54I think it, it brings up a lot of talk about infant formula, FDA regulation, um, around formula, um, you know, companies and how difficult it is to break that market.
- 18:08New companies trying to come in, and then also, you know, the fact that it's, there's been issues. Two babies died because of the recent, um, you know, why, uh, the Abbott plant is closed.
- 18:20Mm-hmm.You know, there's definitely great concern here. Yeah, yeah.
- 18:23You so, so what I hear you saying is there's, there's legitimate concern and some pretty big top level issues that need to be addressed, uh, to start tackling- Yeah... these issues.
- 18:34Yeah, I mean, my experience with the FDA has been really, really favorable. I honestly can't say enough good things.
- 18:40I think a lot of the time the FDA gets a bad rap because they're always looking at it, taking a reactionary approach as opposed to a proactive approach. Mm-hmm.
- 18:49But the reality is we have nine FDA regulator, apparently, this is per quoting the head of the USDA, who I've spoken to, but, um, basically there's nine folks that are, um, in charge of regulating the dairy industry and four for infant, um, formula and product.
- 19:05So they're just... They're so un- understaffed, you know? Yeah. And I mean, I think that if anything, this has enlightened, uh, everybody's notion of what's been going on and what needs to change.
- 19:19What needs to change is there needs to be more manpower, there needs to be more proactive, um, you know, talks with the companies and making sure that the facilities are up to par, meeting standards on a continuous basis so that this idea of just reacting to something bad never happens again.
- 19:38Got it. What's your take on the, you know, the, well, not just the infant formula market, but, you know, maternal health, uh, as it pertains to women's health as a global health moonshot.
- 19:51Um, do you feel like there's a certain area of innovation and type of founder that we're, that we're really lacking right now?
- 20:00Uh, w- what, what's your thinking on where this area of health innovation stands and where it has some big gaps? I think there's still some huge gaps. I would say women's health, whether it be from
- 20:13fertility, you know, you can even say puberty to menopause, basically. I think there's still, um, a lack of female founders, a lack of, um... I think there's still a very dismissive attitude, especially amongst some VCs.
- 20:30"This is not a problem. Your market's not big enough." Um, I don't know how many female founders are gonna, you know, agree with me on those ones. "Oh, your market's not big enough. Your...
- 20:39You know, this isn't a problem. This is just a phase," or whatever it is. And, uh, that's, that's gotta change.
- 20:45I mean, if we see anything that's happened, it's really the fertility stuff, I think, that's made the first big change and opened people's eyes to the fact that women want data, they want answers, and they want, um, more information.
- 20:58Those that don't want it are not gonna get it. That's fine [laughs] right? But there's still a large number of people.
- 21:02So the idea that, you know, in, in women's healthcare for years, right, there's just been so many assumptions made. So let's stop assuming,
- 21:11let's get behind the science, and then provide solutions so that women have answers. Now, I think this is implied in what you just said, but, but you felt like you got that pushback when you talked to VCs and investors.
- 21:24That's what I'm, I'm hearing from you, that this market isn't big enough. Oh, yeah. Yeah. You experienced it firsthand. If I had a dollar for every time I would've... You know, I mean,
- 21:34I've pitched to, I would say 90% of folks that I've pitched to are middle to older age white men. So talking about breastfeeding and challenges with breastfeeding, I'm not sure I had [laughs] you know?
- 21:50I'm not sure that I was really speaking and, and driving the point home. Yeah. Every now and then when someone has a child who's been born prematurely in the NICU, it's like, "Oh, my God." It's like nothing, you know?
- 22:01Yeah. Don't even need to discuss it. And I think there's been a lot of polarized, um, folks in this space, right?
- 22:07You've got the people that are like, "Breastfeeding is best, and if you give your child formula, you're poisoning them." And then you've got the lob- formula lobbyists, right?
- 22:14Look, look at why we're in the state we're in right now. Why is it that there's four plants? I mean, there's a huge monopoly the way that formula is, is manufactured in the United States. It's just a fact.
- 22:25The barriers to entry, if you talk to some of the new up-and-coming companies, there's huge barriers. It costs a lot of money to get into the market here, and there's a lot of regulation around it.
- 22:35For good reason, right? Because we've seen devastating consequences when things go wrong. However, I think the reality is that people [laughs] need to understand, you know, women make up half the population.
- 22:50A lot of women, not everyone's gonna have a baby, but some will have 10 of them. Yeah. You know what I mean?
- 22:54And not, uh, not everyone's gonna be symptomatic from menopause, but the reality is these are issues that apply to half the population. Yeah. That's good. Um, so obviously, you are... You're, you're busy.
- 23:08You just came out with this infant supplement, the, uh, breakthrough designation. You said six months, end of year, you could have this really tied up. Um, last question for you is kinda the what's next.
- 23:19Um, are you, are you raising, looking for any kind of particular kinds of partners? Um, what does the next six months look for you otherwise?
- 23:28It's surprising because, you know, we're getting ready to raise a round, and then when we got our FDA breakthrough designation, the idea of acquisition came out, and so we've been approached by a lot of people.
- 23:39I think the timing is sort of, it might be the right time for an exit for us because of all of the f- all of the variables that have come together, right?
- 23:47A lot of people are working remotely, so moms can breastfeed at home if they want to or maybe have a little more flexibility than the mom who traditionally had to go back to the office, let's say, at six weeks and so forth.
- 24:01Um, the infant formula shortage and the distrust that... And, uh, that is unfortunately happened right now. And then the opportunities for,
- 24:14in the NICU, to not only, you know, like, like I said, the FDA gave us a stamp of approval of a life-saving device [laughs] but beyond that, it's really, um-Being a game changer, uh, in the NICU and feeding practices in the NICU.
- 24:28Yeah. So it's exciting. Yeah. I mean, we've all these, you know, all of a sudden... I've been busy with Call, which is great. That's great. But, you know. COVID.
- 24:34It- it's not something I had imagined would happen right now, so. Yeah. I think it's just everything, the universe is telling us maybe this is the time to exit. I don't know. Interesting. We'll see.
- 24:42You know, because this is such an emotional topic for, for parents, um, y- of a child who's not feeding, uh, and you, 'cause you're a doctor, I kinda wanna end by giving you a chance to, like, give your advice to those parents, that mother, who is really struggling, and who might end up on the Lactation Lab website, but struggling to feed for whatever reason, and is scared, feels alone.
- 25:07What's your, what's your message to them? Well, a couple messages I wanna say. So first off, you know, there's more brands, there's some great brands of infant formula that there's currently not a shortage of right now.
- 25:19So like, you know, as a, there, you know, there, there, you can get your hands on formula. I really strongly believe it doesn't have to be all or none. I think that stress plays such a huge role
- 25:32in milk production and success with breastfeeding. And then lastly, just like back to my glasses analogy, i- not everyone is, i- it's not gonna work for everybody, and we need to talk about that and accept that.
- 25:48That it's not just a, you know, you don't, we don't just need cheerleaders. We don't just say, "Go try harder. Go do it longer." We know that some people are not gonna be as successful as others.
- 25:59So again, just like back to, you know, needing a hearing aid or, I don't know, trying to think of any other body part that may break down, or a type 1 diabetic whose pancreas doesn't make insulin. Right.
- 26:10It's not their fault. Yeah. Right? It's, they're genetically predisposed to it.
- 26:15So I would say what I'm excited about is, like, you know, bringing more science to women's health all across the board, every aspect, so that the assumptions, the,
- 26:27you know, the wives' tales, the, all of that can start to be, you know, demystified. Yeah. And, and what that'll lead to is really more empowerment for moms. I love it. Dr. Canale, it's always good to talk to you.
- 26:41I, I love what you're working on, and so excited that you got that breakthrough designation, uh, at this- Thank you... at this critical time, and it's gonna do a lot of good. So, so thank you. Thank you so much.
- 26:53It's been a pleasure, as always. All right. Take care. Be well. Thank you. You too. [upbeat music] Thanks for listening to Startup Health Now.
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