04.10-11.24-HST-Startups-Leuko-Labs

CARLOS CASTRO-GONZALEZ: Good afternoon, everyone. My name is Carlos Castro. I'm the CEO and co-founder of Leuko I also used to be a postdoc here at MIT. And this is where I met the rest of the co-founding team and where we developed the initial technology behind Leuko, where we are developing the first medical device that can measure white blood cells non-invasively.

White blood cells are important for many different patients, but they are particularly important for cancer patients. One million patients start chemotherapy treatments every year in the US. As a consequence of the chemotherapy, their white blood cells will drop to very dangerous levels. And that actually leaves these patients exposed to very frequent and life-threatening infections that happen to 170,000 of these patients.

So when these infections happen, the patients need to be hospitalized for about a week. Each of those re-admissions is about $46,000 event. So the US is spending north of $7 billion on this problem alone. And it also comes with really negative clinical outcomes, including more than 15,000 deaths.

And part of why this happens is because current technologies to measure white blood cells, they all require a blood sample. So that means that they can only be performed in the clinic and sporadically. And as a consequence, doctors and patients are mostly in the dark in between chemotherapy cycles.

So the graph that you see on the screen is the journey, the typical journey of a chemotherapy patient. They go to the clinic on day one to receive their treatment. At that point, they receive a blood draw to make sure their white blood cell levels are safe to withstand treatment. And after that, they go home for 21 days. And it is during that time that their white blood cells are going to drop. But because of the limitations in the current technologies that we just mentioned, it's impossible for the patients and the doctors to know which ones are becoming at high-risk of a life-threatening infection.

So that's the critical unmet need that we are trying to address with PointCheck. That's our first product in Leuko. It's also the first technology that can monitor white blood cell levels completely non-invasively. That means that we don't require a blood sample.

So patients insert the finger in our device. We look through the skin, and we are able to make a measurement that is transmitted back to the care team. So our vision is that this way, patients can do the measurements from home every day much more frequently than what is possible today. And the doctors can actually notice early about whose patients are at high-risk of one of these infections. And they can deploy preventive treatment. And in our estimates, this would reduce 50% of these hospital re-admissions and drastically improve the clinical outcomes for these patients.

So this is all based on proprietary technology that we developed here at MIT. We have six patents filed. The core of the technology is microscopy. So we are actually taking optical videos through the skin, and we are looking at that area right on top of the nail where there are very superficial capillaries. So we are able to get the videos that you see on the screen.

So each of the black loops is a micro-capillary. And they are actually so narrow that the white blood cells must squeeze through them one by one. We use one particular illumination wavelength that is absorbed by the red cells, but white blood cells are transparent. So if you focus on the narrow parts of the capillaries, you will be able to see these bright spots that are actually the white blood cells flowing in vivo.

So based on this data, we have trained proprietary computer vision algorithms that are able to make a measurement. We have validated them with more than 200 patients, and we have some excellent diagnostic accuracy compared to the gold standard. So with that validated product, we have also shown a lot of validated customer traction. We have completed more than 200 customer interviews, and we identified integrated delivery networks and pharmaceutical companies as our beachhead customers.

Our value proposition to them is that we can reduce 50% of their hospital readmission costs and also help them monitor the side effects of drugs during clinical trials. We have demonstrated customer traction. We just announced our first partnership with a major pharma company, and we have existing partnerships with some of the top cancer centers in the US and Europe to participate in our clinical trials for regulatory approval.

We have made a lot of progress since we left MIT. We now have a working prototype. We completed our phase I and phase II clinical validation with more than 200 patients. We are set to start our phase III clinical trial for regulatory approval later this year. And we announced our first paid pilot with pharma.

We also raised significant funding from dilutive and non-dilutive SBIR funds. So all of these milestones put us in a great situation to expand on our collaboration and on our existing collaborations. So we ask today for each of you is that if you have introductions or connections to pharmaceutical companies in the oncology space or medical device manufacturers, please let us know. And I also invite you to pass by our table where we will be demoing the device, and we look forward to continuing this conversation. Thank you so much.

[APPLAUSE]