Hillary Pierce, Total Flow Medical - Cannula for Cardiopulmonary Bypass Surgery | LSI USA '24

Hillary Pierce  0:03  
Hi, I'm Hillary Pierce CEO of Total Flow Medical. We're based up in Vancouver in Canada. And I have over 15 years experience bringing mostly structural heart implants from concept to market. So at Total Flow Medical, we're developing products to improve the quality of care for patients who need the use of a heart lung machine. So a heart lung machine can support or replace a patient's heart and lung function during surgery or while they're on life support. And it's in this room, thank you to Wikipedia for this wonderful image, where our story really began with our perfusionist inventor. So the provisioning of the person in the top right corner of this image, they run Heart Lung machines day in day out, and they're responsible for keeping that patient that's in the bottom left corner of that image alive basically, via all of that equipment. So I think it's really clear when you look at the at the photo, that the care that they can deliver is really directly tied to the equipment and tools that are available to them. So back to our perfusionist inventor, he became pretty distraught seeing the equipment and the devices that he's using injure his patients. So he came up with a solution. So the problem that we're solving is is basically due to the the current standard of care. So when patients are hooked up to a heart lung machine cannula, inserted, inserted in the femoral vessels, to basically remove and replace blood between the patient and the heart lung machine. And what can happen is it can interrupt blood flow and that patient's limb, which can lead to ischemic injuries developing which at a minimum means an extended hospital stay, but in the extreme, this can mean amputation, and even death. The incidence of ischemic conditions during femoral cannulation is about 30%. And clinicians don't aren't always able to predict exactly which patient is going to actually develop this issue. So that means that the 100,000 adults that receive femoral cannula every year in the United States could really use a solution. The second part of this issue is that currently the only rescue or preventative technique that clinicians have is really truly this MacGyvered technique, this MacGyvered solution that's been put together so they use a pediatric or smaller catheter, and the inserted further down that patient's leg and then literally splice it into the bypass circuit. So that patient's leg has a small amount of dedicated blood flow. So as you can imagine, this is a second device, this is going to take more time, this is doubling the risk. And the thing is, is that even when this is used, it's not it's not always effective. So we have a solution. It's been designed by clinicians, it's easy to use, integrates seamlessly within existing clinical workflow. We our first product is a familiar chill cannula for use in surgery works like any other cannula except it provides surgeons with the option of dedicated blood flow to their patients limbs via our patented features. It basically is covered as as accessories into larger procedures and each iOS kit use case it's covered under existing procedural coding. We have three we have four patent families, our very first patent has just been granted in Europe, and from our pilots, early pilot, preclinical datas. To date, we're actually showing that our devices provide two times more flow to the limb than the current standard of care on market devices. So we've spoken with clinicians around the world, and it's clear that there is a need for a cannula based solution to ischemic limb conditions during femoral cannulation. So our initial market will be for patients undergoing minimally invasive cardiac surgery. The total global market for cannulas about one and a half billion dollars per year. The total US market is about 14 30 million for our first product line. Our very first step our surgical arterial cannula for surgeon with surgical use will be about 34,000,004 years post commercialization. So we will partner with an established distributor while approaching these industry leaders in the space at key development stages. None of which actually have a solution to this problem in the US and we would offer a nice tuck in product to their existing portfolios. We are aware of about four previous acquisition previous transactions deals within the specialty cannula space. So what's great is leaving OVAs validated this unmet need so they launched the buy flow which is a cannula based solution to this issue. It's available in Europe but not in the United States. We've spoken to clinicians who have used it and are heard their concerns about its very technically challenging insertion technique and the fact that the leg flow features are must use, they can't control that. So these are issues which are addressed in and differentiate our products. So the team to deliver these products are in place. Combined, we've brought multiple medical technologies from concept to commercialization. Martina, Juan Lockwood and myself bring each over 15 years of lessons learned, developing class three permanent implants in both the neuro and cardiac space. And Amy DeVries. Kramer has actually over 20 years experience in cannula. She's worked in sales and marketing and then also most recently, was in charge of the global cardiac surgery advisory boards at Medtronic. Our board includes both US and Canadian based expertise in fundraising, commercialization and scaling growth for medical device companies. And our advisors include both successful entrepreneurs and medical experts. Dr. Anson Chung was the past president of the International Society of many minimally invasive cardiac surgeons. So that's our first user group. And Brian Lich is a perfusionist himself, he founded and grew what is now the third largest perfusion distribution company in the United States. So a little bit about where we've been, and where we're headed, we've we've raised just over four and a half million to date and precede seed and non dilutive funding. And this is should give us runway through to the end of q1 25. With that, we've had three FDA pre submission meetings to de risk our regulatory strategy and upcoming submission. We've had positive really positive preclinical studies. And we're just about to open our Series A to support commercialization, which will include post market studies, as well as working on the next indication for our product. So just in summary, really quickly, we're addressing a real unmet clinical need. We have a strong team in place. We have oversubscribed in our previous financings, and we've shown that we think we can execute there's a really strong group of potential strategics in this space, and we're just getting ready to open our Series A to support commercialization of our first product in the US in 2025. So thank you so much for your attention. Our mission at Total Flow Medical is to improve the quality of care and the quality of life for patients who need the use of a heart lung machine and in heart surgery one device at a time, so please do come and chat if you'd like to know more if you'd like to join us to help support these patients limbs and lives. Thanks so much.