Mike Blue on HistoSonics' Non-Invasive Tumor Destruction Technology

sticks in my head and it is powerful. Uh this was the backbone of Kugan's law. Always be coining. Coinages are extremely valuable. In fact, Kugan's law is really just a transposition of this exact post. Anyway, we have our next guest in the reream waiting room. We have Mike Blue. Welcome to the show, Mike Blue. How are you doing? What's happening guys?

Great. How are you?

Thanks so much for taking the time to join us. Uh first time on the show. Please introduce yourself and the company.

So Mike Blue, I'm the chairman and CEO of Hystoics and we use a proprietary way of delivering high amplitude sound waves into the body to ultimately liquefy and remove unwanted tissue. This can be benign tissue or malignant tumors which is our focus today.

That's remarkable.

Incredible.

Uh walk us through. Yeah. Where did this come from? Pure is this pure from like a science lab an academic? Like what's the background on the company?

Feels like science fiction but it's been uh 20 almost 25 years in the making invented by a group of ultrasound researchers

at the University of Exactly. uh

uh 25-y year overnight success story.

Seriously, invent invented uh back in 2001 by a group of really smart ultrasound researchers at Michigan who were trying to find a way to deliver ultrasound energy completely non-invasively almost anywhere in the body. And it's just taken us this long to get to a point where we get our first FDA clearance.

Okay.

And now we've just got this unbelievable momentum on our on our side.

So, you raised some money. How much did you raise? We have a gong here. We'd love to ring it for you.

We've got a a gong here. It has the sonics, too. So,

good. Good.

The team is going to love this if you hit the gong. So, uh we now raised

uh a little over 500 million since

Whoa. Okay. So, everything that you had, this new 250, this is coinciding with a new milestone with the FDA. Is is am I am I hearing that correctly? like where do you where do you go from here?

A whole host of things converging at one time. So we received our first FDA clearance which was gong worthy.

Uh that's a big honestly.

It was it was a it was

there's a lot of people with money but there's only one FDA.

So it's the seminal milestone for any healthcare company. Uh we achieved that two years ago after 20ome years at both Michigan and and then the company was founded in 2010. And so that was for the non-invasive destruction of liver tumors. So we began to commercialize our Edison platform which is a a surgical robot that delivers hyotripsy completely non-invasively and there's a tremendous amount of uh autonomous therapy delivery. Um we then raised uh series D financing uh 6 months later uh that that summer of of 2024 uh began the IPO process had a had a had a bake off selected bankers and then a whole host of other activity pursued and and ultimately um uh came across a group who decided to buy an ownership ownership stake in the company. um that converged with uh finishing enrollment in a in a kidney tumor trial, beginning enrollment in a pancreatic tumor trial, and then we added that additional 250 million in uh equity infusion.

I imagine that you've spent an inordinate amount of money working with the FDA, doing research to get to this point. designing the actual device to deliver uh to deliver ultrasound sounds expensive but not incredibly expensive. But then the actual delivery of the of the uh ultrasound has got to be pretty cheap. So what does this look like 20 years from now or 40 years from now? Uh this feels like potentially a really great uh medical innovation that could fall in cost over time. Of course, you need to recoup your investment, but uh in the long term, this feels like uh potentially a very scalable technology. How do you think about the long-term impacts of this?

Yeah, you you nailed it. So, and and actually 500 million over the course of the the life of the company is is pretty capital efficient relative to other surgical robotic platforms. Yet we we we really believe that ours is the most complex and sophisticated and and autonomous.

So there there's two significant parts to the story. The one is hystootripsy which which is a mouthful but that's the science of of what we do mechanically breaking down tissue and creating this liquefification that the body can then naturally process. So there's been a lot of development and advancement work in sort of perfecting hyotripsy to deliver it safely and effectively throughout the body anywhere non-invasively in the brain to head and neck through throughout the body and then the platform that delivers histatri which is the Edison which is mobile and can be moved from room to room and has a 42 inch highfidelity touchscreen display that the physician or operator uses and then guided by this robotic arm. term um that uh that's been a significant amount of of development and advancement but we really feel like at this point the serious R&D work both on the histatriy side and the robot side is for the most part complete. There is some additional hardware development enhancement that we have to do over time. But the the technology now is at a place where we we can deliver it anywhere like I said into the brain or throughout the body um with with with not a whole lot more in terms of research and development that needs to be done. It's it's more clinical and regulatory consideration. So how much

clinical evidence does the FDA require to get clearances in the brain or in the thyroid or in the breast?

Those are really the considerations today. 20 years from now, 40 years from now, 100 years from now,

instatry we we believe is going to be the primary way to have unwanted tissue removed from your body completely non-invasively without toxicity and and with much fewer side effects that exist today with traditional therapies.

And uh what kind of patients are going to be the first to benefit from the technology? Like where where where are you furthest along? You mentioned it briefly before, but but

yeah.

Do you have to get approved for specific indications, specific types of cancers or specific locations on the body? How does all that work?

We do right now. So, we aligned with the FDA six years ago on starting with a specific organ which was the liver

and our indication is for any tumor in the liver. And so this is primary liver cancer but uh far more significant number of patients who are affected by metastatic tumors in the liver. There are more women with metastatic breast cancer that ultimately become terminal because of their liver tumors than than even primary liver cancer. So that that's our focus today. Many of these st patients are in advanced stage. So they their physicians have said told them that they're terminal and they're hoping to extend their life and to improve their quality of life and and we believe histatrixy is a great option for them. And then by different application or organ it's really going to um it's really going to depend on whether it's used as a frontline therapy or more advanced or for more advanced stage disease. So kidney will be different than the liver then different than the pancreas

than all the other applications. So today we think it fills we we think it fills a significant gap for patients with more advanced stage disease who are hoping to improve their quality of life, get back to normal living and hopefully extending extend their life. But there's no reason that a physician can't use it for earlier stage patients as well.

What are the benefits over uh just like cutting out a ter a tumor as dumb as that sounds? I I like that does happen. I know uh if you have you can get just the old school surgery. I don't even know the name for what it is, but uh I imagine that there are pros and cons to that methodology. Why is this better?

So, we we believe that we're in the process of completing the evolution of surgery from open invasive procedures to laparoscopic surgery to robotic surgery, which has become a big thing over the last 20 years,

to ultimately non-invasive surgery, which is done using hyotropsy.

Interesting. and the Edison platform. And so there's still a lot of surgery that's done today.

Surgery for a lot of indications is still the gold standard. We don't argue that. In fact, we think that and we have proof now evidence that many patients who undergo hyatrixy who were non-surgical candidates could ultimately get themselves to a condition where they can be surgical surgically reected or or even transplantable. We've got some awesome cases of patients who were told they were terminal, have had multiple hyotropsy treatments, and were able to go on and have a a liver transplant, which is really

the only way to cure these patients. So, so we don't look at this as necessarily, although it could be and maybe should be for certain applications, not necessarily a replacement for surgery.

That makes a ton of sense. Uh, well, thank you for everything you're doing. This is very exciting. a true white pill, an overnight success. Uh the royal flush of of good news on TVPN today. Uh congratulations on the progress andc for us.

Have a great rest.

Have a great time. Great meeting you guys.

Talk to you soon.

Take care.

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