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New approaches to delivering Focal Therapy

Michael Hoey, founder of Francis Medical Minneapolis joins OnFocus

Today’s OnFocus features Michael Hoey, founder of Francis Medical in Minneapolis, Minnesota and a veteran healthcare entrepreneur  with a deep passion for helping men with prostate cancer. Prior to establishing Francis Medical in 2018 to focus on new treatments for prostate cancer, Michael co-founded NxThera to develop and commercialize urology applications of a vapor platform technology that he invented. This resulted in the highly successful treatment for non-cancerous prostate disease known as Rezum which is benefitting thousands of  men  across the world. Michael is a former professor, having taught and led research at the School of Medicine at the University of Minnesota.  He joins OnFocus to discuss new approaches to focal therapy and their adoption into medical practice.

https://www.francismedical.com/

 

Clare Delmar

Hello and welcome to On Focus, brought to you by the Focal Therapy Clinic, where we address issues facing men diagnosed with prostate cancer that are little known, less understood, often avoided and too often ignored. Prostatectomy cancer is the most commonly diagnosed cancer amongst men in the UK, and with this sombre fact comes a multitude of challenges and opportunities. I’m Claire Delmar. Joining me today is Michael Hoey, founder of Francis Medical in Minneapolis, Minnesota, and a veteran healthcare entrepreneur with a deep passion for helping men with prostate disease. Prior to establishing Francis Medical in 2018 to focus on new treatments for prostate cancer, Michael co-founded NxThera to develop and commercialise urology applications of the vapour technology that he invented. This resulted in the highly successful treatment for non-cancerous prostate disease known as Rezum, which is benefiting thousands of men across the world. Michael is a scientist and former professor, having taught and led research at The School of Medicine at The University of Minnesota. He’s here to speak with me today about new approaches to delivering focal therapy and their adoption into medical practise. Michael, thank you so much for joining me today. I’m really looking forward to this conversation.

Michael Hoey

I am too. Happy to be here and good to meet you as well as all your listeners.

Clare Delmar

It’s amusing, I guess, is one way of putting it that you’re speaking from Minnesota. I’m speaking from London, and we’re both sharing equally abhorrent weather. So happy spring and happy April to you, Michael.

Michael Hoey

Likewise.

Clare Delmar

All right, well, let’s jump right in, because there’s a lot of exciting things that you’ve been doing and that I know you want to share with our listeners. And why don’t we kick off by you telling us about how you got involved in finding new approaches to managing prostate cancer?

Michael Hoey

Yeah. Well, it really came about secondarily to a personal experience. And so I grew up in a farm. I spent a lot of time with my father. Ended up leaving that because I knew I couldn’t make a living there, went on to my college, graduate schools, professional schools, whatever, and ended up at the University of Minnesota. I was in several different departments. One was physiology, other urologic surgery, and the Cancer Research Centre. In that process, I spent a lot of time in urology and cancer applications of things. And one day I got a call from my dad and he said that his local physician said that he had prostate cancer. Well, that was very shocking to me because dad was my rock and I did not expect him to get sick that way and especially with prostate cancer. And something that I was working on. I had him come up to the university and I went with him, sat on the other side of the table when we went to see my associates as his treating physician. And it was eye opening. It was an incredible learning experience to be there with somebody that close to you and then listen to people on the other side explaining to him about procedures to treat prostate cancer and about the side effects in the matter of statistics. I was with my dad, it was very different. It was not statistical, it was human. Very different. And so he went on, he ended up getting treated a couple of different types of treatments. He ended up with the side effects. And I saw those. I, in some capacity, lived them through him and realised what a challenge that really is to men who have conventional procedures, such as removal of the prostate or irradiation of the prostate. And there are many others, but those two in particular. And I saw that. And unfortunately for my dad, his cancer had metastasized and he ended up passing from the disease anyway. And so it was a very impactful scenario. And I decided that I was going to make a choice and that was to stay at what I was doing at the University of Minnesota and continue my research and my work and so forth, or I was going to go out into the private world and try to do something about this and find a new way to treat prostate cancer that is more humane, still efficacious but more humane in terms of the side effects and the other implications. And some of the things that people don’t realise also, is that even when you take a prostate out, yes, you are in the majority of the cases, not all the cases, but the majority you are treating their cancer and preventing them from dying. But one thing that people don’t necessarily realise, the prostate is an organ, it does several things, and there are things that we have not fully elucidated. And when you remove that, it has neurofeedback and hormonal situations that no one discusses because it hasn’t been studied well. And the same thing goes with when you irradiate it, let alone all the other things such as the incontinence and the impotence and potential rectal fistulas and protracted pain. And just along with the normal surgery process of removing the prostate, for example, it is a full surgery. The prostate was not designed to be removed. Anyhow, with all that said, I left the University. I wanted to become an entrepreneur, to build a product to do this, but I didn’t have the product design yet. And one day I was working on a dynamometer with my race car engine. I do have a passion for doing those things on the side. And I happened to have my hand resting on the engine while we were going through the dino polls. Wide open throttle, dino poles. These are big horsepower engines and they shake and vibrate and so forth. One of the things that startled me is I didn’t have my gloves on, it was just my hands, how cold the intake runner got. And all of a sudden it dawned on me. It’s like, well, wait a minute, there is vaporised liquid going through the inside of that intake runner. And I saw not an intake runner. I saw a prostate. Prostate has a capsule, and then it has the tissue, the glandular and stromal tissue and urethra and so forth inside of that. If you want to kill the tissue inside, but you don’t want to harm the tissue outside of the prostate capsule, the energy has to stay within. There was no energy source. And I had several other energy sources patented prior to this that I could do that differentiate from the inside to the outside. When I felt that cold temperature on the intake runner, I knew that liquid vapour was running through and I could use that. That’s called convection instead of conduction. Conduction is like touching something and transfer of thermal energy. Conduction is like the moving of hot wind, for example, very different. It can’t leave a container. That’s where that idea came from. I started a company to do this. Unfortunately, even though I also had an MBA, this was my first foray into the private sector world. I was not successful. I spent two and a half years. I spent all the money that I had saved up during my time up to then and ended up with second and third mortgages on properties. And eventually I decided I had to go work for someone else and yet learn or go back to the University. I chose to go work. So I went to another entrepreneur who was being successful. I worked for him, helped him and learned how to do that. Then I went out and started other companies, and this now is my 12th one. It’s been 20 years since I left the University to eventually get to this point to be able to do a company to treat prostate cancer.

Clare Delmar

Well, it’s quite a story with obviously very human origins. And I want to come back to this concept of humanity, which is actually a word that you brought in earlier in your discussion. And in previous conversations, I’ve heard you use the term humane in describing your approach to managing prostate cancer. And I wonder if you could just elaborate bit little a more about how you define this in the context of the diagnosis and treatment of prostate cancer.

Michael Hoey

Well, you know, it’s really interesting because you don’t think about these things until you have an experience. And reminds me when I used to teach is that normally you would just take things you learn out of a book and then turn around and regurgitate that to the students. Right. And if I hadn’t done something and didn’t know it that way, I would go out and experience it. So in my labs, I would do things to recreate what I learned from textbooks, understand it, then I can teach it. Well, it’s the same thing here, is that once I learned what it was like to experience this from the human standpoint, the human side, now I could relate to that and do something about it. So I started thinking about what does it take if you are presented with a patient who has prostate cancer, what does it take to figure out how to treat that cancer in a way that will save and spare his life and yet make it more humane? Get rid of those morbidities and the anxiety and so forth. So if you start with the diagnostics, there’s been a lot of discussion about PSAs and whether or not they have value or not, because they aren’t a one to one indicator of prostate cancer.

Michael Hoey

There are other things, infections in the prostate, or if you have been riding a bicycle or a horse recently, it sloughs off that prostate component, it’s a protein on the membrane that comes off, it gets into the blood and you measure it. However, if you look at it, Clare, and you look at the men who have a very easy methodology to say, Should I even explore whether I’ve got prostate cancer or not? It still plays a role. It plays a very good role that way, albeit not perfect. But now, what happens once you have this higher or accelerating rate of PSA count in your blood? They’ll say, okay, well, let’s go do a biopsy. Well, I personally have not had a biopsy. I was with my father when he did. I have been involved in many biopsies, which is different because that’s sitting back, looking at it as a medical practitioner, if you are looking at it from the human side, which I did with my father, you realise this is not the most inhumane thing that’s ever been done, but it is something that men do not wish to do.

Clare Delmar

That’s certainly true.

Michael Hoey

Yes. And so from that diagnostic standpoint, you think about what’s been done recently, especially with MRIs, multi parametric, MRIs. They’re designed specifically to look at the tissue in the prostate, and especially for ones that are more the tissue that’s more rapidly growing, has more fluid moving in that area, and they can find areas that are suspicious for prostate cancer. And the thing is that it misses the minor things, but it catches the majority of cancers that are intermediate and later stage, the minor ones you would maybe like to know. But at the same time, a lot of times, those patients are just sitting there and being watchful waited anyhow. And so should you really subject the patient to the biopsy? This is just something to think about. And it could be in the future that the MRIs can be adapted even better so that you don’t need a physical biopsy at all. Now, when you get to the treatment again, this was over 20 years ago that I started this at University of Minnesota. In my mind, where to go with the treatment that was going to be less invasive, less morbidities, and yet, just as efficacious. But I wasn’t the only one. In 2008, I believe it was, that the Focal Therapy Society started, and it was a group of people that thought the same way that I did, even back then that’s a long time ago. And since then, they have progressed and progressed, and they’ve gotten to the point now where there are many different technologies available, whether you talk about cryo or laser, RF, even microwaves in there. And one of the best ones out there, high intensity focused ultrasound. There are plenty of options out there that are trying to do exactly what I’m doing, but they’re all just a little bit different.

Clare Delmar

Indeed. And in fact, I wanted to ask you about that, because another way of looking at your approach is you’re kind of adding a new modality to the arsenal if I can call it that way under the focal therapy umbrella. I mean, do you see a world where providers are kind of modality agnostic? And if so, how would we decide the optimal modality for each patient?

Michael Hoey

Now Clare, that’s a really good question, because it doesn’t relate just to prostate cancer. That’s in medical treatment altogether.

Clare Delmar

Okay.

Michael Hoey

But in general, I’m not convinced that most physicians think about, oh, I’ve got to have this product or that product or that product.

Clare Delmar

Yeah.

Michael Hoey

I think it’s more it’s a tool. It’s like when you go into surgery, you’ve got several different tools there, and you pick out the one for a particular application, and you grab that and you use it. Now there are things that can make one stand out more than the other and choose one more than the other. Example, if a patient presents with cancer up in the top part, the anterior part of the prostate, the physician, the urologist surgeon may look at that and say, okay, I’m probably not going to use a particular one. I won’t say which one it is, but there’s two of them, actually, that do not do a good job up on the anterior part. They can’t really get there and treat. Okay. I’ll use that one. That does allow me to do that.

Clare Delmar

So that’s like a locational criteria. If I can describe it that way.

Michael Hoey

Absolutely. That’s one way to look at it, then another way to look at it is even physicians are still business people. I mean, they earn a salary. And so if something at least in the States, and I know it’s different in different countries, but at least in the States, there is reimbursement. And the greater the reimbursement sometimes the greater incentive for some people, if everything else is the same. And that’s not to put anything down. It’s the system and it’s the way it is, they would never do harm. But if you have a choice, that could make a difference also.

Clare Delmar

Okay. All right.

Michael Hoey

The only thing that could happen that could really change that is if what comes in has the ability to treat all parts of the prostate, not just certain parts, but all parts of the prostate. And if it can treat on the inside and not cause the side effects on the outside because the incontinence, the impotence, the rectal fistulas, all those things are outside the prostate. If you can treat inside and not treat outside, then at some point they may take that particular one more than they would the other ones.

Clare Delmar

Okay. I guess I’m curious about going a little bit more general about focal therapy. How do you see its availability improving and increasing over the next few years? And what do you see as the opportunities or indeed the obstacles to adoption?

Michael Hoey

It’s probably like it is in every other field, certainly amplified in the medical field, because in the medical field you have human lives at stake.

Clare Delmar

Yeah.

Michael Hoey

So changes are not made quickly.

Clare Delmar

That’s for sure.

Michael Hoey

Yeah. I mean, as you know, as I mentioned, I’ve been at this now for a couple of decades, and I’ve only had this company started for three years, but I have been driving towards making this happen for almost 20 years, a long time. Generally speaking, it’s about five to seven years to get a product from concept to commercial use. And so everything is going to take a long time, no matter what. That’s number one. Number two, sometimes the regulatory bodies change. I know things have changed in England that occurred a few years ago, which slows down the process somewhat. And the same thing could happen here in the States, and it does. So that’s another thing. Reimbursement changes, economies can change, which can have an impact on things as well as whether you move to new things or not. And so I think the biggest thing about this is, for example, Peter Carroll, who is one of the leading urologic oncologists in the US and in the country. I don’t believe he’s a focal therapist, but on a call with Francis Medical that we had with them a few months ago, we asked him that. We said, well, what do you think about focal therapy? And one of the things that he said was the train has left the station and therefore there’s no turning back. It is heading that direction. And even though it’s taking a longer time than you would like it to, the thing is that it’s driven for the patient. And if you produce and develop something that’s driven for the beneficence of people that are on the receiving end, that the efficacy stays up, but the morbidities go way down. It will eventually get there. Eventually this will occur, and it is occurring. The shift has occurred. And I would guess in another five years it’s going to go up dramatically. As one of my best friends, who has done more robotic prostatectomies than anyone in the world by a long shot, said, you know, Michael, that this is going to replace an awful lot of the robotic assisted prostatectomies.

Clare Delmar

Well, on that note, I think that’s good news for prospective patients and for anyone who has a loved one who’s been diagnosed with prostate cancer so I think we’ll end there Michael, that’s quite an optimistic way to end so I want to thank you so much for speaking with me I think we may want to have another conversation in a few months because, well, on the one hand, it’s slow to be adopted I think we might be in a place now where, as you say, the train has left the station and we might find that to push the metaphor the track and the drivers are getting a lot more expert at this not to mention that the patients out there and prospective ones are becoming more aware.

Michael Hoey

If I could make just one last comment on this. It is so important to me personally and I think everyone else once they understand this. When I set out to do this a long, long time ago, the whole vision was again to treat the patient efficaciously but minimally invasive and when we did our very first patient right now the patients could be done without anaesthesia but they won’t that will be at a future date but that’s just to say how low the pain scores are with us but when we did our very first patient and we woke him up, we sat there and looked at him to see his response, what did it feel like? And this patient looked at us and smiled, he got up, we helped him to his wheelchair, he went, changed his clothes, went through a couple of tests, put on his clothes and he walked out the door, this was in a South American country and he got up, walked out the door, he came back the next morning with his wife.

Clare Delmar

Still smiling?

Michael Hoey

And he was still smiling.

Clare Delmar

Well, wonderful to hear and on that note, I want to thank you again.

Michael Hoey

You’re welcome, Clare, thank you.

Clare Delmar

A transcript of this interview and links to more information about Michael and Francis Medical are available in the programme notes on our website, along with further information on diagnostics and treatment for prostate cancer, as well as additional interviews and stories about living with prostate cancer. Please visit www.thefocaltherapyclinic.co.uk and follow us on Twitter and Facebook at The Focal Therapy Clinic. Thanks for listening and from me, Clare Delmar, see you next time.

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