We recently caught up with Mike Kujak, the President & CEO of Francis Medical, which was founded in 2018. In this interview, Mike breaks down Francis’ innovative new water vapor technologies, and gives advice about developing the alpha & beta versions of a medical device. We’ll also discuss how to navigate the early-stage regulatory environment, and hear Mike’s views on how best to plan & execute a clinical research strategy.
Then we’ll talk about fundraising strategies and ask Mike what’s next for Francis Medical as the company plans for its second-generation development program.
But first, here's a bit more on his background:
Most recently, Mike was the Chief Marketing Officer and Senior Vice President of International Markets for NxThera. Prior to that, he was the Vice President and General Manager of the Prostate Health business unit of American Medical Systems.
Mike received his MBA from the University of St. Thomas and has a Bachelor of Science degree in physics and chemistry from the University of South Dakota.
Read the Interview with Mike Kujak
Mike, please tell us a little about your personal background before joining Francis Medical.
I’ve worked in the urology healthcare space for over 30 years and primarily in medtech since 2004. I started out my career in the pharmaceutical industry holding several different commercial sales and marketing roles. In the mid 90’s, I transitioned into the biotech industry building sales organizations and launched a few novel compounds. Then, in 2004, I transitioned into the urology field within the medical device space. Prior to Francis Medical, I was on the leadership team of two companies -- American Medical Systems & NxThera -- which were sold to Boston Scientific.
How did the idea for the Francis Medical water vapor technology come about?
The formation of Francis Medical in 2018 was personal for Michael Hoey, the company’s Founder and Chief Technology Officer. Francis, Michael’s father, was diagnosed and eventually passed away from prostate cancer in 1991. Shortly after, Michael left the University of Minnesota to focus on the development of new thermal treatment technologies that could be applied throughout the body, including the prostate.
In addition to his commitment to medical research, Michael has a life-long passion for designing and building race cars. These personal and professional passions converged while Michael was testing one of his high-performance race car engines. He recognized that vaporized fuel represented a tremendous level of stored thermal energy and realized it could potentially be applied to various clinical applications when using sterile water vapor, including therapies to treat prostate diseases and other urological conditions.
Mike, you’ve been involved in several innovative medtech companies. When it comes to designing and prototyping the alpha & beta versions of a medical device, what do you think is the biggest mistake most start-ups make?
We have a philosophy of design, prototype, and redesign to make it better. Given most ablation devices need to go through animal or bench-top testing, then extirpated human tissue, then finally, in-human testing, we allow our engineers to learn first-hand from using the device alongside physicians to see where they use the device and observe its performance.
The Francis Medical water vapor technology is currently being studied under an Investigational Device Exemption, or IDE. When it comes to navigating the early-stage regulatory waters, especially with IDE’s, what 1-2 pieces of advice would you give to other start-up leaders?
I don’t know everything and I learned long ago to surround yourself with people who are specialists in the areas that you need advice and guidance. I also have learned the FDA is our friend and CDRH wants to work with medical technology companies to bring innovative products to the market. I would encourage early-stage companies to build and utilize a scientific advisory board -- or SAB -- early on in the development process and make sure the SAB consists of specialty physicians and a couple of solid regulatory consultants.
Mike, tell us more about your approach to clinical studies for your water vapor therapy technology.
We are currently enrolling in a 15-patient, FDA-approved IDE early feasibility study, or EFS. Once we obtain the safety and efficacy data at 6 months, we plan to submit an IDE for our pivotal study, which will support our 510(k) application. Longer term, we need to make further investments in clinical data to support reimbursement and market adoption. We are currently putting together a clinical evidence plan, or CEP, to lay out our clinical roadmap to support our regulatory and commercial needs.
What’s your biggest advice for other early-stage companies that are building out their clinical research roadmap?
Get your team’s initial thoughts down on paper and it doesn’t have to be perfect out of the block. Next, get inputs from all of your stakeholders outside of your company (e.g., physicians, medical directors at payers, etc.). What’s most important is that your CEP doesn’t need to be a novel like War & Peace!
What are a few of the most important lessons you’ve learned over the years when it comes to developing an insurance coverage & reimbursement strategy?
Start early! We started with a reimbursement landscape analysis in the prostate cancer space. We discovered there was not a CPT code for facilities and physicians to report the procedure with our technology so we filed a CPT application with the AMA even before we had a working device. In May 2019, we were granted a category 3 CPT code. We also filed with CMS for a new technology APC and plan to file for CMS reimbursement and payment assignment once the FDA grants us a Category B IDE for our pivotal clinical study.
Coloplast recently invested in Francis Medical. In terms of raising money for early-stage companies, and evaluating different partners like venture capital vs large strategics, what is the most important piece of advice you’d give to other entrepreneurs that are trying to do the same thing?
I would recommend striking a balance between venture and strategic capital. Both provide good insights and resources into your development, regulatory, and clinical plans, but they have different agendas and needs. We have four solid venture capital investors and two strong strategic investors, both in the urology space, and they have been very helpful in providing insights and resources for us to tap into within their organizations.
Mike, can you share what’s next for Francis Medical? What are you most excited about over the next few years?
We are in the midst of our second-generation development program. We are adding enhancements that will make the procedure easier to perform for the physician. We will also be kicking off a Series B raise in mid-2021 to fund our pivotal trial for 510(k) clearance and the development of our commercial device. We are also working with the FDA to obtain a Breakthrough Device Designation which will help us navigate and lay out our final clinical study for regulatory approval.
Where can readers or listeners go to learn more about you and Francis Medical?
The best place to visit and learn more about Francis Medical is our website at www.francismedical.com.
Let's transition to some fun, rapid-fire questions. For someone that is starting their entrepreneurial journey in the medtech or healthcare space, what’s the most critical thing they should know?
Be passionate about what you’re developing! Network with people who can help you. Build a list of advisors and tap into them often. Do your research, follow your instincts, and surround yourself with employees and consultants who are strong in their functional areas. You don’t need to know it all!
What influential books, podcasts, or resources have been most helpful in your entrepreneurial adventures?
I highly recommend these 3 books: The Innovator’s Prescription, The Tipping Point, and Great Teams.
Are there any medtech or healthcare entrepreneurs that you find particularly inspiring?
There are many that come to my mind, but one for sure is Doug Kohrs.
If you had to teach a class on one thing, what would the subject or topic be?
How to build highly effective teams!
Mike, starting over in your mid-20’s, knowing everything you know now, what would you do differently?
I always knew I wanted to be in the healthcare field. And I’ve held many different positions in various aspects of healthcare and learned a lot from looking at problems from many different angles. If I had to do it all over again, I would have taken on more risk earlier in my career.
We recently caught up with Mike Kujak, the President & CEO of Francis Medical, which was founded in 2018. In this interview, Mike breaks down Francis’ innovative new water vapor technologies, and gives advice about developing the alpha & beta versions of a medical device. We’ll also discuss how to navigate the early-stage regulatory environment, and hear Mike’s views on how best to plan & execute a clinical research strategy.
Then we’ll talk about fundraising strategies and ask Mike what’s next for Francis Medical as the company plans for its second-generation development program.
But first, here's a bit more on his background:
Most recently, Mike was the Chief Marketing Officer and Senior Vice President of International Markets for NxThera. Prior to that, he was the Vice President and General Manager of the Prostate Health business unit of American Medical Systems.
Mike received his MBA from the University of St. Thomas and has a Bachelor of Science degree in physics and chemistry from the University of South Dakota.
Read the Interview with Mike Kujak
Mike, please tell us a little about your personal background before joining Francis Medical.
I’ve worked in the urology healthcare space for over 30 years and primarily in medtech since 2004. I started out my career in the pharmaceutical industry holding several different commercial sales and marketing roles. In the mid 90’s, I transitioned into the biotech industry building sales organizations and launched a few novel compounds. Then, in 2004, I transitioned into the urology field within the medical device space. Prior to Francis Medical, I was on the leadership team of two companies -- American Medical Systems & NxThera -- which were sold to Boston Scientific.
How did the idea for the Francis Medical water vapor technology come about?
The formation of Francis Medical in 2018 was personal for Michael Hoey, the company’s Founder and Chief Technology Officer. Francis, Michael’s father, was diagnosed and eventually passed away from prostate cancer in 1991. Shortly after, Michael left the University of Minnesota to focus on the development of new thermal treatment technologies that could be applied throughout the body, including the prostate.
In addition to his commitment to medical research, Michael has a life-long passion for designing and building race cars. These personal and professional passions converged while Michael was testing one of his high-performance race car engines. He recognized that vaporized fuel represented a tremendous level of stored thermal energy and realized it could potentially be applied to various clinical applications when using sterile water vapor, including therapies to treat prostate diseases and other urological conditions.
Mike, you’ve been involved in several innovative medtech companies. When it comes to designing and prototyping the alpha & beta versions of a medical device, what do you think is the biggest mistake most start-ups make?
We have a philosophy of design, prototype, and redesign to make it better. Given most ablation devices need to go through animal or bench-top testing, then extirpated human tissue, then finally, in-human testing, we allow our engineers to learn first-hand from using the device alongside physicians to see where they use the device and observe its performance.
The Francis Medical water vapor technology is currently being studied under an Investigational Device Exemption, or IDE. When it comes to navigating the early-stage regulatory waters, especially with IDE’s, what 1-2 pieces of advice would you give to other start-up leaders?
I don’t know everything and I learned long ago to surround yourself with people who are specialists in the areas that you need advice and guidance. I also have learned the FDA is our friend and CDRH wants to work with medical technology companies to bring innovative products to the market. I would encourage early-stage companies to build and utilize a scientific advisory board -- or SAB -- early on in the development process and make sure the SAB consists of specialty physicians and a couple of solid regulatory consultants.
Mike, tell us more about your approach to clinical studies for your water vapor therapy technology.
We are currently enrolling in a 15-patient, FDA-approved IDE early feasibility study, or EFS. Once we obtain the safety and efficacy data at 6 months, we plan to submit an IDE for our pivotal study, which will support our 510(k) application. Longer term, we need to make further investments in clinical data to support reimbursement and market adoption. We are currently putting together a clinical evidence plan, or CEP, to lay out our clinical roadmap to support our regulatory and commercial needs.
What’s your biggest advice for other early-stage companies that are building out their clinical research roadmap?
Get your team’s initial thoughts down on paper and it doesn’t have to be perfect out of the block. Next, get inputs from all of your stakeholders outside of your company (e.g., physicians, medical directors at payers, etc.). What’s most important is that your CEP doesn’t need to be a novel like War & Peace!
What are a few of the most important lessons you’ve learned over the years when it comes to developing an insurance coverage & reimbursement strategy?
Start early! We started with a reimbursement landscape analysis in the prostate cancer space. We discovered there was not a CPT code for facilities and physicians to report the procedure with our technology so we filed a CPT application with the AMA even before we had a working device. In May 2019, we were granted a category 3 CPT code. We also filed with CMS for a new technology APC and plan to file for CMS reimbursement and payment assignment once the FDA grants us a Category B IDE for our pivotal clinical study.
Coloplast recently invested in Francis Medical. In terms of raising money for early-stage companies, and evaluating different partners like venture capital vs large strategics, what is the most important piece of advice you’d give to other entrepreneurs that are trying to do the same thing?
I would recommend striking a balance between venture and strategic capital. Both provide good insights and resources into your development, regulatory, and clinical plans, but they have different agendas and needs. We have four solid venture capital investors and two strong strategic investors, both in the urology space, and they have been very helpful in providing insights and resources for us to tap into within their organizations.
Mike, can you share what’s next for Francis Medical? What are you most excited about over the next few years?
We are in the midst of our second-generation development program. We are adding enhancements that will make the procedure easier to perform for the physician. We will also be kicking off a Series B raise in mid-2021 to fund our pivotal trial for 510(k) clearance and the development of our commercial device. We are also working with the FDA to obtain a Breakthrough Device Designation which will help us navigate and lay out our final clinical study for regulatory approval.
Where can readers or listeners go to learn more about you and Francis Medical?
The best place to visit and learn more about Francis Medical is our website at www.francismedical.com.
Let's transition to some fun, rapid-fire questions. For someone that is starting their entrepreneurial journey in the medtech or healthcare space, what’s the most critical thing they should know?
Be passionate about what you’re developing! Network with people who can help you. Build a list of advisors and tap into them often. Do your research, follow your instincts, and surround yourself with employees and consultants who are strong in their functional areas. You don’t need to know it all!
What influential books, podcasts, or resources have been most helpful in your entrepreneurial adventures?
I highly recommend these 3 books: The Innovator’s Prescription, The Tipping Point, and Great Teams.
Are there any medtech or healthcare entrepreneurs that you find particularly inspiring?
There are many that come to my mind, but one for sure is Doug Kohrs.
If you had to teach a class on one thing, what would the subject or topic be?
How to build highly effective teams!
Mike, starting over in your mid-20’s, knowing everything you know now, what would you do differently?
I always knew I wanted to be in the healthcare field. And I’ve held many different positions in various aspects of healthcare and learned a lot from looking at problems from many different angles. If I had to do it all over again, I would have taken on more risk earlier in my career.
