Why Early Risk Retirement is the Best Investment You Can Make

Interview with Dr. Sam Mazin, Co-founder and CTO of RefleXion Medical

Dr. Sam Mazin, co-founder and CTO of RefleXion Medical, was trained in computer engineering at the University of Waterloo. After falling in love with technology, Sam initially intended to focus on communication technologies. At least until his academic advisor tuned him into the completely foreign world of biology.

As Sam continued exploring and taking classes in that space, he developed a deep passion for medical imaging, which led to him dipping his toes into the field of radiation therapy.

This inspired Sam to eventually co-found RefleXion Medical, a therapeutic oncology company with a novel technology that marries positron emission tomography (PET) and computed tomography (CT) with radiotherapy.

Named SCINTIX™, this groundbreaking technology leverages live, continuously-updated data throughout the entire treatment session to determine exactly where radiotherapy treatment should be delivered.

SCINTIX therapy utilizes a single radiopharmaceutical injection to transform cancerous tumors into biological beacons that will then transmit signals to communicate the location of the cancer cells. These emissions are received by PET detectors on the RefleXion machine, which will then deliver treatment accordingly.

With this technology, patients with tumors in the lung or bone resulting from primary and metastatic cancer can receive more targeted radiotherapy treatment with a reduced risk of toxicity, potentially resulting in better patient outcomes.

Since its birth in 2009, RefleXion Medical has raised nearly $400 million from premier investment firms, won the 2022 Pantheon Award from California Life Sciences, and received marketing clearance from the U.S. Food and Drug Administration (FDA) for its SCINTIX biology-guided radiotherapy.

In this episode of Medsider, Sam talks about how early-stage risk retirement and investor pitching contributed to the success of RefleXion. Sam also discusses how medtech entrepreneurs can make better-informed decisions on the type of clinical studies to run in order to facilitate regulatory approval and the clinical adoption of their products.

Key Learnings from Sam's Experiences

  • Test and tackle the highest-risk concepts of your product in the early stages. This is one of the most efficient ways to put your initial, and often limited, capital to use.
  • Talk directly to the appropriate audience when determining the type of clinical studies to run. You should design your clinical programs around what a single consumer wants to see from your research instead of trying to meet the needs of different user groups through a single study.
  • It's never too early to start raising capital. Instead of waiting until you’ve perfected your product, start reaching out and pitching to potential stakeholders as soon as you can. And don't be afraid to re-approach investor groups that previously said "no."
Guest
Sam Mazin
Co-founder and CTO of RefleXion Medical

Dr. Sam Mazin received a Bachelor of Applied Science in Computer Engineering from the University of Waterloo, Canada, and holds a Ph.D. in Electrical Engineering from Stanford University. He co-founded RefleXion Medical in 2009 and is the inventor of the company’s core technology, which aims to improve treatment outcomes in patients with tumors in the lung or bone resulting from primary and metastatic cancer. 

Tackle the Biggest Uncertainties First and Foremost

In its early days, one of the biggest challenges that RefleXion Medical faced was convincing stakeholders and early-stage venture capitalists to invest in the development of SCINTIX. And when they finally found a group of investors willing to give their vision a go, Sam had to put his very limited capital to good use.

Thankfully, Sam's company had made the strategic decision to bring on a highly experienced engineering leader, David Larkin, who introduced a life-changing philosophy to the RefleXion Medical team. He recommended they use its limited resources to tackle the most significant risks and uncertainties before anything else.

David's philosophy, "follow your fear," encouraged the team to think about the key risks involved in advancing the company to its next inflection point. Sam and his team then worked on retiring any major risks, even in the company's earliest stages, before they even moved on to address the lower-hanging fruits and more straightforward tasks.

"At the end of the day, you're trying to retire risk. Retiring risk translates directly to value creation. Your stock is worth so little at the beginning because the risk before you is so high. And so the more you can chip away at that risk, whether that's a technical risk, clinical risk, market risk, or regulatory risk, the more you're creating value in the company," Sam explained.

Because of this strategy, the bulk of RefleXion Medical's initial capital was delegated to answering critical questions about the product's viability and functionality.

Productivity in an entrepreneurial sense should revolve around risk retirement and seeking answers to critical dealbreaker questions, rather than the number of tasks you've managed to check off your to-do list.

"At least to just answer the question, can this be done? I thought that was probably the most important set of early decisions the company made. And that was to efficiently invest capital to turn over those cards, the critical cards, and to answer the question of whether it's worth continuing," Sam elaborated.

Reverse-Engineer Your Clinical Studies Based on Your Audience's Needs

When designing a clinical study, all medtech entrepreneurs should first ask themselves what the end goal of the study is or how it can reduce a specific risk.

More often than not, the clinical work required to acquire regulatory clearance from the FDA differs from the research needed to drive market adoption or prove a product's economic viability.

Thus, it's best to only run clinical trials after speaking to your end audience to ensure your resources are utilized effectively.

If you intend to conduct a clinical program that will facilitate regulatory clearance from the FDA, make it a point to first converse with the FDA and get well-acquainted with their requirements for approval.

But if you're looking to run a clinical trial that will help boost your product's clinical adoption, it's crucial that you speak to target users and potential stakeholders to get a sense of what they expect to see from your research.

In any circumstance, Sam's advice is to think about the specific audience of a certain study and design the study around that particular group of consumers.

"You don't want to make a study that's for everybody because you're going to dilute it for everybody. The FDA will be looking for something in particular. Users will be looking for something in particular. Payers will be looking for something in particular. And so ideally, you're tailoring whatever you're trying to do to that specific stakeholder," Sam said.

You Don't Need a Perfect Product to Start Pitching

One crucial concept every medtech entrepreneur must grasp is this; investors like to invest in lines, not dots.

You don't need to wait for a perfected end product before approaching potential capital partners. Investors are captivated by stories that demonstrate progress. Even if your focus isn't to raise funds from the get-go, pitching early on helps you to build your company's story and nurture relationships with investors.

"You may go in for a pitch, and it may not be enough to get you to that next meeting. But you now have a data point for the investor, and the investor has a data point on you. And a quarter later or two quarters later, you go in for another pitch, and now they see what has happened in that time," Sam explained.

"It also helps you track the investor, too; how reliable are they in terms of the types of questions that they need answered? It's a relationship that you're developing. It's not a 'one-time cash comes in the bank,' and then you're not going to see each other again."

Another key concept to keep in mind when fundraising is that "no" is, in fact, a "maybe." Rejection is one of the toughest pills to swallow in entrepreneurship. But being on the receiving end of a "no" doesn't mean you'd have to cross that particular investor group off your list for good.

Because you'll be making constant progress along the way, plus the requirements and interests of potential investors are ever-evolving, don't be afraid to approach the same group when your business gains more ground and achieves new milestones.

And when you first start pitching, Sam recommends casting a wide net in terms of the type of investor you're going for. Staying fixated on what you might think is the perfect investor profile could lead to wasted resources if things don't pan out.

Once you do find a group of investors who are truly compelled by your company's value proposition and mission, that's when you can lower all your nets and devote the bulk of your time and energy to building a relationship with them.

"And then finally, the ones that I think latch on to what you're doing, they may not invest right away, but they become "believers." You can tell there's a different feeling about them because they almost never question your value proposition. They get that if you could do this, this would be big. Those are the ones to spend more time and energy on. Because once you get one of those really revved up, they can amplify your reach considerably," Sam said.

Based on his experience, these people become much more than just initial investors. When they align with your vision, they will help highlight important points that should be communicated and work with you to drive your company forward. Essentially, they will become some of your most valuable marketers and communicators.

Download a copy of the interview transcript right here.
Share:
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Dr. Sam Mazin, co-founder and CTO of RefleXion Medical, was trained in computer engineering at the University of Waterloo. After falling in love with technology, Sam initially intended to focus on communication technologies. At least until his academic advisor tuned him into the completely foreign world of biology.

As Sam continued exploring and taking classes in that space, he developed a deep passion for medical imaging, which led to him dipping his toes into the field of radiation therapy.

This inspired Sam to eventually co-found RefleXion Medical, a therapeutic oncology company with a novel technology that marries positron emission tomography (PET) and computed tomography (CT) with radiotherapy.

Named SCINTIX™, this groundbreaking technology leverages live, continuously-updated data throughout the entire treatment session to determine exactly where radiotherapy treatment should be delivered.

SCINTIX therapy utilizes a single radiopharmaceutical injection to transform cancerous tumors into biological beacons that will then transmit signals to communicate the location of the cancer cells. These emissions are received by PET detectors on the RefleXion machine, which will then deliver treatment accordingly.

With this technology, patients with tumors in the lung or bone resulting from primary and metastatic cancer can receive more targeted radiotherapy treatment with a reduced risk of toxicity, potentially resulting in better patient outcomes.

Since its birth in 2009, RefleXion Medical has raised nearly $400 million from premier investment firms, won the 2022 Pantheon Award from California Life Sciences, and received marketing clearance from the U.S. Food and Drug Administration (FDA) for its SCINTIX biology-guided radiotherapy.

In this episode of Medsider, Sam talks about how early-stage risk retirement and investor pitching contributed to the success of RefleXion. Sam also discusses how medtech entrepreneurs can make better-informed decisions on the type of clinical studies to run in order to facilitate regulatory approval and the clinical adoption of their products.

Key Learnings from Sam's Experiences

  • Test and tackle the highest-risk concepts of your product in the early stages. This is one of the most efficient ways to put your initial, and often limited, capital to use.
  • Talk directly to the appropriate audience when determining the type of clinical studies to run. You should design your clinical programs around what a single consumer wants to see from your research instead of trying to meet the needs of different user groups through a single study.
  • It's never too early to start raising capital. Instead of waiting until you’ve perfected your product, start reaching out and pitching to potential stakeholders as soon as you can. And don't be afraid to re-approach investor groups that previously said "no."
Guest
Sam Mazin
Co-founder and CTO of RefleXion Medical

Dr. Sam Mazin received a Bachelor of Applied Science in Computer Engineering from the University of Waterloo, Canada, and holds a Ph.D. in Electrical Engineering from Stanford University. He co-founded RefleXion Medical in 2009 and is the inventor of the company’s core technology, which aims to improve treatment outcomes in patients with tumors in the lung or bone resulting from primary and metastatic cancer. 

Tackle the Biggest Uncertainties First and Foremost

In its early days, one of the biggest challenges that RefleXion Medical faced was convincing stakeholders and early-stage venture capitalists to invest in the development of SCINTIX. And when they finally found a group of investors willing to give their vision a go, Sam had to put his very limited capital to good use.

Thankfully, Sam's company had made the strategic decision to bring on a highly experienced engineering leader, David Larkin, who introduced a life-changing philosophy to the RefleXion Medical team. He recommended they use its limited resources to tackle the most significant risks and uncertainties before anything else.

David's philosophy, "follow your fear," encouraged the team to think about the key risks involved in advancing the company to its next inflection point. Sam and his team then worked on retiring any major risks, even in the company's earliest stages, before they even moved on to address the lower-hanging fruits and more straightforward tasks.

"At the end of the day, you're trying to retire risk. Retiring risk translates directly to value creation. Your stock is worth so little at the beginning because the risk before you is so high. And so the more you can chip away at that risk, whether that's a technical risk, clinical risk, market risk, or regulatory risk, the more you're creating value in the company," Sam explained.

Because of this strategy, the bulk of RefleXion Medical's initial capital was delegated to answering critical questions about the product's viability and functionality.

Productivity in an entrepreneurial sense should revolve around risk retirement and seeking answers to critical dealbreaker questions, rather than the number of tasks you've managed to check off your to-do list.

"At least to just answer the question, can this be done? I thought that was probably the most important set of early decisions the company made. And that was to efficiently invest capital to turn over those cards, the critical cards, and to answer the question of whether it's worth continuing," Sam elaborated.

Reverse-Engineer Your Clinical Studies Based on Your Audience's Needs

When designing a clinical study, all medtech entrepreneurs should first ask themselves what the end goal of the study is or how it can reduce a specific risk.

More often than not, the clinical work required to acquire regulatory clearance from the FDA differs from the research needed to drive market adoption or prove a product's economic viability.

Thus, it's best to only run clinical trials after speaking to your end audience to ensure your resources are utilized effectively.

If you intend to conduct a clinical program that will facilitate regulatory clearance from the FDA, make it a point to first converse with the FDA and get well-acquainted with their requirements for approval.

But if you're looking to run a clinical trial that will help boost your product's clinical adoption, it's crucial that you speak to target users and potential stakeholders to get a sense of what they expect to see from your research.

In any circumstance, Sam's advice is to think about the specific audience of a certain study and design the study around that particular group of consumers.

"You don't want to make a study that's for everybody because you're going to dilute it for everybody. The FDA will be looking for something in particular. Users will be looking for something in particular. Payers will be looking for something in particular. And so ideally, you're tailoring whatever you're trying to do to that specific stakeholder," Sam said.

You Don't Need a Perfect Product to Start Pitching

One crucial concept every medtech entrepreneur must grasp is this; investors like to invest in lines, not dots.

You don't need to wait for a perfected end product before approaching potential capital partners. Investors are captivated by stories that demonstrate progress. Even if your focus isn't to raise funds from the get-go, pitching early on helps you to build your company's story and nurture relationships with investors.

"You may go in for a pitch, and it may not be enough to get you to that next meeting. But you now have a data point for the investor, and the investor has a data point on you. And a quarter later or two quarters later, you go in for another pitch, and now they see what has happened in that time," Sam explained.

"It also helps you track the investor, too; how reliable are they in terms of the types of questions that they need answered? It's a relationship that you're developing. It's not a 'one-time cash comes in the bank,' and then you're not going to see each other again."

Another key concept to keep in mind when fundraising is that "no" is, in fact, a "maybe." Rejection is one of the toughest pills to swallow in entrepreneurship. But being on the receiving end of a "no" doesn't mean you'd have to cross that particular investor group off your list for good.

Because you'll be making constant progress along the way, plus the requirements and interests of potential investors are ever-evolving, don't be afraid to approach the same group when your business gains more ground and achieves new milestones.

And when you first start pitching, Sam recommends casting a wide net in terms of the type of investor you're going for. Staying fixated on what you might think is the perfect investor profile could lead to wasted resources if things don't pan out.

Once you do find a group of investors who are truly compelled by your company's value proposition and mission, that's when you can lower all your nets and devote the bulk of your time and energy to building a relationship with them.

"And then finally, the ones that I think latch on to what you're doing, they may not invest right away, but they become "believers." You can tell there's a different feeling about them because they almost never question your value proposition. They get that if you could do this, this would be big. Those are the ones to spend more time and energy on. Because once you get one of those really revved up, they can amplify your reach considerably," Sam said.

Based on his experience, these people become much more than just initial investors. When they align with your vision, they will help highlight important points that should be communicated and work with you to drive your company forward. Essentially, they will become some of your most valuable marketers and communicators.

Download a copy of the interview transcript right here.
Share:
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