Rising to the PMA Challenge as a First-Time Founder

Interview with Corveus CEO Tyler Melton

Tyler Melton is the co-founder and CEO of Corveus Medical, a Houston-based startup working on a novel remedy for heart failure. His academic journey from a Biomedical Engineering degree at the University of Texas to an MBA from Rice University has provided him with a solid foundation for his role as CEO.

Before founding Corveus, Tyler cut his teeth at Accenture consulting for top pharmaceutical companies. He later refined his skills at the J&J Center for Device Innovation, where he focused on functional areas like strategic planning and financial model development across various medtech markets.

Tyler’s foray into entrepreneurship was seeded at the Texas Medical Center Biodesign Program — an initiative similar to Stanford's well-known Biodesign Fellowship. It was here that Corveus Medical took root. They seized upon the existing literature on heart failure treatment — particularly its neural components — and quickly set out to develop a cutting-edge solution for this condition.

Heart failure results from the weakening of heart muscles and is a long-term condition in which the heart can't pump blood well enough to meet the body's needs. The inefficient cardiac output leads to fluid accumulation in the heart, lungs, and legs, causing shortness of breath and fatigue. There are more than 6 million people in the US who live with this condition and it’s the leading cause of hospitalization in people older than 65. 

One lesser-understood aspect of this debilitating condition has been its neural aspect. The heart and the autonomic nervous system are interconnected. Evidence suggests that when the heart muscles weaken, this cycle becomes a hyperactive loop that further aggravates the symptoms of the condition. Nearly 80% of heart failure patients experience these exhausting symptoms, and half of them live with no treatment options. 

Corveus Medical's mission is to develop a catheter-based device that allows practitioners to deactivate the nerve responsible for aggravating the symptoms, interrupting the hyperactivity between the heart and the nervous system. Given the complexity of the cardiovascular and nervous systems, the technology requires a high level of precision. This also makes it a higher-risk device, so the approval process involves the rigorous Premarket Approval (PMA) regulatory pathway.

Tyler and his team have already made significant strides in the company's relatively short lifespan, successfully navigating numerous preclinical studies — both acute and chronic. 

Next on the agenda for Corveus are first-in-human trials, which are critical for the FDA approval process.

Key Learnings From Tyler’s Experience

  • Start out lean by using off-the-shelf products for prototyping to save money and time. Tap into existing expertise to drive progress rather than trying to solve everything yourself in a silo.
  • Accelerator programs provide startups with vital networking opportunities and force them to validate or adjust their business assumptions. However, you should carefully evaluate the costs of these programs in equity, time, and other commitments.
  • Don’t shy away from seemingly difficult challenges. The PMA route, despite its rigor and scrutiny, can offer a focused approach to proving clinical efficacy. When it comes to fundraising, early planning and targeted investor engagement can help you efficiently overcome hurdles in your way.
Guest
Tyler Melton
CEO of Corveus Medical

Tyler Melton is the co-founder and CEO of Corveus Medical, a Houston-based startup on a mission to redefine heart failure treatment. He previously worked at Accenture, consulting for top-tier pharmaceutical companies, and at the J&J Center for Device Innovation, where he honed his skills in strategic planning and financial modeling. He then joined the Texas Medical Center Biodesign Program, where he uncovered his current mission: to treat heart failure with targeted nerve ablation.

Don’t Reinvent the Wheel

Tyler is an entrepreneur who believes in working smarter, not harder. The early-stage strategies you adopt as a startup have the potential to make or break your venture, and capital efficiency is first on the list. 

One of Tyler’s most straightforward pieces of advice for capital efficiency is to use off-the-shelf products in the early prototyping stage. Don't try to reinvent the wheel — or in Tyler’s case, the catheter: "In order to save money, you could essentially take apart other catheters, other devices, and harvest some of the different components to test out some of your ideas." Tyler took full advantage of the resources available at the Texas Medical Center, utilizing their abundant supply of expired parts and devices for initial prototyping. This approach lets you conserve your financial resources and accelerates the learning curve. 

Tyler also attributes part of the success of this approach to the strong advisory network from the Texas Medical Center and the expertise of his head of engineering, Byron Smith. As he puts it, "Our network and our team drove the innovation forward." Surrounded by a lot of experts willing to help, they were able to confirm their design assumptions before making significant financial investments.

The key takeaway here is that there's no need to start entirely from scratch and do everything by yourself. There's plenty to learn from existing solutions and experienced operators. Make wise use of the available resources and don’t go at it alone. Save your creative juices and funding for the aspects of your product that truly need custom innovation. Whether he's cobbling together prototypes from off-the-shelf parts or steering a startup through the PMA labyrinth, Tyler understands the importance of calculated risks, meticulous planning, and a strong support network.

Ride the Accelerator Wave

One of the standout benefits of accelerator programs, like TMC Bio Design, is the sheer networking power they offer. Tyler shares, "By utilizing accelerators, we are already establishing that we are working with experts in the industry from fundraising to cardiovascular medical device development." These programs are not just a foot in the door, they offer real connections to proven leaders and organizations that would otherwise be impossible to get access to. 

Networking doesn’t only provide you with vertical relationships with industry experts. Tyler makes it clear that horizontal relationships, or peer-to-peer interactions within the cohort are equally vital: "The best part about our experience with MedTech Innovator specifically was the other companies in the cohort. We learned a lot from each other." Mutual learning within a diverse group adds an extra layer of real-world education that resources and lectures simply can't offer.

Tyler’s favorite aspect of the many programs he’s been involved with is the fact they’ve reconfirmed his team’s assumptions. Accelerators often force startups to face hard truths — ie, get a reality check on their initial thesis. He underlines that the accelerators challenged some of the pieces that they had already built at Corveus. While difficult, this no-holds-barred framework is invaluable for a startup. Validating or rethinking your ideas makes your business model inevitably more resilient.

While accelerators are a blessing in many respects, they aren’t a miracle solution for every business model. Although Tyler and his team benefited from a variety of programs, he cautions that you need to remain mindful of the costs — whether in the form of equity, time, or other commitments. Each accelerator has its unique curbs, or as Tyler puts it, "None are perfect. They all have their different strengths and their different weaknesses." This means you shouldn't enroll in accelerator programs impulsively. In Tyler’s experience, though, the pros often outweigh the cons — access to a robust network of experts, a chance to validate the product development team’s assumptions, and the sense of camaraderie between cohort members. However, you have to evaluate the benefits against the potential costs and make an informed decision that aligns with your startup’s unique needs and objectives.

Beating the Odds

The challenge Corveus has taken up isn't for the faint of heart. When you have a product designed to interact with the complex nervous and cardiovascular systems, you need to have a high level of confidence. 

Most experts would advise green entrepreneurs to steer away from devices that would require the PMA route since it demands more data, comes under tighter FDA scrutiny, and stretches both time and budget.

But Tyler thinks that the “opportunity is too solid to pass up.” Despite the often-cited recommendation for first-time medtech founders to pursue the less rigorous 510(k) pathway, he is boldly steering his startup down the more challenging PMA route. 

Tyler views the PMA process as an opportunity to focus on safety and clinical efficacy, driving the technology to reach its fullest potential. For him, the PMA pathway isn't just a regulatory requirement but a targeted approach that allows his startup to concentrate on demonstrating tangible clinical benefits. By choosing to pursue this tougher road, Tyler isn't sidestepping the advice; he's realigning it in the context of his startup's mission to provide a truly game-changing product.

Tyler is also candid about the fact that the journey to raise capital has been “both good and bad” for Corveus, but he’s not one to shy away from a challenge. Not every investor will understand your vision, but Tyler's advice is crystal clear: "Never take it personally." Keep at it, improve, and be tenacious. When approaching investors, knowledge is your best asset. Do your homework, understand their investment focus, and make sure you're aligned to speed things up. He highly recommends reaching out to peers who are undergoing the same phases: “You can’t know everything. Even if you could, your community, your support in the startup world is really, really important to ensure that you're making the right decisions. Here, one mistake can cost you everything.”

Lastly, don't find yourself backed into a corner. Start your fundraising efforts months before the coffers run dry. This gives you breathing room to choose your investors wisely and not have to settle for less favorable terms. "It's like having a job. You should look for a new job when you have a job," he remarks.

Download a copy of the interview transcript right here.
Share:
Twitter
Facebook
LinkedIn
Email

Tyler Melton is the co-founder and CEO of Corveus Medical, a Houston-based startup working on a novel remedy for heart failure. His academic journey from a Biomedical Engineering degree at the University of Texas to an MBA from Rice University has provided him with a solid foundation for his role as CEO.

Before founding Corveus, Tyler cut his teeth at Accenture consulting for top pharmaceutical companies. He later refined his skills at the J&J Center for Device Innovation, where he focused on functional areas like strategic planning and financial model development across various medtech markets.

Tyler’s foray into entrepreneurship was seeded at the Texas Medical Center Biodesign Program — an initiative similar to Stanford's well-known Biodesign Fellowship. It was here that Corveus Medical took root. They seized upon the existing literature on heart failure treatment — particularly its neural components — and quickly set out to develop a cutting-edge solution for this condition.

Heart failure results from the weakening of heart muscles and is a long-term condition in which the heart can't pump blood well enough to meet the body's needs. The inefficient cardiac output leads to fluid accumulation in the heart, lungs, and legs, causing shortness of breath and fatigue. There are more than 6 million people in the US who live with this condition and it’s the leading cause of hospitalization in people older than 65. 

One lesser-understood aspect of this debilitating condition has been its neural aspect. The heart and the autonomic nervous system are interconnected. Evidence suggests that when the heart muscles weaken, this cycle becomes a hyperactive loop that further aggravates the symptoms of the condition. Nearly 80% of heart failure patients experience these exhausting symptoms, and half of them live with no treatment options. 

Corveus Medical's mission is to develop a catheter-based device that allows practitioners to deactivate the nerve responsible for aggravating the symptoms, interrupting the hyperactivity between the heart and the nervous system. Given the complexity of the cardiovascular and nervous systems, the technology requires a high level of precision. This also makes it a higher-risk device, so the approval process involves the rigorous Premarket Approval (PMA) regulatory pathway.

Tyler and his team have already made significant strides in the company's relatively short lifespan, successfully navigating numerous preclinical studies — both acute and chronic. 

Next on the agenda for Corveus are first-in-human trials, which are critical for the FDA approval process.

Key Learnings From Tyler’s Experience

  • Start out lean by using off-the-shelf products for prototyping to save money and time. Tap into existing expertise to drive progress rather than trying to solve everything yourself in a silo.
  • Accelerator programs provide startups with vital networking opportunities and force them to validate or adjust their business assumptions. However, you should carefully evaluate the costs of these programs in equity, time, and other commitments.
  • Don’t shy away from seemingly difficult challenges. The PMA route, despite its rigor and scrutiny, can offer a focused approach to proving clinical efficacy. When it comes to fundraising, early planning and targeted investor engagement can help you efficiently overcome hurdles in your way.
Guest
Tyler Melton
CEO of Corveus Medical

Tyler Melton is the co-founder and CEO of Corveus Medical, a Houston-based startup on a mission to redefine heart failure treatment. He previously worked at Accenture, consulting for top-tier pharmaceutical companies, and at the J&J Center for Device Innovation, where he honed his skills in strategic planning and financial modeling. He then joined the Texas Medical Center Biodesign Program, where he uncovered his current mission: to treat heart failure with targeted nerve ablation.

Don’t Reinvent the Wheel

Tyler is an entrepreneur who believes in working smarter, not harder. The early-stage strategies you adopt as a startup have the potential to make or break your venture, and capital efficiency is first on the list. 

One of Tyler’s most straightforward pieces of advice for capital efficiency is to use off-the-shelf products in the early prototyping stage. Don't try to reinvent the wheel — or in Tyler’s case, the catheter: "In order to save money, you could essentially take apart other catheters, other devices, and harvest some of the different components to test out some of your ideas." Tyler took full advantage of the resources available at the Texas Medical Center, utilizing their abundant supply of expired parts and devices for initial prototyping. This approach lets you conserve your financial resources and accelerates the learning curve. 

Tyler also attributes part of the success of this approach to the strong advisory network from the Texas Medical Center and the expertise of his head of engineering, Byron Smith. As he puts it, "Our network and our team drove the innovation forward." Surrounded by a lot of experts willing to help, they were able to confirm their design assumptions before making significant financial investments.

The key takeaway here is that there's no need to start entirely from scratch and do everything by yourself. There's plenty to learn from existing solutions and experienced operators. Make wise use of the available resources and don’t go at it alone. Save your creative juices and funding for the aspects of your product that truly need custom innovation. Whether he's cobbling together prototypes from off-the-shelf parts or steering a startup through the PMA labyrinth, Tyler understands the importance of calculated risks, meticulous planning, and a strong support network.

Ride the Accelerator Wave

One of the standout benefits of accelerator programs, like TMC Bio Design, is the sheer networking power they offer. Tyler shares, "By utilizing accelerators, we are already establishing that we are working with experts in the industry from fundraising to cardiovascular medical device development." These programs are not just a foot in the door, they offer real connections to proven leaders and organizations that would otherwise be impossible to get access to. 

Networking doesn’t only provide you with vertical relationships with industry experts. Tyler makes it clear that horizontal relationships, or peer-to-peer interactions within the cohort are equally vital: "The best part about our experience with MedTech Innovator specifically was the other companies in the cohort. We learned a lot from each other." Mutual learning within a diverse group adds an extra layer of real-world education that resources and lectures simply can't offer.

Tyler’s favorite aspect of the many programs he’s been involved with is the fact they’ve reconfirmed his team’s assumptions. Accelerators often force startups to face hard truths — ie, get a reality check on their initial thesis. He underlines that the accelerators challenged some of the pieces that they had already built at Corveus. While difficult, this no-holds-barred framework is invaluable for a startup. Validating or rethinking your ideas makes your business model inevitably more resilient.

While accelerators are a blessing in many respects, they aren’t a miracle solution for every business model. Although Tyler and his team benefited from a variety of programs, he cautions that you need to remain mindful of the costs — whether in the form of equity, time, or other commitments. Each accelerator has its unique curbs, or as Tyler puts it, "None are perfect. They all have their different strengths and their different weaknesses." This means you shouldn't enroll in accelerator programs impulsively. In Tyler’s experience, though, the pros often outweigh the cons — access to a robust network of experts, a chance to validate the product development team’s assumptions, and the sense of camaraderie between cohort members. However, you have to evaluate the benefits against the potential costs and make an informed decision that aligns with your startup’s unique needs and objectives.

Beating the Odds

The challenge Corveus has taken up isn't for the faint of heart. When you have a product designed to interact with the complex nervous and cardiovascular systems, you need to have a high level of confidence. 

Most experts would advise green entrepreneurs to steer away from devices that would require the PMA route since it demands more data, comes under tighter FDA scrutiny, and stretches both time and budget.

But Tyler thinks that the “opportunity is too solid to pass up.” Despite the often-cited recommendation for first-time medtech founders to pursue the less rigorous 510(k) pathway, he is boldly steering his startup down the more challenging PMA route. 

Tyler views the PMA process as an opportunity to focus on safety and clinical efficacy, driving the technology to reach its fullest potential. For him, the PMA pathway isn't just a regulatory requirement but a targeted approach that allows his startup to concentrate on demonstrating tangible clinical benefits. By choosing to pursue this tougher road, Tyler isn't sidestepping the advice; he's realigning it in the context of his startup's mission to provide a truly game-changing product.

Tyler is also candid about the fact that the journey to raise capital has been “both good and bad” for Corveus, but he’s not one to shy away from a challenge. Not every investor will understand your vision, but Tyler's advice is crystal clear: "Never take it personally." Keep at it, improve, and be tenacious. When approaching investors, knowledge is your best asset. Do your homework, understand their investment focus, and make sure you're aligned to speed things up. He highly recommends reaching out to peers who are undergoing the same phases: “You can’t know everything. Even if you could, your community, your support in the startup world is really, really important to ensure that you're making the right decisions. Here, one mistake can cost you everything.”

Lastly, don't find yourself backed into a corner. Start your fundraising efforts months before the coffers run dry. This gives you breathing room to choose your investors wisely and not have to settle for less favorable terms. "It's like having a job. You should look for a new job when you have a job," he remarks.

Download a copy of the interview transcript right here.
Share:
Twitter
Facebook
LinkedIn
Email

You May Like These Articles

Premium

Doing Well by Doing Good

Interview with Proprio CEO Gabriel Jones

Gabriel Jones is a man whose journey covers diverse industries — from engineering in Japan to Wall Street mergers and acquisitions. The culmination of his hard work and versatility, however, came with his current venture, Proprio, a company redefining surgical precision through AI. Gabriel’s eclectic, impressive background has equipped him with a unique framework for creating a thriving startup ecosystem, successful capital fundraising, and using public relations to his favor.

Premium

Build for the User, Not the Spec Sheet

Interview with Phagenesis CEO Reinhard Krickl

Under the leadership of Reinhard Krickl, Phagenesis is commercializing a neurostimulation system designed to treat dysphagia, a condition that impairs a patient's ability to swallow and prevents complications like malnutrition and aspiration pneumonia. In this interview, Reinhard shares insights on the importance of simplicity in design, what thorough market understanding truly means, and how he engages with stakeholders effectively. He also reveals the “market access checklist” he uses before entering the commercialization stage.

Premium

Medsider Mentors

Volume VI

In Medsider Mentors Volume VI, we’ve distilled key insights from founders and CEOs of some of the hottest medical device and health technology startups including LimFlow, Field Medical, Sinaptica, Spark Biomedical, InterShunt and many more.

View More Interviews
See the Playbooks

Join Medsider as a Free Subscriber

Subscribe to Medsider and get access to exclusive benefits for free. No spam, 100% privacy, and your email won’t be shared.