Rising to the PMA Challenge as a First-Time Founder

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.