Finding Opportunities when Curveballs Come Your Way: Interview with Cytovale CEO Ajay Shah

Immerse Yourself in Frontline Insights

As a medtech entrepreneur, your first step is to thoroughly understand the clinical challenge your technology aims to address. This will also inform your clinical strategy and, subsequently, your regulatory pathway. This is important, especially if you're tackling a problem with no established guidelines or predicates to follow. "Take the time to dig in and appreciate where the physician is coming from, what matters to the patients, and ultimately, how your technology changes their care journey," Ajay advises.

Healthcare startups have a crowded spectrum of stakeholders, from insurance companies and government payers like CMS, to various regulatory authorities. Connecting with top key opinion leaders might sound good at first. However, it's crucial to engage with professionals who are directly involved with the technology's everyday use.

In the case of sepsis detection, while broader input from specialties like critical care or infectious disease is valuable, the most grounded insights come from those working in the front line of sepsis diagnosis - emergency departments. Nearly 90% of sepsis cases are enter the healthcare system through emergency settings. Ajay shares, "We focused our core product development around meeting that emergency department need because that's where we saw it to be most acute. Rather than work on contrived samples or theoretical approaches, if we're building a solution for the emergency department, we need to develop it there."

Now, as IntelliSep moves towards commercialization, demonstrating its added value to the broader healthcare ecosystem is becoming more important as a first-of-its-kind technology that allows physicians, in just a few minutes, to triage their entire emergency department and identify which patients are experiencing a life-threatening sepsis condition. "Much like how an EKG quickly identifies a heart attack, or a rapid CT scan detects a stroke," Ajay explains. Its value is not just about faster diagnosis but also the tangible benefits the device brings to healthcare providers - reducing costs, improving patient outcomes, and streamlining emergency care processes.

The real-world application of IntelliSep is already beginning to showcase these advantages. Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, has used IntelliSep for just about a year. "Following implementation in their emergency department, they saw an immediate return on investment," Ajay reports. The cost of care for patients tested with IntelliSep was reduced by over $1,400 per patient, their risk-adjusted mortality index dropped by more than 30%, and they saw a decrease in both mortality and duration of hospital stays.

With these reports illustrating the impact of IntelliSep on patient care, Cytovale is confidently solidifying its position in the market.

Why Alignment with Your Investors is Critical

Navigating fundraising, especially in the initial stages of a startup, can be daunting.

In today's challenging financial climate, it's easy to become desperate and accept any investment to fuel your runway. But securing the right investors may be more crucial than ever for medtech startups - a mismatch will most definitely lead to significant challenges later on. This is critical not only for the company's health but also for future fundraising efforts.

An entrepreneur who has been in the business for over a decade, Ajay's last success was a $80 plus million series C for Cytovale. With all this experience under his belt, Ajay highlights the benefits of long-term relationships with investors. "As you spend time with them, if your visions are fundamentally misaligned, it's going to suck up a ton of your time, energy, and resources, and likely not actually get to a close if you have core different visions on how to build the company." On the other hand, when your visions align, even if your financial cycle is prolonged, it allows for establishing deeper relationships with investors - who might eventually serve as board members or key advisors in your company. This could also enable collaborative diligence processes that can advance the company. That's why it's essential to maintain the trust established during the fundraising process.

The other thing about fundraising Ajay draws attention to is the fact that it often takes longer than expected. If you estimate 6-9 months, be prepared for it to take closer to 12. Hopefully, your business will have grown significantly during that time. Ajay suggests spending that time on refining your story, your pitch, and preparing for the thorough due diligence that institutional investors expect.