Proof Before Funding

Key Learnings From Tim & Geoffrey’s Experience

• In medtech, the first task is to prove your concept. Thoroughly research your space, seek feedback from clinical experts throughout the entire process, and engage with partners who can offer the expertise that you need in your product development. 

• Showcase your market savvy by demonstrating a real problem, a working solution, and a sizable market. Then build early prototypes –  even if they're rough around the edges – learn from them, and continuously improve. Get your device into the hands of potential users as soon as possible and seek early feedback. And don’t forget to build long-term relationships with investors long before you actually need to approach them for capital.

• Forging a collaborative relationship is the golden rule for navigating regulatory interactions. Understand FDA’s perspective, follow their guidance, and foster transparency. At the same time, make sure you capitalize on the advantages of your chosen regulatory pathway and position your device accordingly.

Arteriovenous fistulas (AVFs) – artery-vein connections surgically created in the arm to enable life-saving hemodialysis treatments for chronic kidney disease (CKD) patients – tend to have better clinical outcomes than other forms of dialysis access such as grafts and catheters. However, there’s a critical problem with them: they have a 50% failure rate within the first year. Despite this alarming rate, there are no effective solutions on the market – yet. Tim Boire and Geoffrey Lucks, two innovative thinkers driven by the mission to marry medicine and engineering, co-founded VenoStent to address this issue. Their flagship product, SelfWrap, is a bioabsorbable vascular wrap that acts as a support structure around the vein, reducing the risk of complications.

Tim spent three years working at Genzyme, where his interest in biomaterials and tissue engineering deepened. Then, he joined a Biomedical Engineering PhD program at Vanderbilt University with the goal of conducting translational biomaterials and tissue engineering research, which began with developing a new shape memory polymer. During his PhD, Tim participated in the National Science Foundation’s (NSF’s) Innovation Corps (I-Corps) program in 2014, where he engaged with the medical community and dialysis centers. His conversations with vascular surgeons, nephrologists, nurses, and clinics expanded his conception of the “Achilles heel” of vascular surgery to encapsulate not only bypass grafting surgeries, but also arteriovenous (AV) graft and fistula creation surgeries for hemodialysis patients, where the failures and complications are extremely frequent and can often define life or death for patients. 

From there, Tim felt a calling to pursue this as a company, and worked on figuring out how to pivot his technology from its initial application in bypass grafting to addressing dialysis access. Ultimately, his dissertation work on the matter shaped VenoStent. 

Tim and Geoffrey were introduced when the latter was completing his MBA at Vanderbilt University. His draw towards the healthcare industry was personal, due to his brother’s health struggles with spina bifida and his passing in 2008. Ultimately, his path led him to co-found VenoStent with Tim. 

VenoStent’s SelfWrap addresses arteriovenous (AV) access surgery outcomes by promoting outward vein growth and strengthening and equipping it to handle increased arterial blood pressure and flow. What makes SelfWrap stand out is that it’s made with 3D-printed bioabsorbable polymers that mimic the mechanical properties of the artery and are naturally broken down by the body over time. 

VenoStent recently received IDE approval from FDA and has since enrolled its first patients in a 200-subject U.S. randomized, controlled clinical trial with the goal of launching SelfWrap within the next few years. Geoffrey and Tim envision this technology to have a significant impact on not only improving outcomes for kidney dialysis access but also on potentially benefiting other vascular procedures like coronary and peripheral bypass grafting.

Thoroughly Evaluate the Clinical Landscape

VenoStent’s journey is a reminder that developing medical technology takes time. Still, even knowing it would take years, “It's the best professional decision I've ever made,” Geoffrey reflects. 

In medtech, you really need to understand the power of milestones: They carry you forward and give you momentum to seek more funding. According to Tim, they should always be the focal point. Ask yourself, “What's the highest-impact thing I can do to attract the next round of funding?” 

To borrow a page from VenoStent’s playbook, one of the first things you should aim to do is thoroughly understand the clinical landscape, which involves meticulously researching prior trials. To start off, Tim and Geoffrey created a 150-slide presentation summarizing existing trials in their field, outlining the endpoints and what worked or didn’t work. 

To effectively design clinical trials, you have to understand both the business and clinical regulatory aspects. Make sure to engage with clinical experts and get their feedback at the outset and throughout the whole process, including future iterations. For example, the VenoStent team spent a year refining their trial design, constantly engaging with nephrologists and vascular surgeons. 

These efforts culminated in VenoStent securing funding for a chronic animal study, which revealed the long-term efficacy of SelfWrap. This study showed a significant reduction in neointimal hyperplasia – the primary cause of vein failure under high-pressure, high-flow conditions. Building on this success, the team has now conducted several chronic large animal studies, a 20-patient clinical trial outside the United States, and is currently undertaking a 200-patient randomized controlled trial in the U.S.

Validate, Iterate, Collaborate

When shifting from concept to prototype, you don’t have to aim for perfection from the start. Geoffrey and Tim weren’t fazed by the long road to innovation. "Our first prototype was far from (its desired final form),” Tim admits, but getting something tangible, learning from it, and improving was the key. 

Medtech demands a mindset different from that of other industries like software, where the “ship it fast” mentality works. You can’t rush therapeutic devices into patients’ hands and see if they really align with the market need. You often must conduct extensive testing on bench and animal models before you can even conduct human studies. Yet, that doesn’t mean you can’t get vital feedback early on. 

Geoffrey argues that the core principle of getting the product "in someone's hands" still applies. There are creative ways to introduce a device to the users, like the I-Corps program Tim participated in. It was pivotal in connecting with potential users and gathering insights, even before SelfWrap was ready for clinical trials. Such early user feedback can be invaluable, even within a controlled setting. 

With a refined prototype in hand, the next hurdle is securing funding. Tim and Geoffrey emphasize the importance of proving your concept and demonstrating market savvy to attract investors. Nearly all potential capital partners need to see three things: a real problem that needs solving, a solution that works, and a sizable market. 

Building relationships with investors is equally important, even years in advance – much better than waiting until you desperately need funds. Geoffrey says, “Investors invest in lines, not dots.” The best way to show your lines is to constantly communicate with investors, whether it’s monthly or quarterly. You need to tell them your milestones, and what you’re going to do, and then demonstrate your achievements. Being able to look back and see your progress is important in building trust. And again, to circle back, the central theme here is to continue hitting your milestones. In fact there were times Geoffrey received this feedback: “Your updates are the reason why I felt very comfortable writing the check.”

Embrace FDA Feedback, Not Frustration

FDA can be a good friend – if you approach them the right way. In 2019, Tim and Geoffrey applied for breakthrough device designation. It was denied. Rather than getting demoralized, they used the feedback to strengthen their next submission. 

“Break down their critiques point by point,” advises Tim, “understand where they're coming from and figure out how to address each concern.” To make sure you’re on the same page, initiate pre-submission meetings. That’s what Tim and Geoffrey did, and on top of that, they also sought input from a scientific advisory board, which gave them extra credibility. While he’s not a proponent of outsourcing too much, Tim is confident that expert clinical input makes FDA take notice.

To take a leaf from Tim’s and Geoffrey’s book, do what FDA asks, and do it transparently. Following FDA's recommendations, even with modifications, builds a relationship of trust. Thanks to their ability to adhere to the agency’s feedback and promising early results, the team secured the breakthrough designation. "Don't try to be clever," Tim warns, "transparency with FDA is essential." Otherwise, you risk wasting time and resources, only to hear 'you should have listened to us years ago' from FDA." 

When it comes to choosing your regulatory path, according to Geoffrey, each one of them, even the rigorous Class III PMA, has certain advantages. While more demanding, it provides some competitive benefits such as pricing upsides and reimbursement potential. It’s important to understand and leverage your path's unique strengths. 

Overall, the best strategy for navigating FDA interactions is collaboration. Understanding FDA's perspective, following their guidance, and building a transparent working relationship are key to progressing through the approval process. Seeing the advantages within your specific regulatory pathway and positioning your device accordingly is equally important.