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.