I don’t mind admitting it. I thought a stent was a stent.
#MedDevice guest Sean Morris, the CEO of Veniti Medical, pioneers in the venous disease space, taught me something new. Today, there is no such thing as a dedicated stent for veins!
Well, not yet. That’s where Veniti comes in.
Sean Morris: Thanks for having me, Joe. Veniti Medical is a start up company with multiple products for chronic disease treatment. We have been around since January of 2010 and are unique in that we are the first company dedicated to this space.
Joe Hage: You are two years old now. Did you found the company, Sean? How many are you now?
Sean Morris: I, along with some thought leaders in the venous space, started the company. Veniti now has 15 employees having recently brought on a high caliber COO. I am very proud of the team we’ve assembled.
Joe Hage: Please educate me. Who else is in the space and how big is the market globally?
Sean Morris: There is a huge interest in this $5-billion global market.
Chronic venous disease can be deadly. Serious conditions such as deep venous thrombosis and pulmonary embolisms are dangerous effects of venous disease. 40 percent of adults are estimated to have venous disease. That’s 25 percent of the total population.
Covidien has been very active having purchased VNUS medical, Bacchus Vascular and ev3 in the past three years. Beyond this, every company they compete with (Boston Scientific, Bard, AngioDynamics, Maquet, Abbott; others) are monitoring this area.
Joe Hage: According to your website, your first three products are still in development: an ablation device, a vena cava filter, and a venous stent.
Our ablation system has been designed to provide comprehensive therapy to all types of veins, beyond what is currently available.
Our vena cava filter allows for active anchoring which serves to keep the filter centered and migration free.
Our venous stent is the first of its kind and built from the start to be a venous stent. We also have a unique delivery system.
Joe Hage: Sean, you are saying, the venous stents on the market today are adaptations of competitors’ arterial stents?
Sean Morris: Today, an FDA-cleared venous stent does not exist.
We are bringing the first venous stent to market. It took us an entire year to figure out what our 1st generation stent would need to look like before we made our 1st prototype. Veins are complex and require a complex system for optimal results.
Joe Hage: How protect-able is your technology? How easily can your competitors reverse engineer it and compete against you?
Sean Morris: I believe this would be difficult. Our stent is made of Nitinol and tweaked in a very specific way to optimize clinical results. Given our extensive comprehensive research, we feel we have the right recipe and the recipe is secret.
Sean Morris: I have an extensive background in sales, marketing, strategy and operations. I started Veniti because I have a passion for this space and love the idea of building something and providing jobs to people. I learned from some of the best at my former employer AngioDynamics and it was there were I developed my interest in venous disease therapies.
Sean Morris: I think you are right, Joe. There are great minds and passionate people in every organization. I know I’m not the 1st to do this.
Joe Hage: What is the timeline for clearance? Are you targeting the US first? We’ve been debating the merits of FDA versus CE in the Medical Devices Group.
Sean Morris: There is a global need for our technologies and we intend to work with the FDA and our colleagues overseas to gain approvals. Our product launches will be staged. We expect our ablation system to be ready this summer, followed by our stent, and then filter.
Joe Hage: Without a predicate device, this must be costing you a friggin’ fortune!
Sean Morris: Bringing a medical device to market is expensive and we plan for the worst and hope for the best. We have excellent VC investors that are dedicated to our cause and a strong board. It’s up to us to execute and I am confident the team we have in place is up for the challenge. The key is to stay focused, spend wisely and mitigate risks.
Joe Hage: Will you be going through distribution? Hiring a sales force? Working with a manufacturer’s rep?
Sean Morris: I am very biased towards going direct. With our mission, we need maximum efficiency and direct is the only way to get that.
Joe Hage: Excellent. Last question today, Sean, and thanks so much for joining us.
Sean Morris: Thanks Joe! The best way to answer that is with a real life experience. I spent last week the American Venous Forum meeting in Orlando, FL. Every physician I spoke with discussed how much there was still to learn about this disease state.
Physicians said they understand they don’t have the right devices for venous disease. They “don’t know what they don’t know” and have “decades of research ahead of us.”
I’d conclude by telling the Medical Devices Group to learn more about the differences between aertial and venous disease states and, when our products come to market, to learn more about the possibilities with us.
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