CardioFocus readies HeartLight’s U.S. coming-out party at HRS 2016

Pre-market approval from the FDA in hand, CardioFocus is readying for a coming-out ball of sorts for its HeartLight cardiac visualization and ablation device at this week’s annual meeting of the Heart Rhythm Society in San Francisco.

Chairman Paul LaViolette told MassDevice.com that Marlborough, Mass.-based CardioFocus is planning a selective U.S. launch for HeartLight starting in July. The device combines a balloon dilation catheter with a laser-based micro-endoscope and ablation device to allow electrophysiologists to see the tissue they’re targeting for ablation.

“The nice thing that we offer is because we can see directly, we’re really conducting ablation under direct visualization. We don’t need complex electro-anatomical mapping as a result. We’re really doing an anatomical ablation, not electrical ablation, and it ultimately is actually quite an effective, standalone technology. It doesn’t really need to be integrated into the all of the other complex systems in the EP suite,” LaViolette told us. “That, frankly, enables us to commercialize as a standalone company without having to offer a very broad product line of there ancillary, EP technologies.”

The April 1 FDA approval came earlier than expected, said LaViolette, formerly the longtime operations chief at Boston Scientific (NYSE:BSX), who’s now a managing partner & COO at venture capital shop SV Life Sciences.

“It’s actually quite unusual to find a technology that is so easy to use, and so short in learning curve, and so stand-alone, that a company of our scale can actually launch it directly into the United States. There aren’t many other companies that have the alignment of market factors that enable what we believe will be a successful launch, without either requiring a massive sales organization, or some other grab-bag of technology,”he said. “We consider ourselves quite fortunate to have a technology that can be launched with a small team. We think we can put some impressive results together with the launch, and we’re very excited about doing that.”

Below is a transcript of our chat, edited for clarity.

MassDevice.com: Now that HeartLight is approved for the US, I was hoping you could tell me a little bit about the plans for the commercial roll-out here.

Paul LaViolette: Yes, we are very pleased. Obviously, you know the news. We received full approval from FDA the 1st of April. I will say that actually came in a little bit ahead of time, right around eight months total review time, which is quite swift for PMA. We’re gearing up our commercial launch readiness, as we speak. As you know, that includes a lot of training, and supply chain, and marketing materials. We are going to HRS this week, the largest meeting for arrhythmia management, the Heart Rhythm Society meeting in San Francisco. We will be on display. That in effect becomes our initial launch coming out, if you will.

We’ll be on display as a commercial entity for the first time in the United States, in San Francisco. That’s very good timing for us. We are conveying to the physicians that they can expect us to be commercially available around July. We expect that we’ll actually start shipping the technology for use in July, and we’re going to be quite targeted in our launch activity, so we’ll be hand-selecting the first accounts, and working with them to get started.

We’re starting off with direct selling, and clinical support resources, and then we plan to scale the launch, and our resources in parallel.

MassDevice.com: CardioFocus raised about $32 million last year. Is that going to be enough to carry through to commercialization, or will you be hitting the trail to try to drum up some more backing?

LaViolette

Paul LaViolette: We have sufficient backing today to do the launch that we’re talking about now, so launching in the U.S. and then scaling up through the rest of this year and into early 2017. We have plans to finance additionally beyond that for the next 12 to 18 months thereafter. We have not announced those plans with any level of detail, but as you can imagine, in a market as attractive as this, with a novel technology that’s been demonstrated through a PMA, and with as much differentiation as we have, and how recognizing how scarce cardiovascular PMAs are, that it’s actually not particularly challenging to find investors who are willing to back that launch activity. We will raise additional capital. It’s not critical for this year.

MassDevice.com: You don’t hear that every day in medtech.

Paul LaViolette: Let me say, to the credit of the investors that we have, it takes a lot to get PMA-approved. But once you get there, you have an asset that is so de-risked, and in our particular case, we don’t have to develop the market. The market for afib treatment is very well-established. Reimbursement is in place. Physicians are trained. They’re looking for a better technique, so we feel we have quite fertile ground to approach, and that’s the essence of our launch strategy. It’s a very favorable alignment of commercialization factors, so we’re really quite pleased to be able to do it. If it were a different market, if it were for a new technology going after new indication, where physicians weren’t convinced, and there are many like that, it would be very difficult. In this instance, with the number one arrhythmia a novel technology, head-to-head data published in [the Journal of the American College of Cardiology], we feel quite ready to go.

MassDevice.com: Granted that the old adage is that companies are built, not sold, are you building for CardioFocus to be a stand-alone entity? Are you looking at an eventual IPO, an acquisition by private equity or a strategic?

Paul LaViolette: You nailed it. Companies are run and built, and then strategic interest obviously comes to you, and you don’t go toward it.

We absolutely believe that we’re going to be in a great position in afib. The combination of size and growth in afib makes it 1 of the most attractive cardiovascular markets. We know that afib is central to the growth strategy of the major cardiovascular players. We know that cardiovascular and afib PMAs only come along once every handful of years. We wouldn’t expect another next-generation afib technology to be approved probably until at least 2019.

When it comes to attractive assets, we believe that CardioFocus will absolutely be 1, and is 1 already. Our effort to go into the marketplace is not to build revenue for IPO. That’s not the course of the company. The course of the company is to show penetration in major ablation laser users, who by virtue of their use of the technology are essentially validating its ease of use, its clinical effectiveness, and replicating in a commercial setting the results that we demonstrated both in the pivotal study, as well as in our many published abstracts from trials conducted in Europe.

That, to me, would really complete the story. At that point we can all speculate what would happen after that, but the market is quite active, and it’s quite inquisitive, and we think of course we would fit nicely into the sales channel of many of the leading EP companies.

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