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March 26, 2019

CardioFocus hits triple-digit growth as regulatory approvals roll in

Photo | Courtesy Omari Bouknight, chief commercial officer, CardioFocus

Marlborough medical device firm CardioFocus is looking ahead to the U.S. introduction of its newest innovation to treat atrial fibrillation – an irregular heartbeat causing poor bloodflow – after getting clearance in Europe in March. In an interview with WBJ, President and Chief Commercial Officer Omari Bouknight spoke about the company’s growth and its main competitors in the narrow market focus.

The company was just granted a CE Mark for the HeartLight X3 System in Europe. When will that device come to the U.S.?

We are currently working in conjunction with the U.S. Food & Drug Administration to understand what will be required for approval in the U.S. We anticipate having an updated timeline on the FDA approval process in the second half of 2019. 

How many products does CardioFocus have on the market in the U.S. and Europe?

Currently in the U.S. we offer our second generation balloon platform, which is the HeartLight System with the Excalibur Balloon. 

With the CE Mark approval, we will proceed with upgrading our European users from the second generation platform to the third generation HeartLight X3 System.

The original HeartLight System is also commercially available in Japan after being approved in 2017.

How large is the company, in terms of employees and revenue?

We have 91 employees at our Marlborough headquarters. From a revenue standpoint, we are growing at a rapid rate with sales in the U.S., Europe and Japan all contributing to that growth.

Where are those products manufactured?

We have a manufacturing section of our home office in Marlborough where we manufacture the core components of the technology. We partner with U.S.-based suppliers for the adjunctive components. 

Who are the company's main competitors?

Our key competitors in the atrial fibrillation ablation market are radio frequency and cryoablation technologies from companies like Biosense Webster in California, Abbott Laboratories in Chicago and Medtronic in Ireland.

I noticed a lot of CardioFocus executives came from Boston Scientific, which is just down the street in Marlborough. What can a smaller company like CardioFocus learn from a larger company like Boston Scientific?

Boston Scientific has achieved substantial success over the past two decades by remaining focused on driving innovation and simultaneously opportunistic in making acquisitions. This charter combined with clear views on which market sectors will outperform over time has allowed it to become a leading global medtech company.

At CardioFocus, while we obviously have a narrower market sector focus, we are maniacally focused on introducing innovation to the atrial fibrillation market for the benefit of patients and physician users.

How are revenues and does the company anticipate going back to investors for more funding anytime soon?

We’ve achieved sequential years of triple-digit growth and look forward to continuing to grow rapidly over the coming years. We remain well financed, but have a clear opportunity to accelerate market expansion with the breakthrough HeartLight X3 System and will evaluate financing opportunities in order to do so as well as to drive further innovation.

This interview was conducted and edited for length and clarity by WBJ Staff Writer Zachary Comeau.

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