JenaValve – 2013 Fierce 15

JenaValve Executive Chairman Raymond Cohen

Based: Munich, Germany
Founded: 2006
Chairman: Raymond Cohen

The Scoop: Take a look at the burgeoning global market for transcatheter aortic valve replacement and you'll find heavyweights like Edwards Lifesciences ($EW) and Medtronic ($MDT) battling for market share, trailed by fellow giants St. Jude Medical ($STJ) and Boston Scientific ($BSX) working for a seat at the table. And then there's JenaValve, a soft-J'ed German upstart with an implant it says beats the competition and a whopping fundraise to help make some noise.

What Makes It Fierce: Like its multinational competitors, JenaValve markets a minimally invasive heart valve, inserted through a small incision in the ribs and CE marked to mend calcified valves and treat aortic regurgitation. Unlike competing tech such as Sapien and Engager, however, JenaValve's device is outfitted with clip-bearing feelers at its bottom, allowing it to snap in place during implantation.

"Kind of like the lunar landing module," Executive Chairman of the Board Raymond Cohen said. "When it lands on the moon, the feet deploy."

While that may seem like a fairly pedestrian distinction on paper, it makes all the difference in the world to patients, Cohen said. Once in place, the device snaps onto the native leaflets of the diseased aortic valve, ensuring proper implantation and slashing rates of paravalvular leakage. More importantly, that clip is what allows the valve to treat aortic regurgitation, making it the only TAVI system CE marked to treat an ailment affecting 23% of patients with aortic valve diseases. The only other treatment for aortic regurgitation is invasive surgery.

JenaValve's implant is outfitted with "feelers" that clip it into place.--Courtesy of JenaValve

That was music to the ears of investors, and JenaValve bagged a $62.5 million Series C in July. Some of that cash will go toward expanding its salesforce to build steam in Europe for the rib-inserted version of the tech, Cohen said, and some will fund the ongoing development of a transfemoral model expected to launch next year.

Now, JenaValve has its work cut out for it. Edwards is the dominant player in both through-the-ribs and through-the-leg devices, followed by Medtronic. But what JenaValve lacks in time on the market and sales footprint, it more than makes up for in efficacy and innovation, Cohen said, and the response from physicians bodes well for the future.

"The point is that, when you go head to head, the features of JenaValve are well-appreciated by physicians, and there's a large percentage of those clinicians that would prefer to use a second-generation product," he said. "So, they're buying the product purely based on its technical features, not because of the size of the sales force."

Taking on the likes of Edwards and Medtronic is daunting, but Cohen already has some anti-Goliath experience. Before JenaValve recruited him in January, Cohen served as CEO of 2012 Fierce 15 winner Vessix Vascular, a California outfit with renal denervation technology it said could outperform offerings from St. Jude, Medtronic and Covidien ($COV). Ten months and $425 million later, Vessix is a subsidiary of Boston Scientific, and Cohen has landed at another devicemaker setting sights on an exploding market.

So, is JenaValve eyeing the same path?

"If someone wants to buy it, nobody's opposed to that," Cohen said.

What To Look For: In the short term, JenaValve is working to get its transfemoral implant into the clinic in the coming months, plotting a 2014 overseas launch. From there, it's all about commercialization, Cohen said, as the company will use its venture haul to spread the word about the device's benefits. As for the U.S., Cohen said JenaValve has all options on the table, including partnering to secure a future date with the FDA.

For more:
JenaValve lands $62.5M round for heart valve

-- Damian Garde (email | Twitter)

JenaValve – 2013 Fierce 15