Being a player in a space as competitive as transcatheter aortic valve replacement (TAVR) takes some serious financial backing. Jenavalve Technology (Irvine, Calif.) has risen to that challenge multiple times, most recently with a $26.5 million Series C expansion round to support its growth in the global TAVR market.

RMM (Rudi Mariën) and Valiance co-led the latest financing round, with participation from the company’s existing syndicate of Atlas Venture, Edmond de Rothschild Investment Partners, Gimv, Legand Capital, Neomed Management and VI Partners. The company previously closed a $62.5 million Series C round about two years ago (Medical Device Daily, July 26, 2013).

Although tiny compared to competitors like Edwards Lifesciences (Irvine, Calif.), Medtronic (Dublin) and Boston Scientific (Marlborough, Mass.), Jenavalve has managed to differentiate itself in the global TAVR market and is targeting a broader patient population.

Jenavalve has had a first-generation TAVR valve available in Europe under a CE mark since September 2011 and more than 1,300 patients have received that device since it launched. The company also has a second-generation transapical delivery system available with that first valve.

Victoria Carr-Brendel, who joined the company as CEO in June, told Medical Device Daily the company is currently building a clinical registry in Europe to evaluate the longterm functionality of the first-generation valve. She also said Jenavalve plans to use the new funds to begin enrolling patients in a trial for CE mark approval of its second-generation TAVR system within the next month, and expects to begin a feasibility trial in the U.S. in the fourth quarter of this year. Along with strong financial backing, companies that want to compete in a market like TAVR must have differentiating technology.

“Our secret sauce in the Jenavalve technology is the elements of the valve that are called locators,” Carr-Brendel said. “These locators allow for anatomical positioning of the valve to mimic native valve placement as well as limit depth of placement past the annulus.”

She said the locators also function to clip the native leaflets, which improves paravalvular leakage rates.

“It’s all about the valve when you’re in the TAVR space,” she said. “Valve durability and clinical outcomes are going to determine whether or not a physician votes with their pocketbook.”

Jenavalve’s strategy, Carr-Brendel said, is to offer a product portfolio that includes a new-generation transapical delivery system, a new transfemoral delivery system, a new valve, and the ability to treat both aortic stenosis and aortic regurgitation.

The reason the Jenavalve technology is appropriate for patients with aortic regurgitation, an indication that no other TAVR company currently has, is because the system does not require calcification in order to place the valve. “If we were just going to be another aortic stenosis, high surgical risk or extreme surgical risk product, it probably wouldn’t be a very compelling story because we’d be somewhere about fourth to the market in the U.S.,” Carr-Brendel said. “By having this ability to treat an entire patient population that currently has very limited treatment options with aortic regurgitation, it also makes this valve the valve of choice, we hope, for the intermediate surgical risk patient population.”

As Medtronic and Edwards demonstrate that TAVR is an appropriate treatment for patients with an intermediate surgical risk, Jenavalve stands to benefit from that shift to a younger and broader patient pool.

With analysts predicting that TAVR will grow to be a $3 billion market by 2019, the space offers companies like Jenavalve a huge opportunity and Carr-Brendel said there is plenty of room for new technology in TAVR. But taking on companies like Edwards and Medtronic won’t be easy. Edwards recently reported better-than-expected second quarter sales, which it attributed to significant global TAVR adoption and U.S. approval of Sapien 3 (MDD, July 30, 2015). The FDA also approved Medtronic’s recapturable self-expanding CoreValve Evolut R system for high-risk patients. Another big competitor in the TAVR space, Boston Scientific, is expected to introduce some new sizes later in the year, which will likely boost its market share.

NEW LEADERSHIP, NEW HOME

Jenavalve has gone through a major leadership change over the past two months and has moved its corporate headquarters to Irvine, California (Jenavalve was previously headquartered in Munich, Germany). Carr-Brendel was hired in June as CEO and just last week the company got a new CFO, Peter Wulff.

Carr-Brendel replaced Jan Keltjens, who served as interim CEO after David Drachman resigned in January. Drachman, who had only been with the company for about six months, cited “nonbusiness related personal reasons” for leaving Jenavalve.

Carr-Brendel was previously at Boston Scientific. “I am always attracted to a company based first and foremost on technology,” she said. “I am a CEO with a PhD and the most important thing to me is that we make a difference in patient lives and it’s refreshing to have a technology that we think is really going to be beneficial.”

Wulff, the company’s new CFO, has served as CFO of private and public life sciences companies for 15 years. He told MDD he was impressed by Jenavalve’s ability to be adaptive and responsive to the market.

“The board shifted its strategy in late 2012 or early 2013 in recognizing that the U.S. really is the next go-to location and as a consequence they’ve shifted headquarters into the U.S. and Irvine, being the center of the universe for TAVR,” Wulff said. “You’ve got to have the three Ps: great people, great products, great processes. Pretty much in that order.”