JenaValve Technology said it plans to use a $62.5 million Series C round to expand its footprint in Europe and enter the transcatheter aortic heart implant markets in the U.S. and China.
The Wilmington, Del.- and Munich-based medical device company said the round was led by Gimv NV (EBR:GIMB) of Belgium and new investors Legend Capital (Beijing) and Omega Funds. Existing backers Edmond de Rothschild Investment Partners (Paris), Atlas Venture Fund, NeoMed Management, VI Partners AG and Sunstone Capital A/S also participated, according to a press release.
JenaValve said it plans to use the cash to fund clinical trials for its transfemoral TAVI device and expand its commercial base (a transapical TAVI model is already on the market in Europe). The company also said "it plans to pursue clinical initiatives in the U.S. as well as pursue regulatory approval for its TAVI product in China," according to the release.
"JenaValve is gaining momentum in the European TAVI market with our novel transapical TAVI system primarily based on our products’ unique features and clinical benefits," CEO Helmut Straubiger said in prepared remarks. "We are at an exciting point in our Company’s growth as we commence a clinical study for our new transfemoral TAVI product and endeavor to significantly increase revenue in 2013, and beyond, from our transapical product across Europe and other global markets. Based on the positive feedback from our expanding network of hospital customers, we believe our technology represents an important advancement in the treatment of aortic valve disease."
JenaValve is 1 of several smaller players in the TAVI space hoping to challenge market leader Edwards, arch-rival Medtronic (NYSE:MDT) and other big device makers like St. Jude Medical (NYSE:STJ) and Boston Scientific (NYSE:BSX).
Although Medtronic was first to market with its CoreValve TAVI in 2007, Edwards wasn’t far behind, putting its Sapien TAVI in the EuroZone a few months later and beating CoreValve to the U.S. market late last year. St. Jude is next in line with its Portico TAVI device, which won CE Mark approval in November 2012 and has a U.S. investigational device exemption trial slated to start in 2014. Boston Scientific’s Lotus valve could win CE Mark approval by the end of this year, backed by data suggesting that it delivers lower rates of paravalvular leakage at 30 days compared with rival devices.
JenaValve is chasing Direct Flow Medical for the U.S. market. In June Direct Flow won FDA approval for an investigational device exemption trial for its eponymous device, having won CE Mark approval for the device in January. Then there’s Symetis, which has had a transapical TAVI on the market in Europe since 2011.
In February JenaValve lured John Migliazza, a 12-year veteran of Edwards Lifesciences (NYSE:EW) who most recently was Edwards’ senior director of engineering, to be its new COO.
