JenaValve raising $100 million in a series C round could be the shot in the arm the transcatheter aortic valve replacement (TAVR) market needs.

The Irvine, CA-based company will use proceeds from the round to help get the Trilogy Heart Valve System through an IDE study. The company will also use the proceeds to bolster its real-world data development initiatives in Europe, as well as to expand its worldwide manufacturing capabilities.

FDA granted approval for an IDE for a pivotal trial evaluating Trilogy a little more than a year ago. Trilogy is for the treatment of high surgical risk patients with symptomatic, severe aortic regurgitation.

The round was led by Bain Capital Life Sciences with participation from existing investors Andera Partners, Valiance Advisors, Gimv, Cormorant Asset Management, RMM, and Venture Incubator. New investors joining the syndicate included Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.

“JenaValve is committed to becoming the first and only FDA-approved transfemoral transcatheter valve system indicated for symptomatic, severe aortic regurgitation, addressing an estimated multi-billion-dollar U.S. market opportunity. This financing provides sufficient capital for us to conclude our ALIGN-AR clinical trial and prepare for a commercial launch in the U.S.,” said John Kilcoyne, CEO. “Additionally, this financing further enhances our ability to leverage our commercial sales in Europe to expand our real-world body of evidence in Europe for the treatment of both symptomatic, severe aortic regurgitation (AR) and aortic stenosis (AS) in high surgical risk patients, while also expanding our manufacturing capabilities worldwide, in preparation of a U.S. launch.

Alexander Tamm shares with Alessandro Sticchi the results of the JenaValve Trilogy study, the first experience of implantation of the JenaValve device for treating aortic regurgitation, at EuroPCR.

The TAVR space is undergoing a metamorphosis – from a niche market of patients who were very old and too sick to undergo surgical aortic valve replacement, to a procedure for a younger population, according to a report from Cardiovascular Business.

The shift is opening the market and TAVR is changing how cardiologists view aortic valve replacement, according to Cardiovascular Business.  

But the reality is, in the short-term, the market potential for TAVR is being hampered by some severe headwinds now. Even Edwards Lifesciences, a TAVR pioneer, reported sluggish 2Q22 earnings – missing on Wall Street Consensus. The Irvine, CA-based company even reduced its 2022 guidance.

“Sales were below our expectations due to the ongoing U.S. hospital staffing constraints and foreign exchange headwinds, but still represented our highest quarter of TAVR sales,” said Mike Mussallem, Chairman and CEO of Edwards, according to a Motley Fool transcript of the earnings call. “We estimate global TAVR procedure growth was comparable with Edwards growth in the second quarter.”