In a fitting move for the maker of heart-valve-opening technology, California-based startup JenaValve has taken another step toward opening up the device’s pathway to the U.S. commercial market.
The company announced that it recently closed a series C funding round for a total of $100 million. The fresh infusion of VC cash will largely go toward ushering JenaValve’s transcatheter aortic valve replacement (TAVR) system through the end of a clinical trial to support its FDA submission, then preparing the system for its hopeful launch.
The series C is exactly double the size of its series B, which got JenaValve’s blood pumping with $50 million in early 2020. As with the previous round, Bain Capital Life Sciences led the series C. Additional investors this time around included almost a dozen other supporters both new and old, like Andera Partners, Valiance Advisors, Gimv, Qatar Investment Authority and more.
Besides the TAVR system’s U.S. launch, the new funds will also help expand the company’s manufacturing capabilities around the world and “expand our real-world body of evidence in Europe fand our real-world body of evidence iurgitation and aortic stenosis in high surgical risk patients,” CEO John Kilcoyne said in a press release about the financing.
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TAVR systems like JenaValve’s Trilogy device are artificial valves that are implanted in the opening between the aorta and the left lower chamber of the heart. They’re meant to keep that passageway opening correctly to maintain normal blood flow from the heart to the rest of the body.
Because the devices are put in place using only a catheter sent through the blood vessels via a small incision, the procedure is ideal for people who face an increased risk of complications from the open-heart surgery required for other valve replacement methods.
The FDA has so far cleared TAVR systems only to open up the aortic valves in people with aortic stenosis, in which the valve has thickened and therefore narrowed, limiting the amount of blood that can pass through. JenaValve’s Trilogy system, however, is also meant to treat people with symptomatic and severe cases of aortic regurgitation, in which the valve doesn’t close tightly enough, allowing blood to leak backward into the heart.
JenaValve’s system is already cleared in the EU, earning CE mark approval in May 2021.
Stateside, JenaValve received an investigational device exemption from the FDA in August 2021, giving it the go-ahead to begin a clinical trial of the Trilogy system—the results of which will be submitted to the agency for potential premarket approval. That green light came after the FDA gave the TAVR implant breakthrough-device designation in early 2020.
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