Irvine-based JenaValve Technology Inc., which develops, manufactures, and markets transcatheter aortic heart valves and delivery systems, has raised $14.5 million in funding, regulatory filings indicate.
The June 6 deal involved 10 unnamed investors, according to a Securities and Exchange Commission filing.
It’s the largest reported financing deal for the privately held company since 2015, when it completed a $26.5 million fund raise.
Great Britain’s Valiance Asset Management Ltd., along with Belgian-based RMM, co-led the 2015 financing round; others included Edmond de Rothschild Investment Partners.
New CEO
JenaValve is one of several local medical device companies involved in the transcatheter aortic valve replacement, or TAVR, space. The largest include Irvine’s Edwards Lifesciences Corp., Orange County’s leading public company with a nearly $40 billion market value; and Ireland’s Medtronic PLC, which centered its less-invasive work in Irvine after its 2009 purchase of CoreValve Inc.
JenaValve moved headquarters from Germany to Irvine in 2014, because “the [industry] center of the universe is in Irvine,” former Chief Executive Victoria Carr-Brendel told the Business Journal in 2015.
Carr-Brendel is now with Swiss hearing care company Sonova Holding; the chief executive role was turned over to John Kilcoyne around the start of the year.
Prior to JenaValve, he served as president and chief executive of ReVision Optics; from 2004 to 2010, he was president and chief exec at Micrus Endovascular Corp., where he led an IPO in 2005.
Competition
The cardiovascular medical device company has its sights set on a new kind of TAVR device, the Everdur valve and Coronatix delivery system.
Medtronic and Edwards currently represent 90% of the market share for TAVR devices; JenaValve marketing materials suggest it intends to compete directly with them—and not go after the remaining 10% of unclaimed market space.
TAVR was popularized overthe past decade in operating rooms by cardiothoracic surgeons looking to treat high-risk patients without traditional open-heart surgery.
Late last year, the FDA approved the expansion of a trial of the JenaValve system, from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or aortic regurgitation.
A separate clinical study enrolled 99 patients in 2016, with a completion date set for September 2024. The study is composed of two patient groups: one patient group study is focused on reducing aortic regurgitation with the pericardial TAVR device, while the other patient group is indicated for severe aortic stenosis.
The company’s technology has a unique biological donor—a porcine, or pig, pericardial trileaflet valve mounted on a nitinol self-expanding frame.
Nitinol is a nickel-titanium alloy that is unusual from other metals in its ability to “retain shape memory” and superelasticity.
2019 Goals
Data from past and ongoing trials clearly indicate “the strong potential that the JenaValve technology can greatly improve the health of patients with aortic stenosis and aortic regurgitation,” Kilcoyne said in January, at the time of his appointment as chief exec.
“Our focus in 2019 is on completing the current clinical development programs and gaining commercial readiness for potential international launch activities.”
