Irvine-based Edwards Lifesciences Corp. has dipped its toe into the investment waters of the medical device business.
The heart valve maker recently led a $50 million investment in CardioKinetix Inc.
The Menlo Park-based company is developing a catheter-based medical device known as the Parachute to treat heart failure—a condition in which the heart is unable to supply sufficient blood flow to meet the body’s needs. About 20 million people around the world have the condition, according to CardioKinetix.
The Edwards-led investment will be used by CardioKinetix to complete its Parachute IV clinical trial. The study is now enrolling patients in the U.S., and data will be used as the basis of its premarket approval submission to the Food and Drug Administration.
Edwards also signed a deal with CardioKinetix that gives it the right to buy the company for an undisclosed upfront payment, plus milestones on regulatory and reimbursement benchmarks.
Investing in CardioKinetix is “a reflection of our strategy to invest in multiple structural heart disease technologies,” Edwards Chief Executive Michael Mussallem said last month during the company’s annual investor conference. “We’re going to be an aggressive investor in new interventional or minimally invasive opportunities pointed at structural heart disease.”
He didn’t specify the volume of investment it plans to make.
Parachute is “approved in Europe, but really the most substantial value creation effort that’s taking place today is the U.S. randomized clinical trial,” Mussallem said. “[CardioKinetix’s] started in that, and that will continue.”
Parachute is implanted through a small catheter inserted into a patient’s femoral artery during a minimally invasive procedure performed under limited sedation. The device is then deployed in the heart’s left ventricle in order to partition damaged heart muscle. It’s designed in a way to exclude a nonfunctional part of the heart from the healthy segment in order to restore its function.
Edwards is a long-established device maker, with annual sales of just more than $2 billion and about 9,000 employees, including an estimated 3,200 in Orange County. The company has experience with catheter-based medical devices through its popular Sapien line of less-invasive replacement heart valves.
CardioKinetix said the new investment would also allow it to pursue international market development efforts.
“Heart failure remains a huge global clinical and economic challenge for healthcare systems, and Parachute holds the promise to bring needed improvements in mortality, quality of life and care efficiency to clinical providers,” said CardioKinetix’s Chief Executive Maria Sainz in a news release.
She noted that Parachute has been used to treat more than 300 patients; been involved in four completed clinical trials; and has been written about in 23 publications.
U.S. Venture Partners and New Leaf Venture Partners, both of Menlo Park; Boston-based Tekla Healthcare Investors and Tekla Venture Partners; San Francisco-based SV Life Sciences; New York-based Lexington Private Equity; and Campbell-based Panorama Capital also participated in the investment.
