Edwards Lifesciences Invests $50M In Heart Failure Device Startup
By Jof Enriquez,
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Edwards Lifesciences recently announced a $50 million investment in CardioKinetix, a privately-held company developing a novel intracatheter implant for heart failure patients. The financing deal will help CardioKinetix complete a key clinical trial that will serve as basis for a pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA).
“This transaction increases Edwards’ existing minority interest in CardioKinetix and provides an option to purchase the remaining outstanding shares for a future payment, plus additional milestone payments based on future regulatory and reimbursement approvals,” according to a statement issued by Edwards ahead of its recent annual investor conference.
CardioKinetix is developing the Parachute implant, an investigational device for percutaneous ventricular restoration therapy (PVRT) for heart failure patients who have suffered from heart attacks. According to the company’s website, the implant partitions damaged muscular tissue of the left ventricular wall and isolates the non-functional muscle segment from the functional segment, thereby decreasing “the overall volume and restores a more normal geometry and function in the left ventricle.”
The implant received expanded CE Mark approvals in Europe and won an Edison Award in the Surgical Aid (Medical Device) category in 2012.
CardoKinetix is currently enrolling patients in the United States for its randomized PARACHUTE IV clinical trial to support a future PMA submission to the FDA. The investment from Edwards will help fund the trial and support international market development efforts, according to a CardioKinetix press release.
“We are very proud of our accomplishments to date, with more than 300 patients treated, four clinical trials completed and 23 publications on the Parachute therapy,” Maria Sainz, president and chief executive of CardioKinetix, said in the company press release. “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. We are pleased to have the support of Edwards Lifesciences and our premier investor syndicate as we further our efforts to complete the PARACHUTE IV trial and bring the Parachute therapy to patients around the world.”
Investors who participated in the financing round included U.S. Venture Partners, Tekla Life Sciences Investors, Tekla Healthcare Investors, Panorama Capital, SV Life Sciences, New Leaf Venture Partners, and Lexington Private Equity.