Heart failure device startup CardioKinetix should have ample funding to wrap up a pivotal clinical trial that’ll allow it to receive pre-market approval from the FDA: It just raised $50 million in financing, led by Edwards Lifesciences Corp. – which also scooped up exclusive rights to acquire CardioKinetix based on future regulatory milestones.
Menlo Park-based CardioKinetix has developed a transcatheter implant, called the Parachute Ventricular Partitioning Device, which will treat heart failure that results from heart attacks. Here’s how it works:
Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under limited sedation.
The device received the ubiquitous European CE Mark in 2011, but is still an investigational device in the U.S.
Existing investors U.S. Venture Partners, Tekla Healthcare Investors, SV Life Sciences, Panorama Capital, New Leaf Venture Partners and Lexington Private Equity also participated in the round.
The company’s thus far treated more than 300 patients, completed four clinical trials and published 23 papers on Parachute therapy, CEO Maria Sainz said in a 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,” Sainz said.
