MENLO PARK, Calif.--(BUSINESS WIRE)--CardioKinetix, Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has completed a $50 million financing led by Edwards Lifesciences Corporation, with participation from existing investors U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, and Lexington Private Equity.
CardioKinetix has also entered into an agreement that provides Edwards Lifesciences the right to acquire CardioKinetix based on future regulatory milestones.
This financing provides the company with the capital necessary to complete the PARACHUTE IV randomized pivotal clinical trial of the Parachute® Ventricular Partitioning Device for the treatment of heart failure. Data from the study, which is currently enrolling patients in the United States, will be the basis for the company’s pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA). The financing will also enable CardioKinetix to pursue international market development efforts in key geographies.
“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,” said Maria Sainz, president and CEO of CardioKinetix. “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.”
Cooley LLP served as legal counsel to CardioKinetix.
About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.[i]
About the Parachute® Ventricular Partitioning Device
The novel Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
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 Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.
About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.
[i] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125: e2-e220.