|The Parachute implant--Courtesy of CardioKinetix|
Edwards Lifesciences ($EW) led a $50 million financing for catheter-based heart failure treatment startup CardioKinetix. The cash is expected to enable the completion of an ongoing U.S. pivotal trial for the company's Parachute Ventricular Partitioning Device with a PMA submission to the FDA to follow, as well as to finance international marketing efforts.
As part of the deal, Edwards gained the right to acquire CardioKinetix based on future regulatory milestones; the details of this aspect of the deal remain undisclosed.
The Parachute device is the first minimally invasive, catheter-based treatment to partition the coronary muscle damaged by a heart attack, according to the company. Via a small catheter inserted into the femoral artery, it excludes the nonfunctioning portion of the heart to decrease the overall volume of the left ventricle as well as to restore its geometry and function. The minimally invasive procedure is performed in a cauterization lab with the patient under conscious sedation.
CardioKinetix is currently enrolling patients in the U.S. for the multicenter, randomized, pivotal clinical trial. The company started the trial of this novel device in January 2013. The study is expected to be in about 500 ischemic heart failure patients at up to 65 centers with half of the patients randomized to receive either Parachute or optimal medical therapy.
The event-driven primary endpoint of the trial includes all-cause mortality and hospitalization for worsening heart failure. Secondary endpoints include functional outcomes, quality of life and hemodynamic measures by echocardiography.
The CardioKinetix device received a CE mark in 2011. The company is currently pursuing a joint U.S. and Chinese regulatory strategy. In October, the startup began a pivotal trial in China in ambulatory IV ischemic heart failure patients designed to support a submission to the China Food and Drug Administration.
In one-year European data reported by the company in September, the procedure had a 97% success rate and 7% of patients had a device or procedure-related safety issue. The sustained reduction of left ventricle volumes resulted in statistically significant improvements in systolic and diastolic function. Function was improved or maintained in 80% of patients.
Patients improved on the 6-minute walk distance with 46% able to walk an additional 20 meters or more. The death rate in the trial was 9.5%, with a repeat hospitalization rate for heart failure of 26%. More than 300 patients have been treated with the Parachute device.
"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," Maria Sainz, president and CEO of CardioKinetix, said in a statement.
Existing investors participating in the financing include U.S. Venture Partners, Tekla Healthcare Investors, Tekla Life Sciences Investors, SV Life Sciences, Panorama Capital, New Leaf Venture Partners, and Lexington Private Equity.
- here is the release
Special Report: FierceMedicalDevices' 2012 Fierce 15 - CardioKinetix