|Maria Sainz, CEO of CardioKinetix|
Based: Menlo Park, CA
The Scoop: CardioKinetix's "first-of-its-kind" Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle after a heart attack. Delivered through a catheter and inserted in the femoral artery, the small parachute-shaped implant (an inverted V-shaped umbrella) partitions off the damaged portion of the heart, decreasing overall volume and restoring the geometry and function of the heart's left ventricle to its V-shaped tip.
What Makes It Fierce: The product is cutting-edge, pure and simple. And its forward-looking design and treatment mission have attracted $81 million in venture capital to date from the likes of U.S. Venture Partners, Panorama Capital, H&Q Capital Management, St. Jude Medical, New Leaf Venture Partners and SV Life Sciences. CardioKinetix raised its most recent round--a $44 million Series E--last fall. This enabled the company to launch a pivotal, randomized study involving nearly 500 patients that will, if successful, enable the company to ultimately file its PMA application with the FDA.
The milestone is a long time coming, President and CEO Maria Sainz explains, 12 years after CardioKinetix initially launched in Texas. Approval to go ahead with the pivotal trial--dubbed Parachute IV--actually came a few years ago, but Sainz says the company waited to start until its latest funding round came through. That time was crucial, Sainz notes, allowing scientists to tinker with the technology, develop tools to maximize the success of the procedure and master the catheter delivery of the Parachute device. Meanwhile, a CE mark is already in hand (since 2011) and CardioKinetix is pursuing a post-marketing surveillance study before beginning to sell Parachute in Europe.
Parachute represents a big advance to the existing standards of care. Right now, patients with ischemic heart failure (post heart attack-related heart failure) face a heart that is damaged and scarred, becomes distorted and destroys the patient's quality of life over time. Drugs can treat symptoms but gradually the heart declines and patients suffer from prolonged and worsening heart failure as they deal with water retention, shortness of breath, trouble exercising and eventually an enormous struggle to even get out of bed. Heart transplantation becomes the only alternative as patients progress to end-stage heart failure.
With Parachute, the device "lightly protrudes into the muscle of the heart" as Sainz describes, and helps isolate the scarred area, restoring the heart's "V" shape and its ability to contract, pump and function. Ideally, patients experience a huge improvement in their quality of life, regaining their ability to exercise and perform routine activities. Trial patients have reported improved quality of life for three years and counting, Sainz says.
What To Look For: Edwards Lifesciences became an investor in the company a little more than two years ago, Sainz notes, and the company has served as an adviser (and holds a board seat). But CardioKinetix is focused for now on remaining "an independent company with a very clear focus on bringing technology to major markets."
"We are proud of being almost there in Europe and having a clear focus and path in the U.S. market," Sainz says. Developing a new heart therapy is "a large undertaking for a small company," she explains, so "in the future it makes sense for partnering or being closer to a larger company in the structural heart space."
-- Mark Hollmer (Twitter | email)
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