Magenta Medical LogoMiniature heart pump developer Magenta Medical announced today that it raised $55 million in a financing round led by OrbiMed.

Existing investors New Enterprise Associates, Pitango VC and ALIVE – Israel HealthTech Fund all participated, too.

Magenta said it intends to use proceeds to advance its clinical programs in the U.S. toward a first FDA approval.

The Kadima, Israel–based company develops a percutaneous left ventricular assist device (LVAD). The powerful heart pump is initially folded, inserted through the groin using a small puncture, and expanded to activate inside the left ventricle. The clinical circumstances of the patient determine how the flow of the pump adjusts. This ranges up to the entire cardiac output, allowing the heart to rest and the patient to recover.

Magenta said that, once approved, physicians can use the device to treat mechanical circulatory support (MCS) patients. This could eliminate the need to escalate therapy to a new device and subject the patient to invasive replacement procedures.

“Magenta is proud to add OrbiMed to its growing roster of leading MedTech investors as a highly reputable partner for innovative medical device companies,” said Dr. David Israeli, CEO of Magenta Medical. “I am confident that together we can build an organization well-equipped to bring to the market high-impact technology that can potentially address multiple unmet needs in the general cardiology patient population, as well as in many under-served patient groups.”

More about the Magenta Medical miniature heart pump

Magenta’s high-flow, low-profile device holds a duo FDA breakthrough device designations. The agency recognized it as a breakthrough option for high-risk percutaneous coronary intervention and cardiogenic shock.

In terms of clinical evidence, the company completed a first-in-human study in Tbilisi, Georgia, and presented results last year. Magenta now plans to launch clinical programs in the U.S., starting with an early feasibility study.

The proprietary technology miniaturizes the powerful, percutaneous LVAD to fit an 8 Fr delivery system. Magenta says this marks the smallest crimping profile of any such device.

Inserted over a guidewire, through the aorta and across the aortic valve using 10 Fr introducer sheaths, the system offers ease of use, safety, physician access and vascular access closure. Once deployed, the speed of the pump can adjust to provide more than 5 L/min of mean blood flow at physiological blood pressures. Magenta says that represents the full cardiac output of an adult. Its peak flows exceed 7 L/min, making it the most powerful known percutaneous pump, Magenta noted.