Magenta Medical, the developer of Elevate (the world’s smallest heart pump), announced it had closed a $105 million funding round led by global healthcare investment firm Novo Holdings. The new investors Viking Global Investors and RA Capital Management, as well as existing investors OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE – Israel HealthTech Fund, also participated in this round.
The funding will advance the company’s U.S. clinical programs in multiple mechanical circulatory support (MCS) indications and secure the first FDA approval for the Elevate System in patients undergoing high-risk percutaneous coronary interventions (HR-PCI).
MCS is one of the fastest growing markets in interventional cardiology. And it encompasses devices designed for mechanically unload the failing heart and augment cardiac output in the setting of dangerously low blood pressure, offering a bridge to recovery over a period of hours to days.
The widely recognized unmet clinical needs in MCS revolve around the ability to provide full cardiac support with a single device and a truly percutaneous and minimally invasive placement procedure. And Elevate was designed to meet those needs, while overcoming the significant limitations of existing temporary MCS devices. Due to these potential advantages, Magenta’s Elevate System was granted Breakthrough Device Designation by the U.S. FDA for two clinical indications: high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS).
Magenta had completed a U.S. Early Feasibility Study with the HR-PCI indication in 2023. And the results were presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco by Dr. Perwaiz Meraj of North Shore University Hospital. Building on this study, Magenta is preparing to launch a pivotal study in the U.S.
Magenta’s proprietary technology miniaturizes a powerful percutaneous Left Ventricular Assist Device to fit into a 9 Fr delivery system, the smallest crimping profile of any such device. And the Elevate pump is first folded and then inserted percutaneously through a small puncture in the groin to accommodate a commercially available 10 Fr introducer sheath. This pump is delivered into the heart fully sheathed, over a guidewire, through the aorta, and across the aortic valve.
Employing standard catheterization techniques and equipment for placement offers important advantages in terms of ease of use, safety, physician access, and vascular access closure.
Before activation, the device self-expands inside the heart, and the flow through the pump is adjusted based on the clinical circumstances of the patient, up to the entire cardiac output of an adult (> 5 L/min of mean flow at physiological blood pressures). This enables the heart to rest and the patient to recover.
With peak flows exceeding 8 L/min, Elevate is the most powerful known percutaneous pump, comparing favorably even with surgically placed catheter pumps with over twice Magenta’s insertion profile.
KEY QUOTES:
“Magenta’s technology stands at the forefront of innovation in the MCS field and has the potential to significantly improve outcomes in patients with severe cardiovascular conditions. We look forward to supporting Magenta’s team in bringing better care to even more patients in need of mechanical circulatory support.”
– Eric Snyder, Partner, Venture Investments, Novo Holdings US
“Magenta is thrilled to add these exceptional MedTech investors to its mission of disrupting the MCS space. Together with our existing partners, we are fortunate to have brought together a world-class group of investors that has both the resources and expertise to shepherd Magenta through regulatory approvals and commercial growth.”
“Magenta’s technology will potentially enable physicians to rely on a single device to treat the full spectrum of MCS indications and is expected to eliminate the need to escalate therapy to a different device and subject patients to unnecessary and invasive replacement procedures.”
– Magenta Medical’s CEO Dr. David Israeli
