Magenta Medical, developer of Elevate, the world's smallest heart pump, has closed a $105M financing round led by global healthcare investment firm Novo Holdings. Funding will support Magenta's clinical programs in support of FDA approval for Elevate, described as the world's smallest heart pump, according to a statement issued by the company, led by CEO Dr. David Israeli.
July 29, 2024 — Magenta Medical, developer of Elevate, the world's smallest heart pump, has closed a $105M financing round led by global healthcare investment firm Novo Holdings. New investors Viking Global Investors and RA Capital Management, and existing investors OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE - Israel HealthTech Fund, also participated in this round, according to the Kadima, Israel-based company in a written statement detailing the news.
The financing will be used to advance the company’s U.S. clinical programs in multiple mechanical circulatory support (MCS) indications and to secure the first FDA approval for the Elevate System in patients undergoing high-risk percutaneous coronary interventions (HR-PCI).
“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,” said Eric Snyder, Partner, Venture Investments, Novo Holdings US. “We look forward to supporting Magenta’s team in bringing better care to even more patients in need of mechanical circulatory support."
Magenta Medical CEO, Dr. David Israeli, said, "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." Israeli added, “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.”
MCS is one of the fastest growing markets in interventional cardiology. It encompasses devices designed to mechanically unload the failing heart and augment cardiac output in the setting of dangerously low blood pressure, providing 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. Elevate™ is designed to meet those needs, while overcoming the significant limitations of existing temporary MCS devices. Because of 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 completed a U.S. Early Feasibility Study with the HR-PCI indication in 2023. 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 now preparing to launch a pivotal study in the U.S.
About the Elevate Technology
The company reports that 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. It further notes the following on the technology:
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. The 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 provides important advantages in terms of ease-of-use, safety, physician access, and vascular access closure.
Prior to 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 allows 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 that have more than twice Magenta's insertion profile.
Magenta Medical Ltd. is a privately-held company dedicated to the development of miniaturized blood pumps intended to provide minimally-invasive support to the native heart during acute episodes of dysfunction that could lead to dangerously low blood pressure and compromised perfusion of vital organs. Magenta's Elevate percutaneous Left Ventricular Assist Device (pLVAD) is currently in clinical trials to be evaluated for at least two indications: patients undergoing high-risk percutaneous coronary interventions (HR-PCI) and patients with cardiogenic shock.
In June, 2023, the company announced the initiation of its FDA-approved Early Feasibility Study with the Elevate percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) indication. The study began with the treatment of two patients: one in Mount Sinai Health System and one in St. Francis Hospital and Heart Center, both in New York.
More information: www.magentamed.com
November 25, 2024 
