Magenta Medical Secures $105M Series E Financing to Advance World’s Smallest Percutaneous Heart Pump Elevate Toward FDA Approval

Magenta Medical, the developer of Elevate, the world's smallest heart pump, has completed a $105 million financing round led by global healthcare investment firm Novo Holdings. According to a statement released by the company, the funds will support Magenta’s clinical programs aimed at securing FDA approval for Elevate, which is described as the world’s smallest heart pump.

Recently, Magenta Medical, the developer of the world's smallest heart pump Elevate, completed a $105 million financing round led by global healthcare investment firm Novo Holdings. According to the Israel-based company, new investors Viking Global Investors and RA Capital Management, along with existing investors OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE-Israel HealthTech Fund also participated in this round. The funding will be used to advance the company’s U.S. clinical programs across various mechanical circulatory support (MCS) indications and secure the first FDA approval for the Elevate system in patients undergoing high-risk percutaneous coronary intervention (HR-PCI).

Novo Holdings US Venture Partner Eric Snyder said, "Magenta's technology is at the forefront of innovation in the MCS field and has the potential to significantly improve outcomes for patients with severe cardiovascular diseases. We look forward to supporting Magenta's team in providing better care for more patients in need of mechanical circulatory support."

Magenta Medical CEO Dr. David Israeli stated, "Magenta is thrilled to bring these exceptional medtech investors into its mission to revolutionize the MCS field. We are fortunate to have, alongside our existing partners, assembled a world-class team of investors with the resources and expertise to guide Magenta through regulatory approvals and commercial growth." Israele added, "Magenta's technology will enable physicians to rely on a single device to treat all MCS indications, potentially eliminating the need to escalate treatment to different devices and sparing patients from unnecessary and invasive replacement procedures."

MCS is one of the fastest-growing markets in the field of interventional cardiology. It includes devices designed to mechanically unload a failing heart and increase cardiac output during dangerously low blood pressure situations, serving as a bridge to recovery over hours to days.

The unmet clinical needs widely recognized in MCS revolve around the ability to provide comprehensive cardiac support using a single device and truly percutaneous and minimally invasive placement procedures. Elevate™ is designed to address these needs while overcoming significant limitations of existing temporary MCS devices. Due to these potential advantages, Magenta Medical's Elevate™ system has been granted Breakthrough Device Designation by the US FDA for two clinical indications: high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS).

Magenta Medical completed the early feasibility study for the HR-PCI indication in the United States in 2023. The results of this study were presented by Dr. Perwaiz Meraj of North Shore University Hospital at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference held in San Francisco. Based on this study, Magenta Medical is now preparing to conduct a pivotal study in the United States.

The company reported that Magenta's proprietary technology miniaturizes a powerful transdermal left ventricular assist device to fit a 9 Fr delivery system, which is the smallest crimping profile of any such device.

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 via a guidewire, through the aorta and aortic valve, into the fully sheathed heart. The use of standard catheterization and placement equipment offers significant advantages in terms of ease of use, safety, physician access, and vascular access closure.

Before activation, the device self-expands inside the heart and adjusts the flow through the pump according to the patient's clinical condition until it reaches the full cardiac output for adults (>5 L/min at physiological pressure). This allows the heart to rest and the patient to recover. Elevate’s peak flow exceeds 8 L/min, making it the most powerful percutaneous pump known, with an insertion profile more than twice that of Magenta Medical’s insertion profile, even when compared to surgically placed catheter pumps.

Magenta Medical, Ltd. is a private company dedicated to developing miniaturized blood pumps, aiming to provide minimally invasive support for the natural heart during acute episodes of dysfunction that may lead to dangerously low blood pressure and impaired perfusion of vital organs. Magenta's Elevate percutaneous left ventricular assist device (pLVAD) is currently undergoing clinical trials to evaluate its efficacy in at least two indications: patients undergoing high-risk percutaneous coronary intervention (HR-PCI) and patients with cardiogenic shock.

In June 2023, the company announced the initiation of an early feasibility study for its FDA-approved Elevate percutaneous left ventricular assist device (pLVAD) for high-risk percutaneous coronary intervention (HR-PCI) indications. The study began with the treatment of two patients: one at the Mount Sinai Health System and the other at St. Francis Hospital and Heart Center in New York.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production: Ling Wujuan