Healthcare Industry News: FDA
News Release - July 23, 2024
Magenta Medical Closes $105M Financing Led by Novo Holdings
Other new investors include Viking Global Investors and RA Capital ManagementFunding will support Magenta's clinical programs in support of FDA approval for Elevate, the world's smallest heart pump
KADIMA, Israel, July 23, 2024 -- (Healthcare Sales & Marketing Network) -- 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.
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's 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."
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.
The Elevate™ Technology
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.
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.
Dr. Israeli noted, "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."
About Novo Holdings
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people's health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S and manages an investment portfolio with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Asia, Planetary Health Investments and Principal Investments teams, Novo Holdings invests directly in life science companies at all stages of development. In addition, it manages a broad portfolio of Capital Investments, including equities, bonds, fixed income, real estate, and infrastructure assets.
As of year-end 2023, Novo Holdings had total assets of EUR 149 billion.
www.novoholdings.dk
About RA Capital Management
RA Capital Management is a multi-stage investment manager dedicated to company formation and evidence-based investing in healthcare and life science companies developing drugs, medical devices, diagnostics, services, and research tools. The firm's portfolio of private and public companies spans the globe and most therapeutic areas across all stages from discovery through commercialization. We come from many backgrounds, bring different perspectives, work collaboratively, and are persistently curious.
About Magenta Medical
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.
For more information, please visit www.magentamed.com
Source: Magenta Medical
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