percutaneous Left Ventricular Assist Device (pLVAD) – An Israeli startup, Magenta Medical, behind the world’s smallest heart pump has raised $55 million
Curator: Aviva Lev-Ari, PhD, RN
May 3, 2023 at 8am ESTMagenta Medical Closes $55M Funding Round Led by OrbiMed
Funding will further Magenta’s clinical programs in support of FDA approval for world’s smallest heart pumpKadima, Israel – May 03, 2023 – Magenta Medical, developer of the world’s smallest heart pump, announced today a $55M financing round led by global healthcare investment manager OrbiMed, with participation from existing investors New Enterprise Associates (NEA), Pitango VC, and ALIVE – Israel HealthTech Fund. The financing will be used, among other things, to advance the clinical programs of the company’s product in the United States towards its first FDA approval.Temporary mechanical circulatory support (MCS) is one of the fastest growing markets in interventional cardiology, encompassing devices that aim to augment the output of a failing heart, in the setting of dangerously low blood pressure, while resting the heart and providing a bridge to recovery over a period of hours or days. Existing temporary MCS devices provide limited flow, require an invasive surgical procedure, or both.Magenta’s percutaneous Left Ventricular Assist Device (pLVAD) is a powerful heart pump that is initially folded, inserted through the groin using a small puncture, and expanded for activation inside the left ventricle. The flow of the pump is adjusted based on the clinical circumstances of the patient, up to the entire cardiac output, allowing the heart to rest and the patient to recover. Once the Magenta technology is approved, physicians will be able to rely on a single device to treat the full range of MCS patients, thus eliminating the need to escalate therapy to a new device and subject the patient to unnecessary and 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.”The potential advantages of Magenta’s high-flow, low-profile device were recognized by the US FDA, resulting in Breakthrough Device Designation for two indications: high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS).Magenta successfully completed a HR-PCI first-in-human (FIH) study in Tbilisi, Georgia, the results of which were presented at the recent 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston, MA, by Dr. Duane Pinto of Beth Israel Deaconess Medical Center and Harvard Medical School. Building on this experience, Magenta is now preparing to launch its clinical programs in the US, starting with an imminent HR-PCI Early Feasibility Study.“Having supported Magenta’s FIH study, I was thoroughly impressed with the unique combination of a low-profile device delivering best-in-class flow,” said Dr. Pinto. “Magenta’s device is inserted with ease percutaneously and can accommodate the full gamut of flows required by MCS patients in the various situations I encounter as an interventional cardiologist. Use of this technology can be mastered by a wide range of proceduralists to better address the unmet needs of contemporary patients, such as those with small or challenging vascular anatomies, especially if high flows are needed.”“We are excited to have identified the merits of Magenta’s technology, with its strong disruptive potential, and are extremely pleased with the relationships that we have built with management, the founders, and the existing investors,” said Dr. David Bonita, General Partner at OrbiMed. “We look forward to advancing the clinical programs and accelerating the introduction of this important technology to the market in the US and globally.”Magenta’s proprietary technology miniaturizes a powerful percutaneous Left Ventricular Assist Device to fit an 8 Fr delivery system – the smallest crimping profile of any such device. The pump is inserted percutaneously, over a guidewire, through the aorta and across the aortic valve, using commercially available 10 Fr introducer sheaths. Employing standard catheterization techniques and equipment for placement has important advantages in terms of ease-of-use, safety, physician access, and vascular access closure. Once deployed inside the heart, the speed of the pump can be adjusted to provide more than 5 L/min of mean blood flow at physiological blood pressures – the full cardiac output of an adult – allowing the heart to rest and the patient to recover. With peak flows exceeding 7 L/min, this is the most powerful known percutaneous pump, comparing favorably even with surgically placed catheter pumps that have more than twice Magenta’s insertion profile.###About Magenta MedicalMagenta 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 is currently in clinical testing, with the ultimate goal of securing approval for at least two indications: patients undergoing high-risk coronary interventions and patients with cardiogenic shock. Magenta Medical was founded by two serial entrepreneurs, Professor Ehud Schwammenthal and Mr. Yosi Tuval, who previously founded Ventor Technologies – a medical device company that was acquired by Medtronic in 2009. For more info, visit https://magentamed.com/.About OrbiMedOrbiMed is a healthcare investment firm, with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya and other key global markets.
Media ContactChaya ZabihiGK for Magenta Medical
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From: Chaya Zabihi <chaya@gkpr.com>
Date: Tuesday, May 2, 2023 at 2:29 PM
To: Aviva Lev-Ari <avivalev-ari@alum.berkeley.edu>
Subject: Re: Embargo: Magenta Medical raises significant funding round for world’s smallest heart pump
Magenta has developed a miniaturized catheter-mounted axial flow-pump for mechanical circulatory support of the left ventricle.
Israeli company Magenta Medical has announced the completion of a $55 million financing round led by OrbiMed Advisors and with the participation of previous investors NEA, Pitango and Alive.Magenta has developed a miniaturized catheter-mounted axial flow-pump for mechanical circulatory support of the left ventricle, based on Magenta’s core technology of a self-expanding impeller and pump head. The self-expanding impeller is comprised of a thin memory-shape metallic frame and a soft, flexible material that forms the body of the blades.Magenta Medical was founded in 2012 by CMO Prof. Ehud Schwammenthal and CTO Dr. Yosi Tuva, who had previously founded heart valve developer Ventor, which was sold to Medtronic in 2009 for $350 million. Magenta’s CEO is Dr. David Israeli, a former senior executive at Medtronic and Pitango, which invested in the company. Magenta has raised $100 million to date. Dr. Israel told “Globes” that Magenta has changed its focus in recent years but not its technology – only the use it is aiming for. The pump was first developed to treat heart failure and was intended to be implanted in the renal veins to regulate blood pressure and evacuate salts and fluids – an improved replacement for diuretic drugs that are the standard treatment for heart failure, but they are not always helpful, and may have side effects. This product was already advanced, so with the company’s previous fundraising, it believed it could get the product approved without additional fundraising.
The reason for the change was the realization that the road to approval was longer than it seemed at first, because there is no such product on the market, and it was necessary to develop the protocol from start to finish, together with the FDA, and then overcome another hurdle of proving the economic value of the product to obtain insurance indemnity. So even though the product worked well, and despite (or rather because) there being no similar solutions on the market, the road looked too long and uncertain.
Meanwhile, another area began to capture the company’s attention: using a coronary artery pump to support patients arriving at the hospital with acute heart failure or undergoing high-risk interventional catheterization. The pump supports the heart’s activity and can even replace it until it recovers.
The field called Temporary Mechanical Circulatory Support has been growing in recent years led by Johnson & Johnson unit Abiomed. Magenta believes that as other products have already trod the regulatory path and then received insurance indemnity, the way forward in this sector is clearer while there remains plenty of room in the market for their distinct product.
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NEA makes first Israeli investment in Magenta Medical
The product has undergone trials with 15 patients in Georgia and is now undergoing a trial with 15 more patients in the US.
Published by Globes, Israel business news – en.globes.co.il – on May 3, 2023.
SOURCE
https://en.globes.co.il/en/article-heart-pump-co-magenta-medical-raises-55m-1001445415
World’s Smallest Heart Pump Yields $55M For Startup
An Israeli startup behind the world’s smallest heart pump has raised $55 million.
Magenta Medical’s device will be used to support patients arriving at the hospital with heart failure, or undergoing high-risk treatments to alleviate their symptoms.
The pump can support the heart’s activity, and even replace it for several days until it recovers, by temporarily opening clogged arteries in the hearts of cardiac patients, and improving symptoms like chest pain and shortness of breath.
The pump is folded up and inserted through a catheter via the groin. Once it has been guided to the heart’s left ventricle (which is responsible for pumping oxygenated blood all over the body), and the catheter has been removed, it expands by up to three and a half times.
Inside the heart, the speed of the pump can be adjusted to provide more than five liters of blood a minute – the full cardiac output of an adult at rest. The company says the pump is more powerful than others, with peak flows exceeding seven liters per minute.
Existing temporary devices provide a more limited flow of oxygenated blood to the body’s tissues or require an invasive surgical procedure – or both.
Magenta Medical’s product has undergone trials with 15 patients in Georgia, USA. The company is now preparing to launch its clinical programs in the US. The financing will be used to advance the clinical programs of the product towards its first FDA approval.
The funding was raised by global healthcare investment manager OrbiMed, with participation from existing investors New Enterprise Associates, Pitango VC, and ALIVE – Israel HealthTech Fund.
“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 CEO Dr. David Israeli.
“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.”
Magenta Medical was founded in 2012, and is based in Kadima Zoran, central Israel.
SOURCE
https://nocamels.com/2023/05/worlds-smallest-heart-pump-yields-55m-for-startup/
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Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical
7.1 Trends in the Industry
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
In addition to minimally invasive treatments for coronary disease and valve disease, there are minimally invasive alternatives to heart transplant for the dangerously weak heart (extreme heart failure) which can otherwise result in Cardiogenic Shock. These involve various means to augment or complement the pumping function of the heart, such as a Ventricular Assist Device (VAD) .
With respect to the performance of Mitral Valve Replacement, the current practice favors bioprosthetic valves over mechanical valve replacement for most patients, initially just used for elderly to avoid need for coumadin, but now used at younger ages due to improvements in longevity of the bioprosthetic valves, plus less damage to red cells.
7.1.1 Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros
Reporter and Curator: Aviva Lev-Ari, PhD, RN
7.1.2 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia
Reporter: Aviva Lev-Ari, PhD, RN
7.1.3 Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony
Reporter: Aviva Lev-Ari, PhD, RN
7.2 Left Ventricular Failure
7.2.1 Entire Family of Impella Abiomed Impella® Therapy Left Side Heart Pumps: FDA Approved To Enable Heart Recovery
Reporter: Aviva Lev-Ari, PhD, RN
7.2.2 Treatment Options for Left Ventricular Failure – Temporary Circulatory Support: Intra-aortic balloon pump (IABP) – Impella Recover LD/LP 5.0 and 2.5, Pump Catheters (Non-surgical) vs Bridge Therapy: Percutaneous Left Ventricular Assist Devices (pLVADs) and LVADs (Surgical)
Author: Larry H Bernstein, MD, FCAP And Curator: Justin D Pearlman, MD, PhD, FACC
7.2.3 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock
Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
7.2.4 Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction
Article Curator: Aviva Lev-Ari, PhD, RN
7.2.5 CELLWAVE Randomized Clinical Trial: Modest improvement in LVEF at 4 months – “Shock wave–facilitated intracoronary administration of BMCs” vs “Shock wave treatment alone”
Reporter: Aviva Lev-Ari, PhD, RN
7.2.6 Three-Dimensional Fibroblast Matrix Improves Left Ventricular Function post MI
Curators: Larry H. Bernstein, MD. FCAP and Aviva Lev-Ari, PhD, RN
7.3 Right Ventricular Failure
7.3.1 Dilated Cardiomyopathy: Decisions on implantable cardioverter-defibrillators (ICDs) using left ventricular ejection fraction (LVEF) and Midwall Fibrosis: Decisions on Replacement using late gadolinium enhancement cardiovascular MR (LGE-CMR)
Reporter: Aviva Lev-Ari, PhD, RN
Amyloidosis and Right Ventricular Hypertrophy
Amyloidosis inserts abnormal proteins into tissues – in the heart, that results in an insidious decline cardiac function marked by increased stiffness (requiring high filling pressures that wet the lungs) and decreased contractility or inotropy (pumping ability). resulting in poor circulation of nutrients to tissues and organs. Amyoloidosis is suspected when imaging shows thickened heart muscle and thickened valves with reduced function, but thickened muscle also occurs as a reaction to incomplete control of elevated blood pressures, as well as by other infiltrative disorders.
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